The Rodeo manual wheelchairs are a tilt in space mobile positioning system for everyday use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user. It is an attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position.
Convaid's Rodeo manual wheelchairs and Sunrise Medical Zippie TS are a tilt in space mobile positioning system for everyday indoor and outdoor use on flat firm terrain. They are available in a range of sizes to accommodate a particular fit to the user. The Convaid Rodeo is a attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position. It has a variety of options to control or support the users specific needs.
This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions: Amputee; Arthritis: Arthrogriposis; Cerebral Palsy; Geriatric conditions; Head injury or trauma; Hemiplegics; Multiple Scierosis; Muscular Dystrophy; Paraplegic; Polio; Quadriplegic; Spina Bifida; StokeJCVA; Tetraplegic; and Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis

Device Description

The Rodeo model is constructed of the same materials and contains the same typical components found on most manual wheelchairs. The frame consists primarily of powder coated round tubular steel from 5/8" to 1" diameter, that is welded, bolted and riveted. With 6" front wheels attached to pivoting casters for steering and turning, and 8" wheels in the rear. The product is a lightweight folding or non-rigid type wheelchair, which is designed for everyday indoor or outdoor use on firm terrain. Also available with a transit option for use in approved transport vehicles. The Rodeo offers its users a 10°-45° of adjustable tilt and 90°-105° of seat to back angle adjustment and comes with a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy. Adjustable seat depth, footplate and height of push handle.

AI/ML Overview

The Convaid Rodeo Manual Wheelchair is a Class 1 device that was cleared via the 510(k) pathway (K032402) on September 24, 2003. This submission focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with performance metrics in the traditional sense of AI/diagnostic devices. Therefore, some of the requested information regarding AI study design is not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ANSI/RESNA or ISO 7176 Wheelchair Standards)	Reported Device Performance
Overall Dimensions, Mass and Turning Space (ANSI/RESNA W/C 5, ISO 7179-8-10)	Convaid's Rodeo manual wheelchairs meet the applicable performance requirements as specified in these standards.
Fatigue Strength Test (ANSI/RESNA W/C 15)	Convaid's Rodeo manual wheelchairs meet the applicable performance requirements as specified in these standards.
Documentation and Labeling (ANSI/RESNA W/C 16)	Convaid's Rodeo manual wheelchairs meet the applicable performance requirements as specified in these standards.
Flammability (CAL 117 Standard)	Upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.
Wheelchair use as seating in motor vehicles (ANSI/RESNA W/C 19)	Convaid's Rodeo manual wheelchairs meet the applicable performance requirements as specified in this standard.

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

Sample Size: Not applicable. The "test set" here refers to the physical wheelchairs undergoing non-clinical performance and safety testing, not a dataset of patient data. The quantity of wheelchairs tested is not specified, but it would typically involve representative samples.
Data Provenance: Not applicable in the context of patient data. The testing refers to engineering and mechanical assessments of the device itself.

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

Number of Experts: Not applicable. The "ground truth" for mechanical performance is established through adherence to standardized testing protocols and measurements, not expert consensus on diagnostic images or patient outcomes.
Qualifications of Experts: Not applicable. The personnel conducting the tests would be qualified engineers or technicians with expertise in wheelchair testing protocols, but they are not "experts establishing ground truth" in a medical diagnostic sense.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical data. For non-clinical device testing, results are typically determined by direct measurement against established objective criteria in the standards.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI/diagnostic imaging devices.

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

Standalone Study: No, a standalone study (in the context of an algorithm) was not done. This device is a manual wheelchair, not an AI algorithm.

7. The type of ground truth used

Type of Ground Truth: The "ground truth" for this device's performance is objective compliance with established engineering and safety standards (ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards, and California Technical Bulletin CAL 117 for flammability).

8. The sample size for the training set

Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Ground Truth Establishment: Not applicable. There is no training set for this type of device.

Summary of the Study:

The provided information describes a substantial equivalence submission for a manual wheelchair. The core of the "study" demonstrating that the device meets acceptance criteria is non-clinical testing against relevant industry standards. Convaid Products Inc. states that their Rodeo manual wheelchairs meet the applicable performance requirements of ANSI/RESNA WC vol. 1 or ISO 7176 Wheelchair Standards for various aspects like dimensions, fatigue strength, documentation, labeling, and use as seating in motor vehicles (ANSI/RESNA W/C 19). Additionally, the upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.

The FDA's clearance (K032402) confirms that Convaid demonstrated substantial equivalence to predicate devices (Sunrise Medical's Quickie Model "Zippie TS Folding Model" and Quickie/Zippie Series) based on these non-clinical tests and a comparison of technological characteristics. The equivalence is based on shared performance features, technology, construction, and the absence of new safety and effectiveness issues.

Summary

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K032402

FP 2 4 2003

Image /page/0/Picture/2 description: The image shows the logo for Convaid Products Inc. The logo consists of a black square with a white curved line running through it, followed by the word "Convaid" in bold, sans-serif font. Below "Convaid" is the text "PRODUCTS INC" in a smaller, thinner font.

P.O. Box 4209 · Palos Verdes, CA 90274 USA Toll Free (888) CONVAID (266-8243) or (800) 552-1020 (310) 539-6814 * Fax. (310) 539-2570

Convaid Product Inc. Model: RODEO Manual Wheelchair

510(k) Summary of Safety and Efficacy

A. General Information

1.	Submitter Name:	Convaid Products Inc.
2.	Address:	2830 California St.Torrance CA, 90503
3.	Telephone:	310-618-0111
	Fax:	310-618-2166
4.	Contact Person:	Donald GriggsQuality Assurance Manager
5.	Registration Number:	2022883

Date Prepared: 6.

