(22 days)
Not Found
No
The device description lists several advanced imaging technologies, but none are explicitly identified as AI or ML. The "Mentions AI, DNN, or ML" section is marked "Not Found".
No.
This device is described as a "diagnostic ultrasound system" and is intended for "ultrasound evaluations" to acquire and display images, not to treat conditions.
Yes
Explanation: The "Device Description" explicitly states, "The Acclarix AX8 is a portable laptop diagnostic ultrasound system." The "Predicate Device(s)" also refers to it as a "Diagnostic ultrasound system."
No
The device description explicitly states it is a "portable laptop diagnostic ultrasound system" and mentions hardware components like an LCD display, touch screen, track pad, and diverse probes, indicating it is a hardware device with integrated software.
Based on the provided information, the Edan Acclarix AX8 Ultrasound system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The Edan Acclarix AX8 is an ultrasound system. It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) imaging technique.
- Intended Use: The intended use clearly states it's for "ultrasound evaluations" of various anatomical sites within the body.
- Device Description: The description details its function as a "diagnostic ultrasound system" that acquires and displays ultrasound images.
Therefore, because the device operates by imaging structures within the body rather than testing specimens outside the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
For Acclarix AX8 Diagnostic Ultrasound System with C5-2Q Transducer:
Fetal / Obstetrics (N, N, N, , N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
Abdominal (N, N, N, , N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
Other (Specify) ** (N, N, N, , N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
For Acclarix AX8 with L12-5Q Transducer:
Small Organ (Specify) * (N, N, N, N, N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal (Conventional) (N, N, N, N, N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal (Superficial) (N, N, N, N, N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
Other (Specify) ** (N, N, N, N, N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
Peripheral vascular (N, N, N, N, N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
For Acclarix AX8 with MC8-4Q Transducer:
Musculo-skeletal(Conventional) (N, N, N, N, N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal (Superficial) (N, N, N, N, N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
Peripheral vascular (N, N, N, N, N, N, N for B, M, PW, CW, Color, Combined, Other modes respectively)
For Acclarix AX8 with L10-4Q Transducer:
Small Organ (Specify) * (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal(Conventional) (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal (Superficial) (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Peripheral vascular (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
For Acclarix AX8 with E8-4Q Transducer:
Fetal / Obstetrics (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Trans-rectal (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Trans-vaginal (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
For Acclarix AX8 with L17-7HQ Transducer:
Small Organ (Specify) * (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal(Conventional) (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal (Superficial) (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Peripheral vascular (P, P, P, , P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
For Acclarix AX8 with C5-2XQ Transducer:
Fetal / Obstetrics (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Abdominal (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Other (Specify) ** (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
For Acclarix AX8 with P5-1XQ Transducer:
Abdominal (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Adult Cardiac (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Pediatric Cardiac (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
For Acclarix AX8 with L17-7SQ Transducer:
Intra-operative (Specify) (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal(Conventional) (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Musculo-skeletal (Superficial) (P, P, P, P, P, P, P for B, M, PW, CW, Color, Combined, Other modes respectively)
Product codes
IYO, ITX, IYN
Device Description
The Acclarix AX8 is a portable laptop diagnostic ultrasound system, intended for use by a qualified physician or sonographer for ultrasound evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers, 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed echo imaging system
Anatomical Site
Abdominal, Gynecology (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral vascular, Intra-operative.
Also specifically for certain transducers: Fetal / Obstetrics, Trans-rectal, Trans-vaginal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician or allied health professional for ultrasound evaluations. Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical test: Clinical testing is not required.
Non-clinical test: The Acclarix AX8 Ultrasound Imaging System complies with:
- (1) IEC 60601-1 Electrical Safety
- (2) IEC 60601-1-2 Electromagnetic Compatibility
- (3) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated September 9, 2008.
