MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR

• K Number: K990157
• Device Name: MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR
• Manufacturer: INVACARE CORP.
• Date Cleared: 1999-02-03 ( 15 days)
• Product Code: IOR
• Regulation Number: 890.3850

Intended Use

To provide mobility to persons limited to a sitting position.

Device Description

The Invacare Corporation Model Top End Terminator SS is a manually operated, self propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons who may be restricted to a sitting position. The product consists basically of a metal frame, larger 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 SS Wheelchair incorporates a one piece frame. The frame is constructed from 1'' and 1 1/8 " diameter chrome-moly steel tubing, that is brazed together. The wheelchair upholstery is a vinyl material which meets the requirements of EN 1021:1 standard for flame retardancy. The Top End Terminator SS also includes a front and rear suspension feature. This feature which mounts to the front and rear of the wheelchair, is designed to absorb minor bumps and shocks encountered during everyday use, thus providing added comfort to the wheelchair user.

Predicate Devices

K922535, K982989

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a purely mechanical wheelchair with no mention of software, algorithms, or any technology that would suggest AI/ML. The performance studies reference a standard for manual wheelchairs.

Therapeutic

No
The device is a manual wheelchair providing mobility, which is a supportive function, not a therapeutic treatment for disease or injury.

Diagnostic

No

Explanation: The device is described as a "manually operated, self propelled, manual, mechanical wheelchair" intended to "provide mobility to persons who may be restricted to a sitting position." There is no mention of it being used to diagnose, detect, or monitor any medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, mechanical wheelchair with a metal frame, wheels, casters, and upholstery, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• Device Function: The description clearly states the device's intended use is "To provide mobility to persons limited to a sitting position." It is a mechanical wheelchair designed for physical support and movement.
• Lack of Diagnostic Testing: There is no mention of the device performing any tests on biological samples or providing diagnostic information.
• Device Description: The description focuses on the physical components and mechanical function of the wheelchair.

The device is a medical device, but specifically a mobility aid, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

IOR

Device Description

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

The product consists basically of a metal frame, larger 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 SS Wheelchair incorporates a one piece frame. The frame is constructed from 1'' and 1 1/8 " diameter chrome-moly steel tubing, that is brazed together. The wheelchair upholstery is a vinyl material which meets the requirements of EN 1021:1 standard for flame retardancy.

The Top End Terminator SS also includes a front and rear suspension feature. This feature which mounts to the front and rear of the wheelchair, is designed to absorb minor bumps and shocks encountered during everyday use, thus providing added comfort to the wheelchair user.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K922535, K982989

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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3 1999 FEB

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510(k) SUMMARY

K99015-7

Invacare Corporation's Model Top End Terminator SS Manual Wheelchair

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

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: [phone]

Edward A. Kroll Contact Person: Director, TQM and Regulatory Affairs

January 18, 1999 Date Prepared:

Name of Device and Name/Address of Sponsor

Model Top End Terminator SS Manual Wheelchair Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: [phone]

Manual Wheelchair Common or Usual Name:

Wheelchair, Mechanical 89IOR Classification Name:

Predicate Devices

Invacare Top End Terminator SS is substantially equivalent to the Model "Top End Terminator" Manual Wheelchair (K922535 7/24/92) and the Quickie Designs Model "Quickie Suspension Wheelchair Series Model XTR" Manual Wheelchairs (K982989 10/5/98).

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

1

Technological Characteristics and Substantial Equivalence

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

The product consists basically of a metal frame, larger 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 SS Wheelchair incorporates a one piece frame. The frame is constructed from 1'' and 1 1/8 " diameter chrome-moly steel tubing, that is brazed together. The wheelchair upholstery is a vinyl material which meets the requirements of EN 1021:1 standard for flame retardancy.

The Top End Terminator SS also includes a front and rear suspension feature. This feature which mounts to the front and rear of the wheelchair, is designed to absorb minor bumps and shocks encountered during everyday use, thus providing added comfort to the wheelchair user.

Substantial Equivalence The Invacare Top End Terminator SS is substantially equivalent to the Model "Top End Terminator" Manual Wheelchair (K922535 7/24/92) and the Quickie Designs Model "Quickie Suspension Wheelchair Series Model XTR" Manual Wheelchairs (K982989 10/5/98).

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).

2

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble a person's head and torso.

3 1099 FEB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Edward A. Kroll Director, TQM and Regulatory Affairs Invacare Corporation One Invacare Way P.O. Box 4028 44036-2125 Elyria, Ohio

K990157 Re: Top End Terminator SS Manual Wheelchair Trade Name: Requlatory Class: I Product Code: IOR Dated: January 18, 1999 Received: January 19, 1999

Dear Mr. Kroll:

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 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 The general controls provisions of the Act 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. ਕਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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. Edward A. Kroll

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 [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 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely

Sincerely yours,

Neil R.P. Osher for

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative 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 SS Manual Wheelchair

Indications For Use: To provide mobility to persons limited to a sitting position.

NRRO

(Division Sign-Off)

(Division of General Restorative Devices 190157 510(k) Number -

(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 &

(Optional Format 1-2-96)