Acclarix AX4 Diagnostic Ultrasound System

• K Number: K171900
• Device Name: Acclarix AX4 Diagnostic Ultrasound System
• Manufacturer: Edan Instruments, Inc
• Date Cleared: 2017-08-18 ( 53 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K171824
• Predicate For: K190186 , K192791

Intended 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

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

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.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the Acclarix AX4 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data to define acceptance criteria for novel device performance. Therefore, the document does not describe acceptance criteria for device performance based on a study, nor does it present results from such a study.

Instead, it asserts substantial equivalence by comparing the Acclarix AX4 to a predicate device (Acclarix AX8 Diagnostic Ultrasound System, K171824) across various parameters, including intended use, indications for use, safety standards, patient contact materials, modes of operation, measurements, principle of operation, acoustic output, transducer types, and features.

The document states that "Clinical testing is not required" for this submission, further indicating that no study was conducted to prove the device meets specific performance acceptance criteria beyond demonstrating equivalence to the predicate.

However, based on the information provided, I can respond to some of your specific questions related to the non-clinical testing performed to support substantial equivalence.

1. A table of acceptance criteria and the reported device performance:

The document does not provide specific performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or effect size. Instead, it relies on demonstrating compliance with recognized safety and performance standards, and sameness in various operational and technical specifications compared to the predicate device.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Acclarix AX4)
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body
Indications for Use	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. While the general list is similar, the document notes a "Difference" in the specific list of indications between the Acclarix AX4 and the predicate Acclarix AX8 R1.3. For the Acclarix AX4 System specifically, the provided tables show which applications are "P" (previously cleared) or "N" (new indication) for each transducer (e.g., P5-1Q transducer lists "N" for Abdominal, Adult Cephalic, Adult Cardiac, Pediatric Cardiac).
Installation and Use	Portable (laptop), Mobile Equipment
Safety Standards Compliance	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, -12, AIUM, NEMA UD 2, UD 3
Patient Contact Materials	Compliant with ISO 10993
Mode of Operations	B-Mode, M-Mode, Color, PDI/DPDI, PW, CW, 3D/4D
Measurements	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
Principle of Operation	Applying high voltage burst to the Piezoelectric material in the transducer and detect reflected echo to construct diagnostic image
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 mW/cm2; and MI ≤ 0.23
Transducer Frequency	1-17 MHz
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

Note: The document explicitly states "Clinical testing is not required." The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical testing demonstrating compliance with recognized standards and comparable specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical performance study was conducted. The non-clinical testing involved device verification and validation activities against standards and specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical ground truth was established from expert review for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical ground truth was established.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasound system, not an AI-assisted diagnostic tool, and no MRMC comparative effectiveness study was mentioned.

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

Not applicable. This device is an ultrasound system, not an algorithm, and no standalone performance study was mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this 510(k) submission, the "ground truth" for the device's acceptability relies on its compliance with international safety and performance standards and its substantial equivalence to a previously cleared predicate device, rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

Not applicable, as no AI/machine learning model was trained for this device.

9. How the ground truth for the training set was established

Not applicable, as no AI/machine learning model was trained for this device.

Summary

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

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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
FetalImaging& 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
Peripheralvascular	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) *
FetalImaging& 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
FetalImaging& 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
Peripheralvascular	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)

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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) *
FetalImaging& 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) *
FetalImaging& 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
Peripheralvascular	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
FetalImaging& 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
Peripheralvascular	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) *
FetalImaging& 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
Peripheralvascular	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.

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

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) *
FetalImaging& 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
Peripheralvascular	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)

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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.: [phone] Fax: [phone]
Contact Person:	Crystal Cai
Date prepared:	June 22, 2017
2. Device nameandclassification:	Device Name: Diagnostic Ultrasound SystemModel: Acclarix AX4Classification Name:892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN892.1560 Ultrasonic, Pulsed echo, ImagingProduct code: IYO892.1570 Transducer, Ultrasonic, DiagnosticProduct code: ITXRegulatory Class: Class II
3.PremarketNotificationClass IIICertificationand Summary	Not applicable, the subject device is Class II.
4. PredicateDevice(s):	Edan Instruments, Inc., Acclarix AX8 Diagnostic Ultrasound Systemcleared under K171824 (Predicate)
5. Reason forSubmission	By submission of the Traditional 510(k), Edan Instruments is requesting forDiagnostic Ultrasound System, model Acclarix AX4 after the change on theprevious cleared version.
6.Pre-Submission,IDE	Not applicable, there is no prior submission.

