(21 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, following Track 3 for all applications in the 510(k) submission.
The provided text is a 510(k) summary for the Edan Acclarix Diagnostic Ultrasound System. It details the device's indications for use and compares it to predicate devices. However, this document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.
The document states:
- "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. The tests were selected to show substantial equivalence between the subject device and the predicate."
This indicates that the device's equivalence to existing devices was established through adherence to recognized electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility standards, rather than through specific performance metrics outlined in a clinical or detailed non-clinical study for acceptance criteria.
Therefore, I cannot provide the requested information because it is not present in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through compliance with general safety and performance standards, not through detailed acceptance criteria with reported device performance figures from a specific study.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized emblem with three abstract human profiles facing right, stacked on top of each other. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2015
Edan Instruments, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K150999
Trade/Device Name: Acclarix Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 14, 2015 Received: April 15, 2015
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{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 A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K150999
Device Name Acclarix Diagnostic Ultrasound System
Indications for Use (Describe)
The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:
Abdominal Gynecology (including endovaginal) Obstetric Cardiac Small parts (Breast, Testes, Thyroid, etc.) Urology Musculoskeletal Peripheral vascular Intra-operative
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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{4}------------------------------------------------
Acclarix AX8 Diagnostic Ultrasound System
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | N | N | N | N | N | N | ||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | N | N | N | N | N | N | ||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | N | ||
| Trans-vaginal | N | N | N | N | N | N | ||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | ||
| Intravascular | ||||||||
| Other (Specify) ** | N | N | N | N | N | N | ||
| Adult Cardiac | N | N | N | N | N | N | N | |
| Cardiac | Pediatric Cardiac | N | N | N | N | N | N | N |
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | N | N | N | N | N | N | |
| vascular | Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PD//DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast - Caracter - Career - Career - Career - Career
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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Acclarix AX8 with L10-4Q Transducer
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(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) ** | ||||||||
| Adult Cardiac | ||||||||
| Cardiac | Pediatric Cardiac | |||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | N | N | N | N | N | N | N |
| vascular | Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast. Note
| ** Other use includes Urology, Gynecology. | ||
|---|---|---|
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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Acclarix AX8 with E8-4Q Transducer
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | N | N | N | N | N | N | ||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal | Neonatal Cephalic | |||||||
| Imaging& Other | Adult Cephalic | |||||||
| Trans-rectal | N | N | N | N | N | N | ||
| Trans-vaginal | N | N | N | N | N | N | ||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{7}------------------------------------------------
Acclarix AX8 with L17-7HQ Transducer
| 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) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | N | N | N | N | N | N | N |
| vascular | Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast
