SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)

• K Number: K022924
• Device Name: SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)
• Manufacturer: OTTO BACK HEALTHCARE, LP
• Date Cleared: 2002-10-17 ( 43 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Manual transportation device for person who are unable to walk or have a . walking impediment, propulsion by an attendant.

Device Description

Manual Wheelchair

AI/ML Overview

This document is a 510(k) submission for a manual wheelchair and does not contain information about the acceptance criteria or a study proving device performance as it relates to AI or software.

The provided text is a 510(k) summary and the FDA's clearance letter for the "Sherpa Mobility System (Manual Wheelchair)." This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the context of advanced algorithms or AI.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document describes a traditional mechanical device (a manual wheelchair) and its regulatory clearance process, not a device involving complex performance metrics tied to AI or specific acceptance criteria for such algorithms.

Specifically, the document lacks the following information:

• A table of acceptance criteria and reported device performance: This is not typically part of a 510(k) summary for a mechanical device like a wheelchair, which focuses on safety and substantial equivalence to a predicate.
• Sample size used for the test set and data provenance: No "test set" in the context of an algorithm is mentioned.
• Number of experts used to establish ground truth: Not applicable to a manual wheelchair.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable as there is no algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: No "training set" in the context of an algorithm is mentioned.
• How the ground truth for the training set was established: Not applicable.

Summary

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OTTO Bock
HEALTH CARE

1622924

OCT 1 7 2002

A COMPANY OF THE OTTO BOCK GROUP

North American Parkway N., Suite 100
Two Carlson Parlsway N., Suite 100
Minneapolis, M., S.J., Suite 100
Tollate 203-533-94664
Toull-fee 1-800-328-91464
Bourfree 1-800-328-40

Fax [phone]

510(k) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

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A. General Information		Toll-free 1-800-328-4058Fax [phone]Toll-free Fax [phone]www.ottobockus.com
1. Submitter's Name:	Otto Bock Health Care, Inc.	Technical Center14800 28th Avenue North, Suite 110Minneapolis, MN 55447-4873Phone [phone]Toll-free 1-800-795-8846Fax [phone]Toll-free Fax [phone]www.ottobockus.com/services
2. Address:	Two Carlson Parkway N., Suite 100Minneapolis, MN 55447-4467
3. Telephone:	763-553-9464
4. Contact Person:	E.P. (Bert) Harman	Customer Support &Distribution Center14630 28th Avenue NorthMinneapolis, MN 55447-4821Phone [phone]Toll-free 1-800-328-4058Fax [phone]Toll-free Fax [phone]
5. Date Prepared:	August 14, 2002
6. Registration Number:	2182293
:. Device		Design & Manufacturing Center3820 Great Lakes DriveSalt Lake City, UT 84120-7205Phone [phone]
1. Name:	Sherpa Mobility System(Manual Wheelchair)
2. Trade Name:	Sherpa Mobility System(Manual Wheelchair)
3. Common Name:	Manual Wheelchair
4. Classification Name:	Manual Wheelchair
5. Product Code:	IOR
6. Class:	I
7. Regulation Number:	890.3850

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles merging into a single form, resembling a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2002

Otto Bock Healthcare E. P. (Bert) Harman CEO/President 2 Carlson Parkway, North Suite 100 Minneapolis, Minnesota 55447-4467

Re: K022924

Trade/Device Name: Sherpa Mobility System (Manual Wheelchair) Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: August 14, 2002 Received: September 4, 2002

Dear Mr. Harman:

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. Iisting 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. E. P. (Bert) Harman

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N Milburn
for Celia M. Witten, 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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510(k) Number: To be determined

Sherpa Mobility System (Manual Wheelchair) Device Name:

Indications for Use:

• Manual transportation device for person who are unable to walk or have a . walking impediment, propulsion by an attendant.
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PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

OVER-THE-COUNTER USE (optional Form 1-2-96)

Mark N. Millison

(Division Sign-Of Restorative and rous ological De

510(k) Number .

Regulation Number and Section

§ 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).