(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.
§ 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).