(80 days)
The intended use of the IMC- Heartway Model HPS Wheelchair is to provide mobility to adults with the ability to place themselves or be placed in a sitting position and have the capacity to operate a simple hand control.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific criteria for the IMC-Heartway Model HPS Electric Powered Wheelchair.
The document is a 510(k) substantial equivalence determination letter from the FDA. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities. However, it does not detail:
- Acceptance criteria
- Reported device performance
- Sample sizes
- Data provenance
- Number or qualifications of experts
- Adjudication method
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
- Training set sample size
- Ground truth establishment for training set
The "Indications for Use Statement" simply describes the intended user and purpose of the wheelchair, not performance metrics or study results.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2003
Mr. Juan Carlos Rivera President IMC-Heartway, LLC 6140 Mid Metro Drive, Suite 6 Fort Myers, FL 33912
Re: K030432
Trade Name: IMC-Heartway Model HPS Electric Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 22, 2003 Received: April 23, 2003
Dear Mr. Rivera:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Juan Carlos Rivera
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark M. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510K number:
Device Name: Model HPS Electric Powered Wheelchair
The intended use of the IMC- Heartway Model HPS Wheelchair is to Indications For Use: provide mobility to adults with the ability to place themselves or be placed in a sitting position and have the capacity to operate a simple hand control.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | ||
|---|---|---|
| Division of General, Restorative and Neurological Devices | ||
| 510(k) Number | K 030432 | |
| Prescription Use | OR | Over-The-Counter Use |
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).