(9 days)
Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages suc as:
Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic
Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy_
Multiple Sclerosis Polio Geriatric conditions And other immobilizeing or debilitating conditions
A wheelchair with Bus Transport Option may be used for motor vehicle transportatio with the use of wheelchair tie down and occupant restraint system (WTORS) that me the requirements of SAE J2249
Zippie GS wheelchairs are light weight, low maintenance, manual chairs, which are intended to provide mobility based on an individual users' needs and capabilities. They are available in a range of sizes (dimensions) to allow fit to a particular user.
The key change covered by this submission is the addition of optional growing solid seat and growing adjustable back. Individuals who use these wheelchairs benefit from the use of different seat cushions and back shapes as required by their individual postures and level of disability.
The addition of an optional growing solid seat facilitates the use of various cushions. The seat has been designed to offer a low cost support for these cushions. By being able to "grow" with the frame as it is adjusted in width and depth to accommodate change in the client's posture, dimensions or condition, the cost of these changes is reduced.
The addition of an optional growing adjustable back upholstery provides users the ability to adjust the contours of the upholstery by adjusting the length of individual straps at various contact points on the trunk. The back is also adjustable in height to match the height of various clients and their need for various degrees of posterior trunk support. The individuals straps also allow for adjustment of the depth of contour or "hammocking" of the back. This allows the client to adjust for lateral support of the trunk. The back has been designed to offer a low cost means for the adjustment of the aforementioned supporting shapes. Additionally by being able to "grow" with the frame as it is adjusted in width to accommodate change in the client's width, the cost of these changes is reduced.
When couple with the adjustment of the following performance factors the users function and comfort can be enhanced.
Here's an analysis of the provided text regarding the Zippie GS wheelchair's acceptance criteria and studies:
Important Note: The provided document is a 510(k) summary for a medical device (a wheelchair). Unlike typical AI/software device submissions, this document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving specific performance metrics through detailed clinical trials. Therefore, many of the requested fields (like sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable (N/A) in this context, as the regulatory pathway for this type of device does not typically require that level of performance data. The "acceptance criteria" here relate more to meeting established safety and performance standards for wheelchairs.
Acceptance Criteria and Device Performance (Zippie GS Wheelchair)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Factors) | Reported Device Performance/Compliance |
|---|---|
| Camber adjustments range | "Camber adjustments range from 0 to 6 degrees." (This is a feature/capability, not a performance metric to be 'met' beyond being available) |
| Wheel position (Rear wheel setback for stability) | "Rear wheels are set back to increase the wheelchair base. This improves stability." (A design feature for stability) |
| Wheel Base or Track Width adjustment range | "Currently adjustable over a 4-inch range, a wider wheel base increases stability." (A feature/capability for adjustment) |
| Caster height adjustment range | "Caster fork allows adjustments to be made ranging from +/-1 inch." (A feature/capability for adjustment) |
| Back Rest Angle adjustment range | "Adjustable from 78 degrees to 120 degrees." (A feature/capability for adjustment) |
| Seat Angle or Squeeze adjustment range | "Adjustable squeeze from 0 - 2 inches." (A feature/capability for adjustment) |
| Center of Gravity adjustment (via axle position, seat angle, seat depth) | "This adjustment is made by the rider to his personal sense of balance, and reactivity." (A feature allowing user adjustment, not a specific performance value to be met by a single study) |
| **Determination of Static Stability (ISO7176 | ANSVRESNA)** |
| **Overall Dimensions, Mass, and Turning Space (ISO7176 | ANSVRESNA)** |
| **Seating Dimensions (ISO7176 | ANSVRESNA)** |
| **Static Impact and Fatigue Strength (ISO7176 | ANSVRESNA)** |
| Safety (Analysis of complaints & literature search) | "Analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share." (This indicates the device is not expected to be less safe than comparators, as the design changes do not introduce new safety issues.) |
| Efficacy (Mechanical reclining wheelchairs) | "Articles are being provided on the use and efficacy of mechanical reclining wheelchairs." (References existing literature for the general efficacy of the type of chair, not device-specific efficacy testing.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated or applicable for a 510(k) submission for this type of device. The "testing" refers to adherence to established general wheelchair standards and internal design verification, not a clinical trial with a defined patient test set.
