Predicate Devices

Reference Devices

Not Found

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 and features.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" used for "imaging or fluid flow analysis," indicating its purpose is for diagnosis and evaluation, not treatment.

Diagnostic

Yes

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

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system" and a "custom fabricated digital electronic design," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the FUJIFILM SonoSite Edge II Ultrasound System 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 (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states the device is a "general purpose ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes." This involves using sound waves to create images of internal body structures.
Intended Use: The intended use describes imaging and fluid flow analysis of the human body, not analysis of specimens taken from the human body.
Lack of Specimen Analysis: There is no mention of the device analyzing biological samples or performing tests on substances outside of the body.

Therefore, the SonoSite Edge II Ultrasound System is an in vivo diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FUJIFILM 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-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

Product codes

IYN, IYO, ITX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, 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

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

Summary of Non-Clinical Tests:
The SonoSite Edge II 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 has 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

Not Found

Predicate Device(s)

K133454, K152209

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing design below them.

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

January 20, 2016

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

Re: K153626

Trade/Device Name: 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: January 13, 2016 Received: January 14, 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

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,

Robert Ocks

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) TBD K153626

Device Name

FUJIFILM SonoSite Edge II Ultrasound System

Indications for Use (Describe)

The FUJIFILM 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-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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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

4

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

Table 1.3-2 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) K133454.

5

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 Application	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal	N	N	N		N	B+M; B+PWD; B+CD	1,2,4,5
Abdominal	N	N	N		N	B+M; B+PWD; B+CD	1,2,4,5
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N	N		N	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.)	N	N	N		N	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	N	N	N		N	B+M; B+PWD; B+CD	1,2,4,5
Other (spec.)

Table 1.3-3 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

6

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

Table 1.3-4 Diagnostic Ultrasound Indications for Use Form – HFL38xi/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) K152209.

7

Table 1.3-5 Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 Transducer
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 Application	Mode of Operation

	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles. prostate)	P	P	P		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	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		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	P		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) K133454.

8

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

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 Application		Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Fetal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles. prostate)	P	P	P		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	P		P	B+M; B+PWD; B+CD	1,4,5
Musculo-skel. (Superfic.)	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-luminal
Other (spec.)
Cardiac Adult	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		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) K152209.

9

Table 1.3-7 Diagnostic Ultrasound Indications for Use Form – ICTx/8-5 Transducer

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 Application					Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal	P	P	P		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	P		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) K133454.

10

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

Table 1.3-8 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) K152209.

11

Table 1.3-9 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 Application	Mode of Operation
		Color
Combined
Other
	B	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Small Organ (breast, thyroid,
testicles. prostate)	P	P	P		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	P		P	B+M; B+PWD; B+CD	1,4,5
Cardiac Pediatric	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	P	P	P		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) K152209.

12

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

Table 1.3-10 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) K133454.

13

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 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.)

Table 1.3-11 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 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.

14

Table 1.3-12 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 Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	N	N	N	N	N	B+M; B+PWD; B+CD	1-3
Fetal	N	N	N	N	N	B+M; B+PWD; B+CD	1-3
Abdominal	N	N	N	N	N	B+M; B+PWD; B+CD	1-3
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1-3
Small Organ (breast, thyroid,
testicles. prostate)	N	N	N	N	N	B+M; B+PWD; B+CD	1-3
Neonatal Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1-3
Adult Cephalic	N	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	N	N	N	N	N	B+M; B+PWD; B+CWD; B+CD	1-3
Cardiac Pediatric	N	N	N	N	N	B+M; B+PWD; B+CWD; B+CD	1-3
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	N	N	N	N	N	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

15

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 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
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.)	P	P	P	P	P	B+M; B+PWD; B+CWD; B+CD	1,3
Other (spec.)
Peripheral vessel
Other (spec.)

Table 1.3-13 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 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) K152209.

16

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:	Patricia Liau
	Manager, Regulatory Affairs
E-mail:	Patricia.Liau@sonosite.com
Telephone:	(425) 951-6870
Facsimile:	(425) 951-1201
Date prepared:	December 9, 2015

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)

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 Ultrasound System	K133454
SonoSite X-Porte Ultrasound System	K152209

4) Device Description:

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.

