(49 days)
The indication for use of the Invacare® TDX® SP2-HD with Captain's Seat is to provide mobility and positioning to persons limited to a sitting position.
The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes:
- Increase in the weight capacity of the previously cleared device from 300 lb to 450 lb.
Invacare® 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 center-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. No new accessories were added to the new device.
The provided text describes a 510(k) premarket notification for a powered wheelchair, the Invacare® TDX® SP2-HD with Captain's Seat. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Invacare® TDX® SP2 Power Wheelchair, K170507), primarily by performing non-clinical testing to meet recognized consensus standards.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "The acceptance criteria for the full verification of the design and acceptance criteria for each section of the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) testing standard was met." However, it does not provide a specific table detailing the acceptance criteria for each test and the corresponding reported performance of the device.
It lists the following design characteristics and notes some differences compared to the predicate device, which could be interpreted as performance metrics:
| Description | Subject Device Invacare® TDX® SP2-HD with Captain's Seat | Predicate Device Invacare® TDX® SP2 Power Wheelchair | Met Acceptance Criteria (Implied) |
|---|---|---|---|
| Weight Capacity | 450lb. | 300lb. | Yes (improved) |
| Speed | 5mph | 5mph or 5.8mph | Yes |
| Range (GP24 Batteries) | > 20.7 miles | > 20.7 miles | Yes |
| Stopping Distance | 45.7" to 69.3" (depending on chair configuration) | 45.7" to 69.3" (depending on chair configuration) | Yes |
| Incline Capability | 9° | 9° | Yes |
| Ground Clearance | > 2.5" | > 2.5" | Yes |
| Obstacle Climbing (Forward) | 2.95" | 2.95" | Yes |
| Obstacle Climbing (Reverse) | 0.98" | 0.98" | Yes |
| Motor Gearbox Sound Level | 54dBa | 54dBa | Yes |
| Base Width | 25.5" | 24" or 25.5" (depending on battery type) | Yes |
| Turning Diameter | 50.4" to 65.4" (depending on seat configuration) | 50.4" to 65.4" (depending on seat configuration) | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Design verification and validation testing was performed on the subject device," but it does not specify the sample size used for the test set. It describes non-clinical testing, implying a prospective testing approach on physical units of the device. There is no information provided about the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a powered wheelchair and the testing described is non-clinical, focusing on engineering and performance standards (RESNA). Therefore, the concept of "ground truth established by experts" in the context of medical image analysis or diagnostics does not apply to this type of device and study. The "ground truth" here is the defined performance parameters and limits specified by the RESNA standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described in point 3, this is non-clinical performance testing against established engineering standards, so there is no expert adjudication process for ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a powered wheelchair; it is not an AI-assisted diagnostic tool or system that would involve human readers or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (a powered wheelchair), not an algorithm or AI system. The "standalone" performance here relates to the wheelchair's physical performance characteristics according to engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance requirements and limits specified by recognized consensus standards, specifically ANSI/RESNA WC-1 and WC-2 series. The device's performance was compared against these established engineering standards.
8. The sample size for the training set
Not applicable. This device is a physical powered wheelchair, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As described in point 8, there is no training set for a physical device like a powered wheelchair.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 11, 2018
Invacare Corporation Elijah Wreh Regulatory Affairs Manager One Invacare Way Elyria, Ohio 44035
Re: K182946
Trade/Device Name: Invacare TDX SPV2-HD with Captain's Seat Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 22, 2018 Received: October 23, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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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 Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -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) K182946
Device Name Invacare® TDX® SP2-HD with Captain's Seat
Indications for Use (Describe)
The indication for use of the Invacare® TDX® SP2-HD with Captain's Seat is to provide mobility and positioning to persons limited to a sitting position.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C) | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | |||
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
SUBMITTER per 21 CFR 807.92(a)(1):
Invacare Corporation One Invacare Way Elyria, OH 44035 Phone: (440) 329-6840 Email: ewreh@invacare.com
CONTACT PERSON: Elijah Wreh Regulatory Affairs Manager
MANUFACTURER:
Invacare Corporation 1200 Taylor Street Elyria, OH 44035
Date Prepared per 21 CFR 807.92(a)(1):
December 10, 2018
DEVICE INFORMATION per 21 CFR 807.92(a)(2)
| Name of Device: | Invacare® TDX® SP2-HD with Captain's Seat | |
|---|---|---|
| Common or Usual Name: | Wheelchair, Powered | |
| Classification Name: | Powered Wheelchair 21 CFR § 890.3860 | |
| Regulatory Class: | 2 | |
| Product Code: | ITI | |
| PREDICATE DEVICE: | Invacare® TDX® SP2 Power Wheelchair (K170507) | |
| Patient Population: | Adult Patient Only |
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DEVICE DESCRIPTION per 21 CFR 808.92(a)(4)
The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes:
- · Increase in the weight capacity of the previously cleared device from 300 lb to 450 lb.
| Model Number | Description |
|---|---|
| TDXSP2V-HD | Invacare® TDX® SP2-HD with Captain's Seat |
Invacare® 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 center-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. No new accessories were added to the new device.
