(95 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) point towards a personal transportation device, not one that would inherently require AI/ML for its primary function.
No
The device is described as personal transportation for senior active and walking-impaired individuals, which is not an indication for a therapeutic purpose.
No
The device is described as "personal transportation for senior active and walking impaired individuals," which indicates it is for mobility and not for diagnosing medical conditions.
No
The provided text describes a device for "personal transportation" and mentions "walking impaired individuals," which strongly suggests a physical device (like a scooter or walker) rather than software. There is no mention of software or digital components.
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 senior active and walking impaired individuals." This clearly describes a device used for mobility and assistance, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: While "Not Found," the intended use is the primary indicator.
- Mentions image processing, AI, DNN, or ML: These are often associated with IVDs that analyze images or data for diagnostic purposes. Their absence further supports it not being an IVD.
- Input Imaging Modality, Anatomical Site: These are not applicable, which is consistent with a transportation device.
- Indicated Patient Age Range, Intended User / Care Setting: These describe the target user and environment, which are relevant for a personal transportation device.
- Lack of information on training/test sets, performance studies, and key metrics: This type of information is crucial for evaluating the performance and accuracy of an IVD, which analyzes biological samples. Its absence suggests the device doesn't perform such analysis.
In summary, the intended use and the lack of information related to biological sample analysis strongly indicate that this device is a personal transportation aid and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended use is personal transportation for senior active and walking impaired individuals.
Product codes
INI
Device Description
Not Found
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
senior active and walking impaired individuals
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 1998
Ms. Andrea Lupo ·Executive Assistant Amigo Mobility International, Inc. 6693 Dixie Highway Bridgeport, Michigan 48722-0402
K981121 Re : Amigo RT Trade Name: Requlatory Class: II Product Code: INI Dated: June 12, 1998 Received: June 15, 1998
Dear Ms. Lupo:
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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.
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Page 2 - Ms. Andrea Lupo
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 requlation (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.
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K981121 510(k) NUMBER (IF KNOWN):
AMIGO RT DEVICE NAME:
INDICATIONS FOR USE:
ﺑﺮﺩ ﮐﮯ ﻣ
Intended use is personal transportation for senior active and walking impaired individuals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2-96)
les
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K961121