QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR

• K Number: K982989
• Device Name: QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR
• Manufacturer: SUNRISE MEDICAL, INC.
• Date Cleared: 1998-10-05 ( 40 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: K052521 , K990157

Intended Use

Sunrise mechanical wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent 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 immobilizeing or debilitating conditions

Device Description

Sunrise Medical Suspension Wheelchairs consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. 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. The kev change covered by this submission is the suspension feature, which allows the user to traverse uneven terrain or obstacles with greater comfort.

AI/ML Overview

The provided text describes a 510(k) submission for a Suspension Wheelchair Series. For this type of medical device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrated through substantial equivalence to a predicate device, supported by performance testing against established standards.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from text)	Reported Device Performance (from text)
Safety & Efficacy	Substantial Equivalence to predicate devices; Does not raise new issues of safety and effectiveness.	Concluded that the device is "substantially equivalent to the predicated devices" and "the technology and construction... does not raise any new issues of safety and effectiveness." This is the overarching "performance."
Mechanical Performance	Meet ISO7176 Wheelchair Standards	Device has been "tested to both ISO7176 and ANSI/RESNA Wheelchair Standards."
	Meet ANSI/RESNA Wheelchair Standards	Device has been "tested to both ISO7176 and ANSI/RESNA Wheelchair Standards."
	Static Stability	Testing mentioned as including "Static Stability."
	Overall Dimensions	Testing mentioned as including "Overall Dimensions."
	Fatigue Strength	Testing mentioned as including "Fatigue Strength."
Complaint Analysis	Analysis of complaints against Sunrise manual chairs for the period from 4/1/97 through 2/28/98 to demonstrate no unique use issues.	Analysis completed and charted; "demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share. Sunrise has concluded that there are no use issues exclusive to Sunrise chairs at this time."
Intended Use	Provide mobility for physically challenged persons with various conditions (e.g., Arthritis, Amputee, Paraplegic, etc.).	Device is a "light weight manual chair which is intended to provide mobility based on an individual users' needs and capabilities." The stated "Indications for Use" directly align with the conditions listed in the "Intended use" section.
Key Change Performance (Suspension Feature)	Allows the user to traverse uneven terrain or obstacles with greater comfort.	The "kev change covered by this submission is the suspension feature, which allows the user to traverse uneven terrain or obstacles with greater comfort." (This is a description of the feature's intended performance rather than a measured performance metric from a specific test, implying that meeting the standards for general wheelchair performance covers this new feature adequately in the context of substantial equivalence).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of how many wheelchairs were tested for ISO7176 and ANSI/RESNA standards. These standards typically involve testing a representative number of units, but the exact count is not given. For the complaint analysis, the "sample" was complaints received against Sunrise manual chairs from 4/1/97 through 2/28/98, and "MDR's and recalls that have been reported to the FDA concerning wheelchairs in general," but no specific numerical count is provided.
• Data Provenance:
  • Standards Testing (ISO7176, ANSI/RESNA): This performance data would be generated directly by Sunrise Medical or a contracted testing facility (not specified) based on tests performed on their Suspension Wheelchair Series. The context suggests this is internal testing for the specific device for the submission.
  • Complaint Analysis: Originates from "complaints against Sunrise manual chairs" (internal company data) and a "literature search" for FDA complaints, MDR's, and recalls "concerning wheelchairs in general" (external, potentially public data). This appears to be retrospective analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. "Ground truth" and "expert evaluation" in the sense of clinical consensus or pathology are typically relevant for diagnostic devices, AI/ML-driven analyses, or certain therapeutic devices where expert judgment is central to accuracy. For a manual wheelchair, the "ground truth" for performance is compliance with established safety and performance standards (like ISO/ANSI/RESNA) and the absence of new safety concerns compared to predicate devices. These standards define objective pass/fail criteria.

4. Adjudication Method for the Test Set

This is not applicable to this 510(k) submission. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for subjective or complex diagnostic/interpretive tasks, often in clinical studies. For mechanical testing against standards, the results are typically objective measurements.

