(24 days)
The device is intended for medical purposes to provide mobility to person restricted to a sitting position.
BIOTECH B900 SUPER LIGHT WHEELCHAIR
This document is a 510(k) premarket notification letter from the FDA regarding the Biotech B900 Super Light Wheelchair. It focuses on the regulatory approval and substantial equivalence to a predicate device, rather than detailed performance studies or AI-driven diagnostic tools. Therefore, information related to AI acceptance criteria, study methodologies, and expert involvement is not present in this document.
Here's an analysis based on the provided text, recognizing the limitations for the requested AI-centric information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance results for the Biotech B900 Super Light Wheelchair in a format applicable to AI device evaluation (e.g., sensitivity, specificity, AUC). The approval is based on "substantial equivalence" to a legally marketed predicate device, meaning its safety and effectiveness are considered comparable.
| Acceptance Criteria (Not explicitly stated for AI performance) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Safe for intended use | Considered safe for medical purposes |
| Effective for intended use | Considered effective for providing mobility |
| Comparable to predicate device in terms of safety and effectiveness | Substantially equivalent to legally marketed predicate devices |
Information Not Available in the Document:
- Details on specific mechanical or functional performance metrics used to establish equivalence.
- Any quantitative data on device performance, as this is an FDA approval letter, not a study report.
The following points are pertinent to AI device evaluation but are not present in the provided document because it pertains to a mechanical wheelchair and not an AI-driven medical device:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable/Not present. This document is for a mechanical wheelchair, not an AI device.
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/Not present. Ground truth establishment with experts is not relevant for a mechanical wheelchair approval.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not present. Adjudication methods are used in studies involving human interpretation or consensus, not for mechanical device approval.
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/Not present. This is relevant for AI-assisted diagnostic devices, not for a mechanical wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. This concept applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not present. The "ground truth" for a mechanical wheelchair would be its physical properties and functional performance under testing, which are not detailed here.
8. The sample size for the training set:
- Not applicable/Not present. Training sets are for machine learning models, not mechanical devices.
9. How the ground truth for the training set was established:
- Not applicable/Not present. Again, this is for AI model development.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for a mechanical wheelchair. It indicates that the device has been found substantially equivalent to legally marketed predicate devices for its intended use: "to provide mobility to person restricted to a sitting position." The letter confirms regulatory compliance and allows marketing but does not contain information on detailed performance studies, clinical trials, or any aspects related to AI device evaluation as requested in the prompt.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
MAR 8 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Taiwan Armada Enterprise Co., Inc. c/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun Street Hsin-Chu City, Taiwan, ROC
Re: K020472
Trade/Device Name: Biotech B900 Super Light Wheelchair Regulation Number: 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 6, 2002 Received: February 12, 2002
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the based in the 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 I ou may, atteresy missions 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 r hat 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 or any I vith 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.
{1}------------------------------------------------
Page 2 - Dr. Ke-Min Jen
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
b. Mark N. Millers
celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page_1_of 1
210 (K) NUMBER ( IF KNOW ): _ TBA __ KOLO472 DEVICE NAME: BIOTECH B900 SUPER LIGHT WHEELCHAIR_
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to person restricted to a sitting position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, office of Device Evaluation (ODE )
| Prescription Use | OR Over-The-Counter-Use ✓ |
|---|---|
| (Per 21 CFR 801.109 ) | ( Optional Format 1-2-96 ) |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K020472 |
|---|---|
| --------------- | --------- |
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).