(314 days)
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No
The description details a standard electrically powered mobility scooter with basic controls and indicators. There is no mention of AI, ML, or any features that would suggest the use of such technologies. The troubleshooting is based on a fixed number of flashes indicating specific issues, not a learning system.
No.
Explanation: The device is described as a "mobility assistive device" for individuals with mobility limitations that are still able to walk. It helps with moving around but does not treat, diagnose, or prevent any medical condition, which are characteristics of a therapeutic device.
No
The device description clearly states it is a mobility assistive device and does not mention any diagnostic functions. Its purpose is to aid individuals with mobility limitations, not to diagnose medical conditions.
No
The device description clearly outlines a physical, electrically powered scooter with various hardware components (motor, battery, wheels, control panel, lights, etc.). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Titan 3W Function: The description clearly states that the Titan 3W is a "mobility assistive device." Its purpose is to help individuals with mobility limitations move around. It does not interact with or analyze biological specimens.
The information provided about the Titan 3W focuses on its mechanical and electrical functions, safety standards, and performance as a mobility aid. There is no mention of any diagnostic testing or analysis of biological samples.
N/A
Intended Use / Indications for Use
The Titan 3W 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 3W 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 3W alone and to safely steer under all driving conditions.
The Titan 3W is intended for indoor use and outdoor use. The Titan 3W has reflectors and lights, which should be used in the dark or in limited visibility conditions.
The Titan 3W can be folded and disassembled into two parts, the Front Frame and the Rear Frame. Separating both frame parts allows for easy storage and enables portability of the Titan 3W.
The Front Frame consists of the steering column, control panel, front wheels, footrest plate and seat.
The Rear Frame consists of the motor, controller and battery holders.
The control panel houses all the controls for operating the device. The control panel has a key switch for turning the device on and off. a lever for forward/reverse driving, knobs and switches for speed adjustment and lights (front and rear lights, indicators and hazard lights). The control panel also contains the control indicator for the status of the device and a battery gauge.
The LED control indicator shows the status of the scooter: steady light mean that all is well, blinking indicates an issue. The number of flashes indicate the type of issue. The User Manual contains a troubleshooting section where each type of error and its solution is specified.
The steering column can be adjusted and put it in the position which is most comfortable for the operator.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance and safety tests were conducted with the Titan 3W:
- ISO 7176-1:2014 Wheelchairs Part 1: Determination of static stability .
- ISO 7176-2:2001 Wheelchairs Part 2: Determination of dynamic stability of . electric wheelchairs
- ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and . manoeuvring space
- . ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- ISO 7176-7:1998 Wheelchairs Part 7: Measurement of seating and wheel . dimensions
- ISO 7176-8:2014 Wheelchairs Part 8: Requirements and test methods for static, . impact and fatigue strengths
- . ISO 7176-10:2008 Wheelchairs – Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- . ISO 7176-15:1996 Wheelchairs – Part 15: Requirements for information disclosure, documentation and labeling
- ISO 7176-21:2009 Wheelchairs Part Requirements and test methods for . electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered . wheelchairs
The following performance and safety tests were conducted with the Titan 4W and the results are also valid for the Titan 3W, since the modification does not affect the requirements of these standards:
- ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes .
- ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs . and scooters for determination of theoretical distance range
- . ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-13:1989 Wheelchairs Part 13: Determination of coefficient of friction of ● test surfaces
- ISO 7176-14:2008 Wheelchairs Part 14: Power and control systems for electrically . powered wheelchairs and scooters - Requirements and test methods
- . ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
The performance testing and comparison to the predicate device demonstrate that the Titan 3W is as safe, as effective and performs as well as the legally marketed Titan 4W predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2017
Tzora Active Systems Ltd. % Moshe Rosenberg Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as St. (pob 124) Kfar Saba, 4442520 IL
Re: K160835
Trade/Device Name: Titan 3W Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: December 27, 2016 Received: January 3, 2017
Dear Mr. 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 Part 807); labeling (21 CFR Part 801 and Part 809); 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
1
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 and Part 809), 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, Michael J. Hoffmann -S 2017.02.02 10:58:44 -05'00'
Carlos L. Peña, PhD, MS for 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) K160835
Device Name Titan 3W
Indications for Use (Describe)
The Titan 3W 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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SUMMARY OF SAFETY AND EFFECTIVENESS
K160835 (Premarket Notification [510(k)] Number)
1. Submitter Information
| Manufacturer Name and Address | Tzora Active Systems Ltd. |
|---|---|
| Kibbutz Tzora, | |
| 9980300, | |
| Israel | |
| Official Correspondent | Moshe Rosenberg / Ahava Stein |
| A. Stein - Regulatory Affairs Consulting Ltd. | |
| 20 Hata'as St. (Beit Hapaamon, Suite 102) | |
| Kfar Saba 4442520, | |
| Israel |
2. Date Prepared: February 2, 2017
-
- Device Name Titan
| Proprietary Name: | Titan 3W |
|---|---|
| Common Name: | Vehicle, Motorized 3-Wheeled |
| FDA Classification | |
| Name: | 21 CFR 890.3800; Vehicle, Motorized 3-Wheeled |
- FDA Classification: Class II, Product Code INI
Predicate Devices 4.
