(140 days)
No reference devices were used in this submission.
No
The document describes a power wheelchair with standard electronic controls and mechanical components. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a power wheelchair, indicated to provide mobility and positioning to persons limited to a sitting position, which is a supportive and assistive function, not a therapeutic treatment.
No
The device is a power wheelchair, indicated to provide mobility and positioning to persons limited to a sitting position. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines a physical power wheelchair with a base, motors, batteries, and seating system, indicating it is a hardware device with integrated electronics.
No, 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 on a patient for physical support and movement, not a device used to examine specimens from a patient to diagnose or monitor a condition.
- Device Description: The description details a power wheelchair with a base, wheels, motors, batteries, and a seating system. This is a mechanical and electrical device for mobility, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The Invacare® AVIVA FX Power Wheelchair is a medical device, but it falls under a different category than IVDs. It is a mobility aid.
N/A
Intended Use / Indications for Use
The Invacare® AVIVA FX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.
Product codes
ITI
Device Description
The subject device is a front wheel drive version of the existing previously cleared Invacare TDX SP2 (Center Wheel Drive) Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The subject version of the Invacare TDX SP2 Power Wheelchair consists of the following changes:
- . Alternative Front Wheel Drive Base
- Seating Brackets to connect the Ultra Low Maxx Seating System to the base .
- . Wiring Harness to connect the LiNX controller, the AVIVA FX base and the Ultra Low Maxx Seating System
The Invacare® AVIVA FX Power Wheelchair is a 24V DC battery-powered, motor-driven wheelchair, utilizing the predicate device LiNX® Control System and Ultra Low Maxx Seating System. The subject device consists of a rigid or "non-folding" type power wheelchair base with front wheel drive with 2 casters in the rear and two anti-tippers in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.
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 following components are equipped with wireless technology:
- Primary Driver Controls ●
- . Direct Access
- . Display Modules
- Indirect Access (via input module) Wireless mouse emulator .
The following components are not equipped with wireless technology:
- Power Modules .
- Stability Control
- Indirect Access (via input module) Compact ●
- Attendant Driver Controls
- Actuator Control
- Alternative Driver Controls (LiNX Electronic options) ●
- Input Module with Integrated Sip-n-Puff
- USB Charger Module ●
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test per 21 CFR 807.92(b)(1)
International Organization of Standardization (ISO) testing, California Technical (CAL), American National Standards Institute (ANSI) and European (EN) standards testing were performed to demonstrate that the subject Invacare® AVIVA FX 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.
The performance testing, device comparison, and dimensional analysis demonstrate that the subject device components and features are the same or substantially equivalent to the predicate device regarding 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 Maneuvering Space .
-
Maximum Speed Acceleration and Deceleration of Electric Wheelchairs ●
-
. Seating and Wheel Dimensions
-
. 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 ●
-
Wheeled Mobility Devices for Use as Seats in Motor Vehicles ●
-
. Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters and Battery Chargers
-
Batteries and chargers for powered wheelchairs ●
-
Software Life Cycle
-
Flammability Testing
-
Assessment of the Ignitability of Upholstered Furniture Ignition Source Smoldering . Cigarette
-
Wireless Coexistence .
The data generated from the subject Invacare® (front wheel drive) AVIVA FX Power
Wheelchair design verification test reports support a finding of substantial equivalence regarding the device comparison, dimensional analysis, device specifications, design characteristics and to provide mobility and positioning to persons limited to a sitting position.
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.
Biocompatibility evaluation for the subject Invacare® AVIVA FX 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Invacare TDX SP2 Power Wheelchair (K170507)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the text is in a clear, sans-serif font, with "FDA" in a blue square.