The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5 and ISO 10993-10, ISO 10993-12
The tests were selected to show substantial equivalence between the subject device and the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/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 (800) 638-2041 or (301) 796-7100 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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)
3
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal / Obstetrics | 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)
5
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (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 | ||||||||
| Imaging | ||||||||
| & 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)
6
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | N | N | N | N | N | N | N | |
| Fetal | ||||||||
| Imaging | ||||||||
| & 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 | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal | ||||||||
| 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 | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | P | P | P | P | P | P | ||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| 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 | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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)
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PW | CW | Color | Combined | ||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | P | P | P | P | P | P | ||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| 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)
11
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| 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 | ||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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 | ||||||||
| 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)
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PW | CW | Color | Combined | ||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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 | ||||||||
| 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)
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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, | |||
| Nanshan Shenzhen, 518067 P.R. China | |||
| Tel.: (0755) 26858739 | |||
| Fax: +1 (408) 418-4059 | |||
| Contact Person: | Erico Li | ||
| Date prepared: | April 28, 2016 | ||
| 2. Device name | |||
| and classification: | Device Name: Diagnostic Ultrasound System | ||
| Model: Acclarix AX8 | |||
| Classification Name: | |||
| 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic | |||
| Product code: IYN | |||
| 892.1560 Ultrasonic, Pulsed echo, Imaging | |||
| Product code: IYO | |||
| 892.1570 Transducer, Ultrasonic, Diagnostic | |||
| Product code: ITX | |||
| Regulatory Class: Class II | |||
| 3.Premarket | |||
| Notification Class | |||
| III Certification | |||
| and Summary | Not applicable, the subject device is Class II. | ||
| 4. Predicate | |||
| Device(s): | Acclarix AX8 Diagnostic ultrasound system/ K150999/ Shenzhen Edan | ||
| Instruments, Inc. | |||
| U50 Diagnostic ultrasound system/ K142511/ Shenzhen Edan | |||
| Instruments, Inc. | |||
| 5. Reason for | |||
| Submission | Modification for previous cleared product Diagnostic ultrasound system, | ||
| model Acclarix AX8. | |||
| 6. Pre-Submission, | |||
| IDE | Not applicable, there is no prior submission. |
15
| 7. Device
Description: | The Acclarix AX8 is a portable laptop diagnostic ultrasound system,
intended for use by a qualified physician or sonographer for ultrasound
evaluation in Point of Care environments such as Emergency
Departments, Interventional procedures and mobile imaging centers,
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. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8. 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, 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
Ultrasound System
(Edan Instruments) | Acclarix AX8 r.10 Diagnostic
Ultrasound System
(Edan Instruments) | Comparison
Result |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | Current Submission | K150999 | - |
| Intended Use | Diagnostic ultrasound imaging
or fluid flow analysis of the
human body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Same |
| Indications for
Use | The Edan Acclarix 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, and
Intra-operative. | 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, and
Intra-operative. | Same |
| Installation and
Use | Portable (laptop)
Mobile Equipment | Portable (laptop)
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 | |||
| Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Mode of | |||
| Operations | B-Mode, M-Mode, Color, | ||
| PDI/DPDI, PW, CW | B-Mode, M-Mode, Color, | ||
| PDI/DPDI, PW, CW | Same | ||
| Measurements | B-Mode: Distance, Circ/Area, | ||
| Angle, Volume, Stenosis ratio | B-Mode: Distance, Circ/Area, | ||
| Angle, Volume, Stenosis ratio | Same | ||
| M-Mode: Distance, Time, Slope | |||
| and Heart Rate | M-Mode: Distance, Time, Slope | ||
| and Heart Rate | |||
| D-Mode: Velocity, RI, Time, PI, | |||
| Heart Rate, Auto Trace | |||
| PG, S/D, ΔV, Acceleration, PHT, | |||
| VTI | D-Mode: Velocity, RI, Time, PI, | ||
| Heart Rate, Auto Trace | |||
| PG, S/D, ΔV, Acceleration, PHT, | |||
| VTI | |||
| Principle of | |||
| Operation | Applying high voltage burst to | ||
| the Piezoelectric material in the | |||
| transducer and detect reflected | |||
| echo to construct diagnostic | |||
| image | Applying high voltage burst to the | ||
| Piezoelectric material in the | |||
| transducer and detect reflected | |||
| echo to construct diagnostic | |||
| image | Same | ||
| Acoustic Output | Track 3: MI, TIS, TIC, TIB (TI | ||
| Range 0-6.0) | |||
| Derated ISPTA: 720W/cm2 | |||
| maximum, | |||
| Mechanic Index ≤ 1.9 | |||
| maximum or Derated ISPPA 190 | |||
| W/cm2 max | |||
| Ophthalmic use: | |||
| TI = Max (TIS_as, TIC) ≤1; | |||
| ISPTA.3 ≤ 50m/W/cm2; and MI |