(55 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard power wheelchair and does not mention any AI or ML capabilities.
No
The device is a power wheelchair, which is a mobility aid for individuals who can operate it. Its function is to provide mobility, not to treat or cure a disease or condition.
No
The intended use of the Invacare ZX2 Power Wheelchair is to provide mobility to persons limited to a sitting position, not to diagnose any condition.
No
The device description clearly details a physical power wheelchair with a frame, motors, batteries, and other hardware components. 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 to individuals with limited sitting ability who can operate a powered wheelchair. This is a mechanical function related to physical movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a battery-powered, motor-driven wheelchair with a rigid frame, suspension, direct drive train, and upholstery. These are all components of a mobility aid, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Invacare ZX2 Power Wheelchair is a medical device (specifically, a mobility aid), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Invacare Model Xterra GT Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
Product codes
ITI
Device Description
The Invacare Model Xterra GT power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with front wheel drive capability.
The wheelchair frame is of rigid or non-folding type design. The frame consists of a combination both 2" diameter and 1 ¼ " diameter x . 109 wall, steel tubing. The frame is of one piece, welded construction.
The wheelchair is designed with front wheel, beam type suspension. That is, the front swivel casters are mounted to two separate front extension frame members, and are thus, independent of each other. Each extension frame member pivots independently about its' This allows the chair to better negotiate small obstacles such as curbs, or own axis. ramps, from a complete stop. The rear casters pivot as well, and also serve as wheelchair anti-tippers.
The Invacare Xterra GT wheelchair incorporates a direct, front wheel drive train, which includes two separate right angle gear motors. Because it is a direct drive system, there are no belts, pulleys, chains, sprockets or the like, to periodically adjust or maintain. Both gearboxes are sealed and maintenance free. The upholstery is fabricated from either U240 Nylon, or reinforced vinyl, depending upon the user's preference. Both of these materials meet California 116 and 117 and Boston Fire Department BFD-1 specifications for fire retardancy.
The Invacare Xterra GT wheelchair is powered by two 22NF 12 VDC batteries. Access to the batteries is gained from underneath the chair. The chairs will travel approximately 15 to 21 miles between charges, depending on use.
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
As required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three- Wheeled Vehicles", the Invacare Xterra GT Power Wheelchair was tested in accordance with ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters. In all instances, the Invacare Xterra GT Power Wheelchair met the required performance criteria and functioned as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Korgog
OFD
510(k) SUMMARY
Invacare Corporation's Model Xterra GT Power Wheelchair
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way PO Box 4028 Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person: Edward A. Kroll Director, Regulatory Affairs
Date Prepared: August 27, 2001
Name of Device and Name/Address of Sponsor
Model Xterra GT Power Wheelchair
Invacare Corporation One Invacare Way Elyria, Ohio 44036-2028 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Common or Usual Name
Power Wheelchair
Classification Name
Wheelchair, Powered
Predicate Devices
Invacare Corporations' Action Arrow Front Wheel Drive Power Wheelchairs (K991168 June 25, 1999) and Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997).
1
Intended Use
The intended use of the Invacare Model Xterra GT Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Invacare Model Xterra GT power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with front wheel drive capability.
The wheelchair frame is of rigid or non-folding type design. The frame consists of a combination both 2" diameter and 1 ¼ " diameter x . 109 wall, steel tubing. The frame is of one piece, welded construction.
The wheelchair is designed with front wheel, beam type suspension. That is, the front swivel casters are mounted to two separate front extension frame members, and are thus, independent of each other. Each extension frame member pivots independently about its' This allows the chair to better negotiate small obstacles such as curbs, or own axis. ramps, from a complete stop. The rear casters pivot as well, and also serve as wheelchair anti-tippers.
The Invacare Xterra GT wheelchair incorporates a direct, front wheel drive train, which includes two separate right angle gear motors. Because it is a direct drive system, there are no belts, pulleys, chains, sprockets or the like, to periodically adjust or maintain. Both gearboxes are sealed and maintenance free. The upholstery is fabricated from either U240 Nylon, or reinforced vinyl, depending upon the user's preference. Both of these materials meet California 116 and 117 and Boston Fire Department BFD-1 specifications for fire retardancy.
The Invacare Xterra GT wheelchair is powered by two 22NF 12 VDC batteries. Access to the batteries is gained from underneath the chair. The chairs will travel approximately 15 to 21 miles between charges, depending on use.
B. Substantial Equivalence
The Invacare Model Xterra GT Power Wheelchair is substantially equivalent to Invacare Corporations' Action Arrow (K991168, June 25, 1999) and Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997).
2
PERFORMANCE DATA
As required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three- Wheeled Vehicles", the Invacare Xterra GT Power Wheelchair was tested in accordance with ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters. In all instances, the Invacare Xterra GT Power Wheelchair met the required performance criteria and functioned as intended.
KO12909
3p 3
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a person with their arms outstretched, or a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2001
Mr. Edward A. Kroll Director, Regulatory Affairs Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036
Re: K012909
Trade/Device Name: Invacare ZX2 Power Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 20, 2001 Received: September 24, 2001
Dear Mr. Kroll:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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.
4
Page 2 - Mr. Edward A. Kroll
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
b. Mark N. Milkeron
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): TBD
Device Name: Invacare ZX2 Power Wheelchair
Indications For Use:
The intended use of the Invacare ZX2 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Mark N. Mullinson
Over-The-Counter Use
Division of General, Restorative nd Neurological Device
Neurological D
510(k) Number K012904
(Optional Format 1-2-96)