(104 days)
The Ruike 3431 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 3431 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 document is a 510(k) Summary for a medical device (Ruike 3431 scooter). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found in a 510(k) Summary for a device like this.
Specifically:
- Acceptance Criteria and Reported Device Performance: Instead of explicit acceptance criteria being met by a study, the document presents a comparison to a predicate device (Bewell SC 20). The "performance" is described through the device's technical specifications and intended use, and the claim is that minor differences do not alter the intended function or raise new safety/effectiveness questions.
- Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Study, Training Set: These are all concepts related to clinical or performance studies designed to validate the efficacy or accuracy of a device, especially those involving AI or diagnostic capabilities. The Ruike 3431 scooter is a mobility device, and its approval process relies on demonstrating that it is as safe and effective as pre-existing, legally marketed devices (the predicate). This usually involves engineering tests (e.g., maximum loading, speed, braking distance) and a comparison of specifications, not clinical trials with human subjects to establish ground truth or measure improvements with AI assistance.
However, I can extract the comparative performance table that serves as the basis for demonstrating substantial equivalence:
1. Table of Acceptance Criteria (or Comparison to Predicate) and Reported Device Performance
Instead of "acceptance criteria" against which a study directly validates, the 510(k) process for this device relies on demonstrating "substantial equivalence" to a predicate device. The performance comparison is therefore presented in relation to the predicate.
| Feature | Predicate Device: Bewell SC 20 (K043326) | Ruike 3431 (Reported Performance) |
|---|---|---|
| Intended Use | Both scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. | Same as predicate. |
| Maximum Loading | 130 kg (286 lbs) | 120 kg (265 lbs) |
| Overall Height | 1120 mm (44") | 825 mm (32.5") |
| Overall Length | 1300 mm (51.2") | 1030 mm (40.6") |
| Overall Width | 610 mm (24") | 510mm (20") |
| Seat Overall Height | 370 mm (14.5") | 430 mm (16.9") |
| Seat Overall Width | 450mm (17.7") | 500 mm (19.7") |
| Seat Overall Depth | 450mm (17.7") | 400 mm (15.7") |
| Seat Overall Weight | 7.5 kg (16.5 lbs) | 10 kg (22 lbs) |
| Motor Output | DC24V, 700W, 5000 RPM, 1Pc | 180 W x DC 24V, 1Pc |
| Controller | Dynamic DS72K01 | PG S-Drive 45A |
| Differential Mechanism | Differential rate: 20 : 1 | Differential rate: 17 : 1 |
| Rear Wheel Drive | (Not specified as a distinct feature) | Sealed transaxle direct drive |
| Front Wheel | 4" Pneumatic tire × 2 Pc | 195 mm x 80 mm (7.6"x 3.15") Solid tire x 2 |
| Rear Wheel | 4" Pneumatic tire × 2 Pc | 195 mm x 80 mm (7.6"x 3.15") Solid tire x 2 |
| Charger | Yes, 4V 5AMP (Automatic Type) off-board | 24V 5AMP charger (Automatic Type) off-board |
| Battery | Lead-Acid 12V × 36AH × 2PCs | Lead-Acid 12V×24AH×2 |
| Battery level indicator | (Not specified) | Yes |
| Tiller Foldable | Yes | Yes |
| Rear suspension | No | Yes (Optional) |
| Continuous height adjustab | (Not specified) | Yes |
| Backrest recline angle | (Not specified) | Yes |
| Recline angle | (Not specified) | Yes |
| Operation model | Thumb operated potentiometer throttle control | Thumb operated potentiometer throttle control |
| Warning Ligh(Rear) | No | Yes |
| Tail lights | No | Yes |
| Headrest | (Not specified) | Yes |
| Armrests | Yes | Yes |
| Bumpers | Front: Yes, it's constructed by steel | Front/Rear: Yes, it's constructed by steel |
| Maximum speed | 0 to 9 km/hr (5.6 mph), variable | 0 to 6 km/hr (3.7 mph), variable |
| Turning radius | 1500 mm (59") | 1050 mm (41.3") at max speed |
| Maximum curb over-charge distance | 127 mm (5.0") | 45 mm (1.8") |
| Slope grade ability | 12 degree | 12 degree |
| Braking distance | Standard: 2.58 m(101.6") at max speed | Standard: 1000 mm (39.4") |
| Brake system | Front: Yes, Rear: No (Not specified further) | Intelligent regenerative electromagnetic brake |
| Net weight with battery | 96 kg (213 lbs) | 51 kg (112 lbs) |
| Continuous range | 22 to 35.2 km (22 miles) | 15 km (9 miles) |
| Speed mode | Single mode, Variable | Single mode, Variable |
| Disassemble | No | Yes |
| Horn | Yes | Yes |
Since this is a 510(k) submission for a non-diagnostic, non-AI device like a scooter, the following requested information is not applicable and would not be found in such a regulatory document:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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DEC 1 9 2006
K062645
Page 1 of 4
Shanghai Ruike Sports Goods CO., LTD.
