Acclarix Diagnostic Ultrasound System

K150999 · Edan Instruments, Inc. · IYO · May 6, 2015 · Radiology

Device Facts

• Record ID: K150999
• Device Name: Acclarix Diagnostic Ultrasound System
• Applicant: Edan Instruments, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Edan Acclarix AX8 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

Device Story

Portable laptop-based diagnostic ultrasound system for point-of-care environments (emergency departments, interventional procedures, mobile imaging). Inputs: acoustic echoes via piezoelectric transducers. Processing: high-voltage burst excitation; multi-beam-forming; speckle resistance imaging (eSRI); frequency/spatial compounding; HPRF. Outputs: real-time ultrasound images on 15-inch LCD with 10-inch touch screen and 5-inch trackpad. Operated by physicians or sonographers. Output used for diagnostic imaging and fluid flow analysis; supports clinical decision-making via visualization of anatomy and pathology, biopsy guidance, and measurement tools (distance, volume, velocity, etc.). Benefits: portable, high-resolution imaging for rapid assessment in diverse clinical settings.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (per FDA 2008 guidance), and biocompatibility (ISO 10993-1, -5, -10).

Technological Characteristics

Portable laptop form factor. Piezoelectric transducer technology. Modes: B, M, PW, CW, Color, PDI/DPDI. Features: HPRF, spatial/frequency compounding, multi-beam-forming, eSRI, needle visualization. Connectivity: 15-inch LCD, 10-inch touch screen, 5-inch trackpad. Power: 100-240V, 50/60Hz, rechargeable battery. Biocompatibility: ISO 10993 compliant materials.

Indications for Use

Indicated for ultrasound evaluations in adults, pregnant women, and pediatric patients. Clinical applications include abdominal, gynecological (including endovaginal), obstetric, cardiac, small parts (breast, testes, thyroid), urological, musculoskeletal (conventional and superficial), peripheral vascular, and intra-operative exams.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• U50 Diagnostic ultrasound system (K123249)
• M7 Diagnostic Ultrasound System (K131690)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized emblem with three abstract human profiles facing right, stacked on top of each other. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 6, 2015

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

Re: K150999

Trade/Device Name: Acclarix 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: April 14, 2015 Received: April 15, 2015

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.

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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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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)

## K150999

Device Name Acclarix Diagnostic Ultrasound System

#### Indications for Use (Describe)

The Edan Acclarix AX8 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

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### Acclarix AX8 Diagnostic Ultrasound System

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

______________________________________________________________________________________________________________________________________________________________________________

Note * Small Organ includes Thyroid, Testes, Breast - Caracter - Career - Career - Career - Career

** 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 AX8 with L10-4Q Transducer

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

(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 AX8 with E8-4Q Transducer

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

* 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.

(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 AX8 with L17-7HQ Transducer

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{8}------------------------------------------------

## Acclarix AX8 with C5-2XQ Transducer

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

______________________________________________________________________________________________________________________________________________________________________________

* 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.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{9}------------------------------------------------

## Acclarix AX8 with P5-1XQ Transducer

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{10}------------------------------------------------

### Acclarix AX8 with L17-7SQ Transducer

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

{11}------------------------------------------------

## 510(k) Summary

## Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc. | | | | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--|--|--|--|
| | 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou,<br>Nanshan Shenzhen, 518067 P.R. China | | | | |
| | Tel .: [phone] | | | | |
| | Fax: [phone] | | | | |
| Contact Person: | Queena Chen | | | | |
| Date prepared: | May 4, 2015 | | | | |
| 2. Device name<br>and classification: | Device Name: Diagnostic Ultrasound System<br>Model: Acclarix AX8 | | | | |
| | Classification Name: | | | | |
| | System, Imaging, Pulsed Doppler, Ultrasonic<br>892.1550 | | | | |
| | Product code: IYN | | | | |
| | Ultrasonic, Pulsed echo, Imaging<br>892.1560 | | | | |
| | Product code: IYO | | | | |
| | 892.1570<br>Transducer, Ultrasonic, Diagnostic | | | | |
| | Product code: ITX | | | | |
| | Regulatory Class: Class II | | | | |
| 3.Premarket<br>Notification Class<br>III Certification<br>and Summarv | Not applicable, the subject device is Class II. | | | | |
| 4. Predicate<br>Device(s): | U50 Diagnostic ultrasound system/ K123249/ Shenzhen EDAN<br>Instruments CO., Ltd | | | | |
| | M7 Diagnostic Ultrasound System / K131690/ Shenzhen Mindray<br>Bio-medical Electronics Co., Ltd | | | | |
| 5. Reason for<br>Submission | Acclarix AX8 is a new device. | | | | |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no prior submissions. | | | | |

{12}------------------------------------------------

- The Acclarix AX8 is a portable laptop diagnostic ultrasound system, 7. Device intended for use by a qualified physician or sonographer for ultrasound Description: evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers, which applies advanced technologies such as 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, etc. Various image parameter adjustments, 15 inch LCD display with 10 inch touch screen and 5 inch track pad and diverse probes are configured to acquire and display clear and stable ultrasound images, following Track 3 for all applications in the 510(k) submission.
- The Edan Acclarix AX8 Ultrasound System is intended for use by a 8. Intended Use: 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 Intra-operative.

