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.

AI/ML Overview

The provided text describes the Invacare® TDX® SP2 Power Wheelchair and its substantial equivalence to a predicate device. However, it does not contain the specific information required to complete a table of acceptance criteria and the detailed study proving the device meets those criteria.

The document discusses performance data in terms of compliance with various ANSI/RESNA WC standards and ISO 10993 for biocompatibility. It lists a series of sections from ANSI/RESNA WC-1:2009 and ANSI/RESNA WC-2:2009. While these are standards the device was tested against, the document does not explicitly state the specific acceptance criteria (e.g., "maximum static tipper angle must be > 10 degrees") or the reported device performance against those specific criteria (e.g., "device achieved 12 degrees").

Therefore, I cannot directly populate the requested table or provide details about sample sizes, ground truth establishment, or expert involvement as those specific details are not present in the provided text.

Here is a general outline of how the requested information would be presented if it were available, based on the types of performance data mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric (Derived from Standard)	Acceptance Criteria (Threshold/Range)	Reported Device Performance (Actual Value/Result)
Static Stability (ANSI/RESNA WC-1:2009 Sec 1)	[Specific minimum angle, e.g., > 6°]	[Actual measured angle]
Dynamic Stability (ANSI/RESNA WC-2:2009 Sec 2)	[Specific requirements, e.g., no tip-over under defined conditions]	[Result of test, e.g., passed, no tip-over]
Brake Effectiveness (ANSI/RESNA WC-2:2009 Sec 3)	[Specific stopping distance or holding capacity]	[Actual stopping distance or capacity achieved]
Energy Consumption / Theoretical Distance (ANSI/RESNA WC-2:2009 Sec 4)	[Specific minimum distance, e.g., > 12 miles with 22NF batteries]	[Actual measured distance > 12 miles with 22NF batteries, > 15 miles with GP24 batteries]
Dimensions, Mass, Maneuvering Space (ANSI/RESNA WC-1:2009 Sec 5)	[Specific ranges/limits]	[Measurements provided in comparison table, e.g., 35.5" length, 25.5" width]
Maximum Speed, Acceleration, Deceleration (ANSI/RESNA WC-2:2009 Sec 6)	[Specific maximum/minimum values]	[Maximum speed of 5.8 mph reported]
Biocompatibility (ISO 10993)	[Compliance with specified parts of ISO 10993, e.g., no cytotoxicity, irritation, sensitization]	[Confirmation of compliance]
Electromagnetic Compatibility (ANSI/RESNA WC-2:2009 Sec 21)	[Compliance with EMC limits]	[Confirmation of compliance]
... (and so on for other standards listed)	---	---

Missing Information from the Provided Document:

Specific numeric acceptance criteria: The document lists the standards applied (e.g., ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability), but does not detail what specific quantitative or pass/fail thresholds constituted "acceptance" for each standard.
Specific reported device performance values: While some performance characteristics are given in the comparison table (e.g., Max Speed 5.8 mph, Range >12 miles), these are generally summarized or compared to the predicate, and not directly stated as "reported device performance against an acceptance criterion" for a specific test. The document states "performance testing demonstrates that these differences do not raise any new questions of safety or effectiveness," implying the criteria were met, but without providing the data.

Since the document is a 510(k) summary, it often summarizes compliance rather than providing raw test data or detailed criteria/results for every test.

Regarding the other points requested:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified in the document. Performance testing for medical devices like wheelchairs typically involves a fixed number of prototypes or production units, but the exact count is not here. The data would be prospective, as it involves testing the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in this context. For a physical device like a power wheelchair, "ground truth" isn't established by experts in the typical sense of diagnostic imaging or clinical outcomes. Instead, performance is measured against established engineering and safety standards using calibrated equipment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for reconciling expert opinions or diagnostic disagreements, not for objective engineering tests.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device (power wheelchair), not an AI-assisted diagnostic tool for "human readers."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm. The device itself operates "standalone" in the sense that it functions mechanically and electronically according to its design without human intervention in its core operating principles during testing, though it requires a human user for its intended use.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a power wheelchair, the "ground truth" is compliance with international and national performance and safety standards (e.g., ANSI/RESNA, ISO). These standards define objective, measurable parameters (e.g., static stability angles, brake effectiveness, electromagnetic compatibility limits, biocompatibility requirements).
The sample size for the training set: Not applicable. This is not an AI/machine learning model that requires a "training set." It's a manufactured physical device.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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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 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

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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

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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."

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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 WayP.O. Box 4028Elyria, 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 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.

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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® PowerWheelchair	Invacare® TDX® SP2 PowerWheelchair
Manufacturer	Invacare, Corp.	Invacare, Corp.
510(k) Number	K023589	K141283
Intended Use	The intended use is toprovide mobility to personslimited to a sitting position.	The intended use is toprovide mobility to personslimited to a sitting position.
	Predicate Device	Subject Device
Power SeatingConfigurations	Power seating with tilt,elevate and recline as well aspower leg rests	Power seating with tilt,elevate and recline as well aspower 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 milesGP24 batteries: >15 miles	22NF batteries: >12 milesGP24 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 adjustableheight; desk or full length	Flip back; fixed or adjustableheight; cantilever—desk orfull length
Overall Length without LegRests	35.25"	35.5"
Overall Width with 18" wideASBA (excluding joystick)	25.5"	25.5"
Drive Wheel Size	14"x 3"	14"x 3"
Drive Wheel Frame Material	Aluminum	Aluminum
Base Weight with GP24Batteries	240-310 lbs. depending onmodel	264 lbs.
Total Weight (Base and Seat)	TDX3 = 238 lbs.TDX4 = 256 lbs.TDX 5 = 313 lbs.	291 lbs. - 425 lbs. (dependingon 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 valvemechanism in gas cylinder
Gyroscope Control Module	Ceramic piezoelectricelement based gyroscopecontroller	Spring support polysilicongyro resonating masscontroller
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

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Comparison Table (continued)

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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.

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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.

Regulation Number and Section

§ 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).