Acclarix AX8 Diagnostic Ultrasound System

K161300 · Edan Instruments, Inc. · IYO · May 31, 2016 · Radiology

Device Facts

• Record ID: K161300
• Device Name: Acclarix AX8 Diagnostic Ultrasound System
• Applicant: Edan Instruments, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 31, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

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 (e.g., emergency departments, interventional procedures, mobile imaging). Inputs: ultrasound signals from various transducers (convex, linear, endocavity-micro convex, phased array). Operation: applies high-voltage bursts to piezoelectric materials; detects reflected echoes; processes signals using multi-beam-forming, speckle resistance imaging (eSRI), frequency compounding, and spatial compounding. Outputs: real-time ultrasound images on 15-inch LCD display; touch screen/trackpad interface for parameter adjustment. Clinicians use images for diagnostic evaluation and fluid flow analysis; needle visualization feature assists in interventional procedures. Benefits: provides stable, clear imaging for rapid clinical decision-making in diverse settings.

Clinical Evidence

Bench testing only. No clinical data required. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993 biocompatibility standards demonstrated. Acoustic output testing performed per FDA guidance.

Technological Characteristics

Portable laptop form factor; 128-channel architecture. Piezoelectric transducer sensing; 2.5-15.0 MHz frequency range. Modes: B, M, PW, CW, Color, PDI/DPDI. Connectivity: 15-inch LCD, 10-inch touch screen, 5-inch trackpad. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for ultrasound evaluations in adults, pregnant women, and pediatric patients. Clinical applications include abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal, and cardiac imaging.

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

• Acclarix AX8 Diagnostic ultrasound system (K150999)
• U50 Diagnostic ultrasound system (K142511)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure in profile, with three overlapping heads. The logo is black and white.

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

May 31, 2016

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

Re: K161300

Trade/Device Name: Acclarix AX8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX, IYN Dated: May 5, 2016 Received: May 9, 2016

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 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 Ocks

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K161300

#### Device Name

Acclarix AX8 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)

|× Prescription Use (Part 21 CFR 801 Subpart D)

_ | Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

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

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

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

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

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| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | 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 | | | | | | | |
| | Small Organ (Specify) * | P | P | P | | P | P | P |
| | 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) | 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 | Peripheral vascular | P | P | P | | P | P | P |
| vascular | Other (Specify) | | | | | | | |

#### Acclarix AX8 Diagnostic Ultrasound System

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 demonstrates contrast agents. |

[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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| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][ ] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | N | N | N | | N | N | N |
| | Abdominal | N | N | N | | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | 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) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | N | N | N | | N | N | N |
| | Adult Cardiac | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |

## Acclarix AX8 with C5-2Q Transducer

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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| | 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) ** | N | N | N | N | N | N | N |
| | 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) | | | | | | | |

#### Acclarix AX8 with L12-5Q Transducer

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.

[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)

{7}------------------------------------------------

### Acclarix AX8 with MC8-4Q 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<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) * | | | | | | | |
| Fetal<br>Imaging | Neonatal Cephalic | | | | | | | |
| & Other | 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) | | | | | | | |

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+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}------------------------------------------------

| | 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) * | P | P | P | | P | P | P |
| Fetal<br>Imaging<br>& 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) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | P | P |
| vascular | Other (Specify) | | | | | | | |

#### Acclarix AX8 with L10-4Q Transducer

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)

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

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

### Acclarix AX8 with E8-4Q Transducer

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)

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

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

#### Acclarix AX8 with L17-7HQ Transducer

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)

Prescription Use (Per 21 CFR 801.109)

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| | 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 | 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<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | P | P | P | P |
| | Adult Cardiac | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |

### Acclarix AX8 with C5-2XQ Transducer

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

#### Acclarix AX8 with P5-1XQ Transducer

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)

{13}------------------------------------------------

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

#### Acclarix AX8 with L17-7SQ Transducer

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)

Concurrence of Center for Devices and Radiological Health (CDRH)

{14}------------------------------------------------

## 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: | Erico Li | | |
| Date prepared: | April 28, 2016 | | |
| 2. Device name<br>and classification: | Device Name: Diagnostic Ultrasound System | | |
| | Model: Acclarix AX8 | | |
| | Classification Name: | | |
| | 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic<br>Product code: IYN | | |
| | 892.1560 Ultrasonic, Pulsed echo, Imaging<br>Product code: IYO | | |
| | 892.1570 Transducer, Ultrasonic, Diagnostic<br>Product code: ITX | | |
| | Regulatory Class: Class II | | |
| 3.Premarket<br>Notification Class<br>III Certification<br>and Summary | Not applicable, the subject device is Class II. | | |
| 4. Predicate<br>Device(s): | Acclarix AX8 Diagnostic ultrasound system/ K150999/ Shenzhen Edan<br>Instruments, Inc. | | |
| | U50 Diagnostic ultrasound system/ K142511/ Shenzhen Edan<br>Instruments, Inc. | | |
| 5. Reason for<br>Submission | Modification for previous cleared product Diagnostic ultrasound system,<br>model Acclarix AX8. | | |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. | | |

