STAINLESS STEEL AQUATIC WHEELCHAIR

• K Number: K031910
• Device Name: STAINLESS STEEL AQUATIC WHEELCHAIR
• Manufacturer: DB PERKS & ASSOCIATES LTD.
• Date Cleared: 2003-07-25 ( 35 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: K935398 , K982607
• Predicate For: K051709 , K101217 , K120302

Intended Use

This wheelchair is to provide mobility to persons limited to a sitting position being transported either by an attendant or self-propelled.

This device is designed to be a typical manual wheelchair for use in an aquatic center setting.

Device Description

The Stainless Steel Aquatic Wheelchair is a non-rigid style, folding wheelchair. The wheelchair is suitable to provide mobility indoors or in wet conditions on a firm surface free of obstructions.

Construction is typical for this style of wheelchair. Our chair uses a crossbraced, welded, stainless steel frame with slung fabric (seat and back); swing back armrests and removable foot riggings. The chair uses 8-inch caster wheels at the front for steering with rear push handles for attendant assisted propulsion and 24-inch rear drive wheels with hand rims for self-propulsion. Lever style wheel locks are used on this chair.

All parts on our wheelchair are fabricated from stainless steel and selected plastics suitable for use in a swimming pool environment. The chair can be submersed in pool water without any harmful effects.

Upholstery meets California Technical bulletin CAL 117 standard for flame retardancy.

Users manual provides information on warnings, cautions maintenance and operation instructions.

AI/ML Overview

The provided document is a 510(k) Summary for a "Stainless Steel Aquatic Wheelchair" and a clearance letter from the FDA. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI-powered medical device.

The document discusses:

• The submitter's name and address.
• The product name, generic name, model variations, and FDA classification.
• Predicate devices (Tracer EX Manual Wheelchair and Silhouette 300 Manual Wheelchair).
• Intended use and description of the device.
• A statement of substantial equivalence to predicate devices, noting the material differences for aquatic use.
• The FDA's decision to clear the device for marketing.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it pertains to AI/algorithm performance and clinical studies of that nature, which are not present in this document:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document describes a traditional mechanical medical device, not an AI or algorithm-based one.

Summary

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Image /page/0/Picture/0 description: The image is a black and white drawing of a shark inside of a circle. The shark is facing left and has a dorsal fin, pectoral fin, and tail fin. The shark's mouth is closed and it has a small eye. The circle is thick and black. The background is white.

DB PERKS & ASSOCIATES LTD

commercial aquatic supplies • Team aquatic Supplies • The Swim

HEAD OFFICE: Unit 201-1305 Welch Street, North Vancouver, BC V7P 1B3 Phone: [phone] ● Fax: [phone] ● E-mail: [e-mail]

JUL 25 2003 510K Summary

Premarket Notification - Stainless Steel Aquatic Wheelchair

Submitters Name:	DB Perks & Associates Ltd.
Submitters Address:	#201 - 1305 Welch StreetNorth Vancouver, BCCanadaV7P 1B3
	Phone: [phone] (Toll Free North AmericaFax: 604-980-0196Email: [e-mail]
US Agent:	Mr. Ed OliverCPCS Inc.490 NW Datewood DriveIssaquah, WA98027
	Phone: [phone]Fax: [phone]Email: [e-mail]
Summary Prepared:	June 16, 2003
Proprietary Device Name:	Stainless Steel Aquatic Wheelchair
Generic Name:	Manual Wheelchair (Folding)
Device Name:	Mechanical Wheelchair
Models:	Available in three seat widths - 16 inch,18 inch, 20 inch
FDA Product Code:	IOR
FDA Classification:	Class I
Panel Code:	Physical Medicine (89)
Regulation Number	800 2850

Section 8

COMMERCIAL AQUATIC SUPPLIES #201 - 1305 Welch Street North Vancouver, BC, V7P 1B3 Tel: [phone] Fax: [phone] [e-mail]

TEAM AQUATIC SUPPLIES #101 - 1305 Welch St North Vancouver, BC, V7P 1B3 Tel: [phone] Fax: [phone] [e-mail]

TEAM AQUATIC SUPPLIES 421 Forge Road S.E. Calgary, AB, T2H OS9 Tel: [phone] Fax: [phone] [e-mail] TEAM AQUATIC SUPPLIES #8-4155 Fairview Street Burlington, ON, L7L 2A4 Tel: [phone] Fax: [phone] [e-mail]

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Image /page/1/Picture/0 description: The image is a black and white logo of a shark inside of a circle. The shark is facing left and has a pointed nose and a dorsal fin. The shark has three gills on its side and a white dot for an eye. The circle is thick and black.

