(60 days)
The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor scooter which provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor three-wheeled scooter which is battery operated. It consists of a platform which connects the wheels, an adjustable steering column, and a seat for the rider drives the scooter using hand controls located at the top of the steering column. It can be disassembled into five parts for transport in a car trunk. It comes with a battery charger.
The provided document is a 510(k) premarket notification for a medical device (CTM Mobility Scooter HS-666), not a study report. As such, it does not contain the detailed information typically found in a study or clinical trial report regarding acceptance criteria and performance against those criteria. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of the subsequent questions related to study design, ground truth, or expert involvement.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. The relevant "acceptance criteria" here are the requirements 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." The device aims to demonstrate substantial equivalence to a predicate device.
- Reported Device Performance: The document describes the device's technical characteristics and how they compare to a predicate device. The performance details are descriptive rather than quantitative from a formal study.
| Performance Metric | Stated Performance (for C.T.M. Mobility Scooter HS-666) | Comparison to Predicate (Shoprider TE889) |
|---|---|---|
| Battery operated | Yes | Same |
| Motor horsepower | Less than 1 horsepower | Same |
| Automatic braking system | Yes | Same |
| Battery type | Two 12 volt SLA (sealed lead acid) or gel cell batteries | Similar |
| Battery charger | 24-volt constant current charger, 110V/220V compatible | Similar |
| Disassembly for transport | Into five parts, heaviest 57.5 lbs | Not explicitly compared but implied similar functionality |
| Rider capacity | One person | Same |
| Minimum turning radius | 100 cm | Not explicitly compared |
| Maximum forward speed (flat surface) | 5.5 mph | Very similar, varying only in minor parameters (e.g., curb climbability) |
| Maximum reverse speed | 2.2 mph | Not explicitly compared |
| Forward speed (turtle mode) | 2.2 mph | Not explicitly compared |
| Reverse speed (turtle mode) | 0 mph | Not explicitly compared |
| Braking time | Less than 1 second | Not explicitly compared |
| Braking distance | Less than 1 meter | Not explicitly compared |
| Braking system default | Brakes "on" if electrical system fails | Not explicitly compared |
| Free-wheeling mode | Yes (lever from "D" to "N") | Not explicitly compared |
| Self-diagnostic warnings (examples) | 1 flash: battery needs recharging | Not explicitly compared |
| 2 flashes: dead battery | ||
| 3 flashes: battery overcharge |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No performance or clinical test set was submitted or described. The testing conducted primarily refers to compliance with a "Guidance Document," implying engineering and design verification rather than a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth was established for a test set in the context of a clinical or performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used requiring adjudication.
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 is not an AI-assisted diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, but a physical mobility device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as no clinical or performance study was conducted in the manner of diagnostic or treatment efficacy evaluation. The "ground truth" for this submission is substantial equivalence to the predicate device based on technical characteristics and intended use.
8. The sample size for the training set
- Not applicable. This is not a machine learning device; therefore, no training set was used.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
{0}------------------------------------------------
DEC 1 8 1998
510(k) SUMMARY
Submitter's Name: Warepalmy Enterprise LLC (USA) 1725 NE Orenco Station Parkway Hillsboro, OR 97124 (503) 693-6516
Date summary prepared:
October 6, 1998
Device name:
Proprietary name: Common or usual name: Classification name:
C.T.M. Mobility Scooter HS-666 Electric scooter. Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.
Legally marketed device for substantial equivalence comparison:
Shoprider The TE889 submitted by Pride Health Care, Inc. and cleared for marketing under 510(k) *K920654.
Description of the device:
The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor three-wheeled scooter which is battery operated. It consists of a platform which connects the wheels, an adjustable steering column, and a seat for the rider drives the scooter using hand controls located at the top of the steering column. It can be disassembled into five parts for transport in a car trunk. It comes with a battery charger.
Intended use of device:
The device is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Technological characteristics:
The device features and use parameters of the C.T.M. Mobility Scooter HS-666 and Shoprider scooters are very similar. Both are battery operated, have motors less than 1 horsepower, and have automatic braking systems. Batteries and batterv chargers are similar and are provided with the scooters. Use parameters are very similar, varying only in minor parameters such as the curb climbability of the respective scooters.
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}------------------------------------------------
C.T.M. Mobility Scooter HS-666 510(k) Notification Page 5
SECTION 3 - INTENDED USE
Intended use of device:
The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Intended use of predicate device:
The Shoprider-TE889 is a motorized scooter designed to be used indoors and outdoors by an elderly or disabled person.
Comparison:
The intended uses of the two products are the same. Each provides increased mobility for one individual, who is also the operator. Each device can be used in indoor and outdoor settings.
Labeling:
The intended use of the C.T.M. Mobility Scooter HS-666 is stated on page 4 of the Instructions for Use found in Appendix II. The intended use of the Shoprider can be inferred from the Instructions for Use and the promotional material. These can be found in Appendix IV.
{2}------------------------------------------------
SECTION 4 - DEVICE INFORMATION
Executive Summarv
The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor three-wheeled scooter which is battery operated. It has a base which connects the three wheels, an adjustable steering column, and a seat for the rider. It is driven by the rider using hand controls located at the top of the steering column. It can be disassembled into five parts for transport. It is provided with a battery charger.
The C.T.M. Mobility Scooter HS-666 is a new device, not a modification of a previously cleared device. Numerous motorized scooters are currently on the market.