January 2, 2020
Invacare Corporation Elijah Wreh Regulatory Affairs Manager One Invacare Way Elyria, Ohio 44035
Re: K192216
Trade/Device Name: Invacare® Aviva FX Power Wheelchair, Model: IFX-20MP Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 5, 2019 Received: December 6, 2019
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 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
1
801); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, Ph.D. Acting Assistant Director, Acute Injury Devices DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192216
Device Name Invacare® AVIVA FX Power Wheelchair Model: IFX 20MP
Indications for Use (Describe)
The Invacare® AVIVA FX Power Wheelchair is indicated 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary – K192216
Submitter Information per 21 CFR 807.92(a)(1)
| SPONSOR: | Invacare Corporation
One Invacare Way
Elyria, OH 44035 |
| ---------- | -------------------------------------------------------------- |
|---|
| PRIMARY CONTACT: | Elijah Wreh
Regulatory Affairs Manager
Phone: (440) 329-6840
Email: ewreh@invacare.com |
| ------------------ | ------------------------------------------------------------------------------------------------- |
|---|
| MANUFACTURER: | Invacare Corporation
1200 Taylor Street
Elyria, Ohio 44035 |
| --------------- | ------------------------------------------------------------------ |
|---|
| DATE PREPARED per 21 CFR 807.92(a)(1): | 2 January 2020 |
|---|---|
| ---------------------------------------- | ---------------- |
Device Information per 21 CFR 807.92(a)(2)
| NAME OF SUBJECT DEVICE: | Invacare® AVIVA FX Power Wheelchair
Model: IFX 20MP |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| COMMON/USUAL NAME: | Power Wheelchair |
| CLASSIFICATION NAME: | Powered Wheelchair [21 CFR §890.3860] |
| REGULATORY CLASS: | 2 |
| PRODUCT CODE: | ITI: Wheelchair, Mechanical |
| PREDICATE DEVICES: | Primary: Invacare TDX SP2 Power Wheelchair
(K170507)
No reference devices were used in this submission. |
4
Device Description per 21 CFR 808.92(a)(4)
The subject device is a front wheel drive version of the existing previously cleared Invacare TDX SP2 (Center Wheel Drive) Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The subject version of the Invacare TDX SP2 Power Wheelchair consists of the following changes:
- . Alternative Front Wheel Drive Base
- Seating Brackets to connect the Ultra Low Maxx Seating System to the base .
- . Wiring Harness to connect the LiNX controller, the AVIVA FX base and the Ultra Low Maxx Seating System
The Invacare® AVIVA FX Power Wheelchair is a 24V DC battery-powered, motor-driven wheelchair, utilizing the predicate device LiNX® Control System and Ultra Low Maxx Seating System. The subject device consists of a rigid or "non-folding" type power wheelchair base with front wheel drive with 2 casters in the rear and two anti-tippers in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.
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 following components are equipped with wireless technology:
- Primary Driver Controls ●
- . Direct Access
- . Display Modules
- Indirect Access (via input module) Wireless mouse emulator .
The following components are not equipped with wireless technology:
- Power Modules .
- Stability Control
- Indirect Access (via input module) Compact ●
- Attendant Driver Controls
- Actuator Control
- Alternative Driver Controls (LiNX Electronic options) ●
- Input Module with Integrated Sip-n-Puff
- USB Charger Module ●
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.
5
Indications for Use per FORM FDA 3881
The Invacare® AVIVA FX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.
Indications for Use Characteristics Comparison
Both the subject and predicate device share the same Indications for Use and Intended use.
Technological Characteristics Comparison with the predicate device per 21 CFR 807.92(a)(6) The technological characteristics comparison demonstrates that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared predicate device.
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, 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 is a modification to the previously cleared Invacare TDX SP2 Power Wheelchair (K170507) and contains the same components and features as the predicate device. The modification, use of a front wheel drive base does not raise new questions of safety and effectiveness.
The performance testing, device comparison, and dimensional analysis demonstrate that the subject device components and features are the same or substantially equivalent to the predicate device regarding 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 Maneuvering Space .
- Maximum Speed Acceleration and Deceleration of Electric Wheelchairs ●
- . Seating and Wheel Dimensions
- . Methods for Static Impact and Fatigue Strengths
- . Climatic Tests for Electric Wheelchairs
6
- Climbing Ability of Electrically Powered Wheelchairs .
- . Power and Control Systems for Electrically Powered Wheelchairs and Scooters
- Information Disclosure Documentation and Labeling ●
- Wheeled Mobility Devices for Use as Seats in Motor Vehicles ●
- . Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters and Battery Chargers
- Batteries and chargers for powered wheelchairs ●
- Software Life Cycle
- Flammability Testing
- Assessment of the Ignitability of Upholstered Furniture Ignition Source Smoldering . Cigarette
- Wireless Coexistence .