17

5) Intended Use:

The FUJIFILM 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-vaqinal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

6) Technological Characteristics:

SonoSite Edge and X-Porte Ultrasound Systems are both 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
Ultrasound System
(K133454) | SonoSite X-Porte
Ultrasound System
(K152209) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
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 | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs
and vascular)
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel
Needle guidance |
| Transducer
Types | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Trans-esophageal | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Static Probes
Trans-esophageal | 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 |
| Feature | SonoSite Edge II
Ultrasound System
(This submission) | SonoSite Edge
Ultrasound System
(K133454) | SonoSite X-Porte
Ultrasound System
(K152209) |
| | | | |
| Modes of
Operation | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Simultaneous 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) | 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) | 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) |
| PW Doppler | Available | Available | Available |
| CW Doppler | Available | Available | Available |
| Patient | Transducers: | Transducers: | Transducers: |
| Contact | | Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene |
| Materials | Cycoloy | (ABS)
Cycoloy
Dow Medical Adhesive, Type A | (ABS)
Cycoloy
Dow Medical Adhesive, Type A |
| | 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)
Edge II: | 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)
Edge: | Epoxy paste adhesive
Polyethylene (PE) Ionomer
Polyetheretherketone (PEEK)
Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS)
X-Porte (stand configuration): |
| System
Characteristics | Beamformer 128/128 using SA
(configurable)
Hand held display and control
Single 12.1" Liquid Crystal Display
(LCD)
256 gray shades on LCD | Beamformer 128/128 using SA
(configurable)
Hand held display and control
Single 12.1" Liquid Crystal Display
(LCD)
256 gray shades on LCD | Beamformer 128/128 using SA
(configurable)
12.1" Capacitive touch screen
interface
19" LED LCD HD monitor
256 gray shades on LED LCD |
| | 2 USB ports | 2 USB ports | 6 USB 2.0 ports |
| | Dimensions: 12.8"(W) x 12.1" (L) x
2.5"(H) | Dimensions: 12.9"(W) x 12.4" (L) x
2.5"(H) | Stand Base Dimensions: 26.4" L x
21.2" W
Stand Height (max): 64" (monitor
up)
Stand Height (min): 42.2" (monitor
down) |
| | Weight: 9.0 lbs | Weight: 8.5 lbs | Weight: 149.35 lbs (fully
configured w/ 3 transducers |
| | System operates via battery or AC
power
Battery life: 1.5 - 4 hour operation | System operates via battery or AC
power
Battery life: 1.5 - 4 hour operation | System operates via battery or AC
power
Battery life: 1 hour operational - 3 |
| Feature | SonoSite Edge II
Ultrasound System
(This submission) | SonoSite Edge
Ultrasound System
(K133454) | SonoSite X-Porte
Ultrasound System
(K152209) |
| | per charge | per charge | days idle |
| | 100 - 240V options, 50/60 Hz,
15VDC output | 100 - 240V options, 50/60 Hz,
15VDC output | Input: 100 – 240 VAC, 50/60 Hz
Output 1: 24VDC output, 275 W
max
Output 2: 100-240VAC, 50-60 Hz
(AC Printer) |
| | 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 | 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 | 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
Measurement on Recalled
Images. |
| | Wireless 802.11 (b/g/n) support for
image transfer | Wireless 802.11 (b/g/n) support for
image transfer | Wireless 802.11 (a/b/g/n) support
for image transfer |
| | | | X-Porte (desktop configuration): |
| | | | Same software
features/capabilities as the stand
configuration. Does not have the
stand, touch panel interface, DVR,
and mobile power unit. |
| | | | Weight: 32.80 lbs (w/ 1
transducer) |
| | | | AC power only.
100 - 240V options, 50/60 Hz |
| 510(k) Track | Track 3 | Track 3 | Track 3 |

18

19

20

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The SonoSite Edge II 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 has 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 is designed to comply with the following FDA recognized 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 60601-2-37:2007 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 62304	AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycle
processes
IEC 62359	IEC 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 14971	ISO 14971:2007, Medical devices - Application of risk management to medical
devices
NEMA UD 2-2004	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Summary of Clinical Tests:

The SonoSite Edge II Ultrasound System and transducers, subject of this submission, did not reguire 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 Edge II 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 is substantially equivalent with reqard to safety and effectiveness to the predicate devices.