(202 days)
The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.
The Titan 4W scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Titan 4W alone and to safely steer under all driving conditions. The Titan 4W is intended for indoor use and outdoor use. The Titan 4W has reflectors and lights, which should be used in the dark or in limited visibility conditions. The Titan 4W can be folded and disassembled into two parts. This allows for easy storage and enables portability of the Titan 4W.
The provided document is a 510(k) summary for the Titan 4W, a motorized three-wheeled vehicle (scooter). It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant for an AI/ML medical device.
The "Performance Testing" section mentions that several standards were met and a "Usability Study validated the system's usability by the intended user." This implies testing was done, but the specifics requested in your prompt regarding acceptance criteria and performance metrics for a medical device are not provided in this document.
Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.
Specifically, I cannot extract:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned, other than compliance with general standards.
- Sample sized used for the test set and the data provenance: No information on sample sizes for any tests, nor data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this document does not describe a study involving expert-established ground truth for a diagnostic or AI/ML output.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable; this device is a physical mobility aid, not an AI/ML interpretative tool.
- Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device for a physical mobility aid, not an AI/ML-driven diagnostic or interpretative tool.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2015
Tzora Active Systems, LTD. % Moshe Rosenberg Regulatory Consultant A. Stein- Regulatory Affairs Consulting Ltd. 20 Hata'as St. (PO Box 124), Kfar Saba, 4442520 Israel
K150086 Re: Trade/Device Name: Titan 4W Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 26, 2015 Received: July 6, 2015
Dear Moshe Rosenberg.
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 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Carlos L. Pena न्ज़/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150086
Device Name Titan 4W
Indications for Use (Describe)
The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
K150086 (Premarket Notification [510(k)] Number)
1. Submitter Information
| Manufacturer Name and Address |
|---|
| Tzora Active Systems Ltd. |
| Kibbutz Tzora, |
| 9980300, |
| Israel |
| Official Correspondent |
| Ahava Stein |
| A. Stein - Regulatory Affairs Consulting Ltd. |
| 20 Hata'as St. (Beit Hapaamon, Suite 102) |
| Kfar Saba 4442520, |
| Israel |
Date Prepared: August 5, 2015 2.
-
- Device Name Titan 4W
| Proprietary Name: | Titan 4W |
|---|---|
| Common Name: | Vehicle, Motorized 3-Wheeled |
| FDA ClassificationName: | 21 CFR 890.3800; Vehicle, Motorized 3-Wheeled |
- FDA Classification: Class II, Product Code INI
4. Predicate Devices
The Titan 4W is substantially equivalent to the following device:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Tzora Active Systems Ltd. | Elite | K052204 | February 15, 2006 |
5. Device Description
The Titan 4W scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Titan 4W alone and to safely steer under all driving conditions.
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The Titan 4W is intended for indoor use and outdoor use. The Titan 4W has reflectors and lights, which should be used in the dark or in limited visibility conditions.
The Titan 4W can be folded and disassembled into two parts. This allows for easy storage and enables portability of the Titan 4W.
6. Indications for Use
The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.
7. Performance Standards
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Titan 4W.
Performance Testing 8.
The following performance, safety and usability tests were conducted with the Titan 4W:
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (2007)
- ISO 7176 Wheelchairs -- Parts 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 13, 14, 15, 16, and 21. .
- Usability Study validated the system's usability by the intended user. .
9. Technological Characteristics Compared to Predicate Device
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the indications for use of the Titan 4W are substantially equivalent to the predicate device cited above.
§ 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).