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K Number
K162045
Device Name
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
Manufacturer
FUJIFILM SonoSite, Inc.
Date Cleared
2016-08-18

(24 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
Device Description
SONOSITE EDGE II ULTRASOUND SYSTEM: The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power. SONOSITE SII ULTRASOUND SYSTEM The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.
More Information

K153626, K160734, K133454, K160406

Not Found

No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.

No
The device descriptions and intended use clearly state that these are "diagnostic ultrasound systems" intended for "evaluation by ultrasound imaging" and "fluid flow analysis," without mentioning any therapeutic function.

Yes
The device description explicitly states that the SonoSite Edge II and SonoSite SII Ultrasound Systems are "diagnostic ultrasound systems."

No

The device description explicitly states that the SonoSite Edge II and SII Ultrasound Systems are "custom fabricated digital electronic design" and "portable laptop style" or "mountable style" systems, indicating they are hardware devices with integrated software control.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the system is for "evaluation by ultrasound imaging of the human body" and "evaluation by ultrasound imaging or fluid flow analysis of the human body." This describes a device used on the patient to visualize internal structures and processes.
  • Device Description: The description details a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data." This further reinforces its function as an imaging device used directly on the patient.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The provided information does not mention any analysis of biological specimens.

Therefore, the SonoSite Edge II and SII Ultrasound Systems are diagnostic imaging devices, not In Vitro Diagnostic devices.

N/A

Intended Use / Indications for Use

The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

SONOSITE EDGE II ULTRASOUND SYSTEM: The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.

SONOSITE SII ULTRASOUND SYSTEM The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal - OB/GYN, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physicians and healthcare professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K153626, K160734, K133454, K160406

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2016

FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K162045

Trade/Device Name: SonoSite SII Ultrasound System and SonoSite Edge II Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 21, 2016 Received: July 25, 2016

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Michael D.'Hara

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health For

Enclosure

2

Indications for Use

510(k) Number (if known) K162045

Device Name SonoSite Edge II Ultrasound System

Indications for Use (Describe)

The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include:

Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SonoSite Edge II Ultrasound System:

The following are the Indications for Use for the SonoSite Edge II Ultrasound System

Table 1.3-1: Diagnostic Ultrasound Indications for Use Form - FUJIFILM SonoSite Edge II Ultrasound System

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:N/A
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPPPB+M; B+PWD; B+CD1-5
FetalPPPPB+M; B+PWD; B+CD1-5
AbdominalPPPPB+M; B+PWD; B+CD1-5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1-5
Small Organ (breast, thyroid,
testicles, prostate)PPPPB+M; B+PWD; B+CD1-5
Neonatal CephalicPPPPB+M; B+PWD; B+CD1-3,5
Adult CephalicPPPPB+M; B+PWD; B+CD1-3,5
Trans-rectalNNNNB+M; B+PWD; B+CD1,5
Trans-vaginalPPPPB+M; B+PWD; B+CD1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPPB+M; B+PWD; B+CD1,2,4,5
Musculo-skel. (Superfic.)PPPPB+M; B+PWD; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac AdultPPPPPB+M; B+PWD; B+CWD; B+CD1-5
Cardiac PediatricPPPPPB+M; B+PWD; B+CWD; B+CD1-5
Trans-esophageal (card.)PPPPPB+M; B+PWD; B+CWD; B+CD1,3
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1-5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

4

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:C8x/8-5 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPB+M; B+PWD; B+CD1,5
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – C8x8-5 MHz Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K133454 (Edge).

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System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:C11x/8-5 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationBMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
Fetal
AbdominalPPPPB+M; B+PWD; B+CD1,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,5
Small Organ (breast, thyroid,
testicles. prostate)
Neonatal CephalicPPPPB+M; B+PWD; B+CD1,5
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac PediatricPPPPB+M; B+PWD; B+CD1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,5
Other (spec.)

Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – C11x/8-5 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C35x/8-3 MHz Transducer

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:C35x/8-3 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
FetalPPPPB+M; B+PWD; B+CD1,4,5
AbdominalPPPPB+M; B+PWD; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,4,5
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPPB+M; B+PWD; B+CD1,4,5
Musculo-skel. (Superfic.)PPPPB+M; B+PWD; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160406 (FC1).

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System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:rC60xi/5-2 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
FetalPPPPB+M; B+PWD; B+CD1,2,4,5
AbdominalPPPPB+M; B+PWD; B+CD1,2,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,2,4,5
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPPB+M; B+PWD; B+CD1,2,4,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,2,4,5
Other (spec.)

Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – rC60xi/5-2 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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Table 1.3-6: Diagnostic Ultrasound Indications for Use Form – HFL38xi/13-6 Transducer

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:HFL38xi/13-6 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPPPB+M; B+PWD; B+CD1,4,5
FetalPPPPB+M; B+PWD; B+CD1,4,5
AbdominalPPPPB+M; B+PWD; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,4,5
Small Organ (breast, thyroid,
testicles. prostate)PPPPB+M; B+PWD; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPPB+M; B+PWD; B+CD1,4,5
Musculo-skel. (Superfic.)PPPPB+M; B+PWD; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac AdultPPPPB+M; B+PWD; B+CD1,4,5
Cardiac PediatricPPPPB+M; B+PWD; B+CD1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:HFL50x/15-6 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerCombined (Spec.)Other (Spec.)
Ophthalmic
Fetal
AbdominalPPPPB+M; B+PWD; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,4,5
Small Organ (breast, thyroid,
testicles. prostate)PPPPB+M; B+PWD; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPPB+M; B+PWD; B+CD1,4,5
Musculo-skel. (Superfic.)PPPPB+M; B+PWD; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,4,5
Other (spec.)