INTENDED USE per 21 CFR 807.92(A)(5)
The intended use of the device is to provide mobility and positioning to persons limited to a sitting position.
INDICATIONS FOR USE per FORM FDA 3881
The indication for use of the Invacare® TDX® SP2-HD with Captain's Seat 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 previously cleared predicate device. The determination was made based on Section 513(i)(1)(E)(i) of the FD&C Act.
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COMPARISON of TECHNOLOGICAL CHARACTERISTICS with the PREDICATE DEVICE per 21 CFR 807.92(a)(6)
The device comparison showed that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared predicate device in regard to provide mobility and positioning to persons limited to a sitting position.
The subject device and predicate device are battery powered, motor driven, rigid, non-folding type power wheelchairs with a micro-processor controlled electronic control systems, and nonpowered and powered seating.
The subject device has fixed non-powered and elevate seating systems that are similar to the previously cleared Invacare® TDX® SP2 Power Wheelchair (K170507).
BASIS of SUBSTANTIAL EQUIVALENCE per 21 CFR 807.100(b)(2)(ii)(A)
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, and other device related 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 safe and effective as the predicate device and do not raise different questions of safety and effectiveness. The design verification and validation testing, device comparison, and dimensional analysis demonstrates that the subject device components are substantially equivalent to the predicate device in regard to the following:
The data generated from the subject device design verification and validation test reports support a finding of substantial equivalence regarding device comparison, wireless capability and coexistence, dimensional analysis, device specifications, and design characteristics.
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Indications for Use (IFU) Comparison Table
| Description | Subject Device Invacare® TDX® SP2-HD withCaptain's Seat | Predicate DeviceInvacare® TDX® SP2 Power Wheelchair |
|---|---|---|
| 510(k) Number | Pending Submission | K170507 |
| Indications forUse | The indication for use of the Invacare® TDX® SP2 PowerWheelchair is to provide mobility and positioning topersons limited to a sitting position. | The indication for use of the Invacare® TDX® SP2 Power Wheelchairis to provide mobility and positioning to persons limited to a sittingposition. |
Design Characteristics Comparison – Finished Medical Device
| Description | Subject Device Invacare® TDX® SP2-HD withCaptain's Seat | Predicate DeviceInvacare® TDX® SP2 Power Wheelchair |
|---|---|---|
| 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 | 5mph or 5.8mph |
| Braking System | Electro-mechanical Friction Brake | Electro-mechanical Friction Brake |
| Range | GP24 Batteries > 20.7 miles | 22NF Batteries > 13.7 miles ORGP24 Batteries > 20.7 miles |
| Weight Capacity | 450lb. | 300lb. |
| Length (without leg rests) | 31.5" to 45.3"(depending on seat configuration) | 31.5" to 45.3"(depending on seat configuration) |
| Base Width | 25.5" | 24" or 25.5"(depending on battery type) |
| Incline Capability | 9° | 9° |
| Total Weight(seat and base) | 291-450lbs.(depending on seat configuration) | 291-450lbs.(depending on seat configuration) |
| Obstacle Climbing | Forward 2.76" ANDReverse 0.79" | Forward 2.95" ANDReverse 0.95" |
| Drive Wheel Frame Material | Aluminum | Aluminum |
| Transport Option | Brackets bolt on frame | Brackets bolt on frame |
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Design Characteristics Comparison – Seating System
| Description | Subject Device | Predicate Device |
|---|---|---|
| Invacare® TDX® SP2-HD with Captain's Seat | Invacare® TDX® SP2 Power Wheelchair (K170507) | |
| Seat Types | Fixed, Elevate | Fixed, Tilt/Recline/Elevate, Tilt/Recline, Recline, Elevate, Tilt/Elevate, Tilt Only. |
| Seat Widths | 22" to 24" | 16" to 24" |
| Seat Depths | 18" to 22" | 16" to 23" |
| Back Heights | 18.5" | 18" to 25" (tilt only) OR20" to 27" (tilt and recline) |
| Upholstery | Vinyl | Meshtex, Startex, Spacetex, O-Vinyl, Polyester |
| Elevating Seat Range | 10" | 12" |
| Tilt Range | N/A | 50° |
| Recline Range | 117° | 168° |
POWER BASE SUBSTANTIAL EQUIVALENCE TABLE
| Description | Subject DeviceInvacare® TDX® SP2-HD with Captain's Seat(Pending) | Predicate DeviceInvacare® TDX® SP2 Power Wheelchair(K170507) |
|---|---|---|
| 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 | 5mph, or 5.8mph |
| Number of Batteries | 2 | 2 |
| Battery Types | GP24 | 22NF OR GP24 |
| Battery Chemistry | Sealed VRLA Gel Batteries | Sealed VRLA Gel Batteries |
| Battery Operating Voltage | 24V nominal(2 * 12V) | 24V nominal(2 * 12V) |
| Battery Amp-Hour Rating | GP24 = 63amp-hrs (C5) | 22NF = 43.2amp-hrs (C5)GP24 = 63amp-hrs (C5) |
| Battery Weight | GP24 = 52lbs. | 22NF = 37lbs.GP24 = 52lbs. |
| Subject Device | Predicate Device | |
