The Invacare Corporation Model Top End Terminator Titanium is a manually operated, self-propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons who may be restricted to a sitting position.

The product consists of a titanium frame, large rear wheels with handrims for propelling the chair, and smaller front pivoting casters for steering and turning. The product is designed to be a lightweight, user adaptable, everyday wheelchair, for both indoor and outdoor use. It is a rigid or non-folding type wheelchair, which has a more sporty appearance than the traditional type of manual wheelchairs.

The Top End Terminator Titanium Wheelchair incorporates a one-piece frame. The frame is constructed from 1" diameter, 3-2.5 seamless titanium tubing that is brazed together. The wheelchair adjustable tension back upholstery consists of U850 ballistic material with fiber batting and the wheelchair adjustable tension seat upholstery consists of U240 nylon and webbing. Both upholstery types meet a minimum of the California Bureau of Home Furnishings 116 and 117 Flammability Standards.

AI/ML Overview

This document is a 510(k) summary for a manual wheelchair, not a study describing the acceptance criteria and performance of a device using AI, imaging, or pathology data. Therefore, the requested information elements such as sample sizes, expert qualifications, and ground truth methods are not applicable to this submission.

However, I can provide information based on the performance data section of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meet applicable performance requirements specified in Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters)."	The Invacare Top End Terminator SS Manual Wheelchair meets the applicable performance requirements specified in RESNA Standard ANSI/RESNA WC/Vol.1-1998.

2. Sample size used for the test set and the data provenance:

Not Applicable. This document pertains to a physical medical device (manual wheelchair) and its compliance with established performance standards for such devices, not a study involving a test set of data samples in the context of AI or imaging.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth in the context of this document refers to the established performance requirements of the RESNA standard, not expert consensus on data interpretation.

4. Adjudication method for the test set:

Not Applicable. This is not a study involving adjudication of interpretations. Compliance with the RESNA standard is determined through defined test methods rather than adjudication.

5. 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:

Not Applicable. This document is for a manual wheelchair and does not involve AI or human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This document is for a manual wheelchair and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters)." This standard defines the performance criteria and test methods that wheelchairs must meet.

8. The sample size for the training set:

Not Applicable. This document refers to a physical device and its compliance with a standard, not machine learning model training.

9. How the ground truth for the training set was established:

Not Applicable. No training set as this is not a machine learning study.

Summary

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AUG - 1 2001

510(k) SUMMARY

Invacare Corporation's Model Top End Terminator Titanium Manual Wheelchair

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Contact Person:	Rae Ann Farrow
	Manager, Regulatory Compliance

June 26, 2001 Date Prepared:

Name of Device and Name/Address of Sponsor

Model Top End Terminator Titanium Manual Wheelchair Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Common or Usual Name: Manual Wheelchair

Classification Name: Wheelchair, Mechanical 89IOR

Predicate Devices

The Invacare Top End Terminator Titanium is substantially equivalent to the Model "Top End Terminator' Manual Wheelchair (K922535 7/24/92) and the "Top End Terminator SS Manual Wheelchair" (K990157, 3/4/99).

Intended Use: The intended use of the Model Top End Terminator Titanium Manual Wheelchair is to provide mobility to persons limited to a sitting position.

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Technological Characteristics and Substantial Equivalence

Device Description The Invacare Corporation Model Top End Terminator Titanium is a manually operated, self-propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons who may be restricted to a sitting position.

Substantial Equivalence The Invacare Top End Terminator Titanium is substantially equivalent to the Model "Top End Terminator" Manual Wheelchair (K922535 7/24/92) and the "Top End Terminator SS Manual Wheelchair" (K990157, 3/4/99).

Performance Data

The Invacare Top End Terminator SS Manual Wheelchair meets the applicable performance requirements specified in:

Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (Including Scooters).

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract, overlapping shapes that resemble a bird in flight or a series of waves.

AUG - 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036

Re: K012167

Trade/Device Name: Top End Terminator Titanium Manual Regulation Number: 890.3850 Regulatory Class: I Product Code: IOR Dated: July 10, 2001 Received: July 12, 2001

Dear Ms. Farrow:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Randall Potter

This letter will allow you to begin marketing your device as described in your 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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

MAMhkeuhtrom

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 (if known): TBD

Device Name: Top End Terminator Titanium Manual Wheelchair

Indications For Use:

The intended use of the Model Top End Terminator Titanium Manual Wheelchair is to provide mobility to persons limited to a sitting position.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

trbllewer for cmm

(Division Sign-Off) (Division Sigil-On)
Division of General, Restorative
Division of General, Revices Division of Neurological Devices Kbizib7 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use V

(Optional Format 1-2-96)

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).