(172 days)
Quickie powered wheelchairs empower physically challenged persons by providing a means of mobility. This included conditions in all ages such as: Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic Tetaplegic (Quadraplegic) Spina Bifida Head Injury or Trauma Muscular Dystrophy Multiple Scierosis Polio Geriatric Conditions And other immobilizing or debilitating conditions
Quickie P90 Power Wheelchairs consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. 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. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the medical device:
The provided document describes a 510(k) submission for the Quickie P90 Power Wheelchair Series. It is important to note that this document is for a medical device (a power wheelchair), not an AI/ML-driven diagnostic or prognostic device. Therefore, many of the typical acceptance criteria and study methods associated with AI, such as standalone performance, MRMC studies, ground truth establishment by experts, and sample sizes for training/test sets in the context of machine learning, are not applicable to this type of device submission.
The document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a power wheelchair) and the context of a 510(k) submission, the "acceptance criteria" are primarily established by compliance with recognized engineering and safety standards, and the "performance" is demonstrated by passing tests defined by these standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Successful Testing) |
|---|---|
| ISO 7176 Wheelchair Standards: | Tested to both ISO 7176 |
| - Static Stability | Successful |
| - Dynamic Stability | Successful |
| - Effectiveness of Brakes | Successful |
| - Energy Consumption | Successful |
| - Overall Dimensions | Successful |
| - Maximum Speed acceleration and retardation | Successful |
| - Static Impact | Successful |
| - Fatigue Strength | Successful |
| - Climatic Test | Successful |
| - Obstacle Climbing Ability | Successful |
| - Testing of Power and Control System | Successful |
| ANSI/RESNA Wheelchair Standards: | Tested to both ANSI/RESNA Wheelchair Standards |
| EMC Testing: | Tested to: - Proposed Addition to ANSI/RESNA W/C 14 Electromagnetic Compatibility Requirements for powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94 - ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as "sample size" in the context of clinical trials or data for an AI algorithm. For a physical product like a wheelchair, testing typically involves one or more prototypes of the device model itself, not a "sample size" of patient data. The standards define how those prototypes are tested.
- Data Provenance: Not applicable in the AI/ML sense. The "data" here comes from direct physical testing of the device prototypes in a laboratory or controlled environment, against established engineering standards. There is no patient data or retrospective/prospective data collection described for the testing of substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for a mechanical device like a wheelchair is established by its ability to meet objective, quantifiable measurements and performance targets defined by established engineering and safety standards (e.g., brake effectiveness, stability angles, fatigue cycles). These standards are developed by consensus of engineers and safety experts over time, but there isn't a specific set of experts establishing ground truth for this device's test set in the way one would for diagnostic imaging.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Testing against engineering standards is typically objective; a test either passes or fails according to predefined criteria. There's no subjective interpretation requiring adjudication of results in the way an AI diagnostic result might.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not applicable to a power wheelchair.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. Standalone (Algorithm Only) Performance
- Was a standalone performance study done? No. This concept applies to AI algorithms that can operate independently of human intervention for tasks like detection or classification. A power wheelchair is a physical product directly used by a human.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's acceptance is adherence to established engineering and safety standards. These standards define objective, measurable performance characteristics (e.g., maximum speed, stability angles, brake effectiveness, fatigue resistance, EMC compliance).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
Summary for the Quickie P90 Power Wheelchair Series:
This device's acceptance criteria are based on its compliance with international (ISO 7176) and national (ANSI/RESNA) wheelchair safety and performance standards. The "study" involves subjecting prototypes of the wheelchair to a battery of tests specified by these standards, covering aspects like stability, braking, durability, and electromagnetic compatibility. The demonstration of passing these tests constitutes the evidence that the device meets its performance and safety requirements for market clearance under the 510(k) pathway for substantial equivalence. The submission does not involve clinical trials, AI algorithm performance, or human reader studies.
