(37 days)
INTENDED USE OF THE COMFY Hibt THE WHEEL CHAIR MODEL I is desiGNED THE USER A CHANGE IN SITTING A SCENDED THE Fully EXTENDED ELEVATION.
Not Found
The provided text is a 510(k) summary for a manual wheelchair. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML-driven device.
Therefore, I cannot populate the requested table and answer the following questions:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on the administrative aspects of FDA clearance for a mechanical device (a manual wheelchair), including its identity, classification, and substantial equivalence to legally marketed predicate devices. It does not involve any AI/ML components or performance metrics typically associated with such technologies.
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SEP 1 3 2002
510K Summary
510K Document Number: (Awaiting FDA Approval)
| Date Prepared: | May 28, 2002 |
|---|---|
| Applicant: | Lenjoy Medical Engineering, Inc.13112 Crenshaw Blvd.Gardena, CA 90249 |
| Telephone Number: | 310-353-2481800-582-5332 |
| Fax Number: | 310-353-2484 |
| E-Mail Address: | lenjoy99@aol.com |
| Contact Person: | Leah Rotter / President |
| Device Trade Name: | Comfy High-Riser Model 1 Manual Wheelchair |
| Device Common Name: | Comfy High-Riser Wheelchair |
| Classification Parrel: | Physical Medicine |
| Classification Name: | Manual Wheelchair |
| Product Code: | 89010R |
| Device Class: | II |
Legally Marketed Devices to which we Claim Substantial Equivalence
Standard Manual Wheelchair (See 510K Designator for predicant devices)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2002
Lenjoy Medical Engineering, Inc. Leah Rotter President 13721 Gramercy Place Gardena, California 90249-2469
Re: K022617
Trade/Device Name: Comfy High Riser Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: July 23, 2002 Received: August 7, 2002
Dear Mr. Rotter:
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. Leah Rotter
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 A. Millbern
for Colin M. Wittwer, Ph.D., M.D.
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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S10(k) Number (if known): __ K022617 Device Name: COMEY Hilott, Rise UHEE CHAIR Indications For Use:
INTENDED USE OF THE COMFY Hibt THE WHEEL CHAIR MODEL I is desiGNED THE USER A CHANGE IN SITTING A SCENDED THE Fully EXTENDED ELEVATION.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
for-Muriel N-Millken
(Optiona
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number
§ 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).