Table 1.3-7: Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needler or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MB

4: Steep Needle Profiling (Sono MBe)
5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

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System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:HSL25x/13-6 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPPPB+M; B+PWD; B+CD1,4,5
FetalPPPPB+M; B+PWD; B+CD1,4,5
AbdominalPPPPB+M; B+PWD; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,4,5
Small Organ (breast, thyroid,
testicles.prostate)PPPPB+M; B+PWD; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPPB+M; B+PWD; B+CD1,4,5
Musculo-skel. (Superfic.)PPPPB+M; B+PWD; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac AdultPPPPB+M; B+PWD; B+CD1,4,5
Cardiac PediatricPPPPB+M; B+PWD; B+CD1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,4,5
Other (spec.)

Table 1.3-8: Diagnostic Ultrasound Indications for Use Form – HSL25x/13-6 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needler or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

11

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:ICTx/8-5 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerCombined (Spec.)Other (Spec.)
Ophthalmic
FetalPPPPB+M; B+PWD; B+CD1.5

Table 1.3-9: Diagnostic Ultrasound Indications for Use Form - ICTx/8-5 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

P

P

P

P

B+M; B+PWD; B+CD

1,5

Additional Comments:

Abdominal Intra-operative (Abdominal organs and vascular) Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (breast, thyroid, testicles.prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal

Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Other (spec.) Peripheral vessel Other (spec.)

1: Includes imaging to assist in the placement of needler or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

12

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:L25x/13-6 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationBMPWDCWDColor DopplerCombined (Spec.)Other (Spec.)
OphthalmicPPPPB+M; B+PWD; B+CD1,4,5
Fetal
AbdominalPPPPB+M; B+PWD; B+CD1,4,5
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,4,5
Small Organ (breast, thyroid, testicles. prostate)PPPPB+M; B+PWD; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPPB+M; B+PWD; B+CD1,4,5
Musculo-skel. (Superfic.)PPPPB+M; B+PWD; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac AdultPPPPB+M; B+PWD; B+CD1,4,5
Cardiac PediatricPPPPB+M; B+PWD; B+CD1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,4,5
Other (spec.)

Table 1.3-10: Diagnostic Ultrasound Indications for Use Form – L25x/13-6 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

13

Table 1.3-11: Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 Transducer, L38xi/10-5 Armored Transducer

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:L38xi/10-5 MHz Transducer, L38xi/10-5 MHz Armored Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
Color
Combined
Other
BMPWDCWDDoppler(Spec.)(Spec.)
Ophthalmic
Fetal
AbdominalPPPPB+M; B+PWD; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,4,5
Small Organ (breast, thyroid,
testicles. prostate)PPPPB+M; B+PWD; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac AdultPPPPB+M; B+PWD; B+CD1,4,5
Cardiac PediatricPPPPB+M; B+PWD; B+CD1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

14

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:P10x/8-4 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
ColorCombinedOther
BMPWDCWDDoppler(Spec.)(Spec.)
Ophthalmic
FetalPPPPB+M; B+PWD; B+CD1,5
AbdominalPPPPB+M; B+PWD; B+CD1,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1,5
Small Organ (breast, thyroid,
testicles.prostate)PPPPB+M; B+PWD; B+CD1,5
Neonatal CephalicPPPPB+M; B+PWD; B+CD1,5
Adult CephalicPPPPB+M; B+PWD; B+CD1,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPPB+M; B+PWD; B+CD1,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac AdultPPPPPB+M; B+PWD; B+CWD; B+CD1,3,5
Cardiac PediatricPPPPPB+M; B+PWD; B+CWD; B+CD1,3,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1,5
Other (spec.)

Table 1.3-12: Diagnostic Ultrasound Indications for Use Form – P10x/8-4 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

  • 2: Tissue Harmonic Imaging (THI)
    3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

15

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:P11x/10-5 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1
Small Organ (breast, thyroid,
testicles. prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1
Other (spec.)

Table 1.3-13: Diagnostic Ultrasound Indications for Use Form – P11x/10-5 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

  • 2: Tissue Harmonic Imaging (THI)
    3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

16

Table 1.3-14: Diagnostic Ultrasound Indications for Use Form – rP19x/5-1 Transducer, rP19x/5-1 Armored Transducer

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:rP19x/5-1 MHz Transducer, rP19x/5-1 MHz Armored Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPPPB+M; B+PWD; B+CD1-3
FetalPPPPB+M; B+PWD; B+CD1-3
AbdominalPPPPB+M; B+PWD; B+CD1-3
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPB+M; B+PWD; B+CD1-3
Small Organ (breast, thyroid,
testicles.prostate)PPPPB+M; B+PWD; B+CD1-3
Neonatal CephalicPPPPB+M; B+PWD; B+CD1-3
Adult CephalicPPPPB+M; B+PWD; B+CD1-3
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac AdultPPPPPB+M; B+PWD; B+CWD; B+CD1-3
Cardiac PediatricPPPPPB+M; B+PWD; B+CWD; B+CD1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPPB+M; B+PWD; B+CD1-3
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SònoMB) in É-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

17

System:FUJIFILM SonoSite Edge II Ultrasound System
Transducer:TEExi/8-3 MHz Transducer
Intended Use :Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid,
testicles. prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)PPPPPB+M; B+PWD; B+CWD; B+CD1,3
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-15: Diagnostic Ultrasound Indications for Use Form – TEExi/8-3 Transducer

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placementof needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K153626 (Edge II).