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510(k) SUMMARY OF SAFETY AND EFFICACY 13.0
DEC - 2 1997
Quickie Designs, Inc. Submitter: 2842 Business Park Ave. Fresno, CA 93727 Phone (209) 292-2171 Fax (209) 292-2741
(972230
Rebecca Andersen June 9, 1997 Date:
Name(s) of the device(s):
P90 Power Wheelchair Series
Identification of predicate device(s):
-
- Metro power by Everest & Jennings
-
- Action Power 9000 by Invacare Corporation
-
- Action Power 9000 Storm Series by Invacare Corporation
Description of the device:
Quickie P90 Power Wheelchairs consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. 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. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user. Refer to section 7 for a component diagram of a Quickie P90 chair figure 1; for nominal dimensions see figure 2.
Intended use:
Quickie 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 Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy
Multiple Sclerosis Polio Geriatric conditions And other immobilizing or debilitating condition
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Comparison of device characteristics to predicate(s):
This device has similar technological characteristics as the predicated devices. They all use steel and aluminum in their frame and components, and standard foams and covers for the slings and backs. Microprocessors are typically used with a programmable controller, and the rider controls the chair using a joystick or other equivalent command mode. Motors use permanent magnets, employing 24 volt D.C., with rechargeable deep cycle batteries for an energy source. The operating speeds and maneuverability are equivalent, and recommended for indoor or light outdoor use. The standard accessories and components are common to all power wheel chair lines.
Testing:
This device has been tested to both ISO7176 and ANSI/RESNA Wheelchair Standards. They include: Static Stability Dynamic Stability Effectiveness of Brakes Energy consumption Overall Dimensions Maximum Speed acceleration and retardation Static Impact Fatigue Strength Climatic Test Obstacle Climbing Ability Testing of Power and Control System EMC Testing
We have also tested to the Proposed :
Addition to ANSI/RESNA W/C 14 Electromagnetic Compatibility Requirements for powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94
ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters.
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Safety:
An analysis of complaints against Quickie power chairs was completed and charted. This analysis was supported by a literature search which was conducted by a third party to determine the number of complaints, MDR's and recalls that have been reported to the FDA concerning wheelchairs in general. This information was summarized, and presented in a Management Review report dated 2/20/97. The data and charts are included as Attachment 13 - A. The analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share. Quickie has concluded that there are no use issues exclusive to Quickie chairs at this time.
Efficacy
Articles are being provided on the use and efficacy of power wheelchairs.
-
- "A Question of Power", Team Rehab Report, by Robbie B. Leonard, MS, PT, pp. 22-23, May 1992
-
- "Preventing occupied wheelchairs from falling down stars", Journal of Rehabilitation Research, by R. Lee Kirby, MD. And Angus D. MCLean, Dip Eng Bsc., PP 27 - 32, Vol. 27 No. 1. Winter 1990.
-
- "Powered Mobility and Its Implications", JRRD Clinical Supplement, by C. Gerald Warren, pp. 74 - 85, Technical Paper.
510(k) number:
Not assigned at the writing of this summary
Conclusion:
The Ouickie P90 Power Wheelchair is substantially equivalent to the predicated devices listed in this 510(k) and the technology and construction of the P90 does not raise any new issues of safety and effectiveness.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebecca Andersen ·Vice President, Quality and Regulatory Affairs Sunrise Medical Mobility Products Division 7477 A East Dry Creek Parkway 80503 Longmont, Colorado
DEC - 2 1997
K972230 Re: P120 Series Requlatory Class: II Product Code: ITI Dated: September 4, 1997 Received: September 9, 1997
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. A 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.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | Ol | ||
|---|---|---|---|
| 1 | 1 | Annual Property of |
| 510(k) Number (if known): | K972230 |
|---|---|
| Device Name: | Quickie P90 (New Home P-120) |
Indications For Use:
Please amend Section 12.2, Indications for Use as found on Page 58 to read:
Quickie powered wheelchairs empower physically challenged persons by providing a means of mobility. This included conditions in all ages such as:
Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic Tetaplegic (Quadraplegic) Spina Bifida
Head Injury or Trauma Muscular Dystrophy Multiple Scierosis Polio Geriatric Conditions And other immobilizing or debilitating conditions
(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) of General Restora 510(k) Number
Prascription Use (Per 21 CFR 801. 109) CA
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
. "
§ 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).