(191 days)
No
The summary describes a power wheelchair with upgraded electronics and suspension, but there is no mention of AI or ML technology. The performance studies focus on standard wheelchair safety and performance metrics.
No.
The device's intended use is to provide mobility. While it can assist individuals with limited mobility, it does not directly treat or diagnose a disease or condition inherent to a therapeutic device's function.
No
The device is a power wheelchair, a mobility aid for individuals unable to walk. Its purpose is to provide transportation, not to diagnose medical conditions.
No
The device description clearly states it is a "battery-powered, motor-driven device" and includes hardware components like a Gyroscope Module and Enhanced SureStep® Suspension. While it mentions upgraded software, it is part of a physical power wheelchair.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to persons limited to a sitting position." This is a mechanical function related to physical assistance, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a battery-powered, motor-driven device for mobility. It mentions electronics, suspension, seating, and controls, all related to the physical function of a wheelchair.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is clearly a power wheelchair intended for mobility assistance.
N/A
Intended Use / Indications for Use
The intended use of the device is to provide mobility to persons limited to a sitting position.
Product codes
ITI
Device Description
The Invacare® TDX® SP2 Power Wheelchair is a battery-powered, motor-driven device controlled by the MK6i™ (MK6i) electronics platform. The intended use of the device is to provide mobility to persons limited to a sitting position. Use environments include, but are not limited to, the user's home, assisted living facilities, nursing homes, vocational settings, health care facilities and outdoors on firm terrain. Adult seating has a weight limit of 300 lbs. and junior seating has a weight limit of 165 lbs.
The subject device is the next generation of the TDX Power Wheelchair with:
- Enhanced suspension and stability; ●
- Additional back and arm types as well as leg rest types; and ●
- . A new controller, the MK6i, which incorporates upgraded software.
The Invacare® TDX® SP2 Power Wheelchair includes an upgraded Gyroscope Module (G-Trac Control Module) and Enhanced SureStep® Suspension with Stability Lock.
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
Use environments include, but are not limited to, the user's home, assisted living facilities, nursing homes, vocational settings, health care facilities and outdoors on firm terrain.
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 Invacare® TDX® SP2 Power Wheelchair has been evaluated through non-clinical performance testing and is in compliance with the following test standards:
- ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability
- ANSI/RESNA WC-2:2009 Section 2: Determination of Dynamic Stability
- ANSI/RESNA WC-2:2009 Section 3: Determination of Effectiveness of Brakes ●
- ANSI/RESNA WC-2:2009 Section 4: Energy Consumption for Determination of Theoretical Distance
- ANSI/RESNA WC-1:2009 Section 5: Determination of Dimensions, Mass and ● Maneuvering Space
- ANSI/RESNA WC-2:2009 Section 6: Determination of Maximum Speed, Acceleration ● and Deceleration
- ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions
- ANSI/RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact ● and Fatigue Strengths
- ANSI/RESNA WC-2:2009 Section 9: Climatic Tests ●
- ANSI/RESNA WC-2:2009 Section 10: Determination of Obstacle Climbing
- ANSI/RESNA WC-1:2009 Section 14: Power and Control Systems Requirements and ● Test Methods
- ANSI/RESNA WC-1:2009 Section 15: Requirements for Information Disclosure, Documentation and Labeling
- ANSI/RESNA WC-1:2009 Section 16: Resistance to Ignition of Upholstered Parts-● Requirements and Test Methods
- ANSI/RESNA WC-2:2009 Section 21: Requirements and Test Methods for ● Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters
- ISO 10993 Biocompatibility Testing .
The conclusion drawn from the test data is that the TDX SP2 Power Wheelchair is as safe and effective as the predicate device, has the same intended use as the predicate, performs similarly to other legally marketed power wheelchairs indicated for providing mobility to persons limited to a sitting position and does not raise any new issues of safety or effectiveness.
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.
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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(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 the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, with three figures in profile facing right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2015
Invacare Corporation Doug Uelmen, Sr VP, OA & RA One Invacare Way PO Box 4028 Elyria, OH 44036-2125
Re: K141783
Trade/Device Name: Invacare® TDX® SP2 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 10, 2014 Received: December 11, 2014
Dear Mr. Doug Uelmen,
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
1
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 (OS) 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" (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 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.
