(70 days)
The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor Mobility Scooter that is battery operated. It has a base with four wheels and a lightweight adjustable seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an off board battery charger.
The provided text is a 510(k) summary for the C.T.M. Mobility Scooter HS-118. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a study in the way a medical diagnostic AI device might.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, specific types of ground truth) are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted or deduced from the provided text, tailored to the context of this device:
Acceptance Criteria and Study for C.T.M. Mobility Scooter HS-118
The C.T.M. Mobility Scooter HS-118 sought 510(k) clearance by demonstrating "substantial equivalence" to predicate devices, namely the Go-Go Ultra X (K063389) and VCS S3T (K051131). The primary "acceptance criteria" were met by showing that its technological characteristics, intended use, and performance data were comparable to these predicates, and that any differences did not raise new questions of safety or effectiveness.
1. Table of "Acceptance Criteria" and Reported Device Performance
| Acceptance Criteria Category (Implied by 510(k) Equivalence) | Reported Device Performance (HS-118) |
|---|---|
| Intended Use | Indoor/outdoor transportation for disabled or elderly persons. |
| Regulatory Classification | Class II, Product Code INI (Motorized three-wheeled vehicle, 21 CFR 890.3800) |
| Technological Characteristics | Battery operated, one motor, automatic braking system, off-board charger, disassembled for transport. |
| Key Components | Uses the same controller (STAR 70-Z controller) as the VCS S3T predicate. |
| Safety and Effectiveness | "Non-clinical testing and specification comparison demonstrate that any differences in specifications or technology do not raise new questions of safety or effectiveness." |
| Performance Testing | Tests listed in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995" were conducted. Results were included in the submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This was a submission for a physical device, not an AI/diagnostic algorithm tested on a dataset of patient samples. The "test set" in this context refers to bench testing of the scooter itself.
- Data Provenance: Not applicable in the traditional sense of clinical data. The "data" comes from bench testing of the physical scooter and comparison of its specifications to predicate devices. The country of origin for the data generation would be where C.T.M. Homecare Product, Inc. conducted its testing, likely in China or the US given the company's address and contact. The testing was prospective in the sense that it was performed on the device being submitted for clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for a mechanical device like a scooter is its physical performance against established engineering and safety standards. There isn't a concept of expert consensus for labeling a case as positive or negative.
- Qualifications of Experts: Not applicable. Testing would have been conducted by engineers or technicians familiar with relevant standards (e.g., ISO, ANSI, FDA guidance).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There's no "test set" of cases requiring adjudication by multiple readers or experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." MRMC studies are typically used for diagnostic devices to assess human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a physical mobility device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "bench testing," the ground truth corresponds to accepted engineering specifications and safety standards outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995." Compliance with these predetermined thresholds and successful completion of the specified tests served as the "ground truth" for the device's functional and safety performance.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. There is no AI algorithm being "trained" in this context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
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APR 2 2 2011
510(k) SUMMARY
Submitter's name:
C.T.M. Homecare Product, Inc. 6191 Schaefer Ave Suite B Chino, CA 91710
Contact name and address:
Sheila Ramerman RAC SJR Associates 927 Throne Drive Eugene, OR 97402 PH: (541) 683-3017 Email: sramerman@aol.com
Date Summary prepared:
February 8, 2011
Device Names:
Proprietary name: Common or usual name: Electric scooter Classification name:
C.T.M. Mobility Scooter HS-118 Motorized three-wheeled vehicle (890.3800) Motorized 3-wheeled vehicle (89 INI)
Legally marketed device for substantial equivalence comparison:
The predicate devices for this submission are:
- Go-Go Ultra X (Model No. SC44X 4-wheel), manufactured and . distributed by Pride Mobility Products Corp. and cleared under 510(k) #K063389, and
- VCS S3T, distributed by Vehicles Technology Co., Ltd and cleared under K051131.
Description of the Device:
The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor Mobility Scooter that is battery operated. It has a base with four wheels and a lightweight adjustable seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an off board battery charger.
Intended Use of Device:
The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Technological Characteristics:
The device features of the C.T.M. Mobility Scooter HS-118 and the Go-Go Ultra are very similar. Both are battery operated, have one motor, and have automatic braking systems. Off-board battery chargers are provided with both scooters. Both scooters can be disassembled for transport. The target population is identical and the use parameters are similar.
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The HS-118 and the VCS S3T use the same controller, the STAR 70-Z controller.
Bench Testing:
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission.
Performance Testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
Substantial Equivalence:
The HS-118 and the predicate devices have the same regulatory classification and the same intended use. The HS-118 and the Go Go Ultra have similar the bannelines in the racteristics. The HS-118 and the VCS S3T use the same controller. Non-clinical testing and specification comparison demonstrate that any differences in specifications or technology do not raise new questions of safety or effectiveness. The HS-118 is substantially equivalent to the predicate devices.
0018
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
C.T.M. Homecare Product, Inc. % SJR Associates Ms. Sheila Ramerman 927 Throne Drive Eugene, Oregon 97402
APR 2 2 2011
Re: K110395
Trade/Device Name: C.T.M. Mobility Scooter HS-118 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: February 10, 2011 Received: February 11, 2011
Dear Ms. Ramerman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Sheila Ramerman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
$\overline{H}$ B. re h
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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C.T.M. Mobility Scooter HS-118 510(k) Notification
Indications for Use
510(k) Number (if known):
Device Name: C.T.M. Mobility Scooter HS-118
Indications for Use:
The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110395
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§ 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).