The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K141783) with the MK6i™ control system and Formula™ CG Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes:

. The LiNX® control system, which incorporates updated software, wireless technology and a touch user interface,
The Ultra-Low Maxx™ Seating System, and ●
Minor changes to mechanical components such as rim inserts and new colours. .

The TDX® SP2 Power Wheelchair is a battery-powered, motor-driven powered wheelchair, controlled by the LiNX® control system with enhanced suspension and additional back, arm and leg rest types. The subject device is a rigid or "non-folding" type power wheelchair base with centre-wheel drive capability, two casters in the rear and two casters in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

AI/ML Overview

This document describes acceptance criteria and testing for the Invacare® TDX® SP2 Power Wheelchair.

1. Table of Acceptance Criteria and Reported Device Performance:

The document highlights conformity to various ISO, IEC, ANSI, CAL, and EN standards for different aspects of the wheelchair's hardware, software, and materials. Due to the nature of the device (a configurable power wheelchair) and the submission type (510(k) for substantial equivalence), the acceptance criteria are primarily described as meeting the requirements and passing the tests of these recognized standards. The reported device performance is generally stated as meeting these requirements and demonstrating substantial equivalence.

Here's a summary derived from the document, focusing on categories rather than specific numerical values where not explicitly provided for the subject device in comparison tables:

Test Category	Acceptance Criteria (based on standards)	Reported Device Performance
Hardware Performance (Physical Characteristics)	Conformity to relevant ISO 7176 standards (e.g., static/dynamic stability, braking, energy consumption, dimensions, speed, impact/fatigue strengths, climatic tests, obstacle climbing, power/control systems)	Met all acceptance criteria for each section of ISO 7176
Material Performance	Conformity to flammability standards (CAL117, EN 1021-1, EN 1021-2)	Met relevant flammability standards
Electromagnetic Compatibility (EMC)	Conformity to ISO 7176-21, ANSI/RESNA WC-2:2009 Section 21 EMC requirements	Met relevant EMC requirements
Wireless Coexistence	Conformity to ANSIC63.27 Wireless Coexistence standard	Met relevant wireless coexistence standard requirements
Software Life Cycle	Conformity to IEC 62304:2006 for medical device software life cycle	Evaluated against IEC 62304:2006, passed verification
Software Functionality	Functionality as designed, demonstrating safety and effectiveness	Software verification testing confirmed functionality
Biocompatibility	Conformity to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation)	Passed cytotoxicity and skin irritation tests
Information Disclosure/Labeling	Conformity to ISO 7176-15 requirements	Met requirements for information disclosure/labeling
Risk Management	Conducted in accordance with ISO 14971:2012	Risk management conducted per ISO 14971:2012

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Because the subject Invacare® TDX® SP2 Power Wheelchair is highly configurable Power Wheelchair (PWC), intended to serve a diverse population with unique individual needs, a wide variety of options and accessories have been designed. However, due to the highly customizable nature of the subject device, testing to every possible combination would not be practical. However, every design feature of the subject device was verified. This was accomplished by identifying the specific wheelchair configurations that represent the full range of product permutations."

Sample Size: The exact numerical sample size for "test sets" (e.g., number of individual wheelchairs or components tested) is not explicitly provided. Instead, it indicates that "specific wheelchair configurations that represent the full range of product permutations" were identified and tested for each design feature. This implies a comprehensive, representative testing approach rather than a fixed "sample size" in the sense of clinical trials.
Data Provenance: The testing was "Non-clinical Test" and "Software Verification Testing" performed on the "subject Invacare® TDX® SP2 Power Wheelchair." This indicates that the data was generated through laboratory testing by the manufacturer (Invacare Corporation) as part of their design verification process. There is no mention of country of origin for the data or whether it was retrospective or prospective in the clinical sense, as it was non-clinical laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable to this submission. The device is a physical product (power wheelchair) and the testing performed is non-clinical laboratory testing against established engineering and safety standards (ISO, IEC, etc.). The "ground truth" is defined by the technical specifications and performance limits set by these international standards, not by expert consensus on clinical diagnoses or interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable. As the testing is non-clinical laboratory testing against defined standards, there is no ambiguity or subjective interpretation requiring adjudication by multiple parties or a specific method like 2+1 or 3+1. The tests yield objective results (e.g., pass/fail for a specified load, speed, or range).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation (e.g., radiologists reading images) is involved, and the AI's assistance to human readers is being evaluated. This submission is for a physical medical device (power wheelchair) and involves non-clinical performance and safety testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

While not an "algorithm only" in the sense of an AI diagnostic tool, the non-clinical tests performed on the physical wheelchair and its software are effectively "standalone" tests in that they evaluate the device's performance against defined criteria without active human intervention in the loop of the specific test itself (beyond setting up and observing the test). For example, stability tests, braking tests, and energy consumption tests are direct measurements of the device's inherent capabilities. The "Software Verification Testing" also falls into this category, assessing the software's functionality independently.

