(203 days)
The intended use of the Athena Manual Wheelchair is to provide mobility to a patient restricted to a sitting position. The Athena Manual Wheelchair in not designed, sold, or intended for use except as indicated.
Not Found
The provided text is a 510(k) summary from the FDA for a manual wheelchair called "Athena 190". It is a regulatory document affirming substantial equivalence to a predicate device, not a performance study report for an AI/ML device. Therefore, it does not contain the information requested regarding acceptance criteria, device performance, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to AI/ML devices.
The document states:
- Trade/Device Name: Athena 190
- Regulation Name: Mechanical Wheelchair
- Regulatory Class: Class I
- Product Code: IOR
- Indications for Use: To provide mobility to a patient restricted to a sitting position.
Since the device is a mechanical wheelchair and not an AI/ML diagnostic or assistive technology, the standard acceptance criteria and study designs typically applied to AI/ML devices (e.g., sensitivity, specificity, AUC, human reader improvement) are not applicable or described in this type of regulatory submission. The FDA's 510(k) clearance process for a Class I mechanical device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective as the existing one. This typically involves performance testing related to physical properties and safety rather than diagnostic accuracy or human-AI interaction in a clinical reading environment.
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May 17, 2018
Medical Rehab Products, LLC Brad Evans Production Manager PO Box 1182 Montreat, North Carolina 28757
Re: K173360
Trade/Device Name: Athena 190 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: Mav 8, 2018 Received: May 10, 2018
Dear Brad Evans:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
VivekJ. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173360
Device Name Athena 190
Indications for Use (Describe)
The intended use of the Athena Manual Wheelchair is to provide mobility to a patient restricted to a sitting position. The Athena Manual Wheelchair in not designed, sold, or intended for use except as indicated.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).