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

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.

AI/ML Overview

This document is a 510(k) premarket notification for the FUJIFILM SonoSite Edge II Ultrasound System. It is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission is not a clinical study designed to test acceptance criteria for an AI/ML device in the way you've outlined.

Therefore, many of the specific questions about acceptance criteria for AI/ML performance, sample size for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to this document. This document focuses on demonstrating physical, technological, and intended use equivalence to existing ultrasound systems.

However, I can extract information relevant to similar underlying principles where applicable:

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, AUC) that one would typically see for an AI/ML device's diagnostic performance. Instead, the acceptance criteria are based on substantial equivalence to predicate devices in terms of:

Intended Use: The device performs diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications.
Technological Characteristics: The device utilizes similar transducer types, frequency ranges, modes of operation (B-mode, M-mode, Doppler, etc.), and patient contact materials as the predicate devices.
Safety and Effectiveness: Demonstrated by compliance with recognized FDA standards for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output. This is a qualitative acceptance criterion based on meeting established regulatory standards, not a quantitative performance metric.

Acceptance Criterion Type	Description from Document	Reported Device Performance (as stated or implied)
Intended Use Equivalence	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.	The device's "Indications for Use" (Pages 3-15) show a comprehensive list of clinical applications and modes of operation that are either "new indications" (N) or "previously cleared by FDA" (P) for specific transducers, demonstrating that it covers a range of uses comparable to or expanding upon the predicate devices. The listed indications for use are directly provided as the device's intended performance.
Technological Equivalence	The device should share fundamental scientific technology, transducer types, frequency, modes of operation, and patient contact materials with its predicates.	A detailed comparison table (Pages 17-18) explicitly states that the SonoSite Edge II uses the same fundamental scientific technology, transducer types (Linear, Curved, Intracavitary, Phased Array, Trans-esophageal), frequency range (1.0-15.0 MHz), and modes of operation (B-mode, M-mode, Color Doppler, Pulsed Wave Doppler, Continuous Wave Doppler, etc.) as the predicate devices (SonoSite Edge K133454 and SonoSite X-Porte K152209). Patient contact materials are also listed as equivalent.
Safety and Effectiveness	The device must conform to applicable mandatory medical device safety standards for electrical, thermal, mechanical, and EMC safety, as well as cleaning/disinfection, biocompatibility, and acoustic output.	The device 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." (Page 21) A list of specific FDA-recognized standards (ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, IEC 62359, ISO 14971, NEMA UD 2-2004) is provided, indicating adherence to regulatory requirements.

2. Sample Size Used for the Test Set and Data Provenance:

This document is for a traditional diagnostic ultrasound system, not an AI/ML device. Therefore, there is no "test set" of patient data in the sense of an AI/ML algorithm's performance evaluation. The "testing" referred to is against engineering and safety standards.

The document explicitly states under "Summary of Clinical Tests": "The SonoSite Edge II Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." (Page 21). This means no patient data was used for a clinical performance evaluation in the context of this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. As no clinical studies were required, there was no ground truth for a test set to be established by experts.

4. Adjudication Method for the Test Set:

Not applicable, as no test set of clinical images requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The document states that clinical studies were not required. The comparison is between the technological characteristics and indications for use of the new device and its predicates, not an improvement in human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware and software system for diagnostic imaging, not an AI/ML algorithm that operates independently.

7. The Type of Ground Truth Used:

Not applicable in the context of diagnostic accuracy. The "ground truth" for this submission revolves around:

Confirmation that the device functions as designed and meets technical specifications.
Compliance with recognized industry and regulatory safety standards.
Verification that the device's capabilities align with its stated intended uses and are substantially equivalent to its predicates.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML product developed with training data.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

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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

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Indications for Use

510(k) Number (if known) TBD K153626

Device Name

FUJIFILM SonoSite Edge II Ultrasound System

Indications for Use (Describe)

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)

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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 bodyas follows:
Clinical Application		Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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 (Abdominalorgans 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

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System:		FUJIFILM SonoSite Edge II Ultrasound System
Transducer:		C11x/8-5 MHz Transducer
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human
		body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,5
Intra-operative (Abdominalorgans 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:

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.

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System:	FUJIFILM SonoSite Edge II Ultrasound System
Transducer:	rC60xi/5-2 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical 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:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)
4: Steep Needle Profiling (Sono MBe)

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

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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:

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.

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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	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	P	P	P		P	B+M; B+PWD; B+CD	1,4,5
Intra-operative (Abdominalorgans 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:

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.

