(22 days)
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
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.
The provided document is a 510(k) premarket notification for the Edan Instruments Acclarix AX8 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical studies against specific acceptance criteria for diagnostic performance.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning advanced diagnostic performance (e.g., sensitivity, specificity, accuracy) for a given clinical task.
Instead, the document highlights:
- Substantial equivalence: The device is claimed to be substantially equivalent to predicate devices (Acclarix AX8 r.10 Diagnostic Ultrasound System/K150999 and U50 Diagnostic Ultrasound System/K142511).
- Compliance with safety and technical standards: The device complies with standards like IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and acoustic output testing guidelines, as well as biocompatibility standards (ISO 10993 series).
- Intended Use and Clinical Applications: The document lists the intended use as "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and specifies various clinical applications (e.g., Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative).
Missing Information:
The document explicitly states: "Clinical testing is not required." This means there is no study presented in this document that would provide acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., nor a study proving the device meets such criteria for a specific clinical task.
Therefore, I cannot provide the following information based on the given text:
- A table of acceptance criteria and the reported device performance: No such criteria or performance metrics for diagnostic effectiveness are detailed.
- Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned as clinical testing was not required.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set is described.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted. The focus is on substantial equivalence to existing devices.
- Standalone performance (algorithm only without human-in-the-loop performance): This is not an AI-driven diagnostic algorithm but a general-purpose ultrasound imaging system, so this concept does not apply in the context of this document.
- Type of ground truth used: Not applicable as diagnostic performance metrics (which require ground truth) are not provided.
- Sample size for the training set: Not applicable as this is not an AI algorithm requiring a training set in the sense of machine learning for diagnostic tasks.
- How the ground truth for the training set was established: Not applicable.
Summary of available information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Substantial Equivalence: Demonstrated "same intended use, similar product design, same performance effectiveness, performance safety as the predicate device" (K150999 and K142511).
- Reported Device Performance:
- Safety Standards Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, -12, AIUM, NEMA UD 2, UD 3.
- 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 < 0.23. (Same as predicate)
- Patient Contact Materials: Complies with ISO 10993. (Same as predicate)
- Modes of Operation: B-Mode, M-Mode, Color, PDI/DPDI, PW, CW. (Same as predicate)
- Measurements: B-Mode: Distance, Circ/Area, Angle, Volume, Stenosis ratio; M-Mode: Distance, Time, Slope and Heart Rate; D-Mode: Velocity, RI, Time, PI, Heart Rate, Auto Trace PG, S/D, ΔV, Acceleration, PHT, VTI. (Same as predicate)
- Transducer Types: Convex Array, Linear Array, Endocavity-Micro Convex Array, Phased Array. (Same as predicate)
- Transducer Frequency: 2.5-15.0 MHz. (Same as predicate)
- Physical Specifications: 407mm (W) x 388mm (L) x 77mm (H), Weight: 9.1Kg (with rechargeable battery, without power adaptor or transducers). (Same as predicate)
- Power Requirements: 100-240V, 50/60Hz. (Same as predicate)
- Rechargeable Battery: Yes. (Same as predicate)
2. Sample size used for the test set and the data provenance:
- None provided for diagnostic performance as "Clinical testing is not required."
- "Non-clinical test" references compliance with electrical safety, EMC, acoustic output, and biocompatibility standards. The document does not specify sample sizes or data provenance for these technical tests in detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable, as no clinical test set for diagnostic performance requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set for diagnostic performance is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This is a general ultrasound system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This defines the capabilities of the ultrasound system itself, not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. Diagnostic performance metrics requiring ground truth are not provided.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm in the machine learning sense that requires a training set for diagnostic image analysis.
9. How the ground truth for the training set was established:
- Not applicable.
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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.