| ** Other use includes Urology, Gynecology | ||||
|---|---|---|---|---|
| ------------------------------------------- | -- | -- | -- | -- |
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{8}------------------------------------------------
Acclarix AX8 with C5-2XQ Transducer
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal | Small Organ (Specify) * | |||||||
| Imaging | Neonatal Cephalic | |||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | N | N | N | N | N | N | N | |
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
- Small Organ includes Thyroid, Testes, Breast Note
| ** Other use includes Urology, Gynecology | ||
|---|---|---|
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{9}------------------------------------------------
Acclarix AX8 with P5-1XQ Transducer
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| FetalImaging& Other | Small Organ (Specify) * | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | N | N | N | N | N | N | N | |
| Cardiac | Pediatric Cardiac | N | N | N | N | N | N | N |
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M,B+PW,B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
「2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{10}------------------------------------------------
Acclarix AX8 with L17-7SQ Transducer
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined(Specify) [1] | Other(Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | N | N | N | N | N | N | ||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheralvascular | Peripheral vascular | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast
| ** Other use includes Urology, Gynecology | |
|---|---|
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{11}------------------------------------------------
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc. | ||||
|---|---|---|---|---|---|
| 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou,Nanshan Shenzhen, 518067 P.R. China | |||||
| Tel .: (0755) 26858739 | |||||
| Fax: +1 (408) 418-4059 | |||||
| Contact Person: | Queena Chen | ||||
| Date prepared: | May 4, 2015 | ||||
| 2. Device nameand classification: | Device Name: Diagnostic Ultrasound SystemModel: Acclarix AX8 | ||||
| Classification Name: | |||||
| System, Imaging, Pulsed Doppler, Ultrasonic892.1550 | |||||
| Product code: IYN | |||||
| Ultrasonic, Pulsed echo, Imaging892.1560 | |||||
| Product code: IYO | |||||
| 892.1570Transducer, Ultrasonic, Diagnostic | |||||
| Product code: ITX | |||||
| Regulatory Class: Class II | |||||
| 3.PremarketNotification ClassIII Certificationand Summarv | Not applicable, the subject device is Class II. | ||||
| 4. PredicateDevice(s): | U50 Diagnostic ultrasound system/ K123249/ Shenzhen EDANInstruments CO., Ltd | ||||
| M7 Diagnostic Ultrasound System / K131690/ Shenzhen MindrayBio-medical Electronics Co., Ltd | |||||
| 5. Reason forSubmission | Acclarix AX8 is a new device. | ||||
| 6. Pre-Submission,IDE | Not applicable, there is no prior submissions. |
{12}------------------------------------------------
- The Acclarix AX8 is a portable laptop diagnostic ultrasound system, 7. Device intended for use by a qualified physician or sonographer for ultrasound Description: evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers, which applies advanced technologies such as HPRF. Dual screen display, Panorama, Spatial Compounding Imaging, Frequency Compounding Imaging, Multi-Beam-Forming, Speckle Resistance Imaging (eSRI), One-Key Optimization, B-Steer, Digital Zoom, Needle Visualization, etc. Various image parameter adjustments, 15 inch LCD display with 10 inch touch screen and 5 inch track pad and diverse probes are configured to acquire and display clear and stable ultrasound images, following Track 3 for all applications in the 510(k) submission.
- The Edan Acclarix AX8 Ultrasound System is intended for use by a 8. Intended Use: qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal, Gynecology (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral vascular, and Intra-operative.
9. Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table:
| Item | Acclarix AX8 Ultrasound Imaging System (Edan Instruments) | U50 Diagnostic Ultrasound System (Edan Instruments) | M7 Diagnostic Ultrasound System (Shenzhen Mindray) |
|---|---|---|---|
| 510(k) Number | Current Submission | K123249 | K131690 |
