(88 days)
The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.
The Discovery power wheelchair is a battery powered, motorized mobility vehicle. The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.
The Discovery is designed to be durable, dependable, sporty and aesthetically appealing while being economically priced.
Here's an analysis of the provided information regarding the Karma Discovery Series Power Wheelchair, framed by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO/CD 7176-21 (General requirements for wheelchairs) | Met the required performance criteria and functioned as intended. |
| ANSI/RESNA Vol.2 Section 21 Amendments (Powered wheelchairs and motorized scooters) | Met the required performance criteria and functioned as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size of devices used for testing. The data provenance is also not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The standards (ISO/CD 7176-21 and ANSI/RESNA Vol.2 Section 21 Amendments) are primarily engineering and performance standards, not typically relying on expert interpretation for "ground truth" in the way a medical diagnostic device would.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of performance testing against engineering standards, an adjudication method in the sense of reconciling divergent expert opinions is unlikely to have been relevant. The tests likely have objective pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or assistive devices where human interpretation or interaction is a critical component influencing effectiveness, and the document describes a power wheelchair, a mechanical mobility device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance testing described effectively represents "standalone" performance in the context of this device. The tests were performed on the power wheelchair itself to ensure it met specific engineering and safety standards, without necessarily involving a human user in a "human-in-the-loop" performance evaluation (beyond what's necessary to operate the device for testing purposes). The focus is on the device's inherent mechanical and electrical capabilities.
7. The Type of Ground Truth Used
The ground truth used was compliance with established engineering and safety standards. Specifically, the device's performance was compared against the requirements laid out in:
- ISO/CD 7176-21
- ANSI/RESNA Vol.2 Section 21 Amendments
These standards define objective performance criteria for power wheelchairs.
8. The Sample Size for the Training Set
This information is not provided in the document. The concept of a "training set" is typically associated with machine learning or artificial intelligence algorithms, which are not relevant to the described testing of a power wheelchair against engineering standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of the performance testing described.
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MAR 1 5 2002
510(k) Summary
Innovation In Motion's 510(k) Premarket Notification Karma Discovery Series Power Wheelchair
Submitter's Name, Address, Telephone, Fax Number, Contact Name
Karma Medical Products, Co., LTD. No. 29 Cheng-Kung First Street Min-Hsiung Industrial Zone Chia-Yi Hsien, 621. Taiwan Phone: 886 5 221 1996 Fax: 886 5 221 1965
Manufacturer's Name, Address, Telephone, and Fax Numbers
Karma Medical Products, Co., LTD. No. 29 Cheng-Kung First Street Min-Hsiung Industrial Zone Chia-Yi Hsien, 621. Taiwan Phone: 886 5 221 1996 Fax: 886 5 221 1965
Name of Device
Karma Discovery Series Power Wheelchair
Name of Applicant/Submission Correspondent, Address, Phone, Fax Numbers, and Contact Name:
Innovation In Motion 900 Growth Parkway PO Box 507 Angola, IN 46703 Phone 219.668.5677 Fax: 219.668.8967 Rick Michael - rick@vestil.com
Date Prepared
December 2001
Common or Usual Name Power Wheelchair
C I
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Classification Name Wheelchair, Power
Predicate Devices
The product that is substantially equivalent to the Discovery is Invacare's Ranger X rear wheel drive power wheelchair (K852811).
Intended Use
The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.
Technological Characteristics and Substantial Equivalence
Device Description:
The Discovery power wheelchair is a battery powered, motorized mobility vehicle. The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.
The Discovery is designed to be durable, dependable, sporty and aesthetically appealing while being economically priced.
Substantial Equivalence:
The product that is substantially equivalent to the Discovery rear wheel power wheelchair is Invacare's Ranger X power wheelchair (K852811).
Both of these products are battery powered wheelchairs with the same intended function and use-- the provision of mobility to persons limited to a sitting position that have the canability of operating a powered wheelchair. Similarities include large wheels with attached motor/gearbox drive mechanisms, smaller pivoting casters for turning, and joystick operated motor controllers to engage system motion and steer the wheelchair. They are all constructed from the same basic materials, have the same basic operational principles, and all use DC batteries as their source of power.
Performance Data:
As required by FDA's July 26, 1995 draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Application for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles", the Discovery Power Wheelchair was tested in accordance with ISO/CD 7176-21 and the ANSI/RESNA Vol.2 Section 21 Amendments for powered wheelchairs and motorized scooters. In all instances, the Discovery Power Wheelchair met the required performance criteria and functioned as intended.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around it. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Mr. Rick Michael North American Sales Manager Vestil Manufacturing Corporation 900 Growth Parkway Angola, Indiana 46703
Re: K014127
Trade/Device Name: Karma Discovery Series Power Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: December 14, 2001 Received: December 17, 2001
Dear Mr. Michael:
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.
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Page 2 - Mr. Rick Michael
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 vours.
Sincerery, yours,
Mark N Mather
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
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Applicant: Innovation In Motion
Karma Medical Products Submitter:
Name of Device: Karma Discovery Series Power Wheelchair age___________________________________________________________________________________________________________________
510(k) Number (if known):_KOL412 7
Device Name: Power Wheelchair
Indications For Use:
The intended use of the Discovery rear wheel drive power wheelchair is to provide mobility to persons limited to a sitting position who have the capability of operating a power wheelchair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K014127 |
Prescription Use OR Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96
N/A