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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 humanbody as follows:
Clinical Application		Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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 (Abdominalorgans 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:

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:

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.

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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:

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.

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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
		ColorCombinedOther
	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:

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.

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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	ColorDoppler	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:

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.

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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 bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominalorgans 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:

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.

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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 bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	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 (Abdominalorgans 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:

2: Tissue Harmonic Imaging (THI)

3: Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling (Sono MBe)

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

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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 bodyas follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominalorgans 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:

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.

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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:

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5) Intended Use:

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 IIUltrasound System(This submission)	SonoSite EdgeUltrasound System(K133454)	SonoSite X-PorteUltrasound System(K152209)
Intended Use	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody
Indications forUse	OpthalmicFetal - OB/GYNAbdominalPediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organsand vascular)Intra-operative (Neuro.)PediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organsand vascular)PediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance
TransducerTypes	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal
TransducerFrequency	1.0 - 15.0 MHz	1.0 - 15.0 MHz	1.0 - 15.0 MHz
Feature	SonoSite Edge IIUltrasound System(This submission)	SonoSite EdgeUltrasound System(K133454)	SonoSite X-PorteUltrasound System(K152209)

Modes ofOperation	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoom	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoom	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeSimultaneous M-ModeColor Power DopplerZoom
	Combination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI)	Combination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI)	Combination ModesPulsed Wave (PW) DopplerContinuous Wave (CW) DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue 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)CycoloyDow Medical Adhesive, Type A	(ABS)CycoloyDow Medical Adhesive, Type A
	Epoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone (PEEK)PolycarbonatePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)Edge II:	Epoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone (PEEK)PolycarbonatePolysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)Edge:	Epoxy paste adhesivePolyethylene (PE) IonomerPolyetheretherketone (PEEK)Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)X-Porte (stand configuration):
SystemCharacteristics	Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 12.1" Liquid Crystal Display(LCD)256 gray shades on LCD	Beamformer 128/128 using SA(configurable)Hand held display and controlSingle 12.1" Liquid Crystal Display(LCD)256 gray shades on LCD	Beamformer 128/128 using SA(configurable)12.1" Capacitive touch screeninterface19" LED LCD HD monitor256 gray shades on LED LCD
	2 USB ports	2 USB ports	6 USB 2.0 ports
	Dimensions: 12.8"(W) x 12.1" (L) x2.5"(H)	Dimensions: 12.9"(W) x 12.4" (L) x2.5"(H)	Stand Base Dimensions: 26.4" L x21.2" WStand Height (max): 64" (monitorup)Stand Height (min): 42.2" (monitordown)
	Weight: 9.0 lbs	Weight: 8.5 lbs	Weight: 149.35 lbs (fullyconfigured w/ 3 transducers
	System operates via battery or ACpowerBattery life: 1.5 - 4 hour operation	System operates via battery or ACpowerBattery life: 1.5 - 4 hour operation	System operates via battery or ACpowerBattery life: 1 hour operational - 3
Feature	SonoSite Edge IIUltrasound System(This submission)	SonoSite EdgeUltrasound System(K133454)	SonoSite X-PorteUltrasound 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 HzOutput 1: 24VDC output, 275 WmaxOutput 2: 100-240VAC, 50-60 Hz(AC Printer)
	Various obstetrical, cardiac,volume, M-mode, PW and CWDoppler measurement andcalculation packages	Various obstetrical, cardiac,volume, M-mode, PW and CWDoppler measurement andcalculation packages	Various obstetrical, cardiac,volume, M-mode, PW and CWDoppler measurement andcalculation packages
	ECG acquisition and displaycapabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable media	ECG acquisition and displaycapabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable media	ECG acquisition and displaycapabilitiesCW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaMeasurement on RecalledImages.
	Wireless 802.11 (b/g/n) support forimage transfer	Wireless 802.11 (b/g/n) support forimage transfer	Wireless 802.11 (a/b/g/n) supportfor image transfer
			X-Porte (desktop configuration):
			Same softwarefeatures/capabilities as the standconfiguration. Does not have thestand, touch panel interface, DVR,and mobile power unit.
			Weight: 32.80 lbs (w/ 1transducer)
			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 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements 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 - Collateralstandard: 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: Generalrequirements 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 ultrasonicmedical diagnostic and monitoring equipment
IEC 62304	AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycleprocesses
IEC 62359	IEC 62359 Edition 2.0 2010-10-10, Ultrasonics - Field characterization - Testmethods for the determination of thermal and mechanical indices related to medicaldiagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)]
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management to medicaldevices
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.

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.