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Same | Same |
| Item | Acclarix AX8UltrasoundImaging System(EdanInstruments) | U50 DiagnosticUltrasoundSystem(EdanInstruments) | M7 Diagnostic UltrasoundSystem(Shenzhen Mindray) |
| Indicationsfor Use | The AcclarixAX8 UltrasoundImaging Systemis intended foruse by aqualifiedphysician orsonographer forultrasoundevaluation.Clinicalapplicationsinclude:Abdominal,Gynecology(includingendovaginal),Obstetric,Cardiac, Smallparts (Breast,Testes, Thyroid,etc.), Urology,Musculoskeletal,Peripheralvascular, andIntra-operative. | The diagnosticultrasoundsystem (U50) isapplicable foradults, pregnantwomen,pediatricpatients'ultrasoundevaluation inhospitals andclinics. It isintended for usein abdominal,obstetrics,gynecology,pediatric, smallparts, urology,peripheralvascular,musculoskeletal(conventionaland superficial),endovaginaland cardiacclinicalapplications, byor on the orderof a physicianor similarlyqualified healthcareprofessional. | The M7/M7T diagnosticultrasound system is applicable foradults, pregnant women, pediatricpatients and neonates. It isintended for use in gynecology,obstetric, abdominal, pediatric,small parts (breast, testes, thyroid),neonatal cephalic, transcranial,cardiac, transvaginal, transrectal,peripheral vascular, urology,orthopedic, and musculoskeletal(conventional and superficial),intraoperative and transesophageal(cardiac) exams. |
| Installationand Use | Portable (laptop)MobileEquipment | Same | Same |
| Item | Acclarix AX8UltrasoundImaging System(EdanInstruments) | U50 DiagnosticUltrasoundSystem(EdanInstruments) | M7 Diagnostic UltrasoundSystem(Shenzhen Mindray) |
| SafetyStandards | IEC 60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1, -5,-10, -12AIUM, NEMAUD 2, UD 3 | Same | Same |
| PatientContactMaterials | Complies withISO 10993 | Same | Same |
| Mode ofOperations | B-Mode.,M-Mode, Color,PDI/DPDI, PW,CW | Same | B-Mode, M-Mode, Color,PDI/DPDI, PW, CW Smart 3D,Static 3D, 4D, iScape, and TDI |
| Measurements | B-Mode:Distance,Circ/Area,Angle, Volume,StenosisM-Mode:Distance, Time,Slope and HeartRateD-Mode:Velocity, RI,Time, PI, HeartRate, Auto TracePG, S/D, AV,Acceleration,PHT, VTI | B-Mode:Distance, Area,Volume, Ratio,Histogram andAngleM-Mode: SameD- Mode:Time, HeartRate, Velocity,Acceleration,RI, RI and Autotrace | B-Mode: Distance, Depth, Angle,Are, Volume, Cross Line, ParallelLine, Trace Length, Distance,Ratio, Area Ratio, B HistogramM-Mode: SameD-Mode: Time, HR, D Velocity,Acceleration, D Trace, PS/ED |
| Principle ofOperation | Applying highvoltage burst tothe Piezoelectricmaterial in thetransducer anddetect reflectedecho to constructdiagnostic image | Same | Same |
| Item | Acclarix AX8 | U50 Diagnostic | M7 Diagnostic Ultrasound |
| Ultrasound | Ultrasound | System | |
| Imaging System | System | (Shenzhen Mindray) | |
| (Edan | (Edan | ||
| Instruments) | Instruments) | ||
| Acoustic | Track 3: MI, | Same | Same |
| Output | TIS, TIC, TIB | ||
| (TI Range 0-6.0) | |||
| Derated IspTA: | |||
| 720W/cm² | |||
| maximum, | |||
| Mechanic Index | |||
| < 1.9 maximum | |||
| or Derated Isppa | |||
| 190 W/cm2 max | |||
| Transducer | Convex Array | Same | Convex |
| Types | Linear Array | Linear | |
| Micro Convex | Phased Array | ||
| Array | Transvaginal | ||
| Phased Array | 4D convex | ||
| Pencil probe | |||
| Transducer | 2.5-15.0 MHz | 2.5 - 11.0 MHz | 2.5 – 12.0 MHz |
| Frequency | |||
| Display | Primary Screen: | 12.1 inch LCD | Primary Screen: 15inch |
| 15 inch(1920x1080) | (1024*768) | ||
| Touch Screen: | |||
| 10 inch | |||
| Track Pad: 5 | |||
| inch | |||
| Dimensions/ | 407mm(W)× | 330 mm (W) × | 361mm(H)×357mm(L)×75mm(W) |
| Weight | 388mm(L)× | 320 mm (L) × | Weight: 6.5Kg (including batteries |
| 77mm(H) | 220 mm (H) | and 4D board, no power adapter) | |
| Weight: ≤ 9.1kg | Weight: 7.8 Kg | ||
| (with | |||
| rechargeable | |||
| battery, without | |||
| power adaptor or | |||
| transducers.) | |||
| Power | 100-240V, | Same | Same |
| Requirements | 50/60Hz | Additional 220-240V option when | |
| configured with mobile trolley | |||
| Rechargeable | Yes | Same | Same |
| Battery |
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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 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
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.