(27 days)
The intended function and use is to provide mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair.
The purpose of this pre-market notification is to request marketing clearance from FDA to change the controller of certain power wheelchairs models, manufactured by Invacare Corporation, which have already been granted marketing clearance by FDA under separate submissions.
The controller change applies to the Invacare Pronto Powered Wheelchair Series (K012927, 9/19/2001), and the Nutron Powered Wheelchair Series (K900565, 2/15/1990). Each of these devices are battery powered, motorized mobility vehicles. Their intended function and use, which has not changed, is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position.
The controller for the Nutron and Pronto Series of Wheelchairs is being modified from the Invacare MKIV-RII controller to the Invacare MKV-NX controller. The Invacare MKV-NX controller, which is the subject of this premarket notification, is an electronic, microcomputer based. motion control device designed for use with Invacare powered wheelchairs. The intended function of the controller is to activate and control powered wheelchair motions. Additionally, it provides a method of adjusting, selecting and programming certain powered wheelchair performance characteristics to better suit the specific control needs of the user.
Two versions of the controller will be available. These are the MKV-NX and the MKY-NX LP. The MKV NX version has full programming capability, while the MKV-NX LP version has limited programming capability. Programming capability for the LP version is limited to forward speed, turning speed, and reverse speed only. Otherwise the controllers are identical.
The Invacare MKV-NX and MKV-NX LP controllers are programmed using the Invacare MIV remote programmer, previously cleared with the Model MCC-MKIV Micro Computer Control (K940972, 6/2/1994). The controller software and electronics will not allow wheelchair operation during programming.
The provided text describes a 510(k) premarket notification for a modification to power wheelchairs, specifically a change in the controller. The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance data for the modified device.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, and comparative effectiveness studies are not present in the provided text.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document states:
"The Invacare Elevating Seat meets the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993(E), 'ISO Standard, Wheelchairs -Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs.'"
This indicates the types of standards against which performance was assessed. However, specific numerical acceptance criteria (e.g., maximum speed, minimum turning radius, battery life) and the actual reported performance values are not provided in this summary.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/14 (1991) | Met |
| ISO 7176: 1993(E) | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "the Invacare Elevating Seat" meeting standards, but doesn't specify if this refers to the new controller or a separate component, nor does it detail a specific test set, its size, or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not relevant to this type of device submission, which references engineering standards rather than diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided and is not applicable to a power wheelchair controller. This type of study is relevant for diagnostic AI devices, not mobility devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical controller for a power wheelchair. The "performance data" refers to its ability to meet engineering safety and functional standards. The concept of "standalone" performance in the context of an algorithm's diagnostic accuracy is not applicable to this device. The controller functions as an integral part of the human-in-the-loop system (the user operating the wheelchair).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of engineering device, "ground truth" would be established by objective measurements against the specified performance parameters in the ANSI/RESNA and ISO standards (e.g., speed measurements, control response times, stability tests). The specific method for establishing these ground truths (e.g., specific test equipment, calibrated sensors) is not detailed in this summary.
8. The sample size for the training set
9. How the ground truth for the training set was established
These questions are typically relevant for machine learning algorithms. While the controller is "electronic, microcomputer based," the document does not describe it as an AI/ML device that requires a "training set" in the conventional sense. Therefore, this information is not provided and likely not applicable to this type of device submission.
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KOZI680
10Fd
510(k) SUMMARY
Nutron and Pronto Series Power Wheelchairs (M50, M51, M71, M91) with MKV-NX series of wheelchair controllers
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
ﺗﻢ ﺗﻘ
Contact Person: Rae Ann Farrow
Manager, Regulatory Compliance
Date Prepared: May 21, 2002
Name of Device and Name/Address of Sponsor
Nutron and Pronto Series Power Wheelchairs (M50, M51, M71, M91) with MKV-NX series of wheelchair controllers
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
The Invacare powered wheelchairs with the MK-NX controller are substantially equivalent to devices that are currently being legally marketed within the United States, including Invacare Xterra GT power wheelchair (K012909, 10/24/2001) and the Invacare Pronto M71 power wheelchair (K012927).
Intended Use
The intended function and use is to provide mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair.
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K 021680
2 OF d
Technological Characteristics and Substantial Equivalence
A. Device Description
The purpose of this pre-market notification is to request marketing clearance from FDA to change the controller of certain power wheelchairs models, manufactured by Invacare Corporation, which have already been granted marketing clearance by FDA under separate submissions
The controller change applies to the Invacare Pronto Powered Wheelchair Series (K012927, 9/19/2001), and the Nutron Powered Wheelchair Series (K900565, 2/15/1990). Each of these devices are battery powered, motorized mobility vehicles. Their intended function and use, which has not changed, is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position.
The controller for the Nutron and Pronto Series of Wheelchairs is being modified from the Invacare MKIV-RII controller to the Invacare MKV-NX controller. The Invacare MKV-NX controller, which is the subject of this premarket notification, is an electronic, microcomputer based. motion control device designed for use with Invacare powered wheelchairs. The intended function of the controller is to activate and control powered wheelchair motions. Additionally, it provides a method of adjusting, selecting and programming certain powered wheelchair performance characteristics to better suit the specific control needs of the user.
Two versions of the controller will be available. These are the MKV-NX and the MKY-NX LP. The MKV NX version has full programming capability, while the MKV-NX LP version has limited programming capability. Programming capability for the LP version is limited to forward speed, turning speed, and reverse speed only. Otherwise the controllers are identical.
The Invacare MKV-NX and MKV-NX LP controllers are programmed using the Invacare MIV remote programmer, previously cleared with the Model MCC-MKIV Micro Computer Control (K940972, 6/2/1994). The controller software and electronics will not allow wheelchair operation during programming.
B. Substantial Equivalence
The Invacare powered wheelchairs with the MK-NX controller are substantially equivalent to devices that are currently being legally marketed within the United States, including Invacare Xterra GT power wheelchair (K012909, 10/24/2001) and the Invacare Pronto M71 power wheelchair (K012927).
PERFORMANCE DATA
The Invacare Elevating Seat meets the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs -Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs."
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way PO Box 4028 Elyria, OH 44036-2125
Re: K021680
Trade Name: Invacare Powered Wheelchairs, Models M50, M51, M71 and M91 Regulatory Number: 890.3860 Regulatory Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 21, 2002 Received: May 22, 2002
JUN 1 8 2002
Dear Ms. Farrow:
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 - Ms. Rae Ann Farrow
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,
Celia 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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310(k) Number (if known): TBD
Device Name: Nutron and Pronto Series Power Wheelchairs (M50; M71, M91) with MKV-NX series wheelchair controllers
Indications For Use:
The intended function and use is to provide mobility to persons limited to a sitting position that have 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 OR
(Per 21 CFR 801.109) Mark n Milken
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number
K021680
§ 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).