(34 days)
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.
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 accommodation due 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 patient requirements), a seat pail, from with adjustments for seating configuration, and manual brakes, anti-tip wheels, footrests, and other components such as head and trunk support, and other components as needed. The APB will accommodate the positioning and seating systems currently available in the market.
The product is capable of many configurations of the frame, wheels, and components to accommodate patients with difficult to solve positioning requirements. Using the manual adjustments that can be made to the frame, the angle 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 manual tilt-in-space and recline features. 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.
The provided text describes a 510(k) summary for the Degage's Vari-Able APB Manual Wheelchair. Based on the content, here's a breakdown of the requested information, focusing on what is present and explicitly stating what is not available in this document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence with Predicate Device (Labac MTC (K921136)) in materials, construction, configuration, indications, and use. | The Vari-Able APB and the Labac MTC were tested using a methodology based on ANS/RESNA WC-1:1998, Volume 1-1776 - Requirements and Test Methods for Wheelchairs (Including Wheelchair Seating). Tests for backward, forward, sideways, posterior, and anterior stability indicate the two devices are substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the "Vari-Able APB and the Labac MTC were tested," but it does not specify the sample size for the test set (e.g., number of wheelchairs, number of subjects).
The data provenance is not explicitly stated (e.g., country of origin of the data, retrospective or prospective). It can be inferred that the testing was likely conducted in the US by the submitter, given the FDA submission, but this is not definitively stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for this type of device (a mechanical wheelchair). The performance data refers to stability tests based on a recognized standard (ANS/RESNA WC-1:1998). "Ground truth" in this context would likely be objective measurements of physical properties against the standard, not expert consensus.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of expert consensus or subjective assessments that would require an adjudication method. Performance was assessed via objective stability tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done or mentioned. This type of study is typically for diagnostic imaging or similar devices where reader interpretation is a key component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a mechanical wheelchair, not an algorithm or AI system. Its performance is inherent in its physical design and construction.
7. The Type of Ground Truth Used
For the performance data, the "ground truth" seems to be the objective measurements of stability as defined by the ANS/RESNA WC-1:1998 standard. There is no mention of pathology, expert consensus, or outcomes data used as ground truth for verifying the device's performance in this context.
8. The Sample Size for the Training Set
This is not applicable as the device is a mechanical wheelchair and does not involve a "training set" in the context of an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
{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/
§ 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).