(29 days)
Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.
Wheelchair to be a manual transport device, with 8" fron swivel casters on the front, and 24" mag style wheels on the rear. Wheelchair will be foldable for storage, will be chrom- plate Finnish. Armrests will be padded or plastic and wil have padded embossed upholstery for user comfort. Wheelchair will be equipped with wheel locks to prevent rolling while transferring patient. Push handles will be of a non-slip vinyl material. Standard color available will be dark blue. Chairs to have rear extensions to prevent tip-over. Wheelchairs to be available in models with swing away footrests or elevating legrests as shown in pictures.
This document is a 510(k) summary for the Transport Plus and Transport Deluxe manually propelled transport wheelchairs. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating acceptance criteria met by the device itself. Therefore, many of the requested elements for a study showing device performance are not available in this type of document.
Here's an analysis based on the provided text, highlighting where information is missing due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in the way one would for a diagnostic algorithm (e.g., minimum sensitivity/specificity thresholds). Instead, it aims to demonstrate substantial equivalence to predicate devices based on design, materials, and intended use. The "performance" is implicitly tied to meeting the functionality described for a manual wheelchair.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (from "Device Description" and "Intended Use") |
|---|---|
| Functionality for Maneuvering: | Allows user or user assistant to propel/push chair to maneuver seated individual in a safe, controlled environment. |
| Braking/Locking Mechanism: | Must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality. Equipped with wheel locks to prevent rolling while transferring patient. |
| Portability/Storage: | Foldable for storage. |
| Material/Construction: | Chrome-plate Finnish (frame). Armrests: padded or plastic. Upholstery: padded embossed. Push handles: non-slip vinyl. Rear extensions to prevent tip-over. |
| Wheel Configuration: | 8" front swivel casters, 24" mag style wheels on the rear. |
| User Comfort/Features: | Padded embossed upholstery, padded or plastic armrests. Models with swing away footrests or elevating legrests. |
| Safety: | Rear extensions to prevent tip-over. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This is a 510(k) premarket notification for a physical medical device (wheelchair), not a software or AI/ML device requiring a test set of data. The "test" here refers to the design and features satisfying the requirements for a wheelchair, often through engineering analysis and potentially mechanical testing, though no details are provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. As above, this isn't a diagnostic device where "ground truth" is established by experts interpreting data. The "ground truth" for a wheelchair's safety and effectiveness is established through compliance with established standards for medical devices of its type, and comparison to legally marketed predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable. No data adjudication is described as this is not a study involving human interpretation of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study is not relevant for a manual wheelchair. MRMC studies are typically performed for imaging or diagnostic devices where human readers interpret medical cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- For the purpose of this 510(k) submission, the "ground truth" is the established functionality and safety profile of already legally marketed predicate manual wheelchairs (Everest & Jennings model Universal wheelchair – K930411 and Invacare model Rolls 2000 wheelchair - K881762). The manufacturer asserts that the new device shares the same intended use and fundamental technological characteristics as these predicates.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, no training set is involved.
Summary of the Study (or Basis for Clearance):
The document you provided is a 510(k) Summary for a medical device (manual wheelchair). The "study" in this context is the comparison to legally marketed predicate devices to demonstrate substantial equivalence. The manufacturer asserts that the Transport Plus and Transport Deluxe wheelchairs have the same intended use and similar technological characteristics as the identified predicate devices (Everest & Jennings model Universal wheelchair – K930411 and Invacare model Rolls 2000 wheelchair - K881762).
The core of this submission is not a performance study in the clinical trial sense, but rather a regulatory submission where the "acceptance criteria" are the regulatory requirements for showing equivalence, which are met by detailing the device's design, materials, and intended use, and showing how these align with existing cleared devices. The FDA's letter (K973418) acknowledges receipt and states that the device is "substantially equivalent," allowing it to be marketed.
§ 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).