(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.
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JAN 2 2 1997
Y96934880
DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: DeRoyal Industries, Inc. ADDRESS: 200 DeBusk Lane Powell. TN 37849
TELEPHONE: CONTACT: DATE OF PREPARATION: (423) 938-7828 Camille Matlock August 30, 1996
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder Utility Restraint/ Body Holder Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
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.
DEVICE INTENDED USE
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.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of nylon or cotton.Materials also include blue purr foam, whitebinding, and webbing. | Same |
| Size | Universal | Same |
| Vehicles forAttachment | Body Holder: Bed or WheelchairMulti-Purpose Utility Restraint: OR Table,Gurney, Bed, or Stretcher | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of PatientActivity | Mildly Agitated or DisorientedSurgical PatientPatient Transport | Same |
N/A