- Data Provenance: The standard tests (ISO7176 and ANSVRESNA) are likely performed in a controlled laboratory setting by the manufacturer or accredited testing facilities. The complaint analysis is retrospective, drawing from existing market data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- N/A. For this type of device and regulatory pathway, there is no "ground truth" derived from expert consensus on features like the presence of a disease or lesion. The testing involves engineering and mechanical performance against established standards.
4. Adjudication Method for the Test Set
- N/A. As there isn't a "test set" in the sense of patient cases requiring adjudication, this concept does not apply. The testing is against objective engineering standards.
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
- N/A. This device is a manual wheelchair, not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- Engineering Standards / Objective Measurements: The "ground truth" (or basis for acceptance) is compliance with internationally recognized wheelchair safety and performance standards (ISO7176 and ANSVRESNA), along with internal design specifications meeting functional requirements. The "Pass" results confirm the device meets these objective standards.
8. The Sample Size for the Training Set
- N/A. This device does not use machine learning or AI, so there is no training set.
9. How the Ground Truth for the Training Set was Established
- N/A. As there is no training set, this is not applicable.
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510k Notification - Zippie GS with growing solid seat & growing adjustable back
13.0 510(k) SUMMARY OF SAFETY AND EFFICACY
Rebecca Andersen Submitter: Date: 10/14/98
OCT 26 1998
Name(s) of the device(s):
Zippie GS
Identification of predicate device(s):
- Quickie Kidz Zippie Zippie 2 Action Allegro Action Comet
Description of the device:
Zippie GS wheelchairs are light weight, low maintenance, manual chairs, which are intended to provide mobility based on an individual users' needs and capabilities. They are available in a range of sizes (dimensions) to allow fit to a particular user.
The key change covered by this submission is the addition of optional growing solid seat and growing adjustable back. Individuals who use these wheelchairs benefit from the use of different seat cushions and back shapes as required by their individual postures and level of disability.
The addition of an optional growing solid seat facilitates the use of various cushions. The seat has been designed to offer a low cost support for these cushions. By being able to "grow" with the frame as it is adjusted in width and depth to accommodate change in the client's posture, dimensions or condition, the cost of these changes is reduced.
The addition of an optional growing adjustable back upholstery provides users the ability to adjust the contours of the upholstery by adjusting the length of individual straps at various contact points on the trunk. The back is also adjustable in height to match the height of various clients and their need for various degrees of posterior trunk support. The individuals straps also allow for adjustment of the depth of contour or "hammocking" of the back. This allows the client to adjust for lateral support of the trunk. The back has been designed to offer a low cost means for the adjustment of the aforementioned supporting shapes. Additionally by being able to "grow" with the frame as it is adjusted in width to accommodate change in the client's width, the cost of these changes is reduced.
When couple with the adjustment of the following performance factors the users function and comfort can be enhanced.
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PERFORMANCE FACTORS
The impact of each adjustment has a different performance implication for the rider.
| Camber | Camber adjustments range from 0 to 6 degrees |
|---|---|
| Wheel position | Rear wheels are set back to increase the wheelchair base. This improves stability.Wheelchairs may be susceptible to tipping over backwards. Sunrise recommendsthe use of anti tip tubes. |
| Wheel BaseorTrack Width | Currently adjustable over a 4 inch range, a wider wheel base increases stability.Width can be adjusted to weigh gain or other environmental changes to allowenough space between the rider and the wheel. |
| Caster height. | Caster fork allows adjustments to be made ranging from +/-1 inch |
| Back Rest Angle | Adjustable from 78 degrees to 120 degrees.This angle is adjusted for need or comfort. |
| Seat Angle orSqueeze | Adjustable squeeze from 0 - 2 inches |
| Center of Gravity | The balance point. Different for each individual occupying a chair. Thisadjustment is made by the rider to his personal sense of balance, and reactivity.Center of gravity is adjusted by changes to axle position, seat angle, seat depth |
These factors are interrelated and must be adjusted to complement each other to tune the chair performance.