## 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 AX8 Ultrasound Imaging System (Edan Instruments) | U50 Diagnostic Ultrasound System (Edan Instruments) | M7 Diagnostic Ultrasound System (Shenzhen Mindray) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Current Submission | K123249 | K131690 |
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Same | Same |
| Item | Acclarix AX8<br>Ultrasound<br>Imaging System<br>(Edan<br>Instruments) | U50 Diagnostic<br>Ultrasound<br>System<br>(Edan<br>Instruments) | M7 Diagnostic Ultrasound<br>System<br>(Shenzhen Mindray) |
| Indications<br>for Use | The Acclarix<br>AX8 Ultrasound<br>Imaging System<br>is intended for<br>use by a<br>qualified<br>physician or<br>sonographer for<br>ultrasound<br>evaluation.<br>Clinical<br>applications<br>include:<br>Abdominal,<br>Gynecology<br>(including<br>endovaginal),<br>Obstetric,<br>Cardiac, Small<br>parts (Breast,<br>Testes, Thyroid,<br>etc.), Urology,<br>Musculoskeletal,<br>Peripheral<br>vascular, and<br>Intra-operative. | The diagnostic<br>ultrasound<br>system (U50) is<br>applicable for<br>adults, pregnant<br>women,<br>pediatric<br>patients'<br>ultrasound<br>evaluation in<br>hospitals and<br>clinics. It is<br>intended for use<br>in abdominal,<br>obstetrics,<br>gynecology,<br>pediatric, small<br>parts, urology,<br>peripheral<br>vascular,<br>musculoskeletal<br>(conventional<br>and superficial),<br>endovaginal<br>and cardiac<br>clinical<br>applications, by<br>or on the order<br>of a physician<br>or similarly<br>qualified health<br>care<br>professional. | The M7/M7T diagnostic<br>ultrasound system is applicable for<br>adults, pregnant women, pediatric<br>patients and neonates. It is<br>intended for use in gynecology,<br>obstetric, abdominal, pediatric,<br>small parts (breast, testes, thyroid),<br>neonatal cephalic, transcranial,<br>cardiac, transvaginal, transrectal,<br>peripheral vascular, urology,<br>orthopedic, and musculoskeletal<br>(conventional and superficial),<br>intraoperative and transesophageal<br>(cardiac) exams. |
| Installation<br>and Use | Portable (laptop)<br>Mobile<br>Equipment | Same | Same |
| Item | Acclarix AX8<br>Ultrasound<br>Imaging System<br>(Edan<br>Instruments) | U50 Diagnostic<br>Ultrasound<br>System<br>(Edan<br>Instruments) | M7 Diagnostic Ultrasound<br>System<br>(Shenzhen Mindray) |
| Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-37<br>ISO 10993-1, -5,<br>-10, -12<br>AIUM, NEMA<br>UD 2, UD 3 | Same | Same |
| Patient<br>Contact<br>Materials | Complies with<br>ISO 10993 | Same | Same |
| Mode of<br>Operations | B-Mode.,<br>M-Mode, Color,<br>PDI/DPDI, PW,<br>CW | Same | B-Mode, M-Mode, Color,<br>PDI/DPDI, PW, CW Smart 3D,<br>Static 3D, 4D, iScape, and TDI |
| Measurements | B-Mode:<br>Distance,<br>Circ/Area,<br>Angle, Volume,<br>Stenosis<br>M-Mode:<br>Distance, Time,<br>Slope and Heart<br>Rate<br>D-Mode:<br>Velocity, RI,<br>Time, PI, Heart<br>Rate, Auto Trace<br>PG, S/D, AV,<br>Acceleration,<br>PHT, VTI | B-Mode:<br>Distance, Area,<br>Volume, Ratio,<br>Histogram and<br>Angle<br>M-Mode: Same<br>D- Mode:<br>Time, Heart<br>Rate, Velocity,<br>Acceleration,<br>RI, RI and Auto<br>trace | B-Mode: Distance, Depth, Angle,<br>Are, Volume, Cross Line, Parallel<br>Line, Trace Length, Distance,<br>Ratio, Area Ratio, B Histogram<br>M-Mode: Same<br>D-Mode: Time, HR, D Velocity,<br>Acceleration, D Trace, PS/ED |
| Principle of<br>Operation | Applying high<br>voltage burst to<br>the Piezoelectric<br>material in the<br>transducer and<br>detect reflected<br>echo to construct<br>diagnostic image | Same | Same |
| Item | Acclarix AX8 | U50 Diagnostic | M7 Diagnostic Ultrasound |
| | Ultrasound | Ultrasound | System |
| | Imaging System | System | (Shenzhen Mindray) |
| | (Edan | (Edan | |
| | Instruments) | Instruments) | |
| Acoustic | Track 3: MI, | Same | Same |
| Output | TIS, TIC, TIB | | |
| | (TI Range 0-6.0) | | |
| | Derated IspTA:…