Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology.

Therapeutic

No
The device is described as a "diagnostic ultrasound system," meaning it is used for imaging and evaluation, not for treatment.

Diagnostic

Yes

The 'Device Description' explicitly states that the SonoSite SII Ultrasound System is a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system" and a "custom fabricated digital electronic design," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
SonoSite SII Ultrasound System Function: The description clearly states that the SonoSite SII Ultrasound System is a diagnostic ultrasound system used to acquire and display real-time ultrasound data by imaging the human body directly. It does not involve the analysis of specimens taken from the body.

The intended use and device description focus on imaging the internal structures and fluid flow within the human body, which is the core function of an ultrasound system, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

IYN, IYO, ITX

Device Description

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

Not Found

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, 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 SII Ultrasound System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

Summary of Non-Clinical Tests:
The SonoSite SII Ultrasound System has 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.

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.

K162045

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.

K160734

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" in blue.

February 7, 2019

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

Re: K183235

Trade/Device Name: SonoSite SII Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN IYO ITX Dated: January 30, 2019 Received: February 4, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hse 2. Nils

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

Enclosure

2

Indications for Use

510(k) Number (if known) K183235

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 thuid 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

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

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SonoSite SII Ultrasound System:

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

Table 1.3-1: 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 Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	N		P	B+M; B+PWD;B+CD	1-5
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1-5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1-5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD;B+CD	1-5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1-5
Neonatal Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1-3,5
Adult Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1-3,5
Trans-rectal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Trans-vaginal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N	N	P	B+M; B+PWD; B+CWD;B+CD	1-5
Cardiac Pediatric	P	P	N	N	P	B+M; B+PWD;B+CWD;B+CD	1-5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M;B+PWD;B+CD	1-5
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) K162045 and K160734

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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 Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (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	P	P	N		P	B+M;B+PWD; B+CD	1,5
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 – C8x/8-5 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) K160734 (SII).

5

Table 1.3-3: 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 Application
	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,5
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1,5
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 Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1,5
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).

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Table 1.3-4: 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 Application	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD;B+CD	1,4,5
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD;B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD;B+CD	1,4,5
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).

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Table 1.3-5: 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 Application	Mode of Operation						Other
(Spec.)
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)
Ophthalmic	P				P
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1,2,4,5

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).

8

Table 1.3-6: 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 Application		Mode of Operation
						Combined
(Spec.)	Other
(Spec.)
	B	M	PWD	CWD	Color
Doppler
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
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 & K162045.

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Table 1.3-7: 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 Application		Mode of Operation

	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
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).

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Table 1.3-8: 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 Application	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
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).

11

Table 1.3-9: 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 Application		Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,5
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-vaginal	P	P	N		P	B+M; B+PWD; B+CD	1,5
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 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).

12

Table 1.3-10: 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 Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	N		P	B+M; B+PWD;B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
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).

13

Table 1.3-11: 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 Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
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 Adult	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	N		P	B+M; B+PWD;B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1,4,5
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).

14

Table 1.3-12: 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 Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1,5
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD; B+CD	1,5
Small Organ (breast, thyroid,
testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1,5
Neonatal Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1,5
Adult Cephalic	P	P	N		P	B+M; B+PWD; B+CD	1,5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	P	P	N		P	B+M; B+PWD; B+CD	1,5
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N	N	P	B+M;B+PWD; B+CWD; B+CD	1,3,5
Cardiac Pediatric	P	P	N	N	P	B+M; B+PWD; B+CWD; B+CD	1,3,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1,5
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).

15

Table 1.3-13: 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 Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P			P	B+M; B+CD	1
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	P	P			P	B+M; B+CD	1
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).

16

Table 1.3-14: 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 Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	N		P	B+M; B+PWD; B+CD	1-3
Fetal	P	P	N		P	B+M; B+PWD; B+CD	1-3
Abdominal	P	P	N		P	B+M; B+PWD; B+CD	1-3
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	N		P	B+M; B+PWD;B+CD	1-3
Small Organ (breast, thyroid,
testicles, prostate)	P	P	N		P	B+M; B+PWD; B+CD	1-3
Neonatal Cephalic	N	N	N		N	B+M; B+PWD; B+CD	1-3
Adult Cephalic	N	N	N		N	B+M; B+PWD; B+CD	1-3
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	N	N	P	B+M; B+PWD; B+CWD;B+CD	1-3
Cardiac Pediatric	P	P	N	N	P	B+M; B+PWD; B+CWD; B+CD	1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	N		P	B+M; B+PWD; B+CD	1-3
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).

17

510(k) Summary

K183235

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:	Aditi Chaubal
	Regulatory Affairs Specialist
E-mail:	aditi.chaubal@fujifilm.com
Telephone:	(425) 951-1432
Facsimile:	(425) 951-1201
Date prepared:	September 26, 2018

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 SII Ultrasound System Classification Names

Name	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

3) Identification of the predicate or legally marketed device:

SonoSite Edge II Ultrasound System	K162045
SonoSite SII Ultrasound System	K162045

4) Device Description:

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.

