(211 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is a "Joystick" for personal transportation, which does not typically involve AI/ML.
No
Explanation: The device is described as "personal transportation for walking impaired individuals," which indicates a mobility aid rather than a device intended for therapy or treatment of a medical condition.
No
The intended use is personal transportation, not diagnosis.
No
The device description explicitly states "AMIGO MODEL 590000 (Joystick)", indicating a hardware component (a joystick) is part of the device. The intended use also describes "personal transportation," which is typically a hardware-based function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "personal transportation for walking impaired individuals." This clearly describes a device used to assist with mobility, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a "Joystick" for the "AMIGO MODEL 590000". This further supports the idea of a mobility aid control.
- Lack of IVD Indicators: The document explicitly states "Not Found" for all the typical characteristics of an IVD, such as:
- Image processing
- AI/DNN/ML (often used in analyzing biological data)
- Input Imaging Modality
- Anatomical Site
- Patient Age Range (IVDs often have specific age ranges for testing)
- Intended User/Care Setting (IVDs are typically used in labs or clinical settings)
- Information about training/test sets, performance studies, and key metrics (essential for validating IVD performance)
- Predicate/Reference Devices (IVDs are often compared to existing IVDs)
In summary, the intended use and the lack of any characteristics associated with in vitro diagnostics strongly indicate that this device is a mobility aid and not an IVD.
N/A
Intended Use / Indications for Use
The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.
Product codes
INI
Device Description
AMIGO MODEL 590000 (Joystick)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Not Found
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
§ 890.3800 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).
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 1999
Mr. Dale Confer Product Design Development Manager Amigo Mobility International, Inc. 6693 Dixie Highway Bridgeport, Michigan 48722-0402
Re: K983987 Amigo Model 590000 Trade Name: Regulatory Class: II Product Code: INI April 23, 1999 Dated: April 26, 1999 Received:
Dear Mr. Confer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਕੇ 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 device in the Federal Register. Please note: this response to your premarket notification submission does 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 regulations.
1
Page 2 - Mr. Dale Confer
This letter will allow you to begin marketing your device as described in your 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 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" (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
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510(k) NUMBER (IF KNOWN): K
3A1-1
1.95% 11.2% 26.0% 3.0% 1.0% 1.0% 1.0% 1.0% 1.0% 1.4%
:"""",
AMIGO MODEL 590000 (Joystick) DEVICE NAME:
INDICATIONS FOR USE:
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.
The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
510(k) Number