7. The Type of Ground Truth Used:

The ground truth used for these tests is objective performance specifications and safety requirements defined by internationally recognized standards (e.g., ISO 7176 series for wheelchairs, IEC 62304 for software, ISO 10993 for biocompatibility, flammability standards). The device's performance characteristics are measured and compared against the limits and criteria set forth in these standards.

8. The Sample Size for the Training Set:

This information is not applicable. This is a 510(k) submission for a physical medical device based on engineering and safety testing, not a machine learning or AI-driven diagnostic device that would typically involve a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to form a single, abstract figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 12, 2017

Invacare Corporation Elijah Wreh Regulatory Affairs Manager (pre-market) One Invacare Way Elyria, Ohio 44035

Re: K170507

Trade/Device Name: Invacare® TDX® SP2 Power Wheelchair TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 9, 2017 Received: June 12, 2017

Dear Elijah Wreh:

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.

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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); 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,

Michael J. Hoffmann -S

for

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) K170507

Device Name

Invacare® TDX® SP2 Power Wheelchair

TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx

Indications for Use (Describe)

The indication for use of the Invacare® TDX® SP2 Power Wheelchair is to provide mobility and positioning to persons limited to a sitting position.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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	510(k) Summary (K170507)
SUBMITTER:	Invacare CorporationOne Invacare WayElyria, OH 44035
	Phone: (440) 329-6840Email: ewreh@invacare.com
CONTACT PERSON:	Elijah N. WrehRegulatory Affairs Manager (Pre-Market)
MANUFACTURER:	Invacare Corporation1200 Taylor StElyria, OH 44035
Date Prepared:	July 12, 2017
DEVICE INFORMATION
Name of Devices:	Invacare® TDX® SP2 Power WheelchairTDXSP2 TDX SP2 with LiNX ElectronicsTDXSP2-CG TDX SP2 Base for Single Act. System w/Ultra Low Maxx,TDXSP2-MCG TDX SP2 Base for Multiple ActuatorSystem w/ Ultra Low Maxx
Common or Usual Name:	Wheelchair, Powered
Classification Name:	Powered Wheelchair 21 CFR § 890.3860
Regulatory Class:	II
Product Code:	ITI
PRIMARY PREDICATE DEVICE:	Invacare® TDX® SP2 Power Wheelchair (K141783)
SECONDARY PREDICATE DEVICE:	Modular Power Positioning System (K150574)
REFERENCE DEVICES:	F3 Powered Wheelchair (K143180)F5 Powered Wheelchair (K143014)Quantum Q6 Edge (K143383)Modular Power Positioning System (K150574)

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DEVICE DESCRIPTION

. The LiNX® control system, which incorporates updated software, wireless technology and a touch user interface,
The Ultra-Low Maxx™ Seating System, and ●
Minor changes to mechanical components such as rim inserts and new colours. .

Description
TDXSP2 TDX® SP2 with LiNX Electronics
TDXSP2-CG TDX® SP2 Base for Single Actuator System w/ Ultra Low Maxx
TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx

There are three (3) wireless functions available in the LiNX System. These functions are Mouse Mover, Remote Diagnostics of the Power Wheelchair and Configuration/Programming of the LiNX Control System. The Mouse Mover and Remote Diagnostics of the Power Wheelchair functions are built into all the LiNX Remotes and use a Bluetooth LE wireless connection.

The Mouse Mover function allows the end user of the subject Invacare® TDX® SP2 Power Wheelchair device to operate a standard wireless PC mouse where the joystick or Alternative Driver Control can be used to navigate the cursor on the screen on a PC, tablet or other similar device.

The Remote Diagnostics of the Power Wheelchair function send specific diagnostic information relevant to the status of the wheelchair electronics to an Apple iOS device.

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The Configuration/Programming of the LiNX Control System requires a separate programming access key (LiNX Access Key: LAK) that plugs into the LiNX Control System via one of its remotes (Joysticks) and communicates over a Bluetooth connection. This is used for remote programming of the LiNX Control system.

Each accessory connects to the LiNX Control system either directly by connecting to the LiNX communication bus (direct access) or indirectly by connecting to an Input module (indirect access).

The associated models and accessories and capabilities include:

. Invacare® TDX SP2™ with Motion Concepts Ultra Low Maxx Power Positioning
Primary Driver Controls (Bluetooth LE Wireless Capable: Mouse Mover and Diagnostics)
- o Export data to application
Attendant Driver Controls (No Wireless)
- o Provide a simple interface for the wheelchair attendant using a LiNX System
- Control of actuators through the joystick o
Alternative Driver Controls (Bluetooth LE Wireless Capable: Mouse Mover) ●
- Has a compact, low-profile design, and is a secondary remote module designed to o provide a simple interface for the wheelchair occupant using a LiNX Control System
- o Low force joystick option to improve control for those with low muscle strength
- Controls mouse movement о
Display Modules (Bluetooth LE Wireless Capable: Mouse Mover and Diagnostics) ●
- o Provides a relocatable user interface for use for alternative driver controls
- Provides the same level of functionality as the enhanced rehabilitation primary о display except for the joystick
Actuator Control (No Wireless) ●
- The Actuator Control Module has an in-built accelerometer used to provide O angular feedback of the seating position which is in turn used to limit driving capability
- 2-Channel Actuator Module o
- o 4-Channel Actuator Module
Power Modules (No Wireless) ●
- Process the user commands issued via the joystick or alternative drive control and о control the motion of the wheelchair by varying the amount of power supplied to the left and right wheelchair motors
Stability Control (No Wireless)
- o G-Trac / Gyro
Input Module with Integrated Sip-n-Puff (No Wireless) ●
- Sip and puff nozzle o
- o Jack input (stereo)

