Acclarix AX4 Diagnostic Ultrasound System

K171900 · Edan Instruments, Inc. · IYN · Aug 18, 2017 · Radiology

Device Facts

• Record ID: K171900
• Device Name: Acclarix AX4 Diagnostic Ultrasound System
• Applicant: Edan Instruments, Inc.
• Product Code: IYN · Radiology
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Edan Acclarix AX4 Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: • Abdominal • Gynecology (including endovaginal) • Obstetric • Cardiac • Small parts (Breast, Testes, Thyroid, etc.) • Urology • Musculoskeletal • Peripheral vascular • Intra-operative • Pediatric • Neonatal (including abdominal and cephalic) • Adult Cephalic

Device Story

Portable laptop-based diagnostic ultrasound system; used in point-of-care environments (emergency departments, interventional procedures, mobile imaging centers) by physicians or sonographers. Operates by applying high-voltage bursts to piezoelectric transducer elements; detects reflected echoes to construct diagnostic images. Supports B-mode, M-mode, Color, PDI/DPDI, PW, CW, and 3D/4D modes. Features include spatial/frequency compounding, speckle resistance imaging (eSRI), needle visualization, and auto-IMT. Output displayed on integrated screen for real-time clinical assessment; assists in diagnosis and procedural guidance. Benefits include portable, high-resolution imaging for rapid clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), acoustic output (IEC 60601-2-37, NEMA UD 3), and biocompatibility (ISO 10993).

Technological Characteristics

Portable laptop form factor; 64-channel beamforming; piezoelectric transducers (1-17 MHz). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3, and ISO 10993. Modes: B, M, PW, CW, Color, PDI/DPDI, 3D/4D. Features: spatial/frequency compounding, eSRI, needle visualization, auto-IMT.

Indications for Use

Indicated for ultrasound evaluations in patients requiring diagnostic imaging or fluid flow analysis, including abdominal, gynecological, obstetric, cardiac, small parts, urological, musculoskeletal, peripheral vascular, intra-operative, pediatric, neonatal, and adult cephalic applications.

Regulatory Classification

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.

Predicate Devices

• Acclarix AX8 Diagnostic Ultrasound System (K171824)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

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

August 18, 2017

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

Re: K171900

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

Dear Mr. Worth:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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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][4] |
| | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | P | P |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative (Specify) | P | P | P | | P | P | P |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Specify) * | P | P | P | | P | P | P |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | | P | P | P |
| | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | | P | P | P |
| | Adult Cardiac | P | P | P | P | P | P | P |
| Cardiac | Pediatric Cardiac | P | P | P | P | P | P | P |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | P | P | P |
| vascular | Other (Specify) | | | | | | | |

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

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

* Small Organ includes Thyroid, Testes, Breast Note

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

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Concurrence of Center for Devices and Radiological Health (CDRH)

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### Acclarix AX4 with C5-2Q Transducer

| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|------------|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<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) | 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. |

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

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

* Small Organ includes Thyroid, Testes, Breast. Note

** Other use includes Urology.

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

[2]: Biopsy Guidance

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

(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 MC8-4Q Transducer

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | | 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 | P | P | P | | P | P | P |
| | Small Organ (Specify) * | | | | | | | |
| Fetal<br>Imaging<br>& 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.

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

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### Acclarix AX4 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 | 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.

(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 P5-1Q 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<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Adult Cardiac | N | N | N | N | N | N | N |
| | Pediatric Cardiac | N | N | N | N | N | N | N |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<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)

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### Acclarix AX4 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) | P | P | P | P | P | P | P |
| | 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) | P | P | P | P | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | P | P | P | P |
| | Other (Specify) | | | | | | | |

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

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

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

(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<br>(Specify) [1] | Other<br>(Specify) [2][3][4] |
| | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | 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) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