18

Indications for Use

510(k) Number (if known) K162045

Device Name SonoSite SII Ultrasound System

Indications for Use (Describe)

The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or the human body. Specific clinical applications and exam types include:

Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Type of Use (Select one or both, as applicable)

X Prescription Use (Part21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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19

SonoSite SII Ultrasound System:

The following are the Indications for Use for the SonoSite SII Ultrasound System

Table 1.3-16: Diagnostic Ultrasound Indications for Use Form - FUJIFILM SonoSite SII Ultrasound System

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:N/A
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPPB+M; B+CD1,4,5
FetalPPPB+M; B+CD1,2,4,5
AbdominalPPPB+M; B+CD1,2,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,2,4,5
Small Organ (breast, thyroid,
testicles, prostate)PPPB+M; B+CD1,2,4,5
Neonatal CephalicPPPB+M; B+CD1,5
Adult CephalicPPPB+M; B+CD1,5
Trans-rectalNNNB+M; B+CD1,5
Trans-vaginalPPPB+M; B+CD1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPB+M; B+CD1,2,4,5
Musculo-skel. (Superfic.)PPPB+M; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac AdultPPPB+M; B+CD1,2,4,5
Cardiac PediatricPPPB+M; B+CD1,2,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,2,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

  • 2: Tissue Harmonic Imaging (THI)
  • 3: Tissue Doppler Imaging (TDI)
  • 4: Steep Needle Profiling (Sono MBe)
  • 5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

20

Table 1.3-17: Diagnostic Ultrasound Indications for Use Form – C8x/8-5 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:C8x/8-5 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerCombined (Spec.)Other (Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPB+M; B+CD1,5
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placementofneedles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K133454 (Edge).

21

Table 1.3-18: Diagnostic Ultrasound Indications for Use Form – C11x/8-5 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:C11x/8-5 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
Fetal
AbdominalPPPB+M; B+CD1,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,5
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal CephalicPPPB+M; B+CD1,5
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac PediatricPPPB+M; B+CD1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

22

Table 1.3-19: Diagnostic Ultrasound Indications for Use Form – C35x/8-3 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:C35x/8-3 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
FetalPPPB+M; B+CD1,4,5
AbdominalPPPB+M; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,4,5
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPB+M; B+CD1,4,5
Musculo-skel. (Superfic.)PPPB+M; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

  • 2: Tissue Harmonic Imaging (THI)
    3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160406 (FC1).

23

Table 1.3-20: Diagnostic Ultrasound Indications for Use Form – rC60xi/5-2 MHz Transducer, rC60xi/5-2 MHz Armored Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:rC60xi/5-2 MHz Transducer, rC60xi/5-2 MHz Armored Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
FetalPPPB+M; B+CD1,2,4,5
AbdominalPPPB+M; B+CD1,2,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,2,4,5
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPB+M; B+CD1,2,4,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,2,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

24

Table 1.3-21: Diagnostic Ultrasound Indications for Use Form – HFL38xi/13-6 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:HFL38xi/13-6 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPPB+M; B+CD1,4,5
FetalPPPB+M; B+CD1,4,5
AbdominalPPPB+M; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,4,5
Small Organ (breast, thyroid,
testicles, prostate)PPPB+M; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPB+M; B+CD1,4,5
Musculo-skel. (Superfic.)PPPB+M; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac AdultPPPB+M; B+CD1,4,5
Cardiac PediatricPPPB+M; B+CD1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

25

Table 1.3-22: Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:HFL50x/15-6 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of OperationOther
(Spec.)
BMPWDCWDColor
DopplerCombined
(Spec.)
Ophthalmic
Fetal
AbdominalPPPB+M; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,4,5
Small Organ (breast, thyroid,
testicles, prostate)PPPB+M; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPB+M; B+CD1,4,5
Musculo-skel. (Superfic.)PPPB+M; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

26

Table 1.3-23: Diagnostic Ultrasound Indications for Use Form – HSL25x/13-6 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:HSL25x/13-6 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPPB+M; B+CD1,4,5
FetalPPPB+M; B+CD1,4,5
AbdominalPPPB+M; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,4,5
Small Organ (breast, thyroid,
testicles, prostate)PPPB+M; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPB+M; B+CD1,4,5
Musculo-skel. (Superfic.)PPPB+M; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac AdultPPPB+M; B+CD1,4,5
Cardiac PediatricPPPB+M; B+CD1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

27

Table 1.3-24: Diagnostic Ultrasound Indications for Use Form – ICTx/8-5 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:ICTx/8-5 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationBMPWDCWDColor DopplerCombined (Spec.)Other (Spec.)
Ophthalmic
FetalPPPB+M; B+CD1,5
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginalPPPB+M; B+CD1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

28

Table 1.3-25: Diagnostic Ultrasound Indications for Use Form – L25x/13-6 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:L25x/13-6 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical ApplicationBMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPPB+M; B+CD1,4,5
FetalPP
AbdominalPPPB+M; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,4,5
Small Organ (breast, thyroid,
testicles, prostate)PPPB+M; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPB+M; B+CD1,4,5
Musculo-skel. (Superfic.)PPPB+M; B+CD1,4,5
Intra-luminal
Other (spec.)
Cardiac AdultPPPB+M; B+CD1,4,5
Cardiac PediatricPPPB+M; B+CD1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

29

Table 1.3-26: Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 MHz Transducer, L38xi/10-5 MHz Armored Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:L38xi/10-5 MHz Transducer, L38xi/10-5 MHz Armored Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
Fetal
AbdominalPPPB+M; B+CD1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,4,5
Small Organ (breast, thyroid,
testicles, prostate)PPPB+M; B+CD1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac AdultPPPB+M; B+CD1,4,5
Cardiac PediatricPPPB+M; B+CD1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,4,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

30

Table 1.3-27: Diagnostic Ultrasound Indications for Use Form – P10x/8-4 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:P10x/8-4 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
OphthalmicPPP
FetalPPPB+M; B+CD1,5
AbdominalPPPB+M; B+CD1,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,5
Small Organ (breast, thyroid,
testicles, prostate)PPPB+M; B+CD1,5
Neonatal CephalicPPPB+M; B+CD1,5
Adult CephalicPPPB+M; B+CD1,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)PPPB+M; B+CD1,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac AdultPPPB+M; B+CD1,5
Cardiac PediatricPPPB+M; B+CD1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,5
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (ŠònoMB) in É-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