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7. DeviceDescription:

The Acclarix AX4 is a portable laptop diagnostic ultrasound system,intended for use by a qualified physician or sonographer for ultrasoundevaluation 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 aqualified 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 DiagnosticUltrasound System(Edan Instruments)	ComparisonResult
510(k)Number	Current Submission	K171824	-
IntendedUse	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Same
Indicationsfor Use	The Edan Acclarix AX4 UltrasoundSystem is intended for use by aqualified physician or allied healthprofessional for ultrasoundevaluations. Specific clinicalapplications include: Abdominal,Gynecology (includingendovaginal), Obstetric, Cardiac,Small parts (Breast, Testes, Thyroid,etc.), Urology, Musculoskeletal,Peripheral vascular, and	The Acclarix AX8 DiagnosticUltrasound System is intended for useby a qualified physician orsonographer 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 DiagnosticUltrasound System(Edan Instruments)	ComparisonResult
	Intra-operative, Pediatric andNeonatal (including abdominal andcephalic), Adult Cephalic	(including abdominal andcephalic), and Adult cephalic.
Installationand Use	Portable (laptop)Mobile Equipment	Portable (laptop)Mobile Equipment	Same
Design	64 channel	128 channel	Difference
SafetyStandards	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10, -12AIUM, NEMA UD 2, UD 3	IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5, -10, -12AIUM, NEMA UD 2, UD 3	Same
PatientContactMaterials	Complies with ISO 10993	Complies with ISO 10993	Same
Mode ofOperations	B-Mode, M-Mode, Color,PDI/DPDI, PW, CW, 3D/4D	B-Mode, M-Mode, Color,PDI/DPDI, PW, CW, 3D/4D	same
Measurements	B-Mode: Distance, Circ/Area, Angle,Volume, Stenosis ratioM-Mode: Distance, Time, Slope andHeart RateD-Mode: Velocity, RI, Time, PI,Heart Rate, Auto TracePG, S/D, ΔV, Acceleration, PHT,VTI	B-Mode: Distance, Circ/Area, Angle,Volume, Stenosis ratioM-Mode: Distance, Time, Slope andHeart RateD-Mode: Velocity, RI, Time, PI,Heart Rate, Auto TracePG, S/D, ΔV, Acceleration, PHT,VTI	Same
PrincipleofOperation	Applying high voltage burst to thePiezoelectric material in thetransducer and detect reflected echoto construct diagnostic image	Applying high voltage burst to thePiezoelectric material in thetransducer and detect reflected echoto construct diagnostic image	Same
AcousticOutput	Track 3: MI, TIS, TIC, TIB (TIRange 0-6.0)Derated ISPTA: 720 mW/cm2maximum,Mechanic Index ≤ 1.9 maximum orDerated ISPPA 190 W/cm2 maxOphthalmic use:TI = Max (TIS_as, TIC) ≤1;ISPTA.3 ≤ 50 m/W/cm2; and MI ≤0.23	Track 3: MI, TIS, TIC, TIB (TIRange 0-6.0)Derated ISPTA: 720 mW/cm2maximum,Mechanic Index ≤ 1.9 maximum orDerated ISPPA 190 W/cm2 maxOphthalmic use:TI = Max (TIS_as, TIC) ≤1;ISPTA.3 ≤ 50 m/W/cm2; and MI ≤0.23	Same
TransducerTypes	Convex ArrayLinear ArrayEndocavity-Micro Convex ArrayPhased ArrayMicro Convex Array	Convex ArrayLinear ArrayEndocavity-Micro Convex ArrayPhased ArrayMicro Convex Array	Same
TransducerFrequency	1-17 MHz	1-17 MHz	Same
Item	Acclarix AX4	Acclarix AX8 R1.3 DiagnosticUltrasound System(Edan Instruments)	ComparisonResult
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
PowerRequirements	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.

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.