Felipe Aguel -S
for
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141783
Device Name
Invacare® TDX SP2® Power Wheelchair
- Indications for Use (Describe)
The intended use of the device is to provide mobility to persons limited to a sitting position.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
| Device Proprietary Name: | Invacare® TDX® SP2 Power Wheelchair | |
|---|---|---|
| Common Name: | Powered Wheelchair | |
| Classification Regulation: | 21 CFR, 890.3860 | |
| Product Code: | ITI | |
| Device Class: | II | |
| Submitter's Name: | Invacare, Corp. | |
| Address: | One Invacare Way | |
| P.O. Box 4028 | ||
| Elyria, Ohio 44036-2125 | ||
| Contact Person: | Doug Uelmen | |
| Telephone Number: | (440) 329-6619 | |
| Fax Number: | (440) 329-6975 | |
| Date Summary Prepared: | December 26, 2014 |
Device Description
The Invacare® TDX® SP2 Power Wheelchair is a battery-powered, motor-driven device controlled by the MK6i™ (MK6i) electronics platform. The intended use of the device is to provide mobility to persons limited to a sitting position. Use environments include, but are not limited to, the user's home, assisted living facilities, nursing homes, vocational settings, health care facilities and outdoors on firm terrain. Adult seating has a weight limit of 300 lbs. and junior seating has a weight limit of 165 lbs.
The subject device is the next generation of the TDX Power Wheelchair with:
- Enhanced suspension and stability; ●
- Additional back and arm types as well as leg rest types; and ●
- . A new controller, the MK6i, which incorporates upgraded software.
The Invacare® TDX® SP2 Power Wheelchair includes an upgraded Gyroscope Module (G-Trac Control Module) and Enhanced SureStep® Suspension with Stability Lock.
4
Purpose of Submission
The Invacare® TDX® SP2 Power Wheelchair is a new device and represents the next generation of power wheelchairs in the Invacare® TDX® Power Wheelchair product family.
Indication for Use
The indication for use of the Invacare® TDX® SP2 Power Wheelchair is to provide mobility to persons limited to a sitting position.
Predicate Devices
The predicate device is the Storm TDX® Power Wheelchair, which was cleared under K023589 on November 19, 2002. The Storm TDX® Power Wheelchair also includes the G-Trac Control Module. This technology is similar to the Gyroscope Control technology that was cleared on the Storm Series Power 9000 and Tiger Power Wheelchairs, cleared under K993413 on December 15, 1999.
The previously cleared and subject power wheelchair configurations are similar in that both wheelchairs provide the user with several joystick options, power seating and controllers that are fully programmable for performance characteristics such as forward speed, turning speed, forward and reverse acceleration, braking, torque and others.
The previously cleared and subject gyroscope controllers help to maintain a straight course over uneven terrain by sensing the direction and feeding it back to the controller for direct closed-loop feedback control of the chair.
Technological Characteristics/Substantial Equivalence
The Invacare® TDX® SP2 Power Wheelchair has the same indication for use, is manufactured from the same or similar materials and incorporates similar technological characteristics as the predicate device.
The table below provides a comparison of the subject device to the predicate device.
| Predicate Device | Subject Device | |
|---|---|---|
| Brand Name | Storm TDX® Power | |
| Wheelchair | Invacare® TDX® SP2 Power | |
| Wheelchair | ||
| Manufacturer | Invacare, Corp. | Invacare, Corp. |
| 510(k) Number | K023589 | K141283 |
| Intended Use | The intended use is to | |
| provide mobility to persons | ||
| limited to a sitting position. | The intended use is to | |
| provide mobility to persons | ||
| limited to a sitting position. | ||
| Predicate Device | Subject Device | |
| Power Seating | ||
| Configurations | Power seating with tilt, | |
| elevate and recline as well as | ||
| power leg rests | Power seating with tilt, | |
| elevate and recline as well as | ||
| power leg rests | ||
| Driver Controls | Joysticks, head array and sip- | |
| n-puff | Joysticks, head array and sip- | |
| n-puff | ||
| Weight Capacity | 250 lbs., 300 lbs. and 400 lbs. | |
