(72 days)
The DeRoyal Industries, Inc. Sleeveless Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Sleeved/ Sleeveless Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
The DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoval Sleeved/ Sleeveless Vest Restraint is designed similar to those marketed by other manufacturers. The Sleeved/ Sleeved/ Sleeved/ Sleeved/ of cool knit, cotton, or with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.
This document does not describe acceptance criteria for a medical device and a study to prove the device meets said criteria.
Instead, this is a 510(k) premarket notification summary for a Sleeved/Sleeveless Vest Restraint. The purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to establish novel performance criteria through a new study.
Therefore, I cannot provide the requested information based on the text provided. The document focuses on:
- Device identification and categorization.
- Description of the device's design, materials, and intended use.
- Comparison of the device's technological characteristics with predicate devices to show it is "substantially equivalent." This comparison, as shown in the table, highlights that characteristics like materials, size, vehicles for attachment, length of use, and level of patient activity are "Same" as the predicate devices.
There is no mention of:
- Acceptance criteria or reported device performance.
- Sample sizes, data provenance, or test sets.
- Experts establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone performance studies.
- Types of ground truth.
- Sample size for the training set (as this is not an AI/ML device).
- How ground truth for a training set was established.
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NOV 1 1 1996
DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint
510(k) Summarv
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
FI LEPHONE: 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. Sleeved/ Sleeveless Vest Restraint Sleeved/ Sleeveless Vest Restraint Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posev Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoval Sleeved/ Sleeveless Vest Restraint is designed similar to those marketed by other manufacturers. The Sleeved/ Sleeved/ Sleeved/ Sleeved/ of cool knit, cotton, or with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Sleeveless Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Sleeved/ Sleeveless Vest Restraint is a protective restraint that is intended to 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 tietex, cotton flannel or polyester coolknit. The straps are made of polyester twill tape and whitewebbing. Fasteners are made of hook and loop or steel nickelplated buckles. | Same |
| Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX-Large | Same |
| Vehicles for Attachment | Bed or Wheelchair | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Mildly to moderately agitated or disoriented | Same |
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.