The data generated from the subject Invacare® (front wheel drive) AVIVA FX Power
Wheelchair design verification test reports support a finding of substantial equivalence regarding the device comparison, dimensional analysis, device specifications, design characteristics and to provide mobility and positioning to persons limited to a sitting position.
| Device | Subject Device
Invacare® AVIVA FX Power Wheelchair | Predicate Devices
Invacare TDX SP2 Power Wheelchair
(K170507) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Invacare® AVIVA FX Power
Wheelchair is indicated to provide mobility
and positioning to persons limited to a
sitting position. | The indication for use of the Invacare®
TDX® SP2 Power Wheelchair is to provide
mobility and positioning to persons limited to
a sitting position. |
| Intended Use | To provide mobility and positioning to
persons limited to a sitting position | To provide mobility and positioning to
persons limited to a sitting position |
| Type of Use | Prescription (RX Only) | Prescription (RX Only) |
Indications for Use Comparison Table
7
| Component | Description | Predicate Device
Invacare® TDX SP2 Power Wheelchair
(K170507) | Subject Device
Invacare® AVIVA FX Power Wheelchair
(K192216) |
|--------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SEATING
Ultra LowMaxx | Powered Positioning
Configurations | Fixed, Tilt/Recline/Elevate, Tilt/Recline, Recline,
Elevate, Tilt/Elevate, Tilt Only. | Tilt/Recline/Elevate |
| | Seat Widths | 16" to 22" | 16" to 22" |
| | Seat Depths | 15" to 23" | 15" to 23" |
| | Back Heights | 18" to 25" (tilt) or 20" to 27" (tilt and recline) | 18" to 25" (tilt) or 20" to 27" (tilt and recline) |
| | Upholstery | Meshtex, Startex, Spacetex, O-Vinyl, Polyester | Meshtex, Startex, Spacetex, O-Vinyl, Polyester |
| | Elevating Seat
Range | 12" | 12" |
| | Tilt Range | 50° | 50° |
| | Recline Range | 168° | 168° |
| | Seat Cushion
Accessories | Matrx Libra, Matrx PS, Matrx Vi, Matrx Flo-tech
Lite and Contour | Matrx Libra, Matrx PS, Matrx Vi, Matrx Flo-tech
Lite and Contour |
| | Back Types | High Back, Matrx PB, Matrx PB Elite, Matrx PB
Deep and Matrx PB Elite TR | High Back, Matrx PB, Matrx PB Elite, Matrx PB
Deep and Matrx PB Elite TR |
| | Back and Headrest
Accessories | Motion Concepts standard, Elan standard, Elan
Occipital, Elan 4-point and Motion Concepts Onyx | Motion Concepts standard, Elan standard, Elan
Occipital, Elan 4-point and Motion Concepts Onyx |
| | | Tilt Armrests | Tilt Armrests |
| | Arm Types | Dual post adjustable, Ultra Rail mounted flip back
cantilever Maxx tilt arm | Dual post adjustable, Ultra Rail mounted flip back
cantilever Maxx tilt arm |
| | | Recline Armrests | Recline Armrests |
| | | Adjustable, Maxx style cane mounted straight and
curved. | Adjustable, Maxx style cane mounted straight and
curved. |
| | Armpads | Modular, Standard, Waterfall, Flat and Ergonomic | Modular, Standard, Waterfall, Flat and Ergonomic |
| | Leg Rest Types | Basic fixed center mount, Invacare Action fixed
swing away receiver, Invacare 70° fixed swing
away, LNX powered center mount, Maxx style | Basic fixed center mount, Invacare Action fixed
swing away receiver, Invacare 70° fixed swing
away, LNX powered center mount, Maxx style |
| Component | Description | Predicate Device
Invacare® TDX SP2 Power Wheelchair
(K170507) | Subject Device
Invacare® AVIVA FX Power Wheelchair
(K192216) |
| | | powered swing away, Maxx style manual swing
away, Heavy duty 70° swing away. | powered swing away, Maxx style manual swing
away, Heavy duty 70° swing away. |
| | Leg Rest
Accessories | Flip-up foot platform, Individual foot plates for
center mount, Foot plate options for elevating and
swing-away, Single foot plate options (adjustable
and multi-axis adjustable, Heel loops, Calf panel | Flip-up foot platform, Individual foot plates for
center mount, Foot plate options for elevating and
swing-away, Single foot plate options (adjustable
and multi-axis adjustable, Heel loops, Calf panel |
