(43 days)
Breezy Elegance Folding Manual Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
The product offering consists of a standard folding aluminum wheelchair. (Standard in the sense that it is not built to a specific order, rather it will be built to inventory.)
The wheelchairs are
- User-propelled, as such, chair has 24" wheels with attached handrims
- Foldable (using a cross-brace design) for easier transport and stowage
The device comprises - Cross-braced folding frame
- Quick-release Axle
- Large rear wheels with handrims for self-propulsion
- Smaller front wheels on casters for stability
- Padded seat sling material designed to support a seat cushion and to fold when the wheelchair frame is folded
- An upholstered backrest designed to fold when the wheelchair frame is folded, pre-set angle to 8
- Push handles at top of backrest to allow attendant to aid mobility of rider
- Swing-away armrests and swing-in/swing-out legrests (with footplates)
Available Options
Elevating legrest
Anti-tip Tubes
The provided text describes the 510(k) summary for the Breezy Elegance Manual Folding Wheelchair, which is a Class I medical device. For such devices, the primary "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device and adherence to general controls and recognized standards, rather than specific performance metrics like sensitivity or specificity that are common for AI/diagnostic devices. The study that proves the device meets these criteria is the submission itself, which outlines how the Breezy Elegance wheelchair is substantially equivalent to the Quickie Q2 Lite.
Here's the information broken down based on your request, keeping in mind the nature of this device:
Acceptance Criteria and Device Performance for Breezy Elegance Folding Manual Wheelchair
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a Class I mechanical device (manual wheelchair), the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device and compliance with general safety and performance expectations for such devices. Specific quantitative performance metrics (like sensitivity, specificity, or F1-score) common for AI/diagnostic devices are not applicable.
| Acceptance Criteria Category | Specific Criteria (Expected for Wheelchairs) | Reported Device Performance/Findings |
|---|---|---|
| Intended Use | Provides mobility to persons restricted to a sitting position. | Identical: Provides mobility to persons restricted to a sitting position. |
| Materials | Use of materials common in wheelchair construction (e.g., aluminum, steel, fabric, plastics) that do not raise new safety concerns. | Substantially Equivalent: Aluminum frame, support members, wheels, components; Steel fasteners and components; Flexible polymeric tires; Fabric covered foam upholstery; Fabric straps and slings. No new biocompatibility issues raised. |
| Operating Principle | User-propelled by hand pressure; wheel locks; quick-release hubs; cross-braced, hinged frame for folding; seat/back upholstery; adjustable legrests; push handles. | Identical: User propelled by hand pressure against handrims; wheel locks; quick release wheel hubs; cross-braced, hinged frame for folding; seat cushion and back upholstery; adjustable, swing-away legrests; push handles. |
| Energy Source | User propelled. | Identical: User propelled. |
| Technology | Standard mechanical wheelchair construction and operation. | Identical: Standard mechanical wheelchair construction and operation. |
| Safety and Performance | Accomplishes performance similar to the predicate device in a way that raises no new issues of safety or effectiveness. Adherence to recognized wheelchair standards. | Substantially Equivalent: Accomplishes the same performance in the same way as the predicate with "slightly more weight and weight carrying capacity." No new issues of safety or effectiveness. Design verified and validated. |
| Biocompatibility | Materials in contact with skin (momentary/transient) do not raise biocompatibility issues. | Evaluation: Momentary/transient contact with uncompromised skin on hands/arms using aluminum, steel, nylon fabric, hard/soft plastics for various parts; handrim and armrest materials are identical to predicate, raising no new issues. |
| Design Controls | Adherence to Design Control requirements per 21 CFR 820.30. | Design Verification: Testing/demonstration that all essential specifications show equivalent performance to recognized wheelchair standards or to the predicate device. |
| Human Factors/Usability | Demonstration of fitness for intended use. | Design Validation: Third-party evaluation of chair performance, human factors, and usability demonstrate fitness of design. |
2. Sample Size Used for the Test Set and Data Provenance
For this type of mechanical device, the "test set" refers to the physical units of the device that underwent design verification and validation. The document states:
- Sample Size for Test Set: Not explicitly specified as a number of units. The testing involved "testing/demonstration" for design verification and "Third-party evaluation" for design validation. This typically implies testing a representative sample or prototypes to ensure manufacturing and performance consistency. Specific numerical sample sizes are not provided in this summary.