| Description | Invacare® TDX® SP2-HD with Captain's Seat(Pending) | Invacare® TDX® SP2 Power Wheelchair(K170507) |
| Battery Chargers | 8-amp off board charger(110V) | 8-amp off board charger(110V) |
| Braking System | Electro-mechanical Friction Brake | Electro-mechanical Friction Brake |
| Range | GP24 Batteries > 20.7 miles | 22NF Batteries > 13.7 miles ORGP24 Batteries > 20.7 miles |
| Stopping Distance | 45.7" to 69.3"(depending on chair configuration) | 45.7" to 69.3"(depending on chair configuration) |
| Weight Capacity | 450lbs. | 300lbs. |
| Length (without leg rests) | 31.5" to 55.4" | 31.5" to 55.4" |
| Base Width | 25.5" | 24" OR 25.5"(depending on battery type) |
| Front Forks | Single OR double sided | Single OR double sided |
| Tires | Black gel tires.Foam filled OR pneumatic | Black gel 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 | Gas spring has damping |
| Incline Capability | 9° | 9° |
| Turning Diameter | 50.4" to 65.4"(depending on seat configuration) | 50.4" to 65.4"(depending on seat configuration) |
| Base Weight(with batteries) | 264lbs (GP24 Batteries) | 264lbs (GP24 Batteries) |
| Total Weight(seat and base) | 291 to 450lbs.(depending on seat configuration) | 291 to 450lbs.(depending on seat configuration) |
| Ground Clearance | > 2.5" | > 2.5" |
| Obstacle Climbing | Forward 2.95" ANDReverse 0.98" | Forward 2.95" ANDReverse 0.98" |
| Motor Gearbox Sound Level | 54dBa | 54dBa |
| Drive Wheel Frame Material | Aluminum | Aluminum |
| Transport Option | Brackets bolt on frame | Brackets bolt on frame |
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DESIGN VERIFICATION AND VALIDATION TESTING DATA
Design verification and validation testing was performed on the subject device meets 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. The acceptance criteria for the full verification of the design and acceptance criteria for each section of the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) testing standard was met.
Risk Management
Risk Management has been conducted in accordance with ISO 14971:2007 - Medical Devices -Application of Risk Management to Medical Devices.
Non-Clinical Test per 21 CFR 807.92(b)(1)
Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) testing was performed to demonstrate that the subject Invacare® TDX® SP2-HD with Captain's Seat meets 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.
The following testing was performed according to FDA recognized consensus standards:
- ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability ●
- . ANSI/RESNA WC-1:2009 Section 2: Determination of Dynamic Stability of electrically Powered Wheelchairs
- ANSI/RESNA WC-1:2009 Section 3: Determination of Effectiveness of Brakes .
- ANSI/RESNA WC-2:2009 Section 4: Energy Consumption of Electrically Powered ● Wheelchairs and Scooters for Determination of Theoretical Distance Range
- ANSI/RESNA WC-1:2009 Section 5: Determination of Dimensions, Mass . and Maneuvering Space
- ANSI/RESNA WC-2:2009 Section 6: Determination of Maximum Speed, . Acceleration and Deceleration of Electrically Powered Wheelchairs
- ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and . Wheel Dimensions
- · ANSI/RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
- ANSI/RESNA WC-2:2009 Section 9: Climatic Tests for Electrically Powered Wheelchairs
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- ANSI/RESNA WC-2:2009 Section 10: Determination of Obstacle-Climbing Ability . of Electrically Powered Wheelchairs
- ANSI/RESNA WC-1:2009 Section 11: Test Dummies .
- ANSI/RESNA WC-1:2009 Section 13: Determination of Coefficient of ● Friction of Test Surfaces
- . ANSI/RESNA WC-2:2009 Section 14: Power and Control Systems for Electrically Powered Wheelchairs
- ANSI/RESNA WC-1 :2009 Section 15: Requirements for Information . Disclosure, Documentation and Labeling
- ANSI/RESNA WC-1:2009 Section 16: Resistance to Ignition of Upholstered . Parts
- . ANSI/RESNA WC-4: Section 19: Wheelchairs Used as Seats in Motor Vehicles
- · ANSI/RESNA WC-2: 2009 Section 21: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters
- ISO 7176-25 First Edition 2013 Wheelchairs Part 25: Batteries and Chargers for . Powered Wheelchairs
- . ISO 14971:2012 - Medical Devices - Application of Risk Management to Medical Devices
Verification testing demonstrated that the subject Invacare® TDX® SP2-HD with Captain's Seat is substantially equivalent to the marketed predicate device.
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission.
CONCLUSIONS per 21 CFR 807.92(b)(3)
The subject device has the same intended use and technological characteristics as the predicate device. The design verification and validation data support the safety and performance of the subject device and demonstrate that the subject device will perform as intended in the specified use conditions. Therefore, the subject Invacare® TDX® SP2-HD with Captain's Seat accessories are compatible with the previously cleared Invacare® TDX® SP2 Power Wheelchair (K170507) device and demonstrate a basis of substantial equivalence.
§ 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).