31

Table 1.3-28: Diagnostic Ultrasound Indications for Use Form – P11x/10-5 MHz Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:P11x/10-5 MHz Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SonoMB) in B-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

32

Table 1.3-29: Diagnostic Ultrasound Indications for Use Form – rP19x/5-1 MHz Transducer, rP19x/5-1 MHz Armored Transducer

System:FUJIFILM SonoSite SII Ultrasound System
Transducer:rP19x/5-1 MHz Transducer, rP19x/5-1 MHz Armored Transducer
Intended Use:Diagnostic ultrasound imaging or fluid flow analysis of the human body
as follows:
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerCombined
(Spec.)Other
(Spec.)
Ophthalmic
FetalPPPB+M; B+CD1,2
AbdominalPPPB+M; B+CD1,2
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPB+M; B+CD1,2
Small Organ (breast, thyroid,
testicles, prostate)PPPB+M; B+CD1,2
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac AdultPPPB+M; B+CD1,2
Cardiac PediatricPPPB+M; B+CD1,2
Trans-esophageal (card.)
Other (spec.)
Peripheral vesselPPPB+M; B+CD1,2
Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under this appendix

Additional Comments:

1: Includes imaging to assistin the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures . Color Doppler includes Power/Velocity/Variance. M-Mode includes color M-Mode.

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

5: Multi-beam Imaging (SònoMB) in É-Mode

All items marked "P" were previously cleared in 510(k) K160734 (SII).

33

510(k) Summary

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1) Submitter's name, address, telephone number, contact person:

FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904

Corresponding Official:Jordan Grimmer
Regulatory Affairs Specialist
E-mail:jordan.grimmer@fujifilm.com
Telephone:(425) 951-6984
Facsimile:(425) 951-1201
Date prepared:July 12, 2016

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

SonoSite Edge II Ultrasound System (subject to change) SonoSite SII Ultrasound System (subject to change)

Classification Names

NameFR NumberProduct Code
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasonic Pulsed Echo Imaging System892.156090-IYO
Diagnostic Ultrasound Transducer892.157090-ITX

3) Identification of the predicate or legally marketed device:

SonoSite Edge II Ultrasound SystemK153626
SonoSite SII Ultrasound SystemK160734
SonoSite Edge Ultrasound SystemK133454
FUJIFILM FC1 Ultrasound SystemK160406

4) Device Description:

SONOSITE EDGE II ULTRASOUND SYSTEM:

The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.

34

SONOSITE SII ULTRASOUND SYSTEM

The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.

5) Intended Use:

SONOSITE EDGE II ULTRASOUND SYSTEM

The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

  • Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

SONOSITE SII ULTRASQUND SYSTEM

The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Page 282 of 5512

35

6) Technological Characteristics:

SONOSITE EDGE II ULTRASOUND SYSTEM:

SonoSite Edge II, Edge, and FC1 Ultrasound Systems are all Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

