(97 days)
The Ruike 3331 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The Ruike 3331 scooter 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.
The Ruike 3331 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text is a 510(k) summary for the Ruike 3331 scooter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. Medical devices, especially those like electric scooters, are often evaluated against established performance standards and demonstrated substantial equivalence through detailed comparisons of specifications and intended use.
Therefore, the requested information components related to acceptance criteria, specific study designs (like MRMC or standalone performance), ground truth, and expert evaluation are not present in this type of regulatory submission. The 510(k) process primarily relies on comparing the new device to a legally marketed predicate device.
Here's an analysis based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document states:
"There are minor differences in performance specifications of the scooters, 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."
This suggests that the "acceptance criteria" are implicitly met by demonstrating that any performance differences between the Ruike 3331 and the predicate device (LANDLEX P100X) are minor and do not impact safety or effectiveness. No specific quantitative performance metrics or acceptance criteria are listed.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study reporting on a test set in the traditional sense of a clinical or performance study with a sample size. It's a regulatory submission demonstrating substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth establishment with experts is not part of a substantial equivalence submission for this type of device.
4. Adjudication Method for the Test Set
Not applicable.
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
Not applicable. This is a physical medical device (an electric scooter), not an AI/software-as-a-medical-device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" in this context is the predicate device's established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary based on the document:
The regulatory submission for the Ruike 3331 scooter aims to demonstrate substantial equivalence to a previously cleared device, the LANDLEX P100X (K060042). The core "study" (or comparison) for this type of device involves:
- Comparison of Intended Use: Both devices are "intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position."
- Comparison of Device Description: Both are battery-operated, controlled by a tiller handle and thumb-operated throttle.
- Comparison of Performance Specifications: The document states "minor differences in performance specifications," but crucially, 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." This implies that while specific numbers aren't given, the differences were assessed and deemed not to negatively impact safety or effectiveness compared to the predicate.
Therefore, the "acceptance criteria" for the Ruike 3331 were met by demonstrating that it is as safe and effective as its predicate device, the LANDLEX P100X, based on a direct comparison of features and performance, rather than a clinical trial with specific performance metrics and acceptance thresholds.
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DEC 1 4 2006
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 3331 scooter
Common name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: 89INI
Classification: Class II
Predicate devices
LANDLEX P100X (K060042)/ Besteam Technology Inc.
Intend use of device
Ruike 3331 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The Ruike 3331 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
Substantial equivalence:
The Ruike 3331 scooter is substantially equivalent to the LANDLEX P100X (K060042) manufactured by Besteam Technology Inc.
There are minor differences in performance specifications of the scooters, 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 3331 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Ruike Sports Goods Co., Ltd. % Ms. Junnata Chang 14F-2, No. 1, Lane 25 Banqiao, Taipei County, China (Taiwan) 220
Re: K062676
Trade/Device Name: Ruike 3331 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: November 16, 2006 Received: November 16, 2006
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.
DEC 1 4 2006
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 – Ms. Junnata Chang
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 prematics notification. "The 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 If you desire specific advice io. Jour accipital and please note the regulation entitled, Colliact the Office of Compuner as (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response 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,
for
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3. Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
K062676 510(k) Number (if known): __
Device Name: Ruike 3331
Indications for Use:
The Ruike 3331 scooter 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.
| Prescription Use | Over-The-Counter Use X | |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR | (Part 21 CFR 807 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERPAGE OF NEEDED) | ||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 | |
| L062676(Division Sign-Off) | ||
| Division of General, Restorative,and Neurological Devices | ||
| 510(k) Number | L062676 |
(Posted November 13, 2003)
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§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).