(65 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard mobility scooter and does not mention any AI or ML features. The performance studies reference a 1995 guidance document, further suggesting a lack of advanced AI/ML technology.
No.
A therapeutic device is typically involved in the treatment or alleviation of a medical condition. A mobility scooter, while assistive, primarily aids in transportation for individuals with disabilities or mobility issues rather than directly treating a medical condition. It falls under the category of assistive devices for daily living.
No
The device description indicates it is a mobility scooter used for transportation, not for diagnosing medical conditions. The "Intended Use" also specifies it provides transportation for disabled or elderly persons, not diagnostics.
No
The device description clearly outlines a physical, battery-operated electric scooter with hardware components like wheels, seats, armrests, and hand controls. It is not solely software.
Based on the provided information, the C.T.M. Mobility Scooter HS-320 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide transportation for disabled or elderly persons. This is a physical mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a mechanical and electrical device for transportation, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any processes related to in vitro testing.
Therefore, the C.T.M. Mobility Scooter HS-320 falls under the category of a mobility aid or powered wheelchair/scooter, not an IVD.
N/A
Intended Use / Indications for Use
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.
Product codes
INI
Device Description
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with adjustable padded seats, armrests and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. This modes can be disassembled for transport and is provided with a battery charger.
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)
Testing conducted: Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission.
Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
OCT 2 4 2001
K012791
510(k) SUMMARY
Warepalmy Enterprise LLC (USA) Submitter's Name: 1725 NE Orenco Station Parkway Hillsboro, OR 97124 (503) 693-6516
Date summary prepared:
August 16, 2001
Device name:
Proprietary name: Common or usual name: Classification name:
C.T.M. Mobility Scooter HS-320 Electric scooter. Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.
Legally marketed device for substantial equivalence comparison: Sunrunner TE-777-3 submitted by Pride Health Care, Inc. and cleared for marketing under 510(k) #K923193.
Description of the device:
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with adjustable padded seats, armrests and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. This modes can be disassembled for transport and is provided with a battery charger.
Intended use of device:
The device is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.
Technological characteristics:
The device features and use parameters of the C.T.M. Mobility Scooter and the Sunrunner TE-777-3 are very similar. Both are indoor/outdoor electric scooters that are battery operated and have automatic braking systems. Batteries and battery chargers are provided with each scooter. Use parameters are very similar, varying only slightly with selected parameters, such as with the maximum distance that each scooter can be driven.
Testing conducted:
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT 2 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert S. McQuate Warepalmy Enterprise LLC (USA) C/O R.S. McQuate & Associates, Inc. 3636 East Columbine Drive Phoenix, Arizona 85032
Re: K012791
Trade/Device Name: C.T.M. Mobility Scooter HS-320 Regulation Number: 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: II Product Code: INI Dated: October 3, 2001 Received: October 5, 2001
Dear Mr. McQuate:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 (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 that 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 comply with 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.
2
Page 2 - Mr. Robert S. McQuate
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,
Sincerely yours,
Mark N. Millerson
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
3
C.T.M. Mobility Scooter HS-320 510(k) Notification Page 3
Indications for Use Statement
510(k) Number (if known): K012791
Device name: C.T.M. Mobility Scooter HS-320
Indications for Use:
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
for Mark N Millken
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K01279/ 00000.