FAX: +86-21-66351873 No. 689, Xinhu Road, Shanghai, China TEL: +86-21-66350714
510(k) Summary
Device
Trade name: Ruike 3431 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
Bewell SC 20 (K043326)/Cycling and Health Tech Industry R&D Center/CHC Intend use of device
Ruike 3431 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 3431 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 3431 scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.
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 3431 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
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No. 689, Xinhu Road, Shanghai, China TEL: +86-21-66350714 FAX: +86-21-6635187 hanghai Ruike Sports Goods CO., LTD.
| Bewell SC 20(K043326) | Ruike 3431 | |
|---|---|---|
| Intended use | Both scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to providemobility to disabled or elderly persons limited to a seated position. | |
| Maximum loading | 130 kg (286 lbs) | 120 kg (265 lbs) |
| Overall height | 1120 mm (44") | 825 mm (32.5") |
| Overall length | 1300 mm (51.2") | 1030 mm (40.6") |
| Overall width | 610 mm (24") | 510mm (20") |
| Seat overall height | 370 mm (14.5") | 430 mm (16.9") |
| Seat overall width | 450mm (17.7") | 500 mm (19.7") |
| Seat overall depth | 450mm (17.7") | 400 mm (15.7") |
| Seat overall weight | 7.5 kg (16.5 lbs) | 10 kg (22 lbs) |
| Motor output | DC24V, 700W, 5000 RPM, 1Pc | 180 W x DC 24V, 1Pc |
| Controller | Dynamic DS72K01 | PG S-Drive 45A |
| Differentialmechanism | Differential rate: 20 : 1 | Differential rate: 17 : 1 |
| Rear wheel drive | Sealed transaxle direct drive |
he substantial equivalence comparison of the Ruike 3431 and Bewell SC
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FAX: +86-21-663518 nghai Ruike Sports Goods CO., LT 689, Xinhu Road, Shanghai, China TEL: +86-21-66350714
x 80 mm(7.6"× 3.15") Solid tire x 2 80 mm(7.6"× 3.15") Solid tire x 2 ont/Rear: Yes, it's constructed by steel Ruike 34 ON on Automatic Type) off-be ead-Acid 12V×24AH×2 humb operated potentiometer throttle control ubstantial equivalence comparison of the Ruike 3431 and Bewell Foldable Yes Yes Yes No es, 4V 5AMP (Automatic Type) off-bo well SC 20(K04332 ont: Yes, it's constructed by steel 2V × 36AH × 2PCs 4" Pneumatic tire × 2 Pe 4" Pneumatic tire × 2 Po les ടുറു aluminum allo aluminum alle ead-Acid Rear : No les eight adjustab Backrest recline angle
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K062645
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FAX: +86-21-663518 nghai Ruike Sports Goods CO., LT 689, Xinhu Road, Shanghai, China TEL: +86-21-6635071
ights and signal lights of the SC 20 and Ruike 3431 scooters have the same fur. tions, but only the Single mode, Variab Ruike 34 Rear: les m/hr (3.7 mph) , variab 05 m(41.3") at max sp ont: Yes(Optional), ntelligent regenerative electromagnetic br 000 mm (39.4" .5 km (9 mile kg (112 lbs 5 mm (1.8' 2 degree Yes Yes Yes ard: 2.58 m(101.6") at max spee ewell SC 20(K04331 ingle mode, Varial o 9 km/hr (5.6 mph), varia No to 35.2 km (22 mi ront: Yes, Rear: N kg (213 lbs 500 mm (59) 27 mm (5.0) re differen 2 degre r-charge distan lope grade abilit Braking distance
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faximum cur nti-tip wheel reak systen Varning ligh peed mode isassemble Tail lights
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ibstantial equivalence comparison of the Ruike 3431 and Bewell
K062645
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Image /page/4/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
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
DEC 1 9 2006
Re: K062645
Trade/Device Name: Ruike 3431 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: December 12, 2006 Received: December 12, 2006
Dear Ms. Junnata 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.
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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 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 (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-n P
Mark N. Mellekerson
Mark N. Melkerson 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
1062645 510(k) Number (if known):
Device Name: Ruike 3431
Indications for Use:
The Ruike 3431 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.
Over-The-Counter Use _ X Prescription Use (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 CDRIA Office of Device Evaluation (ODE) Page 1 of 1
(Division Sign-Off)
(Division of General, Restorative and Neurological Devices
510(k) Number
(Posted November 13, 2003)
§ 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).