(38 days)
The Proasia L3402 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 Proasia L3402 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 a medical device, specifically an electrical scooter named Proasia L3402. This document is a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
Key takeaway: 510(k) summaries do not typically contain detailed acceptance criteria and study results in the way a clinical trial report or a performance study for a novel device would. Instead, substantial equivalence is often established by comparing design, materials, and performance specifications to the predicate device, emphasizing that any differences do not raise new questions of safety or efficacy.
Based on the provided text, a formal study demonstrating specific acceptance criteria with performance metrics is not described. The submission relies on establishing substantial equivalence to a predicate device.
Therefore, many of the requested fields cannot be directly answered from the given text.
Here's an attempt to answer based on the information available, and explicitly stating when information is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Function as an indoor/outdoor scooter for disabled/elderly persons. | The device is described as an "indoor/outdoor transportation vehicle" for "disabled or elderly persons limited to a seated position." |
| Operation controlled by tiller handle and thumb-operated potentiometer throttle. | "The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever..." |
| Battery operated. | "The Proasia L3402 scooter is an indoor/outdoor transportation vehicles which is battery operated." |
| Performance specifications similar to predicate device (LANDLEX S300X). | "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." (Specific values are NOT PROVIDED) |
| Safety and effectiveness not compromised compared to predicate. | Implied by the declaration of substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided. The document does not describe a performance study with a test set.
- Data Provenance: Not provided, as no specific performance study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No explicit test set or ground truth establishment by experts is described for this type of regulatory submission. The assessment is primarily based on comparing specifications and design to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process is described.
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
- No. This device is an electrical scooter and does not involve "readers" or "AI assistance" in the context of diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an electrical scooter, not an algorithm, so "standalone" performance in this context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth, in the typical sense for diagnostic or prognostic devices, is established or used for this submission. Substantial equivalence relies on comparing the device's design and intended use to an already legally marketed device.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this device is not an AI/ML algorithm or diagnostic tool that requires training data.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for it is relevant or described.
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OCT 7 - 2005 510(k) Summary
Device
Trade name: Proasia L3402 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 S300X (K050792) / Besteam Technology Inc.
Intend use of device
Proasia L3402 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The Proasia L3402 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 Proasia L3402 scooter is substantially equivalent to the LANDLEX S300X (K050792) 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, Proasia Limited believes that the Proasia L3402 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three overlapping profiles facing to the right.
OCT 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jeff Chang Proasia Limited 16 F-2, No. 462, Sec. 2, Chong-De Road Beitun District, Taichung China (Taiwan) 40653
Re: K052378
Trade/Device Name: Proasia L3402 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 26, 2005 Received: August 30, 2005
Dear Mr. 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 - Jeff 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
25
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Device descriptive information 3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): 长のSと378
Device Name: Proasia L3402
Indications for Use:
The Proasia L3402 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 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (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
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number [K052378](https://510k.innolitics.com/search/K052378)
(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).