(141 days)
No
The summary describes a power wheelchair with an updated control system and seating, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
The device's intended use is to provide mobility and positioning, which are supportive functions, not therapeutic actions aimed at treating or curing a medical condition.
No
The Invacare® TDX® SP2 Power Wheelchair is designed to provide mobility and positioning, not to diagnose a medical condition.
No
The device description clearly states it is a power wheelchair, which is a physical hardware device. While it includes updated software and a control system, it is not solely software.
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 and positioning to persons limited to a sitting position." This describes a device used for physical support and movement, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a power wheelchair with mechanical and electrical components for mobility and seating. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
- Mentioning laboratory settings or procedures for sample analysis.
The device is clearly a medical device intended for mobility and positioning, not for in vitro diagnostic purposes.
N/A
Intended Use / 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.
Product codes
ITI
Device Description
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.
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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical laboratory testing was performed on the subject Invacare® TDX® SP2 Power Wheelchair to determine substantial equivalence, including ISO 7176 standards (parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 21, 22, 25), IEC 62304:2006, ANSI/RESNA WC-2:2009 Section 21, CAL117:2013 Section 1, EN 1021-1:2014, EN 1021-2:2014, and ANSIC63.27. Software verification testing was conducted according to FDA guidance "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005" and IEC 62304:2006. Biocompatibility testing included AAMI/ANSI/ISO 10993-5:2009 and AAMI/ANSI/ISO 10993-10:2010. Clinical testing and animal studies were not required. The performance testing and dimensional analysis demonstrated that the subject device components are substantially equivalent to the predicate and reference devices.
Key Metrics
Not Found
Predicate Device(s)
Invacare® TDX® SP2 Power Wheelchair (K141783), Modular Power Positioning System (K150574)
Reference Device(s)
F3 Powered Wheelchair (K143180), F5 Powered Wheelchair (K143014), Quantum Q6 Edge (K143383), Modular Power Positioning System (K150574)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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.
1
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
2
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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3
| 510(k) Summary (K170507) | |
|---|---|
| SUBMITTER: | Invacare Corporation |
| One Invacare Way | |
| Elyria, OH 44035 | |
| Phone: (440) 329-6840 | |
| Email: ewreh@invacare.com | |
| CONTACT PERSON: | Elijah N. Wreh |
| Regulatory Affairs Manager (Pre-Market) | |
| MANUFACTURER: | Invacare Corporation |
| 1200 Taylor St | |
| Elyria, OH 44035 | |
| Date Prepared: | July 12, 2017 |
| DEVICE INFORMATION | |
| Name of Devices: | 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 | |
| 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 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. .
| 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 |
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.
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.
5
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)
6
- 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
7
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
8
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 ●
9
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.
10
Indications for Use (IFU) Comparison Table
| Description | Subject Device Invacare® TDX® SP2 Power
Wheelchair | Primary Predicate Device
Invacare® TDX® SP2 Power Wheelchair | Secondary Predicate Device
Modular Power Positioning System |
|---------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Pending Submission | K141783 | K150574 |
| Indications for Use | To provide mobility and positioning to persons limited
to a sitting position | To provide mobility to
persons limited to a sitting position. | The Modular Power Positioning system is appropriate for use by any individual
who drives a power wheelchair and who
desires or requires a change of position without having to utilize the services of an
attendant. Needs for position changes
include:
- All positioning benefits associated with the tilt/recline product:
Comfort: As with any individual, able-bodied or disabled, changes in position are
necessary to maintain a state of
comfort.
Positioning: Individuals without adequate upper-body stability can be tilted to
allow gravity to hold them in position.
Pressure Relief or Reduction: Individuals who wish, from time to time, to
redistribute pressure from one area of the body
to another, can do so by tilting and/or reclining. By changing the individual's
orientation in space, pressures caused by
gravity will shift. - Positioning/Versatility: Individuals are able to reach higher elevations in a
seated position, increasing their range of
motion and accessibility.