| Feature | SonoSite Edge II
Ultrasound
System
(This submission) | SonoSite Edge II
Ultrasound
System
(K153626) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body |
| Indications for
Use | Opthalmic
Fetal - OB/GYN | Opthalmic
Fetal - OB/GYN | Opthalmic
Fetal - OB/GYN | Fetal – OB/GYN |
| | Abdominal | Abdominal | Abdominal
Intraoperative
(abdominal organs and
vascular)
Intra-operative (Neuro.) | Abdominal
Intra-operative
(Abdominal organs and
vascular) |
| | Pediatric
Small Organ (breast,
thyroid, testicle,
prostate) | Pediatric
Small Organ (breast,
thyroid, testicle,
prostate) | Pediatric
Small Organ (breast,
thyroid, testicle,
prostate) | Pediatric
Small Organ (breast,
thyroid, testicles,
prostate) |
| | Neonatal Cephalic
Adult Cephalic
Trans-Rectal | Neonatal Cephalic
Adult Cephalic | Neonatal Cephalic
Adult Cephalic
Trans-Rectal | Neonatal Cephalic |
| | Trans-Vaginal | Trans-Vaginal | Trans-Vaginal | Trans-vaginal |
| | Musculo-skeletal
(Conventional) | Musculo-skeletal
(Conventional) | Musculo-skeletal
(Conventional) | Musculo-skel.
(Convent.) |
| | Musculo-skeletal | Musculo-skeletal | Musculo-skeletal | Musculo-skel. |
| | (Superficial) | (Superficial) | (Superficial) | (Superfic.) |
| | Cardiac Adult | Cardiac Adult | Cardiac Adult | Cardiac Adult |
| | Cardiac Pediatric | Cardiac Pediatric | Cardiac Pediatric | Cardiac Pediatric |
| | Trans-esophageal | Trans-esophageal | Trans-esophageal | |
| | (cardiac) | (cardiac) | (cardiac) | |
| | Peripheral Vessel | Peripheral Vessel | Peripheral Vessel | Peripheral Vessel |
| | Needle | Needle | Needle | Needle |
| | guidance | guidance | guidance | guidance |
| Transducer | Linear Array | Linear Array | Linear Array | Linear Array |
| Types | Curved Linear Array | Curved Linear Array | Curved Linear Array | Curved Linear Array |
| | Intracavitary
Phased Array | Intracavitary
Phased Array | Intracavitary
Phased Array | Intracavitary
Phased Array |
| | | | Static Probes | |
| | Trans-esophageal | Trans-esophageal | Trans-esophageal | |
| Transducer | 1.0 - 15.0 MHz | 1.0 – 15.0 MHz | 1.0 — 15.0 MHz | 1.0 – 15.0 MHz |
| Frequency | | | | |
| Global | Ispta.3: 598.9 (HFL50x) | Ispta.3: 598.9 (HFL50x) | Ispta.3: 708.8 (TEEx) | lspta.3: 434mW/cm2 |
| Maximum | TI Type: TIB (rP19x) | TI Type: TIB (rP19x) | TI Type: TIB (L38xi) | TI Type: TIC |
| Outputs/Worst | TI Value: 4.98 (rP19x) | TI Value: 4.98 (rP19x) | TI Value: 4.06 (L38xi) | TI Value: 1.8 |
| Case Setting | MI: 1.7 (rP19x) | MI: 1.7 (rP19x) | MI: 1.51 (P21x) | MI: 1.1 |
| | Ipa.3@MI Max: 776 | Ipa.3@MI Max: 776 | Ipa.3@MI Max: 776 | Ipa.3@MI Max: 265.4 |
| | (L38xi) | (L38xi) | (L38xi) | W/cm2 |
| Acoustic | Display Feature for | Display Feature for | Display Feature for | Display Feature for |
| Feature | SonoSite Edge II
Ultrasound
System
(This submission) | SonoSite Edge II
Ultrasound
System
(K153626) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
| Output Display
& FDA Limits | Higher Outputs
MI Output Display
TI Output Display | Higher Outputs
MI Output Display
TI Output Display | Higher Outputs
MI Output Display
TI Output Display | Higher Outputs
MI Output Display
TI Output Display |
| Modes of
Operation | B-mode Grayscale
Imaging
Tissue Harmonic
Imaging
M-mode
Color M-Mode | B-mode Grayscale
Imaging
Tissue Harmonic
Imaging
M-mode
Color M-Mode | B-mode Grayscale
Imaging
Tissue Harmonic
Imaging
M-mode
Color M-Mode | B-Mode
Pulse Inversion
Harmonic Imaging
Compound Harmonic
Imaging
Spatial Compound
Imaging
M-mode
Velocity Color Doppler |
| | Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW)
Doppler
Continuous Wave (CW)
Doppler
SonoHD2 Noise
Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging
(TDI) | Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW)
Doppler
Continuous Wave (CW)
Doppler
SonoHD2 Noise
Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging
(TDI) | Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW)
Doppler
Continuous Wave (CW)
Doppler
SonoHD2 Noise
Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging
(TDI) | Color Power Doppler
Directional Color Power
Doppler
Pulsed Wave Doppler
Pulsed Wave Tissue
Doppler
Continuous Wave
Doppler, ECG |
| PW Doppler | Available on all imaging
transducers except
P11x | Available on all imaging
transducers except
P11x | Available on all imaging
transducers except D2x
and P11x | Available on all imaging
transducers.
Simultaneous
Duplex
Triplex
Simultaneous B-mode
and PW Doppler
High PRF capability |
| | Adjustable sample
volume size: 1.0 – 25
mm
Simultaneous or duplex
mode of operation
Simultaneous B-mode
and PW Doppler
High PRF capability | Adjustable sample
volume size: 1.0 – 25
mm
Simultaneous or duplex
mode of operation
Simultaneous B-mode
and PW Doppler
High PRF capability | Adjustable sample
volume size: 1.0 – 25
mm
Simultaneous or duplex
mode of operation
Simultaneous B-mode
and PW Doppler
High PRF capability | |
| CW Doppler | Available on P10x,
rP19x, TEExi | Available on P10x,
rP19x, TEExi | Available on C11x, D2x,
P10x, P21x, TEEx | Available on P21x
Simultaneous
Duplex
Triplex
Simultaneous B-mode
and CW Doppler |
| | Simultaneous or duplex
mode of operation
Simultaneous B-mode
and CW Doppler | Simultaneous or duplex
mode of operation
Simultaneous B-mode
and CW Doppler | Simultaneous or duplex
mode of operation
Simultaneous B-mode
and CW Doppler | |
| Velocity Color
Doppler | Available on all
transducers | Available on all
transducers | Available on all
transducers except D2x | Available on all
transducers |
| ECG Feature | 3-lead ECG input, or
ECG Slave Cable | 3-lead ECG input, or
ECG Slave Cable | 3-lead ECG input | One 3-lead ECG input,
or
One external ECG input,
or
One other physio input |
| DICOM | DICOM 3.0 Store, Print,
Modality Worklist,
Perform Procedure Step | DICOM 3.0 Store, Print,
Modality Worklist,
Perform Procedure Step | DICOM 3.0 Store, Print,
and Modality Worklist
Perform Procedure Step | DICOM 3.0 Store, Print,
and Modality Worklist
service class user |
| Feature | SonoSite Edge II
Ultrasound
System
(This submission) | SonoSite Edge II
Ultrasound
System
(K153626) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
| | (PPS), Storage | (PPS), Storage | | features |
| | Commitment | Commitment | | |
| IMT
Measurement | Not available | Not available | SonoCalc IMT provides
the capability for
automated
measurement of intima-
media thickness (IMT) of
the carotid artery. IMT
functionality is available
both on the ultrasound
system and in a stand
alone software program
that runs on a personal
computer. | Manual IMT
measurement
functionality available. |
| #Transmit
Channels | 128 digital channels | 128 digital channels | 128 digital channels | 64 digital channels |
| #Receive
Channels | 64 digital channels
(128 digital channels
using Synthetic | 64 digital channels
(128 digital channels
using Synthetic | 64 digital channels
(128 digital channels
using Synthetic | 64 digital channels |
| | Aperture) | Aperture) | Aperture) | |
| Patient Contact
Materials | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Cycoloy | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Cycoloy | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Cycoloy
Dow Medical Adhesive,
Type A | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Dow Medical Adhesive,
Type A |
| | Epoxy paste adhesive
Polyethylene (PE)
lonomer
Polyetheretherketone
(PEEK)
Polycarbonate
Polysulfone UDEL
P1700
Polyurethane
Poly-Vinyl-Chloride
(PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-
styrene (ABS) | Epoxy paste adhesive
Polyethylene (PE)
lonomer
Polyetheretherketone
(PEEK)
Polycarbonate
Polysulfone UDEL
P1700
Polyurethane
Poly-Vinyl-Chloride
(PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-
styrene (ABS) | Epoxy paste adhesive
Polyethylene (PE)
lonomer
Polyetheretherketone
(PEEK)
Polycarbonate
Polysulfone UDEL
P1700
Polyurethane
Poly-Vinyl-Chloride
(PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-
styrene (ABS) | Epoxy paste adhesive,
Polysulfone UDEL
P1700
Polyurethane
Poly-Vinyl-Chloride
(PVC)
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-
styrene (ABS) |
| Product Safety
Certification | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
60601-1:08
NEMA UD2-2004
IEC 62359:2010 | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
60601-1:08
NEMA UD2-2004
IEC 62359:2010 | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
60601-1:08
NEMA UD2-2004
AIUM RTD2-2004
(NEMA UD3-2004
(R2009)) | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
601.1
JIS T 0601-1, JIS T
1507
CEI/IEC 61157
ANSI/AAMI EC53 |
| Feature | SonoSite Edge II
Ultrasound
System
(This submission) | SonoSite Edge II
Ultrasound
System
(K153626) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
| | | | | NEMA UD2-2004
AIUM RTD2-2004
(NEMA UD3-2004
(R2009)) |
| EMC
Compliance | AAMI / ANSI / IEC
60601-1-2:2007(R)2012
CISPR 11, Group 1,
Class A | AAMI / ANSI / IEC
60601-1-2:2007(R)2012
CISPR 11, Group 1,
Class A | AAMI / ANSI / IEC
60601-1-2:2007(R)2012
CISPR 11, Group 1,
Class A | IEC 60601-1-2:2007
CISPR 11
IEC 61000-4 pt 2-5 |
| DICOM | NEMA PS3.15 2003 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | NEMA PS3.15 2003 |
| Airborne
Equipment
Standards | RTCA/DO160 (section
21) | RTCA/DO160 (section
21) | RTCA/DO160 (section
21) | None |
| System
Characteristics | Edge II:
Beamformer 128/128
using SA (configurable)
Hand held display and
control
Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on
LCD
2 USB ports
Dimensions: 12.8"(W) x
12.1" (L) x 2.5"(H)
Weight: 9.0 lbs
System operates via
battery or AC power
Battery life: 1.5 - 4 hour
operation per charge
100 - 240V options,
50/60 Hz, 15VDC output
Various obstetrical,
cardiac, volume, M-
mode, PW and CW
Doppler measurement
and calculation
packages
ECG acquisition and
display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio
and image storage on
removable media
Wireless 802.11 (b/g/n) | Edge II:
Beamformer 128/128
using SA (configurable)
Hand held display and
control
Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on
LCD
2 USB ports
Dimensions: 12.8"(W) x
12.1" (L) x 2.5"(H)
Weight: 9.0 lbs
System operates via
battery or AC power
Battery life: 1.5 - 4 hour
operation per charge
100 - 240V options,
50/60 Hz, 15VDC output
Various obstetrical,
cardiac, volume, M-
mode, PW and CW
Doppler measurement
and calculation
packages
ECG acquisition and
display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio
and image storage on
removable media
Wireless 802.11 (b/g/n) | Edge:
Beamformer 128/128
using SA (configurable)
Hand held display and
control
Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on
LCD
2 USB ports
Dimensions: 12.9"(W) x
12.4" (L) x 2.5"(H)
Weight: 8.5 lbs
System operates via
battery or AC power
Battery life: 1.5 - 4 hour
operation per charge
100 - 240V options,
50/60 Hz, 15VDC output
Various obstetrical,
cardiac, volume, M-
mode, PW and CW
Doppler measurement
and calculation
packages
ECG acquisition and
display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio
and image storage on
removable media
Wireless 802.11 (b/g/n) | FC1:
Beamformer 64/64
Hand held display and
control
Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on
LCD
4 USB ports
Dimensions: 12.24"(W)
x 13.03" (L) x 3.03"(H)
Weight: 11.9 lbs
System operates via
battery or AC power
Battery operated (1.5 - 4
hour operation per
charge)
100 - 240V options,
50/60 Hz, 15VDC output
Various obstetrical,
cardiac, volume, M-
mode, PW and CW
Doppler measurement
and calculation
packages
ECG acquisition and
display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio
and image storage on
removable media |
| Feature | SonoSite Edge II
Ultrasound
System
(This submission) | SonoSite Edge II
Ultrasound
System
(K153626) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
| | support for image
transfer | support for image
transfer | support for image
transfer | Wireless 802.11 (a\b\g)
support for image
transfer |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Track 3 |