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2 x LiNX bus connectors o
o Activity indicator displaying input demands
USB Charger Module (No Wireless) ●
- The USB charger module includes protection mechanisms for short circuit and o over-current
4-way expansion block (No Wireless)
- o harness for expandable systems
Atom Proton Head Array (Bluetooth LE Wireless: Mouse Mover) ●
- o Direct access
MEC mini joystick (Bluetooth LE Wireless: Mouse Mover)
- o Direct access
Extremity control (Bluetooth LE Wireless: Mouse Mover) ●
- o Direct access
Compact, Single Switch (Bluetooth LE Wireless: Mouse Mover) o Indirect Access (via input module)
Compact (No Wireless)
- o Indirect Access (via input module)
. 4-Switch Proximity (Bluetooth LE Wireless: Mouse Mover)
- o Indirect Access (via input module)
. Sip-n-Puff Head Array (No Wireless)
- o Indirect Access (via input module)
. Wireless double switch receiver (Bluetooth LE Wireless: Mouse Mover)
- o Indirect Access (via input module)
Wireless triple switch receiver (Bluetooth LE Wireless: Mouse Mover)
Wireless mouse emulator (Bluetooth LE Wireless: Mouse Mover) ●
LiNX Access Key (LAK: Bluetooth Wireless: Remote Programming) ●

INDICATIONS FOR USE

The indication for use of the Invacare® TDX® SP2 Power Wheelchair is to provide mobility and positioning to persons limited to a sitting position.

INDICATIONS FOR USE (IFU) COMPARISON

The Indications for Use statement for the subject device is the same as the secondary predicate device, the Modular Power Positioning System cleared under K150574 Indications for Use statement, which is to provide "positioning to individuals without adequate upper-body stability." The determination was made based Section 513(i)(1)(E)(i) of the FD&C Act. The seating system for the subject Invacare® TDX® SP2 Power Wheelchair device is Modular Power Positioning System (K150574) which is indicated for positioning functions that are offered on the subject device and is designed to help patients without adequate upper-body

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stability to be tilted and allow gravity to hold them in position. The subject device positioning also help the patients to reach higher elevations in a seated position, increasing their range of motion and accessibility.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY and SECONDARY PREDICATE DEVICES and REFERENCE DEVICES

The device comparison showed that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared primary and secondary predicate devices and/or specified reference devices below in regards to provide mobility and positioning to persons limited to a sitting position.

Invacare® TDX® SP2 Power Wheelchair (K141783) .
F3 Powered Wheelchair (K143180)
F5 Powered Wheelchair (K143014) ●
Quantum Q6 Edge (K143383)
Modular Power Positioning System (K150574)

The subject device, predicate device and all reference devices excluding the secondary predicate device Motion Concepts Modular Power Positioning System are battery powered, motor driven, rigid, non-folding type power wheelchairs with a micro-processor controlled electronic control systems, non-powered and powered seating and a selection of alternative drive controls.

The subject device has the same seating system as previously cleared secondary predicate Module Power Positioning System device.

The secondary predicate device and the reference devices were chosen to demonstrate substantial equivalence for the following components and features in the subject device:

. LiNX® Control System
Power Wheelchair Base .
. Power Wheelchair Seating

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BASIS OF SUBSTANTIAL EQUIVALENCE

The substantial equivalence of the subject device was determined as per the FDA guidance document. "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and the technological characteristics which include materials, design, energy source, and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A).

The subject device components are as safe and effective as the predicate and reference devices and do not raise different questions of safety and effectiveness. The differences between the subject device features and the previously cleared predicate and reference devices do not raise new issues of safety or effectiveness.

The performance testing, device comparison, and dimensional analysis demonstrates that the subject device components are substantially equivalent to the predicate and reference devices in regards to the following:

. Static Stability
Dynamic Stability of Electric Wheelchairs ●
Effectiveness of Brakes ●
Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range
Dimensions Mass and Manoeuvring Space ●
Maximum Speed Acceleration and Deceleration of Electric Wheelchairs
Methods for Static Impact and Fatigue Strengths
Climatic Tests for Electric Wheelchairs
Climbing Ability of Electrically Powered Wheelchairs
Power and Control Systems for Electrically Powered Wheelchairs and Scooters ●
Information Disclosure Documentation and Labeling
Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters and Battery Chargers
Software Life Cycle
Additional Requirements for Wheelchairs (including scooters) with Electrical Systems
Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters
Flammability Testing ●
Assessment of the Ignitability of Upholstered Furniture Ignition Source Smouldering ● Cigarette
Assessment of the Ignitability of upholstered Furniture Ignition Source Match Flame . Equivalent
Wireless Coexistence ●

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The data generated from the subject Invacare® TDX® SP2 Power Wheelchair Design Verification test report supports a finding of substantial equivalence in regards to the device comparison, dimensional analysis, device specifications, design characteristics and to provide mobility and positioning to persons limited to a sitting position.