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

Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

[4]: 3D/4D

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

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

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

### 9. Predicate Device Comparison

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

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

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

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| Item | Acclarix AX4 | Acclarix AX8 R1.3 Diagnostic<br>Ultrasound System<br>(Edan Instruments) | Comparison<br>Result |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Intra-operative, Pediatric and<br>Neonatal (including abdominal and<br>cephalic), Adult Cephalic | (including abdominal and<br>cephalic), and Adult cephalic. | |
| Installation<br>and Use | Portable (laptop)<br>Mobile Equipment | Portable (laptop)<br>Mobile Equipment | Same |
| Design | 64 channel | 128 channel | Difference |
| Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-37<br>ISO 10993-1, -5, -10, -12<br>AIUM, NEMA UD 2, UD 3 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-37<br>ISO 10993-1, -5, -10, -12<br>AIUM, NEMA UD 2, UD 3 | Same |
| Patient<br>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, 3D/4D | B-Mode, M-Mode, Color,<br>PDI/DPDI, PW, CW, 3D/4D | same |
| Measurem<br>ents | B-Mode: Distance, Circ/Area, Angle,<br>Volume, Stenosis ratio<br><br>M-Mode: Distance, Time, Slope and<br>Heart Rate<br><br>D-Mode: Velocity, RI, Time, PI,<br>Heart Rate, Auto Trace<br>PG, S/D, ΔV, Acceleration, PHT,<br>VTI | B-Mode: Distance, Circ/Area, Angle,<br>Volume, Stenosis ratio<br><br>M-Mode: Distance, Time, Slope and<br>Heart Rate<br><br>D-Mode: Velocity, RI, Time, PI,<br>Heart Rate, Auto Trace<br>PG, S/D, ΔV, Acceleration, PHT,<br>VTI | Same |
| Principle<br>of<br>Operation | Applying high voltage burst to the<br>Piezoelectric material in the<br>transducer and detect reflected echo<br>to construct diagnostic image | Applying high voltage burst to the<br>Piezoelectric material in the<br>transducer and detect reflected echo<br>to construct diagnostic image | Same |
| Acoustic<br>Output | Track 3: MI, TIS, TIC, TIB (TI<br>Range 0-6.0)<br>Derated ISPTA: 720 mW/cm2<br>maximum,<br>Mechanic Index ≤ 1.9 maximum or<br>Derated ISPPA 190 W/cm2 max<br>Ophthalmic use:<br>TI = Max (TIS_as, TIC) ≤1;<br>ISPTA.3 ≤ 50 m/W/cm2; and MI ≤<br>0.23 | Track 3: MI, TIS, TIC, TIB (TI<br>Range 0-6.0)<br>Derated ISPTA: 720 mW/cm2<br>maximum,<br>Mechanic Index ≤ 1.9 maximum or<br>Derated ISPPA 190 W/cm2 max<br>Ophthalmic use:<br>TI = Max (TIS_as, TIC) ≤1;<br>ISPTA.3 ≤ 50 m/W/cm2; and MI ≤<br>0.23 | Same |
| Transducer<br>Types | Convex Array<br>Linear Array<br>Endocavity-Micro Convex Array<br>Phased Array<br>Micro Convex Array | Convex Array<br>Linear Array<br>Endocavity-Micro Convex Array<br>Phased Array<br>Micro Convex Array | Same |
| Transducer<br>Frequency | 1-17 MHz | 1-17 MHz | Same |
| Item | Acclarix AX4 | Acclarix AX8 R1.3 Diagnostic<br>Ultrasound System<br>(Edan Instruments) | Comparison<br>Result |
| Dimensions/ Weight | 407mm (W) x 388mm (L) x77mm (H)<br>Weight: 9.1Kg<br>(with rechargeable battery, without power adaptor or transducers.) | 407mm (W) x 388mm (L) x77mm (H)<br>Weight: 9.1Kg<br>(with rechargeable battery, without power adaptor or transducers.) | Same |
| Power<br>Requirements | 100-240V, 50/60Hz | 100-240V, 50/60Hz | Same |
| Rechargeable Battery | Yes | Yes | Same |
| Features | 3D/4D, CW, HPRF, Dual screen display, Panorama, Spatial Compounding Imaging, Frequency Compounding Imaging,<br>Multi-Beam-Forming, Speckle Resistance Imaging(eSRI),<br>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,<br>Multi-Beam-Forming, Speckle Resistance Imaging(eSRI),<br>One-Key-Optimization, B-Steer, Digital Zoom, Needle Visualization, Auto IMT | Same |

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

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:

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

#### (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.