(34 days)
No
The description focuses on mechanical adjustments and manual operation, with no mention of AI or ML capabilities.
No.
The device is described as a mechanical wheelchair designed for mobility and positioning, not for treating or curing a medical condition.
No
Explanation: The device is described as a mechanical wheelchair and patient positioning system designed for mobility and positioning, not for diagnosing medical conditions.
No
The device is described as a manually operated, attendant controlled, manual, mechanical wheelchair and patient positioning system, consisting of a steel/aluminum frame, wheels, seat, brakes, and other physical components. It is clearly a hardware device.
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 for individuals with physical limitations, specifically a mechanical wheelchair. This is a physical support and mobility device, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical wheelchair with various components for positioning and mobility. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Using reagents or assays.
The device is clearly a medical device intended for physical support and mobility, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The intended use of the Vari-Able, APB (Adaptable Positioning Base) mechanical wheelchair is to provide mobility to persons with a primary pediatric indication who are limited to a sitting position.
Product codes
IOR
Device Description
The Vari-Able, APB (Adaptable Positioning Base) is a manually operated, attendant controlled, manual, mechanical wheelchair and patient positioning system. It is designed to provide mobility and optimized positioning for patients who require long term accommodationdue to conditions of severe physical motion restriction. Patients with diagnosis such as cerebal palsy, would typically benefit from the use of the Vari-Able, APB (Adaptable Positioning Base).
The product consists of a steel/aluminum frame, rear wheels (which can be substituted based on The product consists of a steering maility it and support, and other comports such as and manual patient requirements ,, a seat pail, from with adjustments for seating configuration, and manual brakes, anti-tip wheels, footrests, and inandar adjustinents for other provided, the APB will positioning adjustment of the thi aligic, Willions and seating systems currently available in the market.
The product is capable of many configurations of the frame, wheels, and components to accommodate The product is capable of many configurations of the neanual adjustments that can be made patients with difficult to solve positioning requirements. Using shorizments he chan patients with difficult to solve positioning requirements. Bulligate of the chair may be changed to accommodate the patient's needs.
The Vari-Able APB (Adaptable Postuoling Dass) and Teach Portuges of This also can assist in positioning and feeding.
The product is designed to function indoors or outdoors on surfaces such as sidewalks and other public places.
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
pediatric
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)
The Vari-Able APB and the Labac MTC were tested using a methodology based on ANS/RESNA I he Var-Adle AFD and the Eabac MTC References and Test Methods for Wheelchairs (Including wheelchan Stalluards Volume 1-1776 - Requirements with and laterally, posteriorly, and anteriorly indicate the two devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Labac MTC (K921136)
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
OCT 7 - 2004
510(k) Summary
Degage's Vari-Able APB Manual Wheelchair
Submitter's Name, Address, Telephone Number, Fax Number, Contact Person, and Date Prepared:
American Track Roadsters, Inc. dba Degage 3535 South Kipling Parkway Lakewood, CO 80235 Phone (303) 986-9300 Fax (303) 986-9301
Contact Name: Greg Peek President
Date Prepared: August 27, 2004
Name of Device and Name/Address of Sponsor:
American Track Roadsters, Inc. dba Degage 3535 South Kipling Parkway Lakewood, CO 80235 Phone (303) 986-9300 Fax (303) 986-9301
Device Name: Vari-Able APB
Common Name: Manual Wheelchair
Classification Name: Wheelchair, Mechanica18910R
Predicate Device: Labac MTC (K921136)
Intended Use:
The intended use of the Vari-Able, APB (Adaptable Positioning Base) mechanical wheelchair is to provide mobility to personswith a primary pediatric indication who are limited to a sitting position.
Technological Characteristics and Substantial Equivaence:
Device Description:
The Vari-Able, APB (Adaptable Positioning Base) is a manually operated, attendant controlled, manual, mechanical wheelchair and patient positioning system. It is designed to provide mobility and optimized positioning for patients who require long term accommodationdue to conditions of severe physical motion restriction. Patients with diagnosis such as cerebal palsy, would typically benefit from
1
the use of the Vari-Able, APB (Adaptable Positioning Base).
The product consists of a steel/aluminum frame, rear wheels (which can be substituted based on The product consists of a steering maility it and support, and other comports such as and manual patient requirements ,, a seat pail, from with adjustments for seating configuration, and manual brakes, anti-tip wheels, footrests, and inandar adjustinents for other provided, the APB will positioning adjustment of the thi aligic, Willions and seating systems currently available in the market.
The product is capable of many configurations of the frame, wheels, and components to accommodate The product is capable of many configurations of the neanual adjustments that can be made
patients with difficult to solve positioning requirements. Using shorizments he chan patients with difficult to solve positioning requirements. Bulligate of the chair may be changed to accommodate the patient's needs.
The Vari-Able APB (Adaptable Positioning Base) also features weight shifting capabilities using assist in The Vari-Able APB (Adaptable Postuoling Dass) and Teach Portuges of This also can assist in positioning and feeding.
The product is designed to function indoors or outdoors on surfaces such as sidewalks and other public places.
Substantial Equivalence:
Substantial Equivalentially equivalent to the Labac MTC (K921136) due to similarities in materials, construction, configuration, indications, and use.
Both devices are manually operated by the user or an attendant. Both devices provide mobility to Both devices are manually operated by the user of a tubular frame, four wheels (two persons limited to a sitting position. Doth devices feature a manual till-in-space as associated and large rear wheels, and two shian whools for blooling) - " we mgy - " we winize user comfort and positioning.
Performance Data:
Performance Data:
The Vari-Able APB and the Labac MTC were tested using a methodology based on ANS/RESNA I he Var-Adle AFD and the Eabac MTC References and Test Methods for Wheelchairs (Including wheelchan Stalluards Volume 1-1776 - Requirements with and laterally, posteriorly, and anteriorly indicate the two devices are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
Mr. Gregory A. Peek President American Track Roadsters, Inc. Degage 3535 South Kipling Street Lakewood, Colorado 80235
Re: K042401
Trade/Device Name: Vari-Able, APB Mechanical Wheelchair Regulation Number: 21 CFR 890. 3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: September 16, 2004 Received: September 20, 2004
Dear Mr. Peek:
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.
3
Page 2 - Mr. Gregory A. Peek
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 vours.
Sincerely yours,
Mark A. Millbern
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
4
Indications for Use
510(k) Number (if known): K 042401
Device Name: Vari-Able, APB Mechanical Wheelchair
Indications for Use:
The intended use of the Vari-Able, APB (Adaptable Positioning Base) mechanical wheelchair is to provide mobility to persons with a primary pediatric indication who are limited to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millhorn
Orvision Sign-Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K042410/