36

37

38

39

SONOSITE SII ULTRASOUND SYSTEM

SonoSite SII, Edge, and FC1 Ultrasound Systems are all Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

| Feature | SonoSite SII
Ultrasound
System
(This submission) | SonoSite SII
Ultrasound
System
(K160734) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body |
| Indications for
Use | Opthalmic
Fetal – OB/GYN
Abdominal

Pediatric
Small Organ (breast,
thyroid, testicle, prostate)

Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Cardiac Adult
Cardiac Pediatric

Peripheral Vessel
Needle
guidance | Opthalmic
Fetal - OB/GYN
Abdominal

Pediatric
Small Organ (breast,
thyroid, testicle, prostate)

Neonatal Cephalic
Adult Cephalic

Trans-Vaginal
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Cardiac Adult
Cardiac Pediatric

Peripheral Vessel
Needle
guidance | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative
(abdominal organs and
vascular)
Intra-operative (Neuro.)
Pediatric
Small Organ (breast,
thyroid, testicle, prostate)

Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal
(cardiac)
Peripheral Vessel
Needle
guidance | Fetal - OB/GYN
Abdominal
Intra-operative
(Abdominal organs and
vascular)

Pediatric
Small Organ (breast,
thyroid, testicles,
prostate)

Neonatal Cephalic

Trans-vaginal
Musculo-skel. (Convent.)