- Data Provenance: The testing and evaluation for design verification and validation were conducted by Sunrise Medical (US) LLC (the manufacturer) and a "third-party." The country of origin for this testing data is not explicitly stated, but given the manufacturer's location (Fresno, CA, USA) and the FDA submission, it is assumed to be primarily U.S.-based. The nature of the testing is prospective in that it refers to tests conducted on the proposed device design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For a mechanical wheelchair, "ground truth" is established through engineering and biomechanical testing against recognized standards and functional requirements, as well as human factors and usability evaluations.
- Number of Experts: Not explicitly stated. The document refers to "third-party evaluation" for design validation, which would involve qualified engineers, user groups, and human factors specialists.
- Qualifications of Experts: Not explicitly detailed. These experts would typically include biomedical engineers, mechanical engineers, and potentially physical therapists or other healthcare professionals familiar with wheelchair functionality and user needs for the "human factors and usability" assessment.
4. Adjudication Method for the Test Set
The concept of "adjudication method" (e.g., 2+1, 3+1) is typically used in clinical studies or diagnostic imaging assessments where multiple human readers interpret data, and discrepancies need to be resolved. This is not applicable to the engineering design verification and validation of a mechanical wheelchair. For this device, acceptance is based on meeting pre-defined engineering specifications, performance against recognized standards, and successful completion of human factors evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic accuracy with human readers, often involving AI assistance. It is not applicable to the regulatory submission for a mechanical wheelchair.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance evaluation was not done. This concept is specific to AI/software devices. The Breezy Elegance is a purely mechanical device.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the Breezy Elegance wheelchair primarily involved:
- Engineering Specifications and Recognized Standards: The device was tested against design specifications and relevant wheelchair standards (e.g., ISO, ANSI/RESNA standards, though not explicitly listed by name in this summary). The predicate device's performance also serves as a benchmark for equivalence.
- Functional Performance Data: Data from bench tests and evaluations confirming the wheelchair's mechanical integrity, durability, and functional operation (e.g., folding mechanism, wheel performance, brake effectiveness, weight capacity).
- Usability and Human Factors Data: Outcomes from third-party evaluations confirming the device's fitness for intended use from a user's perspective.
There is no "pathology" or "outcomes data" in the clinical trial sense for this type of device submission.
8. The Sample Size for the Training Set
This question is not applicable. The Breezy Elegance is a mechanical device, not an AI or software algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this mechanical device.
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improving people's lives
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K133855
510(k) Summary
JAN 3 1 2014
| Device | Breezy Elegance Manual Folding Wheelchair | |
|---|---|---|
| Owner | Sunrise Medical (US) LLC | |
| 2842 Business Park Avenue | ||
| Fresno, CA 93727 | ||
| Phone: 559-348-2572 | ||
| Fax: 559-294-2872 | ||
| Contact | Laurie H. Roberts | |
| Senior Manager-Regulatory Affairs | ||
| Date | 17 December 2013 | |
| SubjectDevice | Trade name | Breezy Elegance |
| Common name | Manual Folding Wheelchair | |
| Regulation | 21 CFR 890.3850 | |
| Device name | Mechanical wheelchair | |
| Product code | IOR | |
| Device class | 1 | |
| Panel | Physical Medicine | |
| Predicate | Trade name | Quickie Q2 Lite |
| Manufacturer | Sunrise Medical (US) LLC | |
| Market Clearance | 510(k): K072153 (10 Sep 07) |
Device Description
Device purpose
・・・・・・・・・・・・
The product offering consists of a standard folding aluminum wheelchair. (Standard in the sense that it is not built to a specific order, rather it will be built to inventory.)
