(18 days)
Sunrise Medical powered wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as: Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic (Quadraplegic), Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric Conditions, And other immobilizing or debilitating conditions. A wheel chair with Bus Transport option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J 2249.
The G-424 is a mid-wheel drive, moderate duty chair that comes in one basic configuration. It is available with the Pilot controller. The Quickie G-424 Power Wheelchair consists of the same basic components found on the P200, such as a frame with suspension, seat, armrests, footrest, cushion, casters and drive wheels. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries. Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. Aesthetics have been improved by adding a plastic thermoformed molded cover.
Here's an analysis of the provided text regarding the acceptance criteria and study for the G-424 Power Wheelchair:
Description of Device: The G-424 is a mid-wheel drive, moderate-duty power wheelchair. Key changes from its predicate device (Quickie P200) include:
- Replacement of anti-tip wheels with anti-tip casters.
- Change from aluminum to steel frame construction.
- Revised suspension.
- Revised modular seat.
- Use of the Pilot controller from Penny & Giles.
- Improved aesthetics with a plastic thermoformed molded cover.
Intended Use: To provide mobility for physically challenged persons of all ages, including those with conditions such as Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic (Quadraplegic), Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric conditions, and other immobilizing or debilitating conditions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Static Stability | Pass |
| Dynamic Stability | Pass |
| Effectiveness of Brakes | Pass |
| Energy Consumption | Pass |
| Overall Dimensions | Pass |
| Maximum Speed, Acceleration, and Retardation | Pass |
| Static Impact | Pass |
| Fatigue Strength | Pass |
| Climatic Test | Pass |
| Obstacle Climbing Ability | Pass |
| Testing of Power and Control System | Pass |
| EMC Testing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of wheelchairs or test units) used for the testing. It also does not specify the country of origin of the data or whether the tests were retrospective or prospective. The testing was conducted to "ISO7176 and ANSI/RESNA Wheelchair Standards," which are international and American standards, respectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This document describes performance testing of a physical medical device (power wheelchair) against established engineering and safety standards (ISO7176 and ANSI/RESNA). The "ground truth" here is objective measurement and observation of the device's adherence to these standards. Therefore, "experts" in the context of establishing ground truth for image interpretation or clinical outcomes (like radiologists) are not applicable. The implicit experts would be the qualified engineers and technicians performing the standard tests and interpreting the results according to the specified criteria. The number and specific qualifications of these individuals are not provided.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used for clinical studies involving subjective assessments (e.g., image interpretation by multiple readers). This document pertains to objective engineering and performance testing against predefined standards. There is no mention of an adjudication method in this context, as the results are likely determined by quantitative measurements and pass/fail criteria from the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study assesses human reader performance, often with and without AI assistance, which is not relevant for the performance testing of a physical device like a power wheelchair.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done. This concept is applicable to software algorithms, particularly in AI/ML, not for the physical performance of a power wheelchair. The "performance" discussed here refers to the device's physical capabilities and safety features.
7. Type of Ground Truth Used
The ground truth used for this study is based on objective measurements and pass/fail criteria defined within the ISO7176 and ANSI/RESNA Wheelchair Standards. These standards would specify the methodologies, parameters, and acceptable ranges for each test (e.g., maximum allowable dynamic tilt, braking distance, fatigue cycles).
8. Sample Size for the Training Set
This document describes the testing of a physical medical device. There is no "training set" in the context of machine learning algorithms. The tests performed are to validate the final product's conformance to established engineering standards. Engineering design and development (which could involve iterative testing and refinement, analogous in some ways to training) would precede this final validation testing, but a distinct "training set" as understood in AI/ML is not applicable.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not applicable here. The device's design and manufacturing processes are validated against engineering specifications, which themselves are derived from safety and performance standards. The "ground truth" for the device's performance is ultimately defined by its ability to meet these established engineering and regulatory standards.
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6 1998 NOV
CONFIDENTIAL
983677
13.0 510(k) SUMMARY OF SAFETY AND EFFICACY
Submitter: Sunrise Medical (303) 218-4500 Mobility Products Division 7477 East Dry Creek Parkway Longmont, CO 80503
Rebecca Andersen October 13, 1998 Date:
Name(s) of the device(s): Identification of predicate device(s): 1) Quickie P200 by Sunrise Medical
- Quickie P120 by Sunrise Medical
G-424 Power wheelchair Modification to a Sunrise Device
Description of the device:
The G-424 is a mid-wheel drive, moderate duty chair that comes in one basic configuration. It is available with the Pilot controller.
The Quickie G-424 Power Wheelchair consists of the same basic components found on the P200, such as a frame with suspension, seat, armrests, footrest, cushion, casters and drive wheels. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries
Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. ". Aesthetics have been improved by adding a plastic thermoformed molded cover.
Intended use:
Quickie powered wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as :
| Arthritis | Tetraplegic |
|---|---|
| Amputee | Quadriplegic |
| Paraplegic | Spina Bifida |
| Cerebral Palsy | Head Injury or Trauma |
| Hemiplegic | Muscular Dystrophy |
Multiple Sclerosis Polio Geriatric conditions And other immobilizing or debilitating conditions
Comparison of device characteristics to predicate(s):
The proposed device modifications combine technological characteristics from two Sunrise predicate devices.
Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. ". Aesthetics have been improved by adding plastic thermoformed molding covers.
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Testing:
This device has been tested to both ISO7176 and ANSI/RESNA Wheelchair Standards. They include:
| Static Stability | Pass |
|---|---|
| Dynamic Stability | Pass |
| Effectiveness of Brakes | Pass |
| Energy consumption | Pass |
| Overall Dimensions | Pass |
| Maximum Speed acceleration and retardation | Pass |
| Static Impact | Pass |
| Fatigue Strength | Pass |
| Climatic Test | Pass |
| Obstacle Climbing Ability | Pass |
| Testing of Power and Control System | Pass |
| EMC Testing | Pass |
Safety:
The Quickie G-424 Power Wheelchair is substantially equivalent to the existing Sunrise Medical predicate devices. The modifications to this device have been validated using appropriate Design Controls and therefore have been demonstrated to be "non significant" with respect to safety or effectivenes.
i
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its body and wings.
6 1998 NOV
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. Mobility Products Division 7477 East Dry Creek Parkway Longmont, Colorado 80503
K983677 Re: G-424 Power Wheelchair Trade Name: Regulatory Class: II Product Code: ITI Dated: October 13, 1998 Received: October 19, 1998
Dear Ms. Andersen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Rebecca Andersen
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Sunrise Medical powered wheelchairs empower physically challenged persons by providing a means of mobility
This includes conditions in all ages such as:
| Arthritis | Head Injury or Trauma |
|---|---|
| Amputee | Muscular Dystrophy |
| Paraplegic | Multiple Sclerosis |
| Cerebral Palsy | Polio |
| Hemiplegic | Geriatric Conditions |
| Tetraplegic (Quadraplegic) | And other immobilizing or debilitating conditions |
| Spina Bifida |
A wheel chair with Bus Transport option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J 2249
510(k) number: Not assigned as of this time
Device name: G-424
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (per 21 CFR801.109) 0
0 Over-the-counter use
fcoello
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number ___K983677
ﻨﻤﺴﺘﻤﺮﻳ
§ 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).