(weight distribution) and backrest angle
These adjustments are routinely made today, and usually require disassembly and the exchange of one part for another with different dimensions or geometry.
The predicate devices including the existing Zippie & Quickie product lines allow users to make adjustments to these factors as well as the wheelchairs seat and back support surfaces.
Chairs are configured to customer orders when sold. Configuration to order allows flexibility. Features such as width, depth, and back height are specified and may range from 10 to 18 inches. Specific configuration includes chair accessories and desired use or safety features. Any combination of features from the approved matrix may be configured to create the chair features needed by a given rider II is the rider and the health care professional that determine the appropriate configuration for the users needs. As the individuals condition or size change, other components or accessories may be ordered and the chair reconfigured to meet the evolving needs of its user.
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: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Zippie GS wheelchairs consist of typical components found on most wheelchairs, such as backrest, seat frame, cushion, footrest and casters. Options include growing solid seat and growing adjustable back. Accessories include items such as elevating leg rest, armrests, positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc.
Many of these components may become 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.
The optional growing solid seat and growing adjustable back is much like those used in competitive products.
The chairs have excellent performance indoors and are very good outdoors over surfaces that are firm and free of large obstacles and long steep inclines. That makes them an ideal maneuverable, light duty, light weight "Get out there chair".
The feature/option will be employed to upgrade the performance of existing devices manufactured by Sunrise Medical Mobility Products Division.
COMPARISON OF DEVICE CHARACTERISTICS TO PREDICATE(S):
Testing:
This device has been tested to both ISO7176 and ANSVRESNA Wheelchair Standards. They include:
| Determination of Static Stability | Pass |
|---|---|
| Overall Dimensions, Mass and Turning Space | Pass |
| Seating Dimensions | Pass |
| Static Impact and Fatigue Strength | Pass |
Safety:
An analysis of complaints against Quickie manual 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 Appendix C. The analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share.
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Efficacy
Articles are being provided on the use and efficacy of mechanical reclining wheelchairs. See Appendix C.
510(k) number:
Not assigned at the writing of this summary
Conclusion:
The Zippie GS Wheelchair model shares performance features and technology with a number of devices already legally marketed within the United States. The design changes that allow the user to adjust the back angle of the chair do not introduce issues of safety or efficacy. This feature introduces comfort and convenience. Therefore, the Breezy 510 Reclining wheelchair option is substantially equivalent to the predicate devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and a wavy line representing the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1998
Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. 7477A East Dry Creek Parkway Lonqmont, Colorado 80503
Re: K983639 Zippie GS, Model #EIZGS Trade Name: Requlatory Class: I Product Code: IOR October 14, 1998 Dated: Received: October 16, 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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 qeneral 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.,
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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THE ANDERESSION TAPPING AND WARD ..
12.2 Indications for Use
Intended use:
Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages suc as:
Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic
Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy_
Multiple Sclerosis Polio Geriatric conditions And other immobilizeing or debilitating conditions
A wheelchair with Bus Transport Option may be used for motor vehicle transportatio with the use of wheelchair tie down and occupant restraint system (WTORS) that me the requirements of SAE J2249
510(k) number: Not assigned as of this time
Device name: Zippie GS
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (per 21 CFR801.109) #
Over-the-counter use
Over-the-Counter Use
Bially to
(Division Sign-Off) Division of General Restorative I 510(k) Number
Image /page/6/Picture/16 description: The image shows a black and white drawing of a round object. The object has a dark upper portion and a lighter lower portion. There are curved lines on the surface of the object, suggesting texture or patterns.
10/14/98 Sunrise Medical Inc., HHG, Mobility Products Division
§ 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).