18

5) Intended Use:

SONOSITE SII ULTRASOUND 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

19

6) Technological Characteristics:

SONOSITE SII ULTRASOUND SYSTEM

SonoSite SII and Edge II 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
(K162045) | SonoSite Edge II
Ultrasound System
(K162045) |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Indications for
Use | Opthalmic
Fetal - OB/GYN
Abdominal | Opthalmic
Fetal - OB/GYN
Abdominal | Opthalmic
Fetal - OB/GYN
Abdominal |
| | Pediatric
Small Organ (breast, thyroid,
testicle, prostate) | Pediatric
Small Organ (breast, thyroid,
testicle, prostate) | 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 | Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric | 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 | Peripheral Vessel
Needle guidance | 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
Trans-esophageal |
| Transducer
Frequency | 1.0 — 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Global
Maximum
Outputs/Worst
Case Setting | Ispta.3: 598.9 (HFL50x)
TI Type: TIB (rP19x)
TI Value: 4.98 (rP19x)
MI: 1.7 (rP19x)
lpa.3@MI Max: 776 (L38xi) | Ispta.3: 420.2 (L38xi)
TI Type: TIC (rC60xi)
TI Value: 3.05 (rC60xi)
MI: 1.7 (rP19x)
Ipa.3@MI Max: 776 (L38xi) | Ispta.3: 598.9 (HFL50x)
TI Type: TIB (rP19x)
TI Value: 4.98 (rP19x)
MI: 1.7 (rP19x)
lpa.3@MI Max: 776 (L38xi) |
| 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 |
| 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
Color Power 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 | Zoom
Combination Modes
SonoHD2 Noise Reduction
SonoMB/MBe Image
Compounding | Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction
SonoMB/MBe Image
Compounding |
| Feature | SonoSite SII
Ultrasound System
(This submission) | SonoSite SII Ultrasound
System
(K162045) | SonoSite Edge II
Ultrasound System
(K162045) |
| | Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) | Velocity Color Doppler | Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) |
| PW Doppler | Available on all imaging
transducers except P11x
Adjustable sample volume
size: 1.0 – 25 mm
Simultaneous or duplex mode
of operation
Simultaneous B-mode and
PW Doppler
High PRF capability | Not available | Available on all imaging
transducers except P11x
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 and rP19x
Simultaneous or duplex mode
of operation
Simultaneous B-mode and
CW Doppler | Not available | Available on P10x, rP19x, TEExi
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 |
| ECG Feature | 3-lead ECG input, or
ECG Slave Cable | Not available | 3-lead ECG input, or
ECG Slave Cable |
| 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, Modality
Worklist, Perform Procedure Step
(PPS), Storage Commitment |
| IMT
Measurement | Not available | Not available | Not available |
| #Transmit
Channels | 128 digital channels | 128 digital channels | 128 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) |
| Patient Contact
Materials | Transducers:
Acrylonitrile-butadien-styrene
(ABS)
Cycoloy
Epoxy paste adhesive
Polyethylene (PE) Ionomer
Polyetheretherketone (PEEK)
Polycarbonate | Transducers:
Acrylonitrile-butadien-styrene
(ABS)
Cycoloy
Epoxy paste adhesive
Polyethylene (PE) Ionomer
Polyetheretherketone (PEEK)
Polycarbonate | Transducers:
Acrylonitrile-butadien-styrene
(ABS)
Cycoloy
Epoxy paste adhesive
Polyethylene (PE) Ionomer
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) | Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) | Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) |
| Product Safety
Certification | AAMI/ANSI ES60601-1:2005
(R2012)
IEC 60601-2-37 Ed. 2.1:2015
CAN/CSA C22.2 No. 60601-
1:08
NEMA UD2-2004 | 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 Ed. 2.1 :2015
CAN/CSA C22.2 No. 60601-1:08
NEMA UD2-2004
IEC 62359:2017 |
| Feature | SonoSite SII
Ultrasound System
(This submission) | SonoSite SII Ultrasound
System
(K162045) | SonoSite Edge II
Ultrasound System
(K162045) |
| 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 |
| DICOM | NEMA PS3.15 2011 | NEMA PS3.15 2003 | NEMA PS3.15 2011 |
| Airborne
Equipment
Standards | RTCA/DO160 (section 21) | RTCA/DO160 (section 21) | RTCA/DO160 (section 21) |
| 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
3 USB ports
Dimensions: 11.5"(W) x 17.6"
(L) x 4.8"(H)
Weight: 12.6 lbs
System operates via battery or
AC power | SII:
Beamformer 128/128 using SA
(configurable)
Hand held display and control
Single 12.1" Liquid Crystal
Display (LCD)
256 gray shades on LCD
3 USB ports
Dimensions: 11.5"(W) x 17.6" (L)
x 4.8"(H)
Weight: 12.6 lbs
System operates via battery or
AC power | 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 | 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 |
| | | | 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 |
| 510(k) Track | Track 3 | Track 3 | Track 3 |

20

21

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The SonoSite SII Ultrasound System has 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 SII Ultrasound System is designed to comply with the following FDA recognized

22

standards.

Reference No.	Title
ISO 10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk management process
IEC 60601-1	AAMI / 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 60601-1-2	AAMI / 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 60601-1-6	IEC 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 60601-2-37	IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment
IEC 62304	AAMI / ANSI / IEC 62304:2006+A1:2015, Medical device software - Software
life cycle processes
IEC 62359	IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERISON, Ultrasonics –
Field characterization – Test methods for the determination of thermal and
mechanical indices related to medical diagnostic ultrasonic fields
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management to
medical devices
NEMA UD 2-2004
(R2009)	Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment Revision 3

Summary of Clinical Tests:

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

8) Conclusion:

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The 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 SII Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices.