Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is to identify or diagnose conditions, not to treat them.

Diagnostic

Yes
The "Intended Use" explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body," and the "Device Description" refers to it as a "portable laptop diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable laptop diagnostic ultrasound system," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Edan AX4 Ultrasound system is not an IVD (In Vitro Diagnostic) device.

Here's why:

Definition of IVD: In vitro diagnostic devices are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
Intended Use: The intended use of the Edan AX4 is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This involves imaging the internal structures of the body directly, not examining samples taken from the body.
Device Description: The device is described as a "portable laptop diagnostic ultrasound system". This aligns with in vivo imaging, not in vitro testing.
Lack of Mention of Samples: There is no mention of the device being used with biological samples (blood, tissue, etc.).

Therefore, the Edan AX4 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 Edan AX4 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

Abdominal
Gynecology (including endovaginal)
Obstetric
Cardiac
Small parts (Breast, Testes, Thyroid, etc.)
Urology
Musculoskeletal
Peripheral vascular
Intra-operative
Pediatric
Neonatal (including abdominal and cephalic)
Adult Cephalic

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

IYN, IYO, ITX

Device Description

The Acclarix AX4 is a portable laptop diagnostic ultrasound system, intended for use by a qualified physician or sonographer for ultrasound evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Gynecological (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urological, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal (including abdominal and cephalic), Adult Cephalic.

Indicated Patient Age Range

Pediatric, Neonatal, Adult

Intended User / Care Setting

qualified physician or allied health professional, Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers.

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)

Clinical test: Clinical testing is not required.
Non-clinical test: The Acclarix AX4 Ultrasound Imaging System complies with:
(1) IEC 60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) NEMA UD 3 Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment.
(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.

The following biocompatibility standards are conducted on the subject device:
(1) ISO 10993-1, ISO 10993-5 and ISO 10993-10
The tests were selected to show substantial equivalence between the subject device and the predicate.

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.

K171824

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

Not Found

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

Not Found

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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

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

August 18, 2017

Edan Instruments, Inc. % Mr. Doug Worth Sr. Dir. US RA/OA Edan Medical 1200 Crossman Avenue, Suite 200 SUNNYVALE CA 94089

Re: K171900

Trade/Device Name: Acclarix AX4 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 22, 2017 Received: June 26, 2017

Dear Mr. Worth:

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

1

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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/ResourcesforYou/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.

Michael D. O'Hara

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171900

Device Name

Acclarix AX4 Diagnostic Ultrasound System

Indications for Use (Describe)

The Edan AX4 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

Abdominal
· Gynecology (including endovaginal)
Obstetric
· Cardiac
· Small parts (Breast, Testes, Thyroid, etc.)
· Urology
Musculoskeletal
Peripheral vascular
· Intra-operative
Pediatric
· Neonatal (including abdominal and cephalic)
· Adult Cephalic

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 Druq 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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

PSC Publishing Services (301) 443-6740

EF

3

Acclarix AX4 Diagnostic Ultrasound System

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined (Specify) [1]	Other (Specify) [2]3

Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)	P	P	P		P	P	P
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Specify) *	P	P	P		P	P	P
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac	P	P	P	P	P	P	P
Cardiac	Pediatric Cardiac	P	P	P	P	P	P	P
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular	P	P	P		P	P	P
vascular	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Small Organ includes Thyroid, Testes, Breast Note

** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
4: 3D/4D

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix AX4 with C5-2Q Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
		Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P	P	P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	P
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P
	Intravascular
	Other (Specify) **	P	P	P	P	P	P	P
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging. This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix AX4 with L12-5Q Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P		P	P	P
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular	P	P	P		P	P	P
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Small Organ includes Thyroid, Testes, Breast. Note

** Other use includes Urology.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

6

Acclarix AX4 with MC8-4Q Transducer

Clinical Application		Mode of Operation
		B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
General	Specific

Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Specify) *
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P		P	P	P
vascular	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Note * Small Organ includes Thyroid, Testes, Breast.

** Other use includes Neonatal abdominal.

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix AX4 with E8-4Q Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P	P	P	P	P
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **	P	P	P	P	P	P	P
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix AX4 with P5-1XQ Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
Fetal	Small Organ (Specify) *
Imaging	Neonatal Cephalic
& Other	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac	P	P	P	P	P	P	P
	Pediatric Cardiac	P	P	P	P	P	P	P
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M,B+PW,B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note > * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix AX4 with P5-1Q Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal / Obstetrics
	Abdominal	N	N	N	N	N	N	N
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac	N	N	N	N	N	N	N
	Pediatric Cardiac	N	N	N	N	N	N	N
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M,B+PW,B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix AX4 with L17-7SQ Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)	P	P	P	P	P	P	P
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	P
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular	P	P	P	P	P	P	P
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of Center for Devices and Radiological Health (CDRH)

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Acclarix AX4 with C5-2MQ Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined
(Specify) [1]	Other
(Specify) [2]3

Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral
vascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

12

510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc.
#15 Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
Tel.: (0755) 26858736 Fax: +1 (408) 418-4059 |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Cai |
| Date prepared: | June 22, 2017 |
| 2. Device name
and
classification: | Device Name: Diagnostic Ultrasound System
Model: Acclarix AX4
Classification Name:
892.1550 System, Imaging, Pulsed Doppler, Ultrasonic
Product code: IYN
892.1560 Ultrasonic, Pulsed echo, Imaging
Product code: IYO
892.1570 Transducer, Ultrasonic, Diagnostic
Product code: ITX
Regulatory Class: Class II |
| 3.Premarket
Notification
Class III
Certification
and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate
Device(s): | Edan Instruments, Inc., Acclarix AX8 Diagnostic Ultrasound System
cleared under K171824 (Predicate) |
| 5. Reason for
Submission | By submission of the Traditional 510(k), Edan Instruments is requesting for
Diagnostic Ultrasound System, model Acclarix AX4 after the change on the
previous cleared version. |
| 6.
Pre-Submission,
IDE | Not applicable, there is no prior submission. |

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| 7. Device
Description: | The Acclarix AX4 is a portable laptop diagnostic ultrasound system,
intended for use by a qualified physician or sonographer for ultrasound
evaluation in Point of Care environments such as Emergency Departments,
Interventional procedures and mobile imaging centers. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8. Intended Use: | The Edan Acclarix AX4 Ultrasound System is intended for use by a
qualified physician or allied health professional for ultrasound evaluations.
Specific clinical applications include:
• Abdominal
• Gynecology (including endovaginal)
• Obstetric
• Cardiac
• Small parts (Breast, Testes, Thyroid, etc.)
• Urology
• Musculoskeletal
• Peripheral vascular
• Intra-operative
• Pediatric
• Neonatal (including abdominal and cephalic)
• Adult Cephalic |

9. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table:

| Item | Acclarix AX4 | Acclarix AX8 R1.3 Diagnostic
Ultrasound System
(Edan Instruments) | Comparison
Result |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k)
Number | Current Submission | K171824 | - |
| Intended
Use | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Same |
| Indications
for Use | The Edan Acclarix AX4 Ultrasound
System is intended for use by a
qualified physician or allied health
professional for ultrasound
evaluations. Specific clinical
applications include: Abdominal,
Gynecology (including
endovaginal), Obstetric, Cardiac,
Small parts (Breast, Testes, Thyroid,
etc.), Urology, Musculoskeletal,
Peripheral vascular, and | The Acclarix AX8 Diagnostic
Ultrasound System is intended for use
by a qualified physician or
sonographer for ultrasound evaluation.
Clinical applications include:
Abdominal, Gynecology
(including endovaginal), Obstetric,
Cardiac, Small parts (Breast, Testes,
Thyroid, etc.), Urology,
Musculoskeletal, Peripheral vascular,
Intra-operative, Pediatric and Neonatal | Difference |

				Table 9-1 Comparison between the subject Acclarix AX4 and
the previous cleared Acclarix AX8 R1.3

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| Item | Acclarix AX4 | Acclarix AX8 R1.3 Diagnostic
Ultrasound System
(Edan Instruments) | Comparison
Result |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Intra-operative, Pediatric and
Neonatal (including abdominal and
cephalic), Adult Cephalic | (including abdominal and
cephalic), and Adult cephalic. | |
| Installation
and Use | Portable (laptop)
Mobile Equipment | Portable (laptop)
Mobile Equipment | Same |
| Design | 64 channel | 128 channel | Difference |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10, -12
AIUM, NEMA UD 2, UD 3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10, -12
AIUM, NEMA UD 2, UD 3 | Same |
| Patient
Contact
Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Mode of
Operations | B-Mode, M-Mode, Color,
PDI/DPDI, PW, CW, 3D/4D | B-Mode, M-Mode, Color,
PDI/DPDI, PW, CW, 3D/4D | same |
| Measurem
ents | B-Mode: Distance, Circ/Area, Angle,
Volume, Stenosis ratio

