The Ruike 3421 powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Description

The Ruike 3421 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. But the Ruike 3421 is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

AI/ML Overview

This document is a 510(k) summary for the Ruike 3421 powered wheelchair. It does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML-driven medical devices.

Instead, this submission is for a physical medical device (a powered wheelchair) and relies on demonstrating "substantial equivalence" to a predicate device already on the market. Therefore, the questions related to AI/ML device evaluation (like sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria or reported device performance in the traditional sense for an AI/ML device. For a physical device like a powered wheelchair, acceptance criteria would typically involve engineering specifications, safety standards (e.g., ISO or ANSI standards for wheelchairs), durability tests, and performance metrics like speed, range, turning radius, weight capacity, etc. The document only mentions "minor differences in performance specifications" compared to the predicate, implying that the Ruike 3421's performance is largely comparable while potentially being "a new class of lightweight powered wheelchair." However, no specific performance metrics or acceptance criteria are detailed.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable: This is a physical device, not an AI/ML diagnostic or prognostic tool that uses data for testing. The evaluation focused on substantial equivalence to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable: Ground truth establishment by experts is relevant for diagnostic accuracy studies of AI/ML algorithms. This document does not pertain to such a study.

4. Adjudication Method for the Test Set:

Not Applicable: Adjudication is used in studies with multiple readers/experts. This document describes a traditional medical device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not done. This type of study is for evaluating the impact of AI assistance on human reader performance, which is not relevant for a physical device like a powered wheelchair.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable: "Standalone performance" refers to the performance of an algorithm without human intervention. This device is a powered wheelchair, not an algorithm.

7. The Type of Ground Truth Used:

Not Applicable: The concept of "ground truth" (expert consensus, pathology, outcomes data) is for validating diagnostic or predictive algorithms. For this device, the "ground truth" for regulatory approval is primarily its safety and effectiveness being substantially equivalent to a legally marketed predicate device. This involves demonstrating compliance with relevant standards and functional requirements for a wheelchair.

8. The Sample Size for the Training Set:

Not Applicable: "Training set" refers to data used to train an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable: As above, this concept applies to AI/ML algorithm development.

Summary of what the document does provide regarding the device's acceptance and study:

The acceptance of the Ruike 3421 powered wheelchair by the FDA is based on its substantial equivalence to a predicate device, the CWD01 (K062888) / EMG Technology Co. Ltd.

Acceptance Criteria (Implied by Substantial Equivalence): The device is considered acceptable because it performs its "intended function and use" without raising "any new questions pertaining to safety or effectiveness" compared to the predicate device. This essentially means it meets the safety and basic performance expectations already established for powered wheelchairs on the market.
Study/Evidence: The "study" for this type of submission is the 510(k) Premarket Notification itself, where the manufacturer (Shanghai Ruike Sports Goods CO., LTD.) presents a detailed comparison between their device (Ruike 3421) and the predicate device (CWD01). This comparison would typically include:
- Intended Use: Both devices are intended for indoor/outdoor transportation for disabled or elderly persons limited to a seated position.
- Technology/Design: The Ruike 3421 is "basically similar to other powered wheelchairs," but designed to be lightweight and break down into two components.
- Performance Specifications: The document states "minor differences in performance specifications" but asserts these do not alter function, safety, or effectiveness. (Specific performance data is not provided in this summary, but would have been part of the full 510(k) submission).
- Materials: (Not explicitly mentioned in the summary, but usually part of a full submission).
- Labeling and Controls: The device must comply with general controls provisions of the Act (registration, listing, GMP, labeling, etc.).

In essence, the document serves as evidence that the manufacturer has presented sufficient information to the FDA to demonstrate that their new device is as safe and effective as a legally marketed device, thus allowing it to be marketed.

Summary

{0}------------------------------------------------

Kozosol

MAR 2 2 2007

Shanghai Ruike Sports Goods CO., LTD.

No. 689, Xinhu Road, Shanghai, China TEL: +86-21-66350714 FAX: +86-21-66351873

510(k) Summary

Device

Trade name: Ruike 3421 powered wheelchair

Common name: Powered wheelchair

Classification name: Powered wheelchair

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3860

Product Code: ITI

Classification: Class II

Predicate devices

CWD01 (K062888) / EMG Technology Co. Ltd.

Intend use of device

Ruike 3421 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.

Device description:

Substantial equivalence:

The Ruike 3421 powered wheelchair is substantially equivalent to the CWD01 (K062888) manufactured by EMG Technology Co. Ltd..

There are minor differences in performance specifications of the powered wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Shanghai Ruike Sports Goods CO., LTD. believes that the Ruike 3421 powered wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three trailing lines, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Ruike Sports Goods Co., Ltd. % Ms. Junnata Chang 14 F-2, No. 1, Lane 25, Zhuangjing Road Banqiao. Taipei County, Taiwan (China)

MAR 2 2 2007

Re: K070501

Trade/Device Name: Ruike 3421 powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 12, 2007 Received: February 21, 2007

Dear Ms. Chang:

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. 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.

{2}------------------------------------------------

Page 2 - Ms. Junnata Chang

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

f.o.A
Mark N. Mollen

Mark N. Melke rson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

3. Device descriptive information

3.1 Statement of indication for use

Statement of Indications for Use

510(k) Number (if known):

Device Name: Ruike 3421

Indications for Use:

The Ruike 3421 powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Over-The-Counter Use _ Prescription Use X (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Paul

Drvision Sign-Off) Division of Get-eral, Restorative, auo Neurological Devices

310(k) Number

(Posted November 13, 2003)

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).