(61 days)
Not Found
Not Found
No
The summary describes a standard powered scooter with no mention of AI or ML capabilities.
No.
The device's intended use is to provide mobility, not to treat or alleviate a medical condition.
No
The device, a powered scooter, is intended to provide mobility, not to diagnose any medical condition or disease.
No
The device description clearly states it is an "Electric powered four wheel drive scooter," which is a hardware device.
Based on the provided information, the MERITS Pioneer 3 Powered Scooter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to adults with limited mobility. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as an electric powered four-wheel drive scooter, which is a mobility aid.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are specifically designed to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease. The MERITS Pioneer 3 Powered Scooter does not fit this description.
N/A
Intended Use / Indications for Use
The intended use of the MERITS Pioneer 3 Powered Scooter is to provide mobility to adults, limited to a siting position and have the capability to operate a simple hand control.
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
adults
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines, possibly representing people or services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2001
Mr. Winston Anderson Vice President MERITS Health Products, Inc. P.O. Box 150356 Cape Coral, Florida 33915
Re: K011751
Trade/Device Name: MERITS Pioneer 3 Electric Powered Four Wheel Drive Scooter Regulation Number: 890.3800 Regulatory Class: II Product Code: INI Dated: July 25, 2001 Received: July 25, 2001
Dear Mr. Anderson:
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 legally marketed predicate 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 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 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 requirements, 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 action. In addition, FDA may publish further announcements 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. Winston Anderson
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
hllllllllllmnon
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
Indications for Use Statement
510K number: K011751
Device Name: MERITS Pioneer 3 Electric powered four wheel drive scooter
The intended use of the MERITS Pioneer 3 Powered Scooter is to provide Indications For Use: mobility to adults, limited to a siting position and have the capability to operate a simple hand control.
K.P.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
Prescription Use______________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
DTHuleeeow fr cmu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011751