DB PERKS & ASSOCIATES LTI

AL AQUATIC SUPPLIES • TEAM AQUATIC SUPPLIES • THE SWIM & F

HFAD OFFICE: Unit 201-1305 Welch Street, North Vancouver, BC V7P 1B3 Phone: [phone] ● Fax: [phone] ● E-mail: [e-mail]

Predicate device:

• A) Tracer EX Manual Wheelchair Invacare granted clearance by FDA March 01, 1994 under 510K # K935398.
• B) Silhouette 300 Manual Wheelchair G Hirsch & Co. granted clearance by FDA August 31, 1998 under 510K # K982607.

Intended Use:

This wheelchair is to provide mobility to persons limited to a sitting position being transported either by an attendant or self-propelled.

This device is designed to be a typical manual wheelchair for use in an aquatic center setting.

Description:

The Stainless Steel Aquatic Wheelchair is a non-rigid style, folding wheelchair. The wheelchair is suitable to provide mobility indoors or in wet conditions on a firm surface free of obstructions.

Construction is typical for this style of wheelchair. Our chair uses a crossbraced, welded, stainless steel frame with slung fabric (seat and back); swing back armrests and removable foot riggings. The chair uses 8-inch caster wheels at the front for steering with rear push handles for attendant assisted propulsion and 24-inch rear drive wheels with hand rims for self-propulsion. Lever style wheel locks are used on this chair.

All parts on our wheelchair are fabricated from stainless steel and selected plastics suitable for use in a swimming pool environment. The chair can be submersed in pool water without any harmful effects.

Upholstery meets California Technical bulletin CAL 117 standard for flame retardancy.

Users manual provides information on warnings, cautions maintenance and operation instructions.

Substantial Equivalence:

The Stainless Steel Aquatic Wheelchair is substantially equivalent to the predicate devices listed above. They both have the same technological characteristics and indications for use. Differences that do exist are in the selection of fabrication materials that allow our chair to operate in a swimming pool environment.

Section 8 - 2

COMMERCIAL AQUATIC SUPPLIES #201 - 1305 Welch Street North Vancouver, BC, V7P 1B3 Tel: [phone] Fax: [phone] [e-mail]

TEAM AQUATIC SUPPLIES #101 - 1305 Welch St North Vancouver, BC, V7P 183 Tel: [phone] Fax: [phone] [e-mail]

TEAM AQUATIC SUPPLIES 421 Forge Road S.E. Calgary, AB, T2H OSS Tel: [phone] Fax: [phone] [e-mail] TEAM AQUATIC SUPPLIES #8-4155 Fairview Street Burlingtor, ON, L7L 2A4 Tel: [phone] Fax: [phone] [e-mail]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2003

DB Perks & Associates Ltd. c/o Mr. Ed Oliver CPCS, Inc. 490 NW Datewood Drive Issaquah, WA 98027

Re: K031910

Trade/Device Name: Stainless Steel Aquatic Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: June 16, 2003 Received: July 1, 2003

Dear Mr. Oliver:

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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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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

sincerely yours,

Mark N. Mulkern

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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Image /page/4/Picture/0 description: The image shows a black and white logo of a shark inside of a circle. The shark is facing to the right and has a dorsal fin, pectoral fin, and tail fin. The shark also has gills that are visible on its side. The circle is thick and black, and the background is white.

DB PERKS & ASSOCIATES LTD.

commercial aquatic supplies • TEAM aQUATIC SUPPLIES • THE SWIM & FITNESS •

HEAD OFFICE: Unit 201-1305 Welch Street, North Vancouver, BC V7P 1B3 Phone: [phone] • Fax: [phone] • E-mail: [e-mail]

INDICATIONS FOR USE:

This wheelchair is to provide mobility to persons limited to a sitting position being transported either by an attendant or self-propelled.

This device is designed to be a typical manual wheelchair for use in an aquatic center setting.

for Mark N Milken

Division of General, Restorativ : and Neurological Devices

510(k) Number K031910

COMMERCIAL AQUATIC SUPPLIES #201 - 1305 Welch Street North Vancouver, BC, V7P 1B3 Tel: [phone] Fax: [phone] [e-mail]

TEAM AQUATIC SUPPLIES #101 - 1305 Welch St North Vancouver, BC, V7P 183 Tel: [phone] Fax: [phone] [e-mail]

TEAM AQUATIC SUPPLIES 421 Forge Road S.E. Calgary, AB, T2H OS9 Tel: [phone] Fax: [phone] [e-mail] Section 3

TEAM AQUATIC SUPPLIES #8-4155 Fairview Street Burlington, ON, U7L 2A4 Tel: [phone] Fax: [phone] [e-mail]

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).