Motion Concepts makes no claims as to the therapeutic effectiveness of the
products. Our only claims relate to the ability
of the products to provide safe and reliable powered repositioning on the
equipment onto which they are installed. |
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Design Characteristics Comparison – Finished Medical Device
| Description | Subject Device
TDX® SP2 | Primary Predicate Device
TDX® 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 OR
GP24 Batteries > 20.7 miles | 22NF Batteries > 12 miles OR
GP24 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" AND
Reverse 0.95" | Forward 2.76" AND
Reverse 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 Power | ||||
| Wheelchair | 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® SP2 | |||
| Mk6i | ||||
| Permobil F3 | ||||
| R-Net | ||||
| Permobil F5 | ||||
| R-Net | ||||
| Quantum Q6 Edge EM | ||||
| Q-Logic2 | K141783 | |||
| K143180 | ||||
| K143014 | ||||
| K143383 | 1st September 2015 | |||
| 27th March 2015 | ||||
| 25th March 2015 | ||||
| 23rd July 2015 |
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Design Characteristics Comparison – LiNX® Electronics
| Description | Subject Device
Invacare® TDX® SP2 Power
Wheelchair | Primary Predicate Device
Invacare® TDX® SP2 Power
Wheelchair (K141783) | Reference Devices
F3 Powered Wheelchair & F5
Powered Wheelchair | Quantum Q6 Edge |
|------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| System Name | LiNX | MK6i | R-Net | Q-Logic2 |
| Cables | Variable cable lengths
A range of standard cable lengths available | Primarily fixed length flying leads, connecting at a single "star point" | Variable cable lengths
A range of standard cable lengths available | Variable cable lengths
A 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 | Bluetooth
Infra-Red | Bluetooth
Infra-Red |
| Power Source | 24V nominal | 24V nominal | 24V nominal | 24V nominal |
| Bus Interface | CAN | Mixed
CAN & 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) OR | |||
| 20" 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 Device | |
| Invacare® TDX® SP2 Power Wheelchair | ||
| (Pending) | Primary Predicate Device | |
| Invacare® TDX® SP2 Power Wheelchair | ||
| (K141783) | ||
| Turning Diameter | 50.4" to 65.4" | |
| (depending on seat configuration) | 2.5" | 3" |
| Obstacle Climbing | Forward 2.95" AND | |
| Reverse 0.98" | Forward 2.76" AND | |
| Reverse 0.98" | ||
| Motor Gearbox Sound Level | 54dBa | 58dBa |
| Drive Wheel Frame Material | Aluminum | Aluminum |
| Transport Option | Brackets bolt on frame | Brackets bolt on frame |
14
General Comparison of the Performance Characteristics Associated with the Control System
| Subject Device | Primary Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Description | Invacare® TDX® SP2 | |||
| Power Wheelchair | ||||
| (Pending) | Invacare® TDX® SP2 Power | |||
| Wheelchair | ||||
| (K141783) | Permobil F3 & F5 | |||
| (K143180 & K143014) | Quantum Q6 Edge (K143383) | |||
| Cables | Variable cable lengths | |||
| A range of standard cable | ||||
| lengths available | Primarily fixed length flying | |||
| leads, connecting at a single | ||||
| "star point" | Variable cable lengths | |||
| A range of standard cable | ||||
| lengths available | Variable cable lengths | |||
| A 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 | Bluetooth | |
| Infra-Red | Bluetooth | |||
| Infra-Red | ||||
| Power Source | 24V nominal | 24V nominal | 24V nominal | 24V nominal |
| Bus Interface | CAN | Mixed | ||
| CAN & 2-Wire Serial | CAN | CAN |
15
| Description | Subject Device
Invacare® TDX® SP2 Power Wheelchair
(Pending) | Primary Predicate Device
Invacare® 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
16
| Subject Device | Primary Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Description | Invacare® TDX® SP2 | |||
| Power Wheelchair | ||||
| (Pending) | Invacare® TDX® SP2 Power | |||
| Wheelchair | ||||