The Titan 3W is substantially equivalent to the following devices:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Tzora Active Systems Ltd. | Titan 4W | K150086 | August 5, 2015 |
5. Device Description
The Titan 3W 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 3W alone and to safely steer under all driving conditions.
4
The Titan 3W is intended for indoor use and outdoor use. The Titan 3W has reflectors and lights, which should be used in the dark or in limited visibility conditions.
The Titan 3W can be folded and disassembled into two parts, the Front Frame and the Rear Frame. Separating both frame parts allows for easy storage and enables portability of the Titan 3W.
The Front Frame consists of the steering column, control panel, front wheels, footrest plate and seat.
The Rear Frame consists of the motor, controller and battery holders.
The control panel houses all the controls for operating the device. The control panel has a key switch for turning the device on and off. a lever for forward/reverse driving, knobs and switches for speed adjustment and lights (front and rear lights, indicators and hazard lights). The control panel also contains the control indicator for the status of the device and a battery gauge.
The LED control indicator shows the status of the scooter: steady light mean that all is well, blinking indicates an issue. The number of flashes indicate the type of issue. The User Manual contains a troubleshooting section where each type of error and its solution is specified.
The steering column can be adjusted and put it in the position which is most comfortable for the operator.
6. Indications for Use
The Titan 3W is a mobility assistive device for indoor and outdoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.
This Indication for Use statement is identical to that of the previously cleared Titan 4W.
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Performance Testing 7.
The following performance and safety tests were conducted with the Titan 3W:
- ISO 7176-1:2014 Wheelchairs Part 1: Determination of static stability .
- ISO 7176-2:2001 Wheelchairs Part 2: Determination of dynamic stability of . electric wheelchairs
- ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and . manoeuvring space
- . ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- ISO 7176-7:1998 Wheelchairs Part 7: Measurement of seating and wheel . dimensions
- ISO 7176-8:2014 Wheelchairs Part 8: Requirements and test methods for static, . impact and fatigue strengths
- . ISO 7176-10:2008 Wheelchairs – Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- . ISO 7176-15:1996 Wheelchairs – Part 15: Requirements for information disclosure, documentation and labeling
- ISO 7176-21:2009 Wheelchairs Part Requirements and test methods for . electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered . wheelchairs
The following performance and safety tests were conducted with the Titan 4W and the results are also valid for the Titan 3W, since the modification does not affect the requirements of these standards:
- ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes .
- ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs . and scooters for determination of theoretical distance range
- . ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
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- ISO 7176-13:1989 Wheelchairs Part 13: Determination of coefficient of friction of ● test surfaces
- ISO 7176-14:2008 Wheelchairs Part 14: Power and control systems for electrically . powered wheelchairs and scooters - Requirements and test methods
- . ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
Regarding the biocompatibility, there are three parts that can come into touch with intact skin: the seat, the handgrips and the armrests.
The seat materials, handgrips and armrests are identical to those used for the previously cleared Titan 4W.
No new materials have been introduced in the Titan and therefore biocompatibility retesting is not required.
8. Technological Characteristics Compared to Predicate Device
Control Panel
The Titan 3W has the same control panel as the predicate device.
Maximum speed
The Titan 3W can reach a maximum speed of 6.8 mph, whereas the predicate device has a maximum speed of 7.3 mph. This is due to the difference in size of the rear wheels. The minimum braking distance remained the same: 2.2 m.
Batteries
The Titan 3W batteries are identical to the batteries of the predicate device: two 12V 26A/h sealed lead acid batteries.
Seat
The Titan 3W has the same seat and armrests as the predicate device.
Frame
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The Titan 3W has the same foldable and detachable frame as the predicate device. The rear frame of the Titan 3W is identical to the predicate device. The front frame of the Titan 3W is slightly different due to the difference in front wheels.
Wheels
The Titan 3W has 3 wheels (1 front, 2 rear wheels), whereas the predicate device has 4 wheels (2 front, 2 rear wheels).
Motor
The Titan 3W is propelled by the same transaxle motor with electromagnetic brake as the predicate device. This motor unit is attached to the rear of the frame and has the rear wheels attached to it, identical to the predicate device.
The differences in the above specifications do not adversely affect the safety and effectiveness and performance of the Titan 3W. The Titan 3W was tested according to the in section 7 aforementioned standards and found compliant.
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 3W are substantially equivalent to the predicate device cited above.
| Item | Titan 3W | Titan 4W |
|---|---|---|
| Maximum speed | 11.0 km/h (6.8 mph) | 11.8 km/h (7.3 mph) |
| Minimum braking distance and time |