| depending on model | 165 lbs. (Junior seating) | |
| 300 lbs. (Adult seating) | ||
| Maximum Speed | 4.5-7.5 mph | 5.8 mph |
| Range | 22NF batteries: >12 miles | |
| GP24 batteries: >15 miles | 22NF batteries: >12 miles | |
| GP24 batteries: >15 miles | ||
| Seat Widths | 12"-24" | 12"-24" |
| Seat Depths | 12"-22" | 12"-22" |
| Seat Types | Adjustable back; van; recline; | |
| tilt/recline, tilt/recline/elevate; | ||
| tilt, elevate; elevate | Adjustable back; van; recline; | |
| tilt/recline, tilt/recline/elevate; | ||
| tilt, elevate; elevate | ||
| Caster Size | 6"x 2" | 6"x 2" |
| Upholstery | Cloth or vinyl | Cloth or vinyl |
| Arm Types | Flip back; fixed or adjustable | |
| height; desk or full length | Flip back; fixed or adjustable | |
| height; cantilever—desk or | ||
| full length | ||
| Overall Length without Leg | ||
| Rests | 35.25" | 35.5" |
| Overall Width with 18" wide | ||
| ASBA (excluding joystick) | 25.5" | 25.5" |
| Drive Wheel Size | 14"x 3" | 14"x 3" |
| Drive Wheel Frame Material | Aluminum | Aluminum |
| Base Weight with GP24 | ||
| Batteries | 240-310 lbs. depending on | |
| model | 264 lbs. | |
| Total Weight (Base and Seat) | TDX3 = 238 lbs. | |
| TDX4 = 256 lbs. | ||
| TDX 5 = 313 lbs. | 291 lbs. - 425 lbs. (depending | |
| on seat type/configuration | ||
| Chargers | 8-amp off board charger | |
| (110 or 220V) | 8-amp off board charger | |
| (110 or 220V) | ||
| Motor | Gearless, Brushless | Not applicable |
| Motor | 4-pole | 4-pole |
| Motor | 2-pole | Not applicable |
| Stability Lock Mechanism | Gear teeth to gear teeth | Internal locking valve |
| mechanism in gas cylinder | ||
| Gyroscope Control Module | Ceramic piezoelectric | |
| element based gyroscope | ||
| controller | Spring support polysilicon | |
| gyro resonating mass | ||
| controller | ||
| Suspension | SureStep® Suspension | Enhanced SureStep® |
| Suspension | ||
| Predicate Device | Subject Device | |
| Electronics | MKV | MK6i |
| Miscellaneous Accessories | Wheel locks | Wheel locks |
| O2 Holder (ASBA only) | O2 Holder (ASBA only) |
Comparison Table
5
Comparison Table (continued)
6
Comparison Table (continued)
Performance Data
The Invacare® TDX® SP2 Power Wheelchair has been evaluated through non-clinical performance testing and is in compliance with the following test standards:
- ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability
- ANSI/RESNA WC-2:2009 Section 2: Determination of Dynamic Stability
- ANSI/RESNA WC-2:2009 Section 3: Determination of Effectiveness of Brakes ●
- ANSI/RESNA WC-2:2009 Section 4: Energy Consumption for Determination of Theoretical Distance
- ANSI/RESNA WC-1:2009 Section 5: Determination of Dimensions, Mass and ● Maneuvering Space
- ANSI/RESNA WC-2:2009 Section 6: Determination of Maximum Speed, Acceleration ● and Deceleration
- ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions
- ANSI/RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact ● and Fatigue Strengths
- ANSI/RESNA WC-2:2009 Section 9: Climatic Tests ●
- ANSI/RESNA WC-2:2009 Section 10: Determination of Obstacle Climbing
- ANSI/RESNA WC-1:2009 Section 14: Power and Control Systems Requirements and ● Test Methods
- ANSI/RESNA WC-1:2009 Section 15: Requirements for Information Disclosure, Documentation and Labeling
- ANSI/RESNA WC-1:2009 Section 16: Resistance to Ignition of Upholstered Parts-● Requirements and Test Methods
- ANSI/RESNA WC-2:2009 Section 21: Requirements and Test Methods for ● Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters
- ISO 10993 Biocompatibility Testing .
Conclusion
The proposed TDX SP2 Power Wheelchair has the same indication for use as the predicate TDX Power Wheelchair. There are technological differences between the subject and predicate device however, the results of performance testing demonstrate that these differences do not raise any new questions of safety or effectiveness compared to other similar power wheelchairs currently marketed.
7
The conclusion drawn from the test data is that the TDX SP2 Power Wheelchair is as safe and effective as the predicate device, has the same intended use as the predicate, performs similarly to other legally marketed power wheelchairs indicated for providing mobility to persons limited to a sitting position and does not raise any new issues of safety or effectiveness.