(72 days)
The DeRoyal Industries, Inc. Pediatric Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient movements thereby enabling examination or protection of thers. The Pediatric Vest Restraint is a protective restraint that can be used with a crib or bed.
The DeRoyal Industries, Inc. Pediatric Vest Restraint device that is intended for medical purposes to limit pediatric patient movements thereby enabling examination or protection of the patient or others. The Pediatic Vest Restraint is also available as an immobilization shirt which prevents the pediatric patient's arms from bending at the elbows with the use wooden staves (tongue depressors).
Device Design/Materials Used/Physical Properties: The DeRoyal Pediatric Vest Restraint is designed similar to those marketed by other manufacturers. The Pediatic Vest Restraint is primarily comprised of flannel or cool knit with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.
The provided text describes a medical device, the DeRoyal Industries, Inc. Pediatric Vest Restraint, and its similarity to predicate devices. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
This 510(k) summary focuses on demonstrating substantial equivalence to previously marketed devices based on design, materials, size, intended use, and other characteristics. It does not include data from a clinical or performance study that would typically be required to prove a device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy.
Therefore, I cannot populate the table or answer the specific questions about studying a device's performance against acceptance criteria using the provided text. The document is essentially a comparative analysis of device features, not a performance study report.
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DeRoyal Industries, Inc. Pediatric Vest Restraint
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATI 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. Pediatric Vest Restraint Pediatric Vest Restraint Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Pediatric Vest Restraint device that is intended for medical purposes to limit pediatric patient movements thereby enabling examination or protection of the patient or others. The Pediatic Vest Restraint is also available as an immobilization shirt which prevents the pediatric patient's arms from bending at the elbows with the use wooden staves (tongue depressors).
Device Design/Materials Used/Physical Properties: The DeRoyal Pediatric Vest Restraint is designed similar to those marketed by other manufacturers. The Pediatic Vest Restraint is primarily comprised of flannel or cool knit 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. Pediatric Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient movements thereby enabling examination or protection of thers. The Pediatric Vest Restraint is a protective restraint that can be used with a crib or bed.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of cotton flannel or polyester cool knit. The straps are made of polyester twill tape and white webbing. Fasteners are made of hook and loop or steel nickel plated buckles. The stave for the immobilization shirt is made of wooden tongue depressors. | Same |
| Size | Infant, child (2-4)(4-6)(6-8) | Same |
| Vehicles for Attachment | Crib or Bed | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Vest Restraint: Limb Interference by pediatric patient Immobilization Shirt: Pediatric patient tends to bend elbows | 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.