| (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 suitable | |||
| for both tube and plate. | 4 x M5 screws suitable for both tube and | |||
| plate. | 2 x M5 screws suitable for | |||
| both 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 dial | |||
| operated by touch. | Speed dial. | Virtual speed dial operated by | ||
| toggles. | 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 display | |||
| with supporting icons. | ||||
| Additional LED flash | ||||
| codes for faulty LCD. | Error codes on display with brief | |||
| description. | Error codes with brief | |||
| description on display with | ||||
| LED for faulty LCD. | Error codes with brief description on display | |||
| Mouse Mover | Yes. | |||
| Built-in Bluetooth | ||||
| connection. | No | Yes. | ||
| Built-in Bluetooth connection. | Yes. | |||
| Built-in Bluetooth connection. | ||||
| Remote Diagnostics | Yes. | |||
| Built-in Bluetooth | ||||
| connection. | 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) OR | |||
| 20" 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 Cushion | ||||
| Accessories | Matrx Libra, Matrx PS, Matrx Vi, Matrx Flo-tech Lite | |||
| and Contour | In-TouchTM, TargitTM Cushions, Infinity | |||
| Cushions, Leg Cutouts, Leg Wedges | Matrx Libra, Matrx PS, Matrx Vi | |||
| Back Types | High Back, Matrx PB, Matrx PB Elite, Matrx PB | |||
| Deep and Matrx PB Elite TR | ContouraTM, Conventional, ABS, Back Posts | |||
| Only, Sectional Rear Uprights, Straight Rear | ||||
| Uprights, 85-105 Degree Adjustment | High Back, Matrx PB, Matrx PB Elite, TRx Rehab Back, | |||
| Contour | ||||
| Back and Headrest | ||||
| Accessories | Motion Concepts standard, Elan standard, Elan | |||
| Occipital, Elan 4-point and Motion Concepts Onyx | Reinforced back upholstery, Personal backs, | |||
| Stealth Headrests | Stealth, Stealth Nino, MC Auto Style | |||
| Arm Types | Tilt Armrests | |||
| Dual post adjustable, Ultra Rail mounted flip back | ||||
| cantilever Maxx tilt arm | Flip Back, Fixed or Adjustable Height and | |||
| Desk or Full Length | Dual post adjustable height, Seat mounted height and angle | |||
| adjustable cantilever flip back tilt, Cane mounted height and | ||||
| angle adjustable cantilever flip back, Reclining adjustable | ||||
| height. | ||||
| Armpads | Modular, Standard, Waterfall, Flat and Ergonomic | Not Specified | Modular, Standard, Waterfall, Flat and Ergonomic | |
| Leg Rest Types | Basic fixed centre mount, Invacare Action fixed | |||
| swing away receiver, Invacare 70° fixed swing away, | ||||
| LNX powered centre mount, Maxx style powered | ||||
| swing away, Maxx style manual swing away, Heavy | ||||
| duty 70° swing away. | Centre Mount and Swing-Away Styles | LNX Power centre mount platform, TRX Swing away power | ||
| elevating pivot plus, TRX Pivot Plus manual elevating, TRX | ||||
| HD 70° swing-away footrest, Adjustable 70° to 90° fixed | ||||
| centre mount foot platform. | ||||
| Leg Rest Accessories | Flip-up foot platform, Individual foot plates for centre | |||
| mount. 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 swing | |||
| away, Matrx Elite swing away, Matrx Offset Elite | ||||
| swing away, Matrx lateral trunk support with fixed | ||||
| mounting, Maxx Style swing-away | Not Specified | Matrx standard fixed and offset fixed, Matrx swing away, | ||
| Matrx Elite swing away, Matrx Offset Elite swing away, Maxx | ||||
| Style 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 away | ||
| removable, Stealth flip down knee support |
Comparison of the Performance Characteristics Associated with the Enhanced Rehabilitation Primary Remotes
17
Comparison of the Performance Characteristics Associated with the Ultra-Low Maxx Seating System
18
19
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
20
- . 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.
21
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.
22
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.