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Indications for Use (IFU) Comparison Table

Description	Subject Device Invacare® TDX® SP2 PowerWheelchair	Primary Predicate DeviceInvacare® TDX® SP2 Power Wheelchair	Secondary Predicate DeviceModular Power Positioning System
510(k) Number	Pending Submission	K141783	K150574
Indications for Use	To provide mobility and positioning to persons limitedto a sitting position	To provide mobility topersons limited to a sitting position.	The Modular Power Positioning system is appropriate for use by any individualwho drives a power wheelchair and whodesires or requires a change of position without having to utilize the services of anattendant. Needs for position changesinclude:- All positioning benefits associated with the tilt/recline product:Comfort: As with any individual, able-bodied or disabled, changes in position arenecessary to maintain a state ofcomfort.Positioning: Individuals without adequate upper-body stability can be tilted toallow gravity to hold them in position.Pressure Relief or Reduction: Individuals who wish, from time to time, toredistribute pressure from one area of the bodyto another, can do so by tilting and/or reclining. By changing the individual'sorientation in space, pressures caused bygravity will shift.- Positioning/Versatility: Individuals are able to reach higher elevations in aseated position, increasing their range ofmotion and accessibility.Motion Concepts makes no claims as to the therapeutic effectiveness of theproducts. Our only claims relate to the abilityof the products to provide safe and reliable powered repositioning on theequipment onto which they are installed.

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Design Characteristics Comparison – Finished Medical Device

Description	Subject DeviceTDX® SP2	Primary Predicate DeviceTDX® SP2
Base Configuration	Centre Wheel Drive	Centre Wheel Drive
Suspension	Enhanced SureStep® Suspension	Enhanced SureStep® Suspension
Stability Lock	Locking gas cylinder	Locking gas cylinder
Speed	5mph or 5.8mph	5.8mph
Braking System	Electro-mechanical Friction Brake	Electro-mechanical Friction Brake
Range	22NF Batteries > 13.7 miles ORGP24 Batteries > 20.7 miles	22NF Batteries > 12 miles ORGP24 Batteries > 15 miles
Weight Capacity	300lbs.	300lbs. (Adult seating)165lbs. (Junior seating)
Length (without leg rests)	31.5" to 45.3"(depending on seat configuration)	35.5"
Base Width	24" OR 25.5"(depending on battery type)	24" OR 25.5"(depending on battery type)
Incline Capability	9°	9°
Total Weight(seat and base)	291-450lbs.(depending on seat configuration)	291-425lbs.(depending on seat configuration)
Obstacle Climbing	Forward 2.95" ANDReverse 0.95"	Forward 2.76" ANDReverse 0.98"
Drive Wheel Frame Material	Aluminum	Aluminum
Transport Option	Brackets bolt on frame	Brackets bolt on frame

Secondary and Reference Predicate Devices

Subject Device	Component or Sub-Assembly	Secondary Predicate Device and Reference Devices	510(k) Clearance Code/s	Clearance Date/s
Invacare TDX® SP2 PowerWheelchair	TDX® SP2 Power Base	Invacare® TDX® SP2 Power Wheelchair	K141783	1st September 2015
	Ultra-Low Maxx Seating(Secondary Predicate Device)	Motion Concepts Modular Power Positioning System	K150574	30th June 2015
	LiNX® Control System	Invacare TDX® SP2Mk6iPermobil F3R-NetPermobil F5R-NetQuantum Q6 Edge EMQ-Logic2	K141783 K143180 K143014 K143383	1st September 201527th March 201525th March 201523rd July 2015

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Design Characteristics Comparison – LiNX® Electronics

Description	Subject DeviceInvacare® TDX® SP2 PowerWheelchair	Primary Predicate DeviceInvacare® TDX® SP2 PowerWheelchair (K141783)	Reference DevicesF3 Powered Wheelchair & F5Powered Wheelchair	Quantum Q6 Edge
System Name	LiNX	MK6i	R-Net	Q-Logic2
Cables	Variable cable lengthsA range of standard cable lengths available	Primarily fixed length flying leads, connecting at a single "star point"	Variable cable lengthsA range of standard cable lengths available	Variable cable lengthsA range of standard cable lengths available
System Architecture	Microprocessor Controlled	Microprocessor Controlled	Microprocessor Controlled	Microprocessor Controlled
Non-Expandable Options	Yes	Yes	Yes	Yes
Expandable Options	Yes	Yes	Yes	Yes
Wireless Devices	Bluetooth	None	BluetoothInfra-Red	BluetoothInfra-Red
Power Source	24V nominal	24V nominal	24V nominal	24V nominal
Bus Interface	CAN	MixedCAN & 2-Wire Serial	CAN	CAN