Musculo-skel. (Superfic.)

Cardiac Adult
Cardiac Pediatric

Peripheral Vessel
Needle
guidance |
| Transducer
Types | Linear Array
Curved Linear Array
Intracavitary
Phased Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Static Probes | Linear Array
Curved Linear Array
Intracavitary
Phased Array |
| Feature | SonoSite SII
Ultrasound
System
(This submission) | SonoSite SII
Ultrasound
System
(K160734) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
| | | | Trans-esophageal | |
| Transducer
Frequency | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Global
Maximum
Outputs/Worst
Case Setting | Ispta.3: 420.2 (L38xi)
TI Type: TIC (rC60xi)
TI Value: 3.05 (rC60xi)
MI: 1.7 (rP19x)
Ipa.3@MI Max: 776
(L38xi) | lspta.3: 420.2 (L38xi)
TI Type: TIC (rC60xi)
TI Value: 3.05 (rC60xi)
MI: 1.7 (rP19x)
lpa.3@MI Max: 776
(L38xi) | lspta.3: 708.8 (TEEx)
TI Type: TIB (L38xi)
TI Value: 4.06 (L38xi)
MI: 1.51 (P21x)
lpa.3@MI Max: 776
(L38xi) | lspta.3: 434mW/cm2
TI Type: TIC
TI Value: 1.8
MI: 1.1
lpa.3@MI Max: 265.4
W/cm2 |
| Acoustic
Output Display
& FDA Limits | Display Feature for
Higher Outputs
MI Output Display
TI Output Display | Display Feature for
Higher Outputs
MI Output Display
TI Output Display | Display Feature for
Higher Outputs
MI Output Display
TI Output Display | Display Feature for
Higher Outputs
MI Output Display
TI Output Display |
| Modes of
Operation | B-mode Grayscale
Imaging
Tissue Harmonic
Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes
SonoHD2 Noise
Reduction
SonoMB/MBe Image
Compounding
Velocity Color Doppler | B-mode Grayscale
Imaging
Tissue Harmonic
Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes
SonoHD2 Noise
Reduction
SonoMB/MBe Image
Compounding
Velocity Color Doppler | B-mode Grayscale
Imaging
Tissue Harmonic
Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW)
Doppler
Continuous Wave (CW)
Doppler
SonoHD2 Noise
Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging
(TDI) | B-Mode
Pulse Inversion
Harmonic Imaging
Compound Harmonic
Imaging
Spatial Compound
Imaging
M-mode
Velocity Color Doppler
Color Power Doppler
Directional Color Power
Doppler
Pulsed Wave Doppler
Pulsed Wave Tissue
Doppler
Continuous Wave
Doppler, ECG |
| PW Doppler | Not available | Not available | Available on all imaging
transducers except D2x
and P11x
Adjustable sample
volume size: 1.0 – 25
mm
Simultaneous or duplex
mode of operation
Simultaneous B-mode
and PW Doppler
High PRF capability | Available on all imaging
transducers.
Simultaneous
Duplex
Triplex
Simultaneous B-mode
and PW Doppler
High PRF capability |
| CW Doppler | Not available | Not available | Available on C11x, D2x,
P10x, P21x, TEEx
Simultaneous or duplex
mode of operation
Simultaneous B-mode
and CW Doppler | Available on P21x
Simultaneous
Duplex
Triplex
Simultaneous B-mode
and CW Doppler |
| Velocity Color | Available on all | Available on all | Available on all | Available on all |
| Feature | SonoSite SII
Ultrasound
System
(This submission) | SonoSite SII
Ultrasound
System
(K160734) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
| Doppler | transducers | transducers | transducers except D2x | transducers |
| ECG Feature | Not available | Not available | 3-lead ECG input | One 3-lead ECG input,
or
One external ECG input,
or
One other physio input |
| DICOM | DICOM 3.0 Store, Print,
Modality Worklist,
Perform Procedure Step
(PPS), Storage
Commitment | DICOM 3.0 Store, Print,
Modality Worklist,
Perform Procedure Step
(PPS), Storage
Commitment | DICOM 3.0 Store, Print,
and Modality Worklist | DICOM 3.0 Store, Print,
and Modality Worklist
service class user
features |
| IMT
Measurement | Not available | Not available | SonoCalc IMT provides
the capability for
automated measurement
of intima-media
thickness (IMT) of the
carotid artery. IMT
functionality is available
both on the ultrasound
system and in a stand
alone software program
that runs on a personal
computer. | Manual IMT
measurement
functionality available. |
| #Transmit
Channels | 128 digital channels | 128 digital channels | 128 digital channels | 64 digital channels |
| #Receive
Channels | 64 digital channels
(128 digital channels
using Synthetic
Aperture) | 64 digital channels
(128 digital channels
using Synthetic Aperture) | 64 digital channels
(128 digital channels
using Synthetic Aperture) | 64 digital channels |
| Patient
Contact
Materials | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Cycoloy

Polycarbonate
Polysulfone UDEL
P1700

Poly-Vinyl-Chloride
(PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien- | Transducers:
Cycoloy

