(129 days)
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Not Found
No
The summary describes a battery-powered, motorized three-wheeled vehicle for mobility assistance and does not mention any AI or ML components or functionalities.
No
The device is described as aiding mobility for impaired individuals, which is a supportive function rather than treating or curing a medical condition. While it helps with a physical limitation, it doesn't fall under the typical definition of a therapeutic device designed for treatment or therapy.
No
Explanation: The device, INDEPENDENCE 324, is described as a "battery powered, motorized three-wheeled vehicle" intended to aid mobility. This function does not involve diagnosing medical conditions, but rather providing physical assistance.
No
The intended use clearly describes a "battery powered, motorized three-wheeled vehicle," which is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "battery powered, motorized three-wheeled vehicle" designed to aid in mobility for individuals with temporary or permanent mobility impairment. This describes a physical assistive device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
Therefore, the INDEPENDENCE 324 is a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
THE INDEPENDENCE 324 IS INTENDED TO AID IN THE TEMPORARY OR PERMANENTLY MOBILITY IMPAIRED INDIVIDUAL TO MOVE ABOUT INDOORS, AND OUTDOORS, THROUGH THE USE OF A BATTERY POWERED, MOTORIZED THREE-WHEELED VEHICLE. THE WEIGHT CAPACITY OF THE INDIVIDUAL IS NOT TO EXCEED 300 LBS.
Product codes
ITI
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1999
Charles B. Walker, Jr. Mr. Sales and Marketing Manager Eagle Parts and Products, Inc. 1811 Wilkinson Road Auqusta, Georgia 30904
Re : K990122 Independence 624 Trade Name : K990484 Independence 324 Trade Name : Regulatory Class: II Product Code: ITI Dated: Undated Received: April 30, 1999
Dear Mr. Walker:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Charles B. Walker, Jr.
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 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 devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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STATEMENT OF INDICATED USE
The INDEPENDENCE 324 IS INTENDED TO AID IN THE TEMPORARY OR PERMANENTLY MOBILITY IMPAIRED INDIVIDUAL TO MOVE ABOUT INDOORS, AND OUTDOORS, THROUGH THE USE OF A BATTERY POWERED, MOTORIZED THREE-WHEELED VEHICLE. THE WEIGHT CAPACITY OF THE INDIVIDUAL IS NOT TO EXCEED 300 LBS.
Chute B. Ward
Charles B. Walker Jr
Over-the-Counter Use X
pased
(y-Off)
of General Re 4048 5 | U(k) Number