Design Characteristics Comparison – Seating

	Subject Device	Primary Predicate Device	Secondary Predicate Device
Description	Invacare® TDX® SP2 Power Wheelchair	Invacare® TDX® SP2 Power Wheelchair(K141783)(Formula CG)	Motion Concepts Modular Power Positioning System(K150574)
Seat Types	Fixed, Tilt/Recline/Elevate, Tilt/Recline,Recline, Elevate, Tilt/Elevate, Tilt Only.	ADJASBA, ADJRECL, Formula TRE,Tilt/Recline/Elevate, Tilt/Recline, Recline, TRE,Elevate, Tilt/ Elevate	Fixed, Tilt/Recline/Elevate, Tilt/Recline, Recline, Elevate,Tilt/Elevate, Tilt Only
Seat Widths	16" to 24"	12" to 24"	15" to 24"
Seat Depths	16" to 23"	12" to 22"	15" to 22"
Back Heights	18" to 25" (tilt only) OR20" to 27" (tilt and recline)	12" to 28"	18" to 30"
Upholstery	Meshtex, Startex, Spacetex, O-Vinyl, Polyester	Cloth & Vinyl	Meshtex, Startex, Spacetex, O-Vinyl, Polyester
Elevating Seat Range	12"	ידיי	12"
Tilt Range	500	Not Specified	500
Recline Range	1680	Not Specified	1680

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POWER BASE SUBSTANTIAL EQUIVALENCE TABLE

	Subject Device	Primary Predicate Device
Description	Invacare® TDX® SP2 Power Wheelchair	Invacare® TDX® SP2 Power Wheelchair
	(Pending)	(K141783)
Base Configuration	Centre Wheel Drive	Centre Wheel Drive
Suspension	Enhanced SureStep® Suspension	Enhanced SureStep® Suspension
Stability Lock	Locking gas cylinder	Locking gas cylinder
Stability Lock Mechanism	Internal locking valve mechanism in gas cylinder	Internal locking valve mechanism in gas cylinder
Stability Lock Side Dependency	Both sides lock/unlock together	Both sides lock/unlock together
Motors	4-Pole SSD	4-Pole SSD
Motor Voltage	24V nominal	24V nominal
Motor Power	24V DC/324W (@13.5Amps)	24V DC/324W (@13.5Amps)
Speed	5mph, or 5.8mph	5.8mph
Number of Batteries	2	2
Battery Types	22NF OR GP24	22NF OR GP24
Battery Chemistry	Sealed VRLA Gel Batteries	Sealed VRLA Gel Batteries
	24V nominal	24V nominal
Battery Operating Voltage	(2 * 12V)	(2 * 12V)
	22NF = 43.2amp-hrs (C5)	22NF = 43.2amp-hrs
Battery Amp-Hour Rating	GP24 = 63amp-hrs (C5)	GP24 = 63amp-hrs
	22NF = 37lbs.	22NF = 37lbs.
Battery Weight	GP24 = 52lbs.	GP24 = 52lbs.
	8-amp off board charger	8-amp off board charger
Battery Chargers	(110V)	(110V or 220V)
Braking System	Electro-mechanical Friction Brake	Electro-mechanical Friction Brake
	22NF Batteries > 13.7 miles OR	22NF Batteries > 12 miles OR
Range	GP24 Batteries > 20.7 miles	GP24 Batteries > 15 miles
	45.7" to 69.3"	74.8" to 102.4"
Stopping Distance	(depending on chair configuration)	(depending on chair configuration)
		300lbs. (Adult seating)
Weight Capacity	300lbs.	165lbs. (Junior seating)
Length (without leg rests)	31.5" to 55.4"	35.5"
	24" OR 25.5"	24" OR 25.5"
Base Width	(depending on battery type)	(depending on battery type)
Front Forks	Single OR double sided	Single OR double sided
	Black gel tires.	Pneumatic OR gel/foam filled flat free tires.
Tires	Foam filled OR pneumatic
Drive Wheel Size	14" x 3"	14" x 3"
Castor Size	6" x 2"	6" x 2"
Front Castor Force	Applied by proportional force gas spring	Applied by proportional force gas spring
Damping on Front Swing Arm	Gas spring has damping
Incline Capability	0%	0%
Description	Subject DeviceInvacare® TDX® SP2 Power Wheelchair(Pending)	Primary Predicate DeviceInvacare® TDX® SP2 Power Wheelchair(K141783)
Turning Diameter	50.4" to 65.4"(depending on seat configuration)	< 46"
Base Weight(with batteries)	264lbs (GP24 Batteries)	264lbs (GP24 Batteries)
Total Weight(seat and base)	291 to 450lbs.(depending on seat configuration)	291 to 425lbs.(depending on seat configuration)
Ground Clearance	> 2.5"	3"
Obstacle Climbing	Forward 2.95" ANDReverse 0.98"	Forward 2.76" ANDReverse 0.98"
Motor Gearbox Sound Level	54dBa	58dBa
Drive Wheel Frame Material	Aluminum	Aluminum
Transport Option	Brackets bolt on frame	Brackets bolt on frame

