(202 days)
Not Found
No
The summary describes a standard electric mobility scooter with no mention of AI or ML capabilities. The performance studies listed are standard electrical and wheelchair safety tests.
No
The device is a mobility assistive device, not a therapeutic device. It helps with mobility but does not treat a condition or restore health.
No
The device is described as a "mobility assistive device" and an "electrically powered scooter" for individuals with mobility limitations. Its purpose is to assist with movement, not to diagnose a medical condition.
No
The device description clearly states it is an "electrically powered scooter" and mentions physical components like reflectors, lights, and the ability to be folded and disassembled into two parts. This indicates it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Titan 4W Function: The description clearly states the Titan 4W is a "mobility assistive device" and an "electrically powered scooter." Its purpose is to help individuals with mobility limitations move around.
- Lack of Biological Specimen Analysis: There is no mention of the Titan 4W interacting with or analyzing any biological specimens. Its function is purely mechanical and related to physical mobility.
The information provided focuses on the device's physical characteristics, intended use for mobility, safety standards (like electromagnetic compatibility and wheelchair standards), and usability. None of this aligns with the definition or function of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
INI
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.
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.
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)
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. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.
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
1
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 Classification | |
| Name: | 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.
4
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.