| | 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 | 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 |
| | Hip Supports | Lateral, Lift-off removable, Maxx style quick
release, Swing away removable | Lateral, Lift-off removable, Maxx style quick
release, Swing away removable |
| CONTROL SYSTEM | System Name | LiNX Electronic | LiNX Electronic |
| LINX | Cables | 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 |
| | Non-Expandable
Options | Yes | Yes |
| | Expandable Options | Yes | Yes |
| | Wireless Devices | Bluetooth | Bluetooth |
| | Power Source | 24V nominal | 24V nominal |
| | Bus Interface | CAN | CAN |
| POWER BASE | Base Configuration | Centre Wheel Drive | Front Wheel Drive |
| | Base Width | 24" or 25.5"
(depending on narrow/wide version) | 24.3"
(single option) |
| | Length
(without leg rests) | 31.5" to 45.3"
(depending on seat configuration) | 42.71" |
| Component | Description | Predicate Device | Subject Device |
| | | Invacare® TDX SP2 Power Wheelchair
(K170507) | Invacare® AVIVA FX Power Wheelchair
(K192216) |
| OTHER
SPECIFICATIONS | Ground Clearance | > 2.5" | > 2.5" |
| | Batteries | GP24 Batteries | GP24 Batteries |
| | Braking System | Electro-mechanical Friction Brake | Electro-mechanical Friction Brake |
| | Drive Wheel Size | 14" x 3" | 14" x 3" |
| | Incline Capability | 9° | 9° |
| | Maximum Speed | 5mph, or 5.8mph | 6.25mph |
| | Motors | 4-Pole SSD | 4-Pole SSD |
| | Weight Capacity | 300lbs. | 300lbs. |
| | Suspension | Enhanced SureStep® Suspension | Four-bar linkage Independent Suspension System |
Design and Technological Characteristics Comparison – Finished Device
8
9
Design Characteristics Comparison - LiNX® Electronics
| Description | Predicate Device
Invacare® TDX SP2 Power Wheelchair
(K170507) | Subject Device
Invacare® AVIVA FX Power Wheelchair (K192216) |
|------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| System Name | LiNX | LiNX |
| Cables | 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 |
| Non-Expandable Options | Yes | Yes |
| Expandable Options | Yes | Yes |
| Wireless Devices | Bluetooth | Bluetooth |
| Power Source | 24V nominal | 24V nominal |
| Bus Interface | CAN | CAN |
10
| Description | Predicate Device
Invacare® TDX® SP2 Power Wheelchair | Subject Device
Invacare® AVIVA FX Power Wheelchair (K192216) |
|----------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Seat Types | Fixed, Tilt/Recline/Elevate, Tilt/Recline, Recline, Elevate,
Tilt/Elevate, Tilt Only. | Tilt/Recline/Elevate |
| Seat Widths | 16" to 24" | 16" to 24" |
| Seat Depths | 16" to 23" | 16" to 23" |
| Back Heights | 18" to 25" (tilt only)
or
20" to 27" (tilt and recline) | 18" to 25" (tilt only)
or
20" to 27" (tilt and recline) |
| Upholstery | Meshtex, Startex, Spacetex, O-Vinyl, Polyester | Meshtex, Startex, Spacetex, O-Vinyl, Polyester |
| Elevating Seat Range | 12" | 12" |
| Tilt Range | 50° | 50° |
| Recline Range | 168° | 168° |
Design Characteristics Comparison – Seating
General Comparison of the Performance Characteristics Associated with the Control System
| Description | Subject Device
Invacare® TDX® SP2 Power Wheelchair (K170507) | Subject Device
Invacare® AVIVA FX Power Wheelchair (K192216) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Cables | 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 |
| Non-Expandable
Options | Yes | Yes |
| Expandable Options | Yes | Yes |
| Wireless Devices | Bluetooth | Bluetooth |
| Power Source | 24V nominal | 24V nominal |
| Bus Interface | CAN | CAN |
| Description | Subject Device
Invacare® TDX® SP2 Power Wheelchair (K170507) | Subject Device
Invacare® AVIVA FX Power Wheelchair (K192216) |
| | REM400 | REM400 |
| Mounting | 2 x M5 screws suitable for both tube and plate. | 2 x M5 screws suitable for both tube and plate. |
| Connection | Direct | Direct |
| User Display | LCD - colour. | LCD - colour. |
| Viewable LCD Size | 49 x 74mm | 49 x 74mm |
| Joystick | Magnetic | Magnetic |
| Text & Graphics | Icons & translations.
Customisable. | Icons & translations.