Polycarbonate
Polysulfone UDEL
P1700

Poly-Vinyl-Chloride
(PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien- | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Cycoloy
Dow Medical Adhesive,
Type A
Epoxy paste adhesive
Polyethylene (PE)
lonomer
Polyetheretherketone
(PEEK)

Polycarbonate
Polysulfone UDEL
P1700
Polyurethane
Poly-Vinyl-Chloride
(PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien- | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Dow Medical Adhesive,
Type A
Epoxy paste adhesive,

Polysulfone UDEL
P1700
Polyurethane
Poly-Vinyl-Chloride
(PVC)
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien- |
| Feature | SonoSite SII
Ultrasound
System
(This submission) | SonoSite SII
Ultrasound
System
(K160734) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
| | styrene (ABS) | styrene (ABS) | styrene (ABS) | styrene (ABS) |
| Product Safety
Certification | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
60601-1:08
NEMA UD2-2004
IEC 62359:2010 | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
60601-1:08
NEMA UD2-2004
IEC 62359:2010 | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
60601-1:08
NEMA UD2-2004
AIUM RTD2-2004
(NEMA UD3-2004
(R2009)) | AAMI/ANSI ES60601-
1:2005 (R2012)
IEC 60601-2-37: 2007
CAN/CSA C22.2 No.
601.1
JIS T 0601-1, JIS T 1507
CEI/IEC 61157
ANSI/AAMI EC53
NEMA UD2-2004
AIUM RTD2-2004
(NEMA UD3-2004
(R2009)) |
| EMC
Compliance | AAMI / ANSI / IEC
60601-1-2:2007(R)2012
CISPR 11, Group 1,
Class A | AAMI / ANSI / IEC
60601-1-2:2007(R)2012
CISPR 11, Group 1,
Class A | AAMI / ANSI / IEC
60601-1-2:2007(R)2012
CISPR 11, Group 1,
Class A | IEC 60601-1-2:2007
CISPR 11
IEC 61000-4 pt 2-5 |
| DICOM | NEMA PS3.15 2003 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | NEMA PS3.15 2003 |
| Airborne
Equipment
Standards | RTCA/DO160 (section
21) | RTCA/DO160 (section
21) | RTCA/DO160 (section
21) | None |
| System
Characteristics | SII:
Beamformer 128/128
using SA (configurable)
Hand held display and
control
Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on LCD | SII:
Beamformer 128/128
using SA (configurable)
Hand held display and
control
Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on LCD | Edge:
Beamformer 128/128
using SA (configurable)
Hand held display and
control
Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on LCD | FC1:
Beamformer 64/64
Hand held display and
control
Single 12.1" Liquid
Crystal Display (LCD)
256 gray shades on LCD |
| | 3 USB ports | 3 USB ports | 2 USB ports | 4 USB ports |
| | Dimensions: 11.5"(W) x
17.6" (L) x 4.8"(H) | Dimensions: 11.5"(W) x
17.6" (L) x 4.8"(H) | Dimensions: 12.9"(W) x
12.4" (L) x 2.5"(H) | Dimensions: 12.24"(W) x
13.03" (L) x 3.03"(H) |
| | Weight: 12.6 lbs | Weight: 12.6 lbs | Weight: 8.5 lbs | Weight: 11.9 lbs |
| | System operates via
battery or AC power | System operates via
battery or AC power | System operates via
battery or AC power
Battery life: 1.5 - 4 hour
operation per charge | System operates via
battery or AC power
Battery operated (1.5 - 4
hour operation per
charge) |
| | 100 - 240V options,
50/60 Hz, 15VDC output | 100 - 240V options,
50/60 Hz, 15VDC output | 100 - 240V options,
50/60 Hz, 15VDC output | 100 - 240V options,
50/60 Hz, 15VDC output |
| | Various obstetrical,
cardiac, volume, and M-
mode measurement and
calculation packages | Various obstetrical,
cardiac, volume, and M-
mode measurement and
calculation packages | Various obstetrical,
cardiac, volume, M-
mode, PW and CW
Doppler measurement
and calculation packages | Various obstetrical,
cardiac, volume, M-
mode, PW and CW
Doppler measurement
and calculation
packages |
| Feature | SonoSite SII
Ultrasound
System
(This submission) | SonoSite SII
Ultrasound
System
(K160734) | SonoSite Edge
Ultrasound
System
(K133454) | FUJIFILM FC1
Ultrasound
System
(K160406) |
| | | | ECG acquisition and
display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio
and image storage on
removable media | ECG acquisition and
display capabilities
CW/PW Doppler Audio
Spectral Doppler Audio
and image storage on
removable media |
| | Wireless 802.11 support
for image transfer | Wireless 802.11 support
for image transfer | Wireless 802.11 (b/g/n)
support for image
transfer | Wireless 802.11 (a\b\g)
support for image
transfer |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Track 3 |

40

41

42

43

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System have been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device(s) have been found to conform to applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development but were not limited to: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.

The SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System are designed to comply with the following FDA recognized standards.

Reference No.Title
ISO 10993-1AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk management process
IEC 60601-1AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012
(Consolidated Text) Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-1-6IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard:
Usability
IEC 60601-2-37IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
IEC 62304AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycle
processes
IEC 62359IEC 62359 Edition 2.0 2010-10-10, Ultrasonics - Field characterization - Test
methods for the determination of thermal and mechanical indices related to medical
diagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)]
ISO 14971ISO 14971:2007, Medical devices - Application of risk management to medical
devices

44

Reference No.Title
NEMA UD 2-2004Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Summary of Clinical Tests:

The SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

Conclusion: 8)

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards. FUJIFILM SonoSite, Inc. believes that the SonoSite Edge II Ultrasound System and SonoSite SII Ultrasound System are substantially equivalent with regard to safety and effectiveness to the predicate devices.