The Invacare Model Arrow Front Wheel Drive (FWD) 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.

Front wheel drive means that the drive motors are connected directly to the front wheels of the wheelchair, as opposed to a rear wheel drive chair which connects the drive motors to the rear wheels. Mounting the drive wheels on the front of the wheelchair, results in a chair that is easier to maneuver than the traditional rear wheel drive wheelchair. Because the center line of the pivoting casters is now behind the user, the user experiences a more natural feel when turning the wheelchair.

AI/ML Overview

This is a premarket notification for a power wheelchair, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable. The document describes a traditional medical device (power wheelchair) and its substantial equivalence to previously marketed devices.

However, I can extract the information provided about the device's performance testing:

Device: Invacare Model Arrow Front Wheel Drive Power Wheelchair

Acceptance Criteria/Performance Testing:

Criterion	Reported Device Performance
Electromagnetic Compatibility (EMC)	Met the required performance criteria of ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995)
Functionality	Functioned as intended.

Study Details (of the performance testing described):

Sample size used for the test set and the data provenance: Not explicitly stated, but implies the Invacare Arrow Front Wheel Drive Power Wheelchair itself, likely a representative production model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance criteria for mechanical and electrical devices like wheelchairs are typically established through standardized tests, not expert consensus on ground truth in the context of diagnostic AI.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used: International Standard (ISO EMC Draft Standard 7176-14) for Electromagnetic Compatibility and "functioned as intended" based on mechanical and electrical operation.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Additional Information from the document:

Intended Use: To provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
Predicate Devices: Invacare Corporations' Action Storm Ranger II and Action Storm Power 9000 Front Wheel Drive Power Wheelchairs (K982064, October 5, 1998) and Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997).
Regulatory Class: II
Product Code: ITI

Summary

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KGG 1168

510(k) SUMMARY

Invacare Corporation's Model Arrow Front Wheel Drive Power Wheelchair

ﻣﺜﻞ ﻣﻦ ﻣﻨﻬﺎ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍ

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, TQM and Regulatory Affairs

Date Prepared: April 5, 1999

Name of Device and Name/Address of Sponsor

Models Arrow Front Wheel Drive 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 Storm Ranger II and Action Storm Power 9000 Front Wheel Drive Power Wheelchairs (K982064 , October 5, 1998) 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 Arrow Front Wheel Drive 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 Arrow FWD Power Wheelchair is substantially equivalent to other devices of comparable type that are currently being legally marketed within the United States. The comparable devices include those manufactured by Invacare as well as its' competitors.

Products which are substantially equivalent to these devices are Invacare Corporations' Action Storm Ranger II and Action Storm Power 9000 Front Wheel Drive Power Wheelchairs (K982064 , October 5, 1998) and Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997).

Each of these products are battery powered, motor driven, front wheel drive powered wheelchairs with the same intended function and use which is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered Similarities include large wheels with attached motor/gearbox drive wheelchair. mechanisms, smaller pivoting casters for turning, and joystick operated motor controllers to engage system motion and steer the wheelchair. They are all constructed from the same basic materials, have the same basic operational principles and all use DC batteries as their source of power.

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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 Arrow Front Wheel Drive 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 Arrow Front Wheel Drive Power Wheelchair met the required performance criteria and functioned as intended.

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Image /page/3/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three abstract human profiles arranged in a flowing, wave-like pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

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

Re: K991168 Arrow Front Wheel Drive (FWD) Power Wheelchair Requlatory Class: II Product Code: ITI Dated: April 5, 1999 Received: April 7, 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. A 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 requlation (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 requlations.

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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 (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 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/dsmamain.html".

Sincerely yours,

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

Witten, Ph.D., M.D. a M. 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 K991168 Device Name: Invacare Model Arrow Front Wheel Drive (FWD) Power Wheelchair

Indications For Use:

Its intended use is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number _

Prescription Use (Per 21 CFR 801.109)

OR
Over-The-Counter Use

(Division Sign-Off)
(Optional Format 1-2-96)
Division of General Restorative Devices K991168

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).