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General Comparison of the Performance Characteristics Associated with the Control System

	Subject Device	Primary Predicate Device	Reference Devices
Description	Invacare® TDX® SP2Power Wheelchair(Pending)	Invacare® TDX® SP2 PowerWheelchair(K141783)	Permobil F3 & F5(K143180 & K143014)	Quantum Q6 Edge (K143383)
Cables	Variable cable lengthsA range of standard cablelengths available	Primarily fixed length flyingleads, connecting at a single"star point"	Variable cable lengthsA range of standard cablelengths available	Variable cable lengthsA range of standard cable lengths available
System Architecture	Microprocessor Controlled	Microprocessor Controlled	Microprocessor Controlled	Microprocessor Controlled
Non-ExpandableOptions	Yes	Yes	Yes	Yes
Expandable Options	Yes	Yes	Yes	Yes
Wireless Devices	Bluetooth	None	BluetoothInfra-Red	BluetoothInfra-Red
Power Source	24V nominal	24V nominal	24V nominal	24V nominal
Bus Interface	CAN	MixedCAN & 2-Wire Serial	CAN	CAN

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Description	Subject DeviceInvacare® TDX® SP2 Power Wheelchair(Pending)	Primary Predicate DeviceInvacare® TDX® SP2 Power Wheelchair(K141783)
	REM110	Mk6i SPJ
Mounting	2 x M5 screws suitable for both tube and plate.	4 x M5 screws suitable for both tube and plate.
Connector Type	Direct	Direct
User Display	LED	LED
Joystick	Magnetic	Inductive
On/Off Button	Yes	Yes
Horn	Yes	Yes
Speed Selection	Speed dial.	Speed up and speed down buttons.
Number of Drive Functions	1	1
Battery Gauge	5 x LED's	8 x LED's
Charger Port	XLR	XLR
Status Indicator	Power button 'flash codes'.	Service LED.
Remote Diagnostics	Yes.Built-in Bluetooth connection.	No.

Comparison of the Performance Characteristics Associated with the Drive Only Primary Remotes