{15}------------------------------------------------

| 7. Device<br>Description: | The Acclarix AX8 is a portable laptop diagnostic ultrasound system,<br>intended for use by a qualified physician or sonographer for ultrasound<br>evaluation in Point of Care environments such as Emergency<br>Departments, Interventional procedures and mobile imaging centers,<br>which applies advanced technologies such as HPRF, Dual screen<br>display, Panorama, Spatial Compounding Imaging, Frequency<br>Compounding Imaging, Multi-Beam-Forming, Speckle Resistance<br>Imaging (eSRI), One-Key Optimization, B-Steer, Digital Zoom, Needle<br>Visualization, etc. Various image parameter adjustments, 15 inch LCD<br>display with 10 inch touch screen and 5 inch track pad and diverse<br>probes are configured to acquire and display clear and stable ultrasound<br>images. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8. Intended Use: | The Edan Acclarix AX8 Ultrasound System is intended for use by a<br>qualified physician or allied health professional for ultrasound<br>evaluations. Specific clinical applications include: Abdominal,<br>Gynecology (including endovaginal), Obstetric, Cardiac, Small parts<br>(Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral<br>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 tables:

| Item | Acclarix AX8 r1.2 Diagnostic<br>Ultrasound System<br>(Edan Instruments) | Acclarix AX8 r.10 Diagnostic<br>Ultrasound System<br>(Edan Instruments) | Comparison<br>Result |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K150999 | - |
| Intended Use | Diagnostic ultrasound imaging<br>or fluid flow analysis of the<br>human body | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | Same |
| Indications for<br>Use | The Edan Acclarix AX8<br>Ultrasound System is intended<br>for use by a qualified physician<br>or allied health professional for<br>ultrasound evaluations. Specific<br>clinical applications include:<br>Abdominal, Gynecology<br>(including endovaginal),<br>Obstetric, Cardiac, Small parts<br>(Breast, Testes, Thyroid, etc.),<br>Urology, Musculoskeletal,<br>Peripheral vascular, and<br>Intra-operative. | The Edan Acclarix AX8<br>Ultrasound System is intended for<br>use by a qualified physician or<br>allied health professional for<br>ultrasound evaluations. Specific<br>clinical applications include:<br>Abdominal, Gynecology<br>(including endovaginal),<br>Obstetric, Cardiac, Small parts<br>(Breast, Testes, Thyroid, etc.),<br>Urology, Musculoskeletal,<br>Peripheral vascular, and<br>Intra-operative. | Same |
| Installation and<br>Use | Portable (laptop)<br>Mobile Equipment | Portable (laptop)<br>Mobile Equipment | Same |
| Design | 128 channel | 128 channel | Same |

{16}------------------------------------------------

| Safety Standards | IEC 60601-1 | IEC 60601-1 | Same |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | IEC 60601-1-2 | IEC 60601-1-2 | |
| | IEC 60601-2-37 | IEC 60601-2-37 | |
| | ISO 10993-1, -5, -10, -12 | ISO 10993-1, -5, -10, -12 | |
| | AIUM, NEMA UD 2, UD 3 | AIUM, NEMA UD 2, UD 3 | |
| Patient Contact<br>Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Mode of<br>Operations | B-Mode, M-Mode, Color,<br>PDI/DPDI, PW, CW | B-Mode, M-Mode, Color,<br>PDI/DPDI, PW, CW | Same |
| Measurements | B-Mode: Distance, Circ/Area,<br>Angle, Volume, Stenosis ratio | B-Mode: Distance, Circ/Area,<br>Angle, Volume, Stenosis ratio | Same |
| | M-Mode: Distance, Time, Slope<br>and Heart Rate | M-Mode: Distance, Time, Slope<br>and Heart Rate | |
| | D-Mode: Velocity, RI, Time, PI,<br>Heart Rate, Auto Trace<br>PG, S/D, ΔV, Acceleration, PHT,<br>VTI | D-Mode: Velocity, RI, Time, PI,<br>Heart Rate, Auto Trace<br>PG, S/D, ΔV, Acceleration, PHT,<br>VTI | |
| Principle of<br>Operation | Applying high voltage burst to<br>the Piezoelectric material in the<br>transducer and detect reflected<br>echo to construct diagnostic<br>image | Applying high voltage burst to the<br>Piezoelectric material in the<br>transducer and detect reflected<br>echo to construct diagnostic<br>image | Same |
| Acoustic Output | Track 3: MI, TIS, TIC, TIB (TI<br>Range 0-6.0)<br>Derated ISPTA: 720W/cm2<br>maximum,<br>Mechanic Index ≤ 1.9<br>maximum or Derated ISPPA 190<br>W/cm2 max<br>Ophthalmic use:<br>TI = Max (TIS_as, TIC) ≤1;<br>ISPTA.3 ≤ 50m/W/cm2; and MI<br>< 0.23 | Track 3: MI, TIS, TIC, TIB (TI<br>Range 0-6.0)<br>Derated ISPTA: 720W/cm2<br>maximum,<br>Mechanic Index ≤ 1.9<br>maximum or Derated ISPPA 190<br>W/cm2 max<br>Ophthalmic use:<br>TI = Max (TIS_as, TIC) ≤1;<br>ISPTA.3 ≤ 50m/W/cm2; and MI ≤<br>0.23 | Same |
| Transducer<br>Types | Convex Array<br>Linear Array<br>Endocavity-Micro Convex Array<br>Phased Array | Convex Array<br>Linear Array<br>Endocavity-Micro Convex Array<br>Phased Array | Same |
| Transducer<br>Frequency…