(24 days)
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Not Found
No
The summary does not mention any AI or ML related terms, image processing, or performance studies typically associated with AI/ML devices. The device description is for a wheelchair, which is a mechanical device.
No
The device provides mobility but does not treat or cure a disease or condition.
No
The intended use states the device provides mobility to persons restricted to a sitting position, which is a therapeutic or assistive function, not a diagnostic one.
No
The device description clearly identifies it as a "BIOTECH B900 SUPER LIGHT WHEELCHAIR," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide mobility to person restricted to a sitting position." This describes a device used on a patient for physical support and movement, not a device used to examine specimens outside the body to diagnose or monitor a medical condition.
- Device Description: The device is described as a "WHEELCHAIR." Wheelchairs are mobility aids, not diagnostic tools.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information about a disease or condition
Therefore, the BIOTECH B900 SUPER LIGHT WHEELCHAIR is a medical device, but it falls under the category of a mobility aid, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to person restricted to a sitting position.
Product codes
IOR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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.
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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
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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 |
|---|---|
| --------------- | --------- |