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	Subject Device	Primary Predicate Device	Reference Devices
Description	Invacare® TDX® SP2Power Wheelchair(Pending)	Invacare® TDX® SP2 PowerWheelchair(K141783)	Permobil F3 & F5(K143180 & K143014)	Quantum Q6 Edge(K143383)
	REM400	Mk6i-MPJC	R-Net CJSM2	Q-Logic2 EX Joystick
Mounting	2 x M5 screws suitablefor both tube and plate.	4 x M5 screws suitable for both tube andplate.	2 x M5 screws suitable forboth tube and plate.	4 x 10-32 screws suitable for both tube and plate.
Connection	Direct	Flying Lead	Flying Lead	Flying Lead
User Display	LCD - colour.	LCD - colour.	LCD - colour.	LDC - colour.
Viewable LCD Size	49 x 74mm	46 x 35mm	53 x 71mm	44 x 57mm
Joystick	Magnetic	Inductive	Magnetic	Not Available
Text & Graphics	Icons & translations.Customisable.	Icon based with text.	Icon & translations.Multi-language support	Icon and translations.5 languages.
Touch Interface	Yes - capacitive	No	No	No
On/Off Button	Yes	Yes	Yes	Yes
Horn	Yes	No	Yes	Yes
Mode/Function	Button or Touch	Button	Toggle	Button
Programmable Multi-Function Keys	2 x Configurable	No	4 x Configurable	2 x Configurable
Jack Sockets	2 x Stereo.	1 x Mono * 1 x Stereo	2 x Mono	2 x Mono
Speed Selection	Virtual speed dialoperated by touch.	Speed dial.	Virtual speed dial operated bytoggles.	Speed dial.
Speed Indication	Yes	Yes	Yes	Yes
Number of Drive Functions	36	4	8	5
Battery Gauge	Bar on LCD(continuous)	Battery icon with fill level on LCD(6 discrete segments)	Bar on LCD(10 discrete segments)	Battery icon with fill level on LCD(continuous)
Seating Control	Up to 8 actuators	Up to 6 actuators	Up to 8 actuators	Up to 6 actuators
Lighting Control	Yes	No	Yes	Yes
Real Time Clock	Yes	Yes	Yes	Yes
Charger Port	XLR	XLR	XLR	XLR
Status Indicator	Error codes on displaywith supporting icons.Additional LED flashcodes for faulty LCD.	Error codes on display with briefdescription.	Error codes with briefdescription on display withLED for faulty LCD.	Error codes with brief description on display
Mouse Mover	Yes.Built-in Bluetoothconnection.	No	Yes.Built-in Bluetooth connection.	Yes.Built-in Bluetooth connection.
Remote Diagnostics	Yes.Built-in Bluetoothconnection.	No	No	No
	Subject Device	Primary Predicate Device	Secondary Predicate Device
Description	Invacare® TDX® SP2 Power Wheelchair(Pending)	Invacare® TDX® SP2 Power Wheelchair –(CG Formula)(K141783)	Modular Power Positioning System (K150574)
Seat Types	Fixed, Tilt/Recline/Elevate, Tilt/Recline, Recline,Elevate, Tilt/Elevate, Tilt Only.	ADJASBA, ADJRECL, Formula TRE,Tilt/Recline/Elevate, Tilt/Recline, Recline,TRE, Elevate, Tilt/ Elevate	Fixed, Tilt/Recline/Elevate, Tilt/Recline, Recline, Elevate,Tilt/Elevate, Tilt Only
Seat Widths	16" to 24"	12" to 24"	15" to 24"
Seat Depths	16" to 23"	12" to 22"	15" to 22"
Back Heights	18" to 25" (tilt only) OR20" to 27" (tilt and recline)	12" to 28"	18" to 30"
Upholstery	Meshtex, Startex, Spacetex, O-Vinyl, Polyester	Cloth & Vinyl	Meshtex, Startex, Spacetex, O-Vinyl, Polyester
Elevating Seat Range	12"	7"	12"
Tilt Range	50°	Not Specified	50°
Recline Range	168°	Not Specified	168°
Seat CushionAccessories	Matrx Libra, Matrx PS, Matrx Vi, Matrx Flo-tech Liteand Contour	In-TouchTM, TargitTM Cushions, InfinityCushions, Leg Cutouts, Leg Wedges	Matrx Libra, Matrx PS, Matrx Vi
Back Types	High Back, Matrx PB, Matrx PB Elite, Matrx PBDeep and Matrx PB Elite TR	ContouraTM, Conventional, ABS, Back PostsOnly, Sectional Rear Uprights, Straight RearUprights, 85-105 Degree Adjustment	High Back, Matrx PB, Matrx PB Elite, TRx Rehab Back,Contour
Back and HeadrestAccessories	Motion Concepts standard, Elan standard, ElanOccipital, Elan 4-point and Motion Concepts Onyx	Reinforced back upholstery, Personal backs,Stealth Headrests	Stealth, Stealth Nino, MC Auto Style
Arm Types	Tilt ArmrestsDual post adjustable, Ultra Rail mounted flip backcantilever Maxx tilt arm	Flip Back, Fixed or Adjustable Height andDesk or Full Length	Dual post adjustable height, Seat mounted height and angleadjustable cantilever flip back tilt, Cane mounted height andangle adjustable cantilever flip back, Reclining adjustableheight.
Armpads	Modular, Standard, Waterfall, Flat and Ergonomic	Not Specified	Modular, Standard, Waterfall, Flat and Ergonomic
Leg Rest Types	Basic fixed centre mount, Invacare Action fixedswing away receiver, Invacare 70° fixed swing away,LNX powered centre mount, Maxx style poweredswing away, Maxx style manual swing away, Heavyduty 70° swing away.	Centre Mount and Swing-Away Styles	LNX Power centre mount platform, TRX Swing away powerelevating pivot plus, TRX Pivot Plus manual elevating, TRXHD 70° swing-away footrest, Adjustable 70° to 90° fixedcentre mount foot platform.
Leg Rest Accessories	Flip-up foot platform, Individual foot plates for centremount. Foot plate options for elevating and swing-away, Single foot plate options (adjustable and multi-axis adjustable, Heel loops, Calf panel	Calf Strap, Heel Loops with Ankle Straps,Impact Guards	Not Specified
Description	Subject Device	Primary Predicate Device	Secondary Predicate Device
Invacare® TDX® SP2 Power Wheelchair(Pending)	Invacare® TDX® SP2 Power Wheelchair –(CG Formula)(K141783)	Modular Power Positioning System (K150574)
Laterals	Matrx standard fixed and offset fixed, Matrx swingaway, Matrx Elite swing away, Matrx Offset Eliteswing away, Matrx lateral trunk support with fixedmounting, Maxx Style swing-away	Not Specified	Matrx standard fixed and offset fixed, Matrx swing away,Matrx Elite swing away, Matrx Offset Elite swing away, MaxxStyle swing-away
Hip Supports	Lateral, Lift-off removable, Maxx style quick release,Swing away removable	Not Specified	Lift-off removable, Maxx style quick release, Swing awayremovable, Stealth flip down knee support

Comparison of the Performance Characteristics Associated with the Enhanced Rehabilitation Primary Remotes

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Comparison of the Performance Characteristics Associated with the Ultra-Low Maxx Seating System

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PERFORMANCE TESTING DATA

International Organization of Standardization (ISO) testing. California Technical (CAL) and European standards (EN 1021-1 and 2) testing were performed to demonstrate that the subject Invacare® TDX® SP2 Power Wheelchair meet the performance requirements and is substantially equivalent to the predicate device identified throughout this submission and do not raise any new questions of safety and effectiveness.