B. Device

1.	Device Trade Name:	Rodeo - Mobile Positioning System
2.	Common/Generic Name:	Wheelchair-folding tilt in space
3.	Device Classification Name:	Mechanical Wheelchair
4.	Registration Number:	222022883
5.	Product Code:	IOR
6.	Device Classification	Class 1
7.	Regulatory Number:	980.3850

Manufacture Name: Sunrise Medical ﺍ

1.	Manufacture Name:	Sunrise Medical
2.	Name:	Quickie TSR
3.	K Number:	K952641

K Number: ે. 4. Date Cleared: 07/06/1995
Manufacture Name: Sunrise Medical 1.
Quickie Zippie Series 2. Name:
1. K Number: K973673
11/20/1997 4. Date Cleared:

D. Intended Use

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Image /page/1/Picture/0 description: The image shows the logo for Convaid Products Inc. The logo consists of a black square with a white curved line running through it, followed by the word "Convaid" in bold, black letters. Below "Convaid" is the phrase "PRODUCTS INC" in a smaller, thinner font.

P.O. Box 4209 · Fialos Verges. Toll Free (888) CON) 4.5 (266-8. 1181552-1020

E. Description of the device

F. Technological Characteristics Summary

The Rodeo wheelchair is substantially equivalent to

Sunrise Medicals Quickie Model "Zippie TS Folding Model"

The Sunrise Medical "Quickie TSR" was cleared 07/06/1995 on K952641.

Also reference Sunrise Medicals Quickie/Zippie Series cleared 11/20/1997 on K973673.

Sunrise Medicals "Zippie TS folding frame" and Convaid's "Rodeo" wheel chairs are a tilt-in-space mobility system, manual wheelchair for everyday use, both frames are built using tubular steel that is welded, bolted and riveted. They are a folding non-rigid wheelchair and use a compression folding system that allow for easy transport and storage. The Convaid Rodeo is an attendant propelled manual design and does not come with the Zippie TS option to be self-propelled. Adjustable push handle height, and adjustable back angle, adjustable seat depths. Similar seat widths and weights.

G: Comparison of device characteristics to predicate

This device (Convaid Rodeo) has similar characteristics, construction and technology as the predicate device manufactured by Sunrise Medical the Zeppie TS folding model.

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Image /page/2/Picture/0 description: The image shows the logo for Convaid Products Inc. The logo consists of a black square with a white curved line running through it, resembling a road. To the right of the square is the text "Convaid" in a bold, sans-serif font, and below that is "PRODUCTS INC" in a smaller, thinner font.

P.O. Box 4209 • Palos Verdes, CA 90274 USA Toll Free (888) CONVAID (266-8243) or (800) 552-1029 (310) 539-6814 · Fax: (310) 539-3070

H: Target Population:

This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions:

Amputee;
Arthritis:
Arthrogriposis;
Cerebral Palsy;
Geriatric conditions;
Head injury or trauma;
Hemiplegics;
Multiple Scierosis;
Muscular Dystrophy;
Paraplegic;
Polio;
Quadriplegic;
Spina Bifida;
StokeJCVA;
Tetraplegic; and
Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis

I: Non-Clinical Testing

Convaid's Rodeo manual wheelchairs meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 or ISO 7176 Wheelchair Standards as indicated in section 2 page 2-3. Including ANSI/RESNA W/C 19 Wheelchair use as seating in motor vehicles.

J: Safety:

The Convaid Rodeo Wheelchair Series is substantially equivalent to the predicated device listed in the 510(k); the technology and construction of the Rodeo Wheelchair series does not raise any new issues of safety and effectiveness.

K: Conclusion:

The Rodeo Wheelchair series shares performance features and technology with a number of devices already legally marketed within the United States. Therefore, the Rodeo Series wheelchairs are substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a symbol that looks like three stylized human profiles or a caduceus without the staff.

Public Health Service

SEP 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald Griggs Quality Assurance Manager Convaid Products, Inc. 2830 California Street Torrance, California 90503

Re: K032402

Trade/Device Name: Rodeo Models RD12, RD14, RD16 Rodeo Transit Models RD12T, RD14T and RD16T Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: July 28, 2003 Received: August 4, 2003

Dear: Mr. Griggs:

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. Donald Griggs

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Melleman

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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Voluntary performance standard:

Non-Clinical Testing of Convaid's Rodeo manual wheelchairs meet the applicable performance requirements as specified in the following ANSI/RESNA or ISO Wheelchair Standards.

Determination of Overall Dimensions, Mass and Turning Space ANSI/RESNA W/C 5 ISO 7179- 8-10 Fatigue Strength Test ANSI/RESNA W/C 15 Documentation and Labeling ANSI/RESNA W/C 16 Flammability ANSI/RESNA W/C 19 Wheelchair use as seating in motor vehicles

Statement of Indication of use

Convaid's Rodeo manual wheelchairs and Sunrise Medical Zippie TS are a tilt in space mobile positioning system for everyday indoor and outdoor use on flat firm terrain. They are available in a range of sizes to accommodate a particular fit to the user. The Convaid Rodeo is a attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position. It has a variety of options to control or support the users specific needs.

Target Population:

This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions:

Amputee:
Arthritis;
Arthrogriposis;
Cerebral Palsy;
Geriatric conditions;
Head injury or trauma;
Hemiplegics;
Multiple Sclerosis;
Muscular Dystrophy;
Paraplegic;
Polio:
Quadriplegic;
Spina Bifida;
StokeJCVA;
Tetraplegic; and
Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis

Mark N. Malkerson

eral. Restorative

510(k) Number_

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).