The intended use of the Invacare ZX2 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

Device Description

The Invacare Model Xterra GT power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with front wheel drive capability.

The wheelchair frame is of rigid or non-folding type design. The frame consists of a combination both 2" diameter and 1 ¼ " diameter x . 109 wall, steel tubing. The frame is of one piece, welded construction.

The wheelchair is designed with front wheel, beam type suspension. That is, the front swivel casters are mounted to two separate front extension frame members, and are thus, independent of each other. Each extension frame member pivots independently about its' This allows the chair to better negotiate small obstacles such as curbs, or own axis. ramps, from a complete stop. The rear casters pivot as well, and also serve as wheelchair anti-tippers.

The Invacare Xterra GT wheelchair incorporates a direct, front wheel drive train, which includes two separate right angle gear motors. Because it is a direct drive system, there are no belts, pulleys, chains, sprockets or the like, to periodically adjust or maintain. Both gearboxes are sealed and maintenance free. The upholstery is fabricated from either U240 Nylon, or reinforced vinyl, depending upon the user's preference. Both of these materials meet California 116 and 117 and Boston Fire Department BFD-1 specifications for fire retardancy.

The Invacare Xterra GT wheelchair is powered by two 22NF 12 VDC batteries. Access to the batteries is gained from underneath the chair. The chairs will travel approximately 15 to 21 miles between charges, depending on use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document for the Invacare Model Xterra GT Power Wheelchair:

Acceptance Criteria and Device Performance

The document does not explicitly list quantitative acceptance criteria for the power wheelchair's performance. Instead, it refers to compliance with a specific draft standard.

Acceptance Criterion	Reported Device Performance
Compliance with ISO EMC Draft Standard 7176-14 ("Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" dated April 3, 1995)	"In all instances, the Invacare Xterra GT Power Wheelchair met the required performance criteria and functioned as intended."

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "the Invacare Xterra GT Power Wheelchair" as being tested, suggesting at least one unit of the final device was tested to the standard. It doesn't specify if multiple units were tested or if specific components were tested separately.
- Data Provenance: Not explicitly stated further than being conducted for the 510(k) submission. Likely conducted internally by Invacare or a contracted testing facility. No country of origin for the data is provided, nor is it specified as retrospective or prospective (standard testing for compliance is typically prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is the performance criteria defined by ISO EMC Draft Standard 7176-14. The testing process confirms the device's adherence to these predefined criteria, not an expert-established ground truth.
Adjudication method for the test set:
- Not applicable. The testing is against a standardized set of procedures and criteria. There is no multi-reader or adjudication process mentioned for interpreting test results, rather a pass/fail determination based on the standard.
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 describes a medical device (power wheelchair), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. The "performance" refers to the physical and electrical functioning of the power wheelchair.
The type of ground truth used:
- Regulatory/Standard Compliance: The "ground truth" is defined by the performance criteria outlined in the referenced ISO EMC Draft Standard 7176-14. The device is expected to meet these engineering and safety specifications.
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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Korgog

OFD

510(k) SUMMARY

Invacare Corporation's Model Xterra GT Power Wheelchair

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

Invacare Corporation One Invacare Way PO Box 4028 Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Contact Person: Edward A. Kroll Director, Regulatory Affairs

Date Prepared: August 27, 2001

Name of Device and Name/Address of Sponsor

Model Xterra GT Power Wheelchair

Invacare Corporation One Invacare Way Elyria, Ohio 44036-2028 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Common or Usual Name

Power Wheelchair

Classification Name

Wheelchair, Powered

Predicate Devices

Invacare Corporations' Action Arrow Front Wheel Drive Power Wheelchairs (K991168 June 25, 1999) and Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997).

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Intended Use

The intended use of the Invacare Model Xterra GT Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

Technological Characteristics and Substantial Equivalence

A. Device Description

B. Substantial Equivalence

The Invacare Model Xterra GT Power Wheelchair is substantially equivalent to Invacare Corporations' Action Arrow (K991168, June 25, 1999) and Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997).

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PERFORMANCE DATA

As required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three- Wheeled Vehicles", the Invacare Xterra GT Power Wheelchair was tested in accordance with ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters. In all instances, the Invacare Xterra GT Power Wheelchair met the required performance criteria and functioned as intended.

KO12909

3p 3

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Image /page/3/Picture/1 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" written around it. Inside the circle is a stylized symbol that resembles a person with their arms outstretched, or a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

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

Re: K012909

Trade/Device Name: Invacare ZX2 Power Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 20, 2001 Received: September 24, 2001

Dear Mr. Kroll:

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. Edward A. Kroll

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" (21CFR 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.

b. Mark N. Milkeron

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: Invacare ZX2 Power Wheelchair

Indications For Use:

The intended use of the Invacare ZX2 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

(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)

Mark N. Mullinson

Over-The-Counter Use

Division of General, Restorative nd Neurological Device

Neurological D

510(k) Number K012904

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).