{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 | |||||||
| FetalImaging& 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) * | ||||||||
| FetalImaging& 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 | |
| FetalImaging& 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) * | ||||||||
| FetalImaging | 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 | ||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| 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 | |||||||
| FetalImaging& 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(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 | ||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| 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) * | ||||||||
| FetalImaging& 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. |
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] | |
| General | Ophthalmic | |||||||
| FetalImaging& 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 | ||||||||
| Peripheralvascular | 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 | |||||||
| FetalImaging& 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 | ||||||||
| Peripheralvascular | 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)
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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 nameand classification: | Device Name: Diagnostic Ultrasound System | ||
| Model: Acclarix AX8 | |||
| Classification Name: | |||
| 892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN | |||
| 892.1560 Ultrasonic, Pulsed echo, ImagingProduct code: IYO | |||
| 892.1570 Transducer, Ultrasonic, DiagnosticProduct code: ITX | |||
| Regulatory Class: Class II | |||
| 3.PremarketNotification ClassIII Certificationand Summary | Not applicable, the subject device is Class II. | ||
| 4. PredicateDevice(s): | Acclarix AX8 Diagnostic ultrasound system/ K150999/ Shenzhen EdanInstruments, Inc. | ||
| U50 Diagnostic ultrasound system/ K142511/ Shenzhen EdanInstruments, Inc. | |||
| 5. Reason forSubmission | Modification for previous cleared product Diagnostic ultrasound system,model Acclarix AX8. | ||
| 6. Pre-Submission,IDE | Not applicable, there is no prior submission. |
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| 7. DeviceDescription: | The Acclarix AX8 is a portable laptop diagnostic ultrasound system,intended for use by a qualified physician or sonographer for ultrasoundevaluation in Point of Care environments such as EmergencyDepartments, Interventional procedures and mobile imaging centers,which applies advanced technologies such as HPRF, Dual screendisplay, Panorama, Spatial Compounding Imaging, FrequencyCompounding Imaging, Multi-Beam-Forming, Speckle ResistanceImaging (eSRI), One-Key Optimization, B-Steer, Digital Zoom, NeedleVisualization, etc. Various image parameter adjustments, 15 inch LCDdisplay with 10 inch touch screen and 5 inch track pad and diverseprobes are configured to acquire and display clear and stable ultrasoundimages. |
|---|---|
| 8. Intended Use: | The Edan Acclarix AX8 Ultrasound System is intended for use by aqualified physician or allied health professional for ultrasoundevaluations. Specific clinical applications include: Abdominal,Gynecology (including endovaginal), Obstetric, Cardiac, Small parts(Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheralvascular, 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 DiagnosticUltrasound System(Edan Instruments) | Acclarix AX8 r.10 DiagnosticUltrasound System(Edan Instruments) | ComparisonResult |
|---|---|---|---|
| 510(k) Number | Current Submission | K150999 | - |
| Intended Use | Diagnostic ultrasound imagingor fluid flow analysis of thehuman body | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Same |
| Indications forUse | The Edan Acclarix AX8Ultrasound System is intendedfor use by a qualified physicianor allied health professional forultrasound evaluations. Specificclinical applications include:Abdominal, Gynecology(including endovaginal),Obstetric, Cardiac, Small parts(Breast, Testes, Thyroid, etc.),Urology, Musculoskeletal,Peripheral vascular, andIntra-operative. | The Edan Acclarix AX8Ultrasound System is intended foruse by a qualified physician orallied health professional forultrasound evaluations. Specificclinical applications include:Abdominal, Gynecology(including endovaginal),Obstetric, Cardiac, Small parts(Breast, Testes, Thyroid, etc.),Urology, Musculoskeletal,Peripheral vascular, andIntra-operative. | Same |
