(141 days)
The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enamination or protection of th patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Bod Holder is a protective restraint which can be used with a bed or wheelchair.
The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint / Body Holder is a protective restraint device that is intend medical purposes to limit patients thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Multi-Purpose Utility Restraint/ Body Holde designed similar to those marketed by other manufacturers. The Multi-Purpose Utility Restraint Body Holder is prima - comprised of nylon or cotton.
This document is a 510(k) Summary for the DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/Body Holder. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The purpose of a 510(k) Summary is to demonstrate substantial equivalence to a legally marketed predicate device, not to present performance data against specific acceptance criteria. The document lists characteristics of the device and compares them to "Other Devices" (predicate devices), noting they are "Same". This comparison implicitly serves as the "proof" for the 510(k) pathway – that because it is similar to already marketed devices, its safety and effectiveness are established.
Therefore, I cannot provide the requested information from the given text. The input does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number and qualifications of experts.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.