(9 days)
Not Found
No
The device description details a purely mechanical wheelchair with no mention of software, data processing, or any terms related to AI/ML.
No
This device is a manual wheelchair, whose intended use is to provide mobility. It does not provide any therapeutic function.
No
The device description indicates it is a manual wheelchair used for mobility, not for detecting, diagnosing, or monitoring medical conditions.
No
The device description clearly outlines a physical, mechanical wheelchair constructed of steel tubing, wheels, casters, and other hardware components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Invacare Topaz Bariatric Manual Wheelchair is a mechanical device designed to provide mobility to individuals. It does not perform any tests on biological samples.
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a sitting position. This is a physical function, not a diagnostic one.
The description focuses on the mechanical aspects of the wheelchair, its construction, and its ability to support a certain weight. There is no mention of any diagnostic testing or analysis of biological samples.
N/A
Intended Use / Indications for Use
The intended use of the modified Invacare Topaz Bariatric Manual Wheelchair (Topaz) is to provide mobility to persons that may be restricted to a sitting position.
Product codes
IOR
Device Description
The Invacare Model 9000 Bariatric Manual Wheelchair (Topaz) is a manually operated, user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position. The wheelchair consists primarily of a steel frame, large rear wheels with hand rims for propelling the wheelchair, and smaller front pivoting casters for steering and turning. It is a folding, or non-rigid type of wheelchair that is designed for use by patients weighing up to 1000 lbs.
The frame is constructed of round, steel tubing that is welded. The tubing is 1" outside diameter (O.D.) with a wall thickness of 1/8". The seat width ranges from a minimum of 28" wide to a maximum of 30" wide and seat to floor height ranges from 17½" to 19½". The modification to this device consists of a frame with a reinforced design to withstand the higher weight capacity of 1000 lbs. In particular, two extra gussets have been added to the frontal tube and thicker gussets have been added to the rear upright and head tube. Also, the armrests have been reinforced and a stronger tire is used on the front caster.
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
The performance testing conducted as a result of the modifications to the Invacare Model 9000 Bariatric Manual Wheelchair (Topaz), as required by the Medical Device Amendments, yielded results demonstrated that the predetermined acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in a bold, sans-serif font. The word is placed inside of a black oval shape. There is a small registered trademark symbol to the right of the word.
SPECIAL 510(K) SUMMARY FOR THE MODIFICATION TO INVACARE'S MODEL 9000 BARIATRIC MANUAL WHEELCHAIR (TOPAZ)
This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
The assigned 510(k) number is K060582
Date: March 6, 2006
Submitted by: Invacare Corporation One Invacare Way Elyria, Ohio 44035-4190
Telephone: 440-329-6356 Fax: 440-326-3607
Contact Person: Mr. Carroll Martin
Trade Name: Topaz
Common Name: Manual Wheelchair
Classification Name: Wheelchair, mechanical per 21 CFR Section 890.3850
Legally Marketed Predicate Device(s): Invacare Model 9000 Bariatric Wheelchair K002317, August 25, 2000
Device Description: The Invacare Model 9000 Bariatric Manual Wheelchair (Topaz) is a manually operated, user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position. The wheelchair consists primarily of a steel frame, large rear wheels with hand rims for propelling the wheelchair, and smaller front pivoting casters for steering and turning. It is a folding, or non-rigid type of wheelchair that is designed for use by patients weighing up to 1000 lbs.
The frame is constructed of round, steel tubing that is welded. The tubing is 1" outside diameter (O.D.) with a wall thickness of 1/8". The seat width ranges from a minimum of 28" wide to a maximum of 30" wide and seat to floor height ranges from 17½" to 19½". The modification to this device consists of a frame with a reinforced design to withstand the higher weight capacity of 1000 lbs. In particular, two extra gussets have been added to the frontal tube and thicker gussets have been added to the rear upright and head tube. Also, the armrests have been reinforced and a stronger tire is used on the front caster.
Invacare Special 510(k) Page 9
re Way P.O. Box 4028 Elyria. OH 44036-2125 USA 440-329-6000 Fax: 440-365-4558 www.invacare.com
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Image /page/1/Picture/0 description: The image is a logo for Invacare. The logo is an oval shape with the word "INVACARE" in white letters on a black background. The logo is simple and easy to recognize. The font is sans-serif and bold.
Intended Use: The intended use of the modified Invacare Topaz Bariatric Manual Wheelchair (Topaz) is to provide mobility to persons that may be restricted to a sitting position.
Substantial Equivalence: The modified Topaz is substantially equivalent to the Invacare Substantial Equivateric Manual Wheelchair, cleared on August 25, 2000 under 510(K) Accession Number K002317. It is a modification of the Model 9000 Bariatric Manual Accessfori Namber 1200251771 consist of a frame with a reinforced design to withstand wheeleman. The modifications conbis. In particular, two extra gussets have been added the frontal tube and thicker gussets have been added to the rear upright and head tube. to the froman tabe and therer gaster.
Also, the armrests have been reinforced and a stronger tire is used on the front caster.
The intended use of providing mobility to persons restricted to a sitting position and the functionality of the device, i.e. manual operation, remain the same. The major difference functionally of the devices and the subject of this Special 510(k) is that the Invacare Model 9000 Bariatric Manual Wheelchair has a weight capacity of 700 pounds. This 9000 Dariante Manual Whosehull is weight capacity of the wheelchair to increase to 1000 pounds.
Performance Testing: The performance testing conducted as a result of the modifications I chomiance Testing. The performal Wheelchair (Topaz), as required by the to the mvacare Model 7000 Baradith i results demonstrated that the predetermined acceptance criteria were met.
Performance Standards: Although no performance standards have been established under Performance Stailuards: Annough no percentiality of mechanical wheelchairs, Invacarc
Section 514 of the Food, Drug and Cosmetic Act for mechanical wheelcharie Section 314 of the Food, Drug and Cosmode Ford Color Bariatric Manual Wheelchair (Topaz) in accordance with ISO 7176, parts 1 and 8.
Invacare Special 510(k) Page TO
VACARE CORPORATI
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Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2006
Invacare Corporation c/o Mr. Carroll Martin One Invacare Way Elyria, Ohio 44035-4190
Re: K060582
Trade/Device Name: Invacare Topaz Bariatric Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 6, 2006 Received: March 8, 2006
Dear Mr. Martin:
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. Drue, 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.
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Page 2 - Mr. Carroll Martin
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Herbert Spencer 05
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _
Device Name: Invacare Topaz Bariatric Manual Wheelchair
Indications for Use: The intended use of the Invacare Topaz Bariatic Manual Wheelchair is to provide mobility to persons that may be restricted to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C) X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IT NEEDED)
Concurrence of CDRH, Office af Device Evaluation (ODE)
Herbert Lemmer
Provision Sign-O Division of General, Restorative, ond Neurological Devices
510(k) Number K060582
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