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 is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images) where AI assistance might change their performance. This is a mechanical mobility device; there are no "human readers" interpreting outputs in a clinical context that would be assisted by AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a manual wheelchair, not an algorithm or AI-driven system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's safety and effectiveness is primarily established by:

• Compliance with recognized industry standards: ISO7176 and ANSI/RESNA Wheelchair Standards define objective performance criteria (e.g., static stability, fatigue strength).
• Demonstration of substantial equivalence to predicate devices: This implies that the device's design, materials, and intended use are similar enough to already-marketed legally devices that it presents no new safety or effectiveness concerns.
• Retrospective complaint analysis: Review of existing adverse event data to demonstrate that the manufacturer's products, and wheelchairs generally, do not have unique or unacceptable safety issues.
• Intended Use Alignment: The device meets the needs for mobility for specific patient populations as outlined in the "Indications for Use."

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a mechanical wheelchair submission. Training sets are used in machine learning or AI development.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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OCT 5 1998

510k Notification

CONFIDENTIAL

K982989

510(k) SUMMARY OF SAFETY AND EFFICACY 13.0

Sunrise Medical - Mobility Products Division Submitter: 7477 East Dry Creek Parkway Longmont, CO 80503 Phone [phone] Fax [phone]

Rebecca Andersen August 25, 1998 Date:

Name(s) of the device(s):

Suspension Wheelchair Series

Identification of predicate device(s):

• 1. Ouickie GPS by Sunrise Medical
• 2. Action A4 by Invacare Corporation
• 3. Barracuda by Everest & Jennings
• 4. Boing by Colours

Description of the device:

Sunrise Medical Suspension Wheelchairs consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. 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 Suspension chair (figure 1); for nominal dimensions see figure 2.

Intended use:

Sunrise mechanical 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):

The Suspension Wheelchair is a light weight manual chair which is intended to provide mobility based on an individual users' needs and capabilities. It is available in a range of sizes (dimensions) to allow fit to a particular user. The kev change covered by this submission is the suspension feature, which allows the user to traverse uneven terrain or obstacles with greater comfort.

Testing:

This device has been tested to both ISO7176 and ANSI/RESNA Wheelchair Standards. They include: Static Stability Overall Dimensions Fatigue Strength

Safety:

An analysis of complaints against Sunrise manual chairs was completed and charted for the period from 4/1/97 through 2/28/98. 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. Sunrise has concluded that there are no use issues exclusive to Sunrise chairs at this time.

Efficacy

Articles are being provided on the use and efficacy of manual wheelchairs.

• "Mobility Technology", by Chris Bale, Home Health Products, January 1996 1)
• 2. "Decisions, Decisions", by Marty Ball, Sports and Spokes, March/April 1997, Vol. 23, No. 2
• 3. "Rolling Revolution", by Arnold Henderson, the Wall Street Journal, September 28, I dddc
• 4. "Performance Pointers", by Marty Ball, Sports and Spokes, July/August 1993, Vol. 19, No. 2

August 25, 1998 Sunrise Medical - Mobility Products Division: Suspension Wheelchair

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• 5. "Technology Solutions", by Mia Moody, Home Health Products, October 1996
• 6. "On the Move", by Andrea Vander Pluym, Home Care, April 1997
• 7. "Chairs, Chairs, Everywhere!", Sports and Spokes, March/April 1994, Vol. 9, No. 6 (author unidentified)
• 8. "Lightweight Chairs", HomeCare Forecast '97, Winter 1997 (author unidentified)

510(k) number:

Not assigned at the writing of this summary

Conclusion:

The Sunrise Medical Suspension Wheelchair Series is substantially equivalent to the predicated devices listed in this 510(k) ;the technology and construction of the Suspension Wheelchair Series does not raise any new issues of safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1998

Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. 7477 East Dry Creek Parkway Longmont, Colorado 80503

Re: K982989 Suspension Wheelchair Series Trade Name: Regulatory Class: I Product Code: IOR Dated: August 25, 1998 Received: August 26, 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, Druq, 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 Regulations, 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 In addition, FDA may publish further announcements action. 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 requlations.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

la 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 mechanical wheelchairs empower physically challenged persons by providing a means of mobility.

Intended use:

Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent 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 immobilizeing or debilitating conditions

510(k) number: Not assigned as of this time

Device name: Suspension Wheelchair Series

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (per 21 CFR801.109) #

Over-the-counter use

(Division Sign-Of Division of General Resto 510(k) Number

August 25, 1998 Sunrise Medical - Mobility Products Division: Suspension Wheelchair

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Regulation Number and Section

§ 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).