(42 days)
The Support Vest is intended to provide restraint and upper body support for patients in wheelchairs and restraint for patients in bed.
The Support Vest is a sleeveless, upper body device that has a poncho-style front bib and vest-style rear wings. These wings have 1 1/8-inch-wide polyester webbing sewn to them and brought around to the front of the device, and passed through two slots on the front bib. This closes the vest and causes the wings to criss-cross over the patient's middle chest thus providing posture support. The webbing secures to the wheelchair kickspurs or to the bed frame. The device is edged in bias cut binding in colors that correspond to a size chart included on the package insert. The device is intended for use in the bed or wheelchair.
This 510(k) premarket notification describes a Support Vest, a physical restraint for patients in wheelchairs or beds. The submission does not include a study to prove the device meets specific acceptance criteria based on performance metrics. Instead, it relies on a comparison to an already marketed predicate device and current regulatory frameworks.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit acceptance criteria are stated in terms of measurable performance metrics. The submission focuses on equivalence to a predicate device and adherence to label changes. | The device is intended to "provide restraint and upper body support for patients in wheelchairs and restraint for patients in bed." |
| Functional equivalence to predicate device. | The device is described as having the same intended use and fundamentally similar design as the predicate Support Vest already marketed by Skil-Care Corporation. |
| Compliance with regulatory suggestions for labeling. | Labeling will be changed to incorporate suggestions from FDA's draft document, "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints." |
| Compliance with existing regulations for restraint use. | Use is subject to Health Care Financing Administration's Regulations and accreditation standards for proper use, least restrictive restraint, medical necessity, and supervision. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set or clinical study data is presented.
- Data Provenance: Not applicable. The submission refers to a currently marketed predicate device and regulatory guidelines, rather than new clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No ground truth establishment for a test set is discussed, as no performance study was conducted.
4. Adjudication Method for the Test Set
- Not applicable. No test set or adjudication process is mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The submission focuses on comparing the proposed device to a predicate device already on the market and regulatory compliance, not on comparing human readers' performance with and without AI assistance. The device itself is a physical restraint, not an AI-powered diagnostic tool.
6. Standalone Performance Study
- No, a standalone (algorithm only without human-in-the loop performance) study was not done. The device is a physical product, not an algorithm.
7. Type of Ground Truth Used
- Not applicable. No ground truth derived from clinical data, pathology, or outcomes data is used to establish the device's performance. The basis for safety and effectiveness is primarily through substantial equivalence to a predicate device and adherence to regulatory guidance for medical device labeling and use.
8. Sample Size for the Training Set
- Not applicable. There is no training set mentioned, as this is not an AI/ML device requiring training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set or associated ground truth establishment is described.
§ 890.3910 Wheelchair accessory.
(a)
Identification. A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.(b)
Classification. Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.