| Installation andUse | Portable (laptop)Mobile Equipment | Portable (laptop)Mobile Equipment | Same |
| Design | 128 channel | 128 channel | Same |
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| 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 ContactMaterials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Mode ofOperations | 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, Slopeand Heart Rate | M-Mode: Distance, Time, Slopeand Heart Rate | ||
| D-Mode: Velocity, RI, Time, PI,Heart Rate, Auto TracePG, S/D, ΔV, Acceleration, PHT,VTI | D-Mode: Velocity, RI, Time, PI,Heart Rate, Auto TracePG, S/D, ΔV, Acceleration, PHT,VTI | ||
| Principle ofOperation | Applying high voltage burst tothe Piezoelectric material in thetransducer and detect reflectedecho to construct diagnosticimage | Applying high voltage burst to thePiezoelectric material in thetransducer and detect reflectedecho to construct diagnosticimage | Same |
| Acoustic Output | Track 3: MI, TIS, TIC, TIB (TIRange 0-6.0)Derated ISPTA: 720W/cm2maximum,Mechanic Index ≤ 1.9maximum or Derated ISPPA 190W/cm2 maxOphthalmic use:TI = Max (TIS_as, TIC) ≤1;ISPTA.3 ≤ 50m/W/cm2; and MI< 0.23 | Track 3: MI, TIS, TIC, TIB (TIRange 0-6.0)Derated ISPTA: 720W/cm2maximum,Mechanic Index ≤ 1.9maximum or Derated ISPPA 190W/cm2 maxOphthalmic use:TI = Max (TIS_as, TIC) ≤1;ISPTA.3 ≤ 50m/W/cm2; and MI ≤0.23 | Same |
| TransducerTypes | Convex ArrayLinear ArrayEndocavity-Micro Convex ArrayPhased Array | Convex ArrayLinear ArrayEndocavity-Micro Convex ArrayPhased Array | Same |
| TransducerFrequency | 2.5-15.0 MHz | 2.5-15.0 MHz | Same |
| Dimensions/Weight | 407mm (W) x 388mm (L)x77mm (H)Weight: 9.1Kg(with rechargeable battery,without power adaptor ortransducers.) | 407mm (W) x 388mm (L)x77mm (H)Weight: 9.1Kg(with rechargeable battery,without power adaptor ortransducers.) | Same |
| PowerRequirements | 100-240V, 50/60Hz | 100-240V, 50/60Hz | Same |
| RechargeableBattery | Yes | Yes | Same |
{17}------------------------------------------------
| Table 9-2: Comparison between the subject Acclarix AX8 and U50 | |||||
|---|---|---|---|---|---|
| Item | Acclarix AX8 r1.2 DiagnosticUltrasound System(Edan Instruments) | U50 Diagnostic UltrasoundSystem(Edan Instruments) | ComparisonResult | ||
| 510(k) Number | Current Submission | K142511 | - | ||
| Intended Use | Diagnostic ultrasound imagingor fluid flow analysis of thehuman body | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Same | ||
| Indications forUse | The Edan Acclarix AX8Ultrasound System is intendedfor use by a qualified physicianor allied health professional forultrasound evaluations. Specificclinical applications include:Abdominal, Gynecology(including endovaginal),Obstetric, Cardiac, Small parts(Breast, Testes, Thyroid, etc.),Urology, Musculoskeletal,Peripheral vascular, andIntra-operative. | The diagnostic ultrasound system(U50) is applicable for adults,pregnant women, pediatricpatients' ultrasound evaluation inhospitals and clinics. It isintended for use in abdominal,obstetrics, gynecology, pediatric,small parts, urology, peripheralvascular, musculoskeletal(conventional and superficial),endovaginal and cardiac clinicalapplications, by or on the order ofa physician or similarly qualifiedhealth care professional. | Difference | ||
| 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 | ||||
| TransducerNeedle Guideadaptors | Mechanical Needle guideadaptors which clip ontransducer to provide a fixedangle of insertion for needle | Mechanical Needle guideadaptors which clip on transducerto provide a fixed angle ofinsertion for needle | Same |
Comparison between the subject Acclarix AX8 and U50 Table 9-2:
The subject device has similar intended use, similar product design, and same performance effectiveness, as the predicate device. There are no significant differences between the primary predicate, nor the reference device. There are no new questions of safety and/or effectiveness. There are no changes to the intended use, indications for use, nor fundamental scientific technology.
10. Effectiveness and Safety Considerations:
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
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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.
11. Substantially Equivalent Determination
Verification and validation testing has been conducted on the Acclarix AX8 Ultrasound Imaging System. This premarket notification submission demonstrates that Acclarix AX8 Ultrasound Imaging System is substantially equivalent to the predicate devices.
§ 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.