(65 days)
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.
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.
The provided 510(k) summary for the C.T.M. Mobility Scooter HS-320 does not contain acceptance criteria or a detailed study proving the device meets such criteria in the way typically expected for medical devices involving diagnostic performance or clinical outcomes. Instead, it focuses on substantial equivalence to a predicate device based on technological characteristics and general safety testing.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As stated, no explicit acceptance criteria with quantitative thresholds are provided in the document. The submission relies on demonstrating similarity to a legally marketed predicate device (Sunrunner TE-777-3). The "performance" mentioned refers to general device features and safety tests rather than diagnostic accuracy or clinical effectiveness.
Therefore, a table cannot be constructed as requested.
2. Sample Size Used for the Test Set and Data Provenance
- Sample size: Not applicable. The submission states, "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that no specific test set of users or data for comparative performance was used.
- Data Provenance: Not applicable for comparative performance testing. The "Testing conducted" refers to general safety and design verification tests listed in a guidance document, but details on sample size or provenance for these tests are not provided and are not related to clinical or diagnostic performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical or comparative performance test set was used, and thus no ground truth establishment by experts for such a set was performed or reported.
4. Adjudication Method for the Test Set
Not applicable. No clinical or comparative performance test set was used, and thus no adjudication method was employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mobility scooter, not a diagnostic imaging or AI-assisted device. Therefore, an MRMC study or assessment of AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical mobility scooter, not an algorithm or software-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of diagnostic or clinical performance. The "ground truth" for this device's safety and functionality would implicitly be established by engineering standards and internal testing to ensure the scooter operates as intended and meets safety specifications (e.g., braking performance, stability, battery life). The document mentions "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," which implies that the ground truth for these tests is defined by the standards and methodologies within that guidance document.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML or a diagnostic device that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set was used.
Summary of the Device's "Acceptance" Basis from the Provided Text:
The C.T.M. Mobility Scooter HS-320 received 510(k) clearance based on substantial equivalence to a previously marketed predicate device (Sunrunner TE-777-3). The primary arguments for substantial equivalence are:
- Similar Intended Use: Both are indoor/outdoor scooters for disabled or elderly persons.
- Similar Technological Characteristics: Both are battery-operated electric scooters with three wheels, adjustable seating, hand controls, and automatic braking systems.
- Performance Differences: The document acknowledges "varying only slightly with selected parameters, such as with the maximum distance that each scooter can be driven," implying these slight variations were not deemed significant enough to warrant a finding of non-equivalence.
- Conformance to Guidance Document: Tests outlined 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. While the specific results or acceptance criteria for these tests are not detailed in the summary, their completion contributes to the overall demonstration of safety and effectiveness consistent with the predicate.
Crucially, the submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This reinforces that the clearance was not based on demonstrating superior or even equivalent performance in a clinical study sense, but rather on the similarity of design, function, and intended use as well as compliance with recognized safety standards for this class of device.
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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).
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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.
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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
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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.
§ 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).