Customisable. |
| Touch Interface | Yes - capacitive | Yes - capacitive |
| On/Off Button | Yes | Yes |
| Horn | Yes | Yes |
| Mode/Function | Button or Touch | Button or Touch |
| Programmable Multi-
Function Keys | 2 x Configurable | 2 x Configurable |
| Jack Sockets | 2 x Stereo. | 2 x Stereo. |
| Speed Selection | Virtual speed dial operated by touch. | Virtual speed dial operated by touch. |
| Speed Indication | Yes | Yes |
| Number of Drive Functions | 36 | 36 |
| Battery Gauge | Bar on LCD (continuous) | Bar on LCD (continuous) |
| Seating Control | Up to 8 actuators | Up to 8 actuators |
| Lighting Control | Yes | Yes |
| Real Time Clock | Yes | Yes |
| Charger Port | XLR | XLR |
| Status Indicator | Error codes on display with supporting icons. Additional LED
flash codes for faulty LCD.
Yes. | Error codes on display with supporting icons. Additional
LED flash codes for faulty LCD.
Yes. |
| Mouse Mover | Built-in Bluetooth connection. | Built-in Bluetooth connection. |
| Remote Diagnostics | Built-in Bluetooth connection (Yes). | Built-in Bluetooth connection (Yes). |
11
Comparison of the Performance Characteristics Associated with the Enhanced Rehabilitation Primary Remotes
12
Performance Data
Non-Clinical Test per 21 CFR 807.92(b)(1)
International Organization of Standardization (ISO) testing, California Technical (CAL), American National Standards Institute (ANSI) and European (EN) standards testing were performed to demonstrate that the subject Invacare® AVIVA FX 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.
13
| Test Standard | Test Description |
|---|---|
| ISO 7176-1:2014 | Wheelchairs Part 1: Determination of Static Stability |
| ISO 7176-2:2017 | Wheelchairs Part 2: Determination of Dynamic Stability of Electrically Powered Wheelchairs |
| ISO 7176-3:2012 | Wheelchairs Part 3: Determination of Effectiveness of Brakes |
| ISO 7176-4:2008 | Wheelchairs Part 4: Energy Consumption of Electrical Wheelchairs and Scooters for Determination of Theoretical Distance |
| Range | |
| ISO 7176-5:2008 | Wheelchairs Part 5: Determination of Dimensions, Mass and Maneuvering Space |
| ISO 7176-6:2018 | Wheelchairs Part 6: Determination of Maximum Speed, Acceleration of Electric Wheelchairs |
| ISO 7176-7:1998 | Wheelchairs Part 7: Measurement of Seating and Wheel Dimensions |
| ISO 7176-8:2014 | Wheelchairs Part 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths |
| ISO 7176-9:2009 | Wheelchairs Part 9: Climatic Tests for Electric Wheelchairs |
| ISO 7176-10:2008 | Wheelchairs Part 10: Determination of Obstacle Climbing Ability of Electrically Powered Wheelchairs |
| ISO 7176-11:2012 | Wheelchairs Part 11: Test Dummies |
| ISO 7176-13:1989 | Wheelchairs Part 13: Determination of Coefficient of Friction of Test Surface |
| ISO 7176-14:2008 | Wheelchairs Part 14: Power and Control Systems for Electrically Powered Wheelchairs and Scooters – Requirements and |
| Test Methods | |
| ISO 7176-15:1996 | Wheelchairs Part 15: Requirements for Information Disclosure, Documentation and Labeling |
| ISO 7176-16:2012 | Wheelchairs Part 16: Resistance to Ignition of Postural Support Devices |
| ISO 7176-19:2008 | Wheelchairs Part 19: Wheeled Mobility Devices for Use as Seats in Motor Vehicles |
| ISO 7176-21:2008 | Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs |
| and scooters, and battery chargers | |
| ISO 7176-22:2014 | Wheelchairs Part 22: Set-up Procedures |
| ISO 7176-25:2013 | Wheelchairs Part 25: Batteries and chargers for powered wheelchairs |
14
| Test Standard | Test Description |
|---|---|
| IEC 62304:2006 | Medical Device Software – Software Life Cycle |
| CAL117: 2013, Section 1 | Requirements, Test Procedure and Apparatus for Testing the Smolder Resistance of Materials Used in Upholstered Furniture |
| EN 1021-2:2014 | Furniture Assessment of the Ignitability of Upholstered Furniture: Ignition Source: Match Flame Equivalent |
| ANSI C63.27 | Wireless Coexistence |
15
Performance Data Conclusions per 21 CFR 807.92(b)(3)
The subject device utilizes the same intended use, same material composition, and similar technological characteristics as the predicate device. The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that any differences in technological characteristics do not raise any new questions of safety and effectiveness. Therefore, the subject Invacare® AVIVA FX Power Wheelchair is substantially equivalent to the predicate devices identified throughout this submission.
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® AVIVA FX 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
16
- 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.