M-Mode: Distance, Time, Slope and
Heart Rate

D-Mode: Velocity, RI, Time, PI,
Heart Rate, Auto Trace
PG, S/D, ΔV, Acceleration, PHT,
VTI | B-Mode: Distance, Circ/Area, Angle,
Volume, Stenosis ratio

M-Mode: Distance, Time, Slope and
Heart Rate

D-Mode: Velocity, RI, Time, PI,
Heart Rate, Auto Trace
PG, S/D, ΔV, Acceleration, PHT,
VTI | Same |
| Principle
of
Operation | Applying high voltage burst to the
Piezoelectric material in the
transducer and detect reflected echo
to construct diagnostic image | Applying high voltage burst to the
Piezoelectric material in the
transducer and detect reflected echo
to construct diagnostic image | Same |
| Acoustic
Output | Track 3: MI, TIS, TIC, TIB (TI
Range 0-6.0)
Derated ISPTA: 720 mW/cm2
maximum,
Mechanic Index ≤ 1.9 maximum or
Derated ISPPA 190 W/cm2 max
Ophthalmic use:
TI = Max (TIS_as, TIC) ≤1;
ISPTA.3 ≤ 50 m/W/cm2; and MI ≤
0.23 | Track 3: MI, TIS, TIC, TIB (TI
Range 0-6.0)
Derated ISPTA: 720 mW/cm2
maximum,
Mechanic Index ≤ 1.9 maximum or
Derated ISPPA 190 W/cm2 max
Ophthalmic use:
TI = Max (TIS_as, TIC) ≤1;
ISPTA.3 ≤ 50 m/W/cm2; and MI ≤
0.23 | Same |
| Transducer
Types | Convex Array
Linear Array
Endocavity-Micro Convex Array
Phased Array
Micro Convex Array | Convex Array
Linear Array
Endocavity-Micro Convex Array
Phased Array
Micro Convex Array | Same |
| Transducer
Frequency | 1-17 MHz | 1-17 MHz | Same |
| Item | Acclarix AX4 | Acclarix AX8 R1.3 Diagnostic
Ultrasound System
(Edan Instruments) | Comparison
Result |
| Dimensions/ Weight | 407mm (W) x 388mm (L) x77mm (H)
Weight: 9.1Kg
(with rechargeable battery, without power adaptor or transducers.) | 407mm (W) x 388mm (L) x77mm (H)
Weight: 9.1Kg
(with rechargeable battery, without power adaptor or transducers.) | Same |
| Power
Requirements | 100-240V, 50/60Hz | 100-240V, 50/60Hz | Same |
| Rechargeable Battery | Yes | Yes | Same |
| Features | 3D/4D, CW, HPRF, Dual screen display, Panorama, Spatial Compounding Imaging, Frequency Compounding Imaging,
Multi-Beam-Forming, Speckle Resistance Imaging(eSRI),
One-Key-Optimization, B-Steer, Digital Zoom, Needle Visualization, Auto IMT | 3D/4D, CW, HPRF, Dual screen display, Panorama, Spatial Compounding Imaging, Frequency Compounding Imaging,
Multi-Beam-Forming, Speckle Resistance Imaging(eSRI),
One-Key-Optimization, B-Steer, Digital Zoom, Needle Visualization, Auto IMT | Same |

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The subject device has same intended use, similar product design, same performance effectiveness, and performance safety as the predicate device.

The differences between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

10. Effectiveness and Safety Considerations:

Clinical test:

Clinical testing is not required.

Non-clinical test:

The Acclarix AX4 Ultrasound Imaging System complies with:

(1) IEC 60601-1 Electrical Safety

(2) IEC 60601-1-2 Electromagnetic Compatibility

(3) IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

(4) NEMA UD 3 Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment.

(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.

The following biocompatibility standards are conducted on the subject device:

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(1) ISO 10993-1, ISO 10993-5 and ISO 10993-10

The tests were selected to show substantial equivalence between the subject device and the predicate.

11. Substantially Equivalent Determination

Verification and validation testing has been conducted on the Acclarix AX4 Ultrasound Imaging System. This premarket notification submission demonstrates that Acclarix AX4 Ultrasound Imaging System is substantially equivalent to the predicate devices.