Device components
- The wheelchairs are
- User-propelled, as such, chair has 24" wheels with attached handrims - Foldable (using a cross-brace design) for easier transport and stowage
Continued on next page
2842 Business Park Avenue · Fresno, CA 93727-1328 · USA
800.333.4000
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510(k) Summary: Breezy Elegance Wheelchair
| Devicecomponents(continued) | · The device comprises- Cross-braced folding frame- Quick-release Axle- Large rear wheels with handrims for self-propulsion- Smaller front wheels on casters for stability- Padded seat sling material designed to support a seat cushion and to foldwhen the wheelchair frame is folded- An upholstered backrest designed to fold when the wheelchair frame isfolded, pre-set angle to 8- Push handles at top of backrest to allow attendant to aid mobility of rider- Swing-away armrests and swing-in/swing-out legrests (with footplates)· Available OptionsElevating legrestAnti-tip Tubes | |
|---|---|---|
| Technologicalcharacter-istics | Aluminum frame to reduce weight and provide durabilityTriple cross-brace for easy foldingSwing-away arm and leg rests for easier entry, egress, or transferSeat and back slings to accommodate separate cushion system forrider comfort and ease of foldingTension adjustable back straps for user comfortOptional on Models B & C●Drum brake system to aid attendant to control chair movement-Height adjustable push handles for attendant comfort-Height adjustable armrests for user comfort |
Intended Use
Breezy Elegance Folding Manual Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
Equivalence
The Breezy Elegance Wheelchair is substantially equivalent to its predicate device, Quickie Q2 Lite, based on intended use, materials, operating principle, technology, safety, and performance.
Breezy Elegance equivalence to Quickie Q2 Lite
Intended Use Identical: Provides mobility to persons restricted to a sitting position
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510(k) Summary: Breezy Elegance Wheelchair
| Materials | Substantially equivalent:Aluminum frame, support members, wheels, and components Steel fasteners and components Flexible polymeric tires Fabric covered foam upholstery Fabric straps and slings |
|---|---|
| Operatingprinciple | Identical:User propelled by hand pressure against handrims attached to large (24 inch) wheels Wheel locks to hold chair on slight slopes Quick release wheel hubs for easy removal of wheel for transport and storage Cross-braced, hinged frame for folding of chair for transport and storage Seat cushion and back upholstery for user comfort Adjustable, swing-away legrests with angle-adjustable footrests Push handles to allow assistance by an attendant |
| Energysource | Identical: User propelled |
| Technology | Identical: Standard mechanical wheelchair construction and operation. |
| Safety andperformance | Substantially equivalent:Accomplishes the same performance in the same way as the predicate with slightly more weight and weight carrying capacity Design raises no new issues of safety or effectiveness |
| Bench Tests | |
| DesignVerification | Design Control requirements per 21 CFR 820.30; testing/demonstration thatall essential specifications show equivalent performance to recognizedwheelchair standards or to the predicate device (Quickie Q2 Lite). |
| DesignValidation | Third-party evaluation of chair performance, human factors, and usabilitydemonstrate the fitness of the design to meet the requirements and demandsof its intended use. |
.
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510(k) Summary: Breezy Elegance Wheelchair
Biocompatibility
| Type ofContact | • Momentary contact with uncompromised skin of hands—various parts• Transient contact with uncompromised skin of hands—handrims• Transient contact with uncompromised skin of arms—armrests |
|---|---|
| Evaluation | • Momentary contact of intact skin of hands on aluminum, steel, nylon fabric,hard/soft plastics do not raise biocompatibility issues• Handrim and armrest materials are identical with the predicate device and,thus, raise no biocompatibility issue |
Packaging / Shelf life
Based on the durability, materials, and use of wheelchairs, packaging and shelf life are not relevant to the safe and effective use of these devices.
Conclusion
Breezy Elegance Manual Folding Wheelchairs are substantially equivalent to their predicate devices in technology, performance, and intended use. There are no significant differences between Breezy Elegance Wheelchairs and the Quickie Q2 Lite Wheelchair predicates in design which would raise new issues of safety and effectiveness, performance, function or intended use of the device. In addition, the chair design has been shown to be safe and effective for its intended uses.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 31, 2014
Sunrise Medical (US) LLC c/o Laurie H. Roberts 2842 Business Park Ave. Fresno, CA 93727
Re: K133855
Trade/Device Name: Breezy Elegance Folding Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 2, 2014 Received: January 2, 2014
Dear Ms. Roberts:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Ms. Laurie H. Roberts
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda,gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDeyjces/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ... ... . ....
Indications for Use
510(k) Number (if known) K133855
Device Name
Breezy Elegance Folding Manual Wheelchair
Indications for Use (Describe)
Breezy Elegance Folding Manual Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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§ 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).