Device Description
Scooter
The C.T.M. Mobility Scooter HS-666 is a battery-powered scooter with three wheels. Its design is similar to many other models on the market. Its main parts are a platform base which connects the front and rear wheels, an adjustable seat, and a steering column with control panel. It also has a detachable front basket. The scooter is designed for one person and can be used indoors or outdoors. Diagrams illustrating the scooter features are included in Appendix I. Diagram 1 shows a side view of the scooter with all major parts labeled. Diagram 2 shows front, rear, and side views of the C.T.M. Mobility Scooter HS-666 with major dimensions given.
The scooter can be disassembled for transportation into five components: the rear drive unit, the front platform unit which includes the steering column, the seat, and the two batteries. The heaviest part is the rear unit which weighs 57.5 Ibs. The whole scooter with the batteries weighs 179.7 lbs; 129 lbs. without batteries. Assembly of the scooter does not require any tools. The wheel and tire assemblies are 11" in diameter.
The electrical cables run from the control panel, through the steering column, under the platform, and to the batteries. When assembling the scooter, electrical connections must be made between the front and rear units. Each battery must be connected to the electrical system. There is also a circuit breaker in the line.
All controls for the scooter are located at the top of the steering column and are operated with the hands. Diagram 3 in Appendix I shows the controls on the top of the steering column. Handlebars protrude from either side of the steering column. These keep the hands in the correct position to operate the controls and to steer. The whole steering column is turned in the direction that the operator wants to go. The minimum turning radius of the scooter is 100 cm. Just inside the handlebars are two thumb-control levers. Pushing these levers allows the scooter to move.
{3}------------------------------------------------
The right lever moves the scooter forward; the left one moves it backward. As soon as either thumb control lever is released, the brake engages. On the back of the steering column are the key hole and the charger plug-in. The battery charger plugs directly into the steering column to recharge the batteries.
On the control panel there are buttons for sounding the horn, turning on/off the headlight, and signaling turns. There is also a speed dial with a rabbit indicating higher speed at one end and a turtle representing lower speed at the other end. Maximum forward speed on a flat surface is 5.5 mph. Maximum speed in reverse is 2.2 mph. Turning the speed knob to the turtle picture reduces the speed to 2.2 mph in the forward direction and to 0 in the reverse direction. There is a power reserve indicator which shows the battery reserve. Below this light are red, yellow, and green color zones. When this light is completely lit, the batteries are fully charged. When the light is lit only in the red and yellow zones, the batteries should be recharged as soon as possible.
There is also a self-diagnostic warning light which blinks to indicate selected problems with the scooter. Generally speaking, the scooter can not be driven when the self-diagnostic light is flashing. The number of flashes helps determine the problem. When the light is making only one flash, indicating low batteries, the scooter can still be driven. The self-diagnostic signals are:
| Number of flashes | Problem |
|---|---|
| 1 | battery needs recharging |
| 2 | dead battery |
| 3 | battery overcharge |
| 4 | electrical short |
| 5 | brake problem |
| 6-9 | electrical system malfunctions |
Explanations of the problems and solutions are described in the Instructions for Use for the scooter, which are included in Appendix II.
The braking system is electric. It is on the rear wheels only. The cables for this system run from the steering column to the rear unit. The brakes are automatically "on" except when one of the thumb-control levers is being pushed. Only under these conditions will the brakes disengage. Release of the thumb-control levers engages the brake. Braking time is less than 1 second and braking distance is less than 1 meter. If the electrical brake system fails, the brakes will default to the closed or "brakes on" position, thereby stopping the scooter. A diagram of the brakes is in Diagram 4 in Appendix I.
There is also a free-wheeling device on many scooters. On the C.T.M. Mobility Scooter HS-666 it is located near the base of the seat post. The normal position of
{4}------------------------------------------------
C.T.M. Mobility Scooter HS-666 510(k) Notification Page 8
the lever is "D". In this position the scooter will not move without turning on the key and having charged batteries. Moving the lever to the position marked ''N'' allows the scooter to be rolled freely without the key being turned on. This feature is very useful when maneuvering the scooter for battery charging or storage. The scooter is not intended to be ridden at all in this free-wheeling mode.
Batteries
The C.T.M. Mobility Scooter HS-666 runs on two 12 volt SLA (sealed lead acid) or gel cell batteries. These batteries are provided with the scooter. Replacements can be obtained from the distributor or other local sources.
Battery Charger
The battery charger is also provided with the scooter. It is a 24 volt constant current charger. It plugs into a standard 110 volt wall socket or into a 220 volt socket.
Accessories
Optional accessories include: a rear basket, a storage cover, a cane holder, and a mirror.
Regulatory Status
The C.T.M. Mobility Scooter HS-666 is a new device which has not been previously submitted to the FDA.
{5}------------------------------------------------
Image /page/5/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1998
Mr. Robert S. McQuate R.S. McQuate & Associates, Inc. Representing Warepalmy Enterprise LLC (USA) 3636 East Columbine Drive Phoenix, Arizona 85032
Re : K983662 C.T.M. Mobility Scooter HS-686 Trade Name: K983663 C.T.M. Mobility Scooter HS-666 Trade Name: Regulatory Class: II Product Code: INI Dated: November 12, 1998 November 13, 1998 Received:
Dear Mr. McQuate:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 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 devices in the Federal Register. Please note: this response to your premarket notification submission does
{6}------------------------------------------------
Page 2 - Mr. Robert S. McQuate
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.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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. Whitton, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{7}------------------------------------------------
C.T.M. Mobility Scooter HS-666 510(k) Notification Page 3
Indications for Use Statement
510(k) Number ( if known):
Device name: C.T.M. Mobility Scooter HS-666
Indications for Use:
The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor scooter which provides transportation for a disabled or elderly person.
(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
toseele
(Division Sign-Off Division of General Restorat 510(k) Number.
§ 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).