(70 days)
The DeRoval Industries. Inc. Pediatric Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient finger, hand, and/or limb movements thereby enabling examination or protection of the patient or others. The Pediatric Mittens can be attached to a bed or used alone.
The DeRoyal Industries, Inc. Pediatric Mittens are a protective restraint device that are intended for medical purposes to limit pediatric patient finger and hand movements thereby enabling examination or protection of the patient or others. Limb restraint straps that attach to the Pediatric Mittens are optional, if needed.
Device Design/Materials Used/Physical Properties: The DeRoyal Pediatic Mittens are designed similar to those marketed by other manufacturers. The Pediatric Mittens are primarily comprised of 100% polyester and cotton with hook and loop fasteners.
This document is a 510(k) summary for a medical device called "DeRoyal Industries, Inc. Pediatric Mittens." It describes the device, its intended use, and compares it to predicate devices. It does not contain information about acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study parameters you've requested (sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.).
The document focuses on demonstrating substantial equivalence to existing legally marketed devices based on shared characteristics like materials, size, attachment options, length of use, and patient activity level. It does not present performance data or clinical study results in the way required by your prompt.
Therefore, I cannot provide the requested table and study details.
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DeRoyal Industries, Inc. Pediatric Mittens
510(k) Summarv
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
DeRoyal Industries, Inc. NAME: 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 Mittens Pediatric Mittens Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Pediatric Mittens are a protective restraint device that are intended for medical purposes to limit pediatric patient finger and hand movements thereby enabling examination or protection of the patient or others. Limb restraint straps that attach to the Pediatric Mittens are optional, if needed.
Device Design/Materials Used/Physical Properties: The DeRoyal Pediatic Mittens are designed similar to those marketed by other manufacturers. The Pediatric