Because the subject Invacare® TDX® SP2 Power Wheelchair is highly configurable Power Wheelchair (PWC), intended to serve a diverse population with unique individual needs, a wide variety of options and accessories have been designed. However, due to the highly customizable nature of the subject device, testing to every possible combination would not be practical. However, every design feature of the subject device was verified. This was accomplished by identifying the specific wheelchair configurations that represent the full range of product permutations. The acceptance criteria for the full verification of the design and acceptance criteria for each section of the standard (ISO 7176) was met.

Risk Management

Risk Management has been conducted in accordance with ISO 14971:2012 - Medical Devices -Application of Risk Management to Medical Devices.

Non-Clinical Test

Non-clinical laboratory testing was performed on the subject Invacare® TDX® SP2 Power

Wheelchair to determine substantial equivalence. The following testing was performed:

. ISO 7176-1 Third Edition 2014-10-01, Wheelchairs - Part 1: Determination of Static Stability
ISO 7176-2 Second Edition 2001-06-15. Wheelchairs Part 2: Determination of . Dynamic Stability of Electric Wheelchairs
ISO 7176-3 Third Edition 2012-12-15, Wheelchairs Part 3: Determination of . Effectiveness of Brakes
ISO 7176-4 Third Edition 2008-10-01, Wheelchairs Part 4: Energy Consumption of . Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range
. ISO 7176-5 Second Edition 2008-06-01, Wheelchairs - Part 5: Determination of Overall Dimensions Mass and Manoeuvring Space
ISO 7176-6 Second Edition 2001-10-01, Wheelchairs Part 6: Determination of . Maximum Speed Acceleration and Deceleration of Electric Wheelchairs

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. ISO 7176-7 First Edition 1998-05-15, Wheelchairs - Part 7: Measurement of Seating and Wheel Dimensions
ISO 7176-8 Second Edition 2014-12-15, Wheelchairs - Part 8: Requirements and Test Methods for Static Impact and Fatigue Strengths
ISO 7176-9: Third Edition 2009-11-15, Wheelchairs - Part 9: Climatic Tests for Electric Wheelchairs
. ISO 7176-10 Second Edition 2008-11-01. Wheelchairs - Part 10: Determination of Obstacle - Climbing Ability of Electrically Powered Wheelchairs
ISO 7176-11 Second edition 2012-12-01. Wheelchairs Part 11: Test Dummies ●
ISO 7176-13 First edition 1989-08-01, Wheelchairs Part 13: Determination of ● Coefficient of Friction of Test Surface
. ISO 7176-14 Second Edition 2008-02-15, Wheelchairs - Part 14: Power and Control Systems for Electrically Powered Wheelchairs and Scooters - Requirements and Test Methods
. ISO 7176-15 First Edition 1996-11-15, Wheelchairs - Part 15: Requirements for Information Disclosure Documentation and Labeling
ISO 7176-21 Second Edition 2009-04-01. Wheelchairs - Part 21: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters and Battery Chargers
ISO 7176-22 Second Edition 2014-09-01, Wheelchairs Part 22: Set-up Procedures ●
. ISO 7176-25 First Edition 2013 Wheelchairs - Part 25: Batteries and Chargers for Powered Wheelchairs
IEC 62304:2006, Medical Device Software Software Life Cycle ●
. ANSI / RESNA WC-2:2009. American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including scooters) with Electrical Systems Section 21: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters
CAL117:2013. Section 1: Flammability Testing .
EN 1021-1:2014: Furniture. Assessment of the Ignitability of Upholstered Furniture. Ignition Source Smouldering Cigarette
. EN 1021-2:2014: Furniture. Assessment of the Ignitability of upholstered Furniture. Ignition Source Match Flame Equivalent
ANSIC63.27 Wireless Coexistence .

Verification Testing demonstrated that the subject Invacare® TDX® SP2 Power Wheelchair is substantially equivalent to the marketed primary and secondary predicate devices and reference devices.

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Software Verification Testing

Software Verification Testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. Software verification testing was conducted on the subject device as recommended by the FDA's guidance document "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005." and IEC 62304:2006, Medical Device Software – Software Life Cycle.

Level of Concern: The Level of Concern for the subject device software is moderate. This determination is based on answering the questions in the FDA Guidance Document "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005." All of the questions related to a Major Level of Concern were answered "No." One question in the Moderate Level of Concern was answered "Yes" because "prior to mitigation of hazards, a failure of the Software Device could result in Minor Injury, either to a patient or to a user of the subject device

Biocompatibility Testing

The biocompatibility evaluation for the subject Invacare® TDX® SP2 Power Wheelchair were conducted in accordance with the FDA Blue Book Memorandum #G95 – 1 "Use of International Standard ISO – 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993 - 1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

· AAMI / ANSI / ISO 10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro Cytotoxicity
AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: . Tests for skin irritation

Animal Study

Animal testing was not required for this submission.

Clinical Testing

Clinical testing was not required for this submission.

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CONCLUSIONS

The subject device has the same intended use and similar technological characteristics as the predicate devices. The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the subject Invacare® TDX® SP2 Power Wheelchair is substantially equivalent to the predicate devices identified throughout this submission.

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).