(39 days)
The LANDLEX P100X 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 LANDLEX P100X 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.
This 510(k) summary (K060042) describes a motorized scooter, the LANDLEX P100X. It is a Class II medical device, classified as a "Motorized three-wheeled vehicle."
Here's the breakdown of the information requested, based on the provided document:
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly define specific performance acceptance criteria or report detailed performance metrics for the LANDLEX P100X. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The "minor differences in performance specifications" are mentioned but not detailed, and no specific numerical criteria are given.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The primary "acceptance" is based on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable and does not raise new safety/effectiveness concerns. | "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." |
2. Sample size used for the test set and the data provenance
The document does not describe a specific "test set" or data provenance in the context of typical device performance studies (e.g., clinical trials, bench testing with quantified results). The substantial equivalence claim is made based on the device's design and intended use compared to predicates, rather than a prospective study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided in the document. The substantial equivalence argument for this type of device does not typically involve expert review of a "test set" for ground truth establishment in the way it would for, say, an AI-powered diagnostic tool.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable or provided in the document.
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
This information is not applicable or provided in the document. This device is an electrical scooter; it does not involve human readers interpreting images or data, nor does it incorporate AI in the sense of a diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or provided in the document. The LANDLEX P100X is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth, in the context of demonstrating performance against a standard, is not explicitly mentioned or described for this device. The basis for approval is substantial equivalence to legally marketed predicate devices, meaning that if the predicates were deemed safe and effective, and the new device is sufficiently similar, it can also be considered safe and effective.
8. The sample size for the training set
This information is not applicable or provided in the document. The device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable or provided in the document for the reasons stated above.
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FEB 1 4 2006
Ko60042
Besteam Technology Inc.
No.16-1, Ziqiang 1st Rd., Zhongli City, Taoyuan Hsien, Taiwan
Fax: +886-3-4342572 Phone: +886-3-4345111
510(k) Summary
Device
Trade name: LANDLEX P100X
Common (generic) name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: INI
Classification: Class II
Predicate devices
LANDLEX S300X (K050792) / Besteam Technology Inc.
Proasia L3402 (K052378) / Proasia
Intend use of device
LANDLEX P100X scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The LANDLEX P100X 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 LANDLEX P100X scooter is substantially equivalent to the LANDLEX S300X (K050792) and Proasia L3402 (K052378) manufactured by Besteam and Proasia, respectively.
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, Besteam believes that the LANDLEX P100X scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2006
Mr. Jack Chen Besteam Technology Inc. No.16-1, Ziqiang 1st Rd., Zhongli City, Taoyuan Hsien, Taiwan, 32063
Re: K060042
Trade/Device Name: LANDLEX P100X Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: January 03, 2006 Received: January 06, 2006
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premainted in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate for use stated in the enclosure) the actering and as a concess marketed in interstate for use stated in the encrosule) to regally manator date of the Medical Device Ameral Food. Drug commerce prior to May 28, 1776, the enaounce with the provisions of the Federal Food. Drug. devices that have been reclassince in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act, 7 and Costheile Act (Act) that to hot require approvial controls provisions of the Act. The You may, merelove, market the act include requirements for annual registration, listing of general controls provisions of the rest 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 If your device is classified (500 a0070) ins existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or events concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc advised that I Dri 3 issualles of a complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any it cach stututes and registerients, including, but not limited to: registration and listing (21 comply with an the 11ct 811 Part 801); good manufacturing practice requirements as set CFR Part 807); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jack Chen
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ogin manteans your and equivalence of your device to a legally premarket notification. The PDF mailing of casion 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 for your ac not one one one one one the regulation entitled, Colliact the Office of Complance as (27,74) = (21CFR Part 807.97). You may obtain Misolanding of Icrerchoe to premantonsibilities under the Act from the Division of Small other general 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. 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): _
Device Name: LANDLEX P100X
Indications for Use:
The LANDLEX P100X 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 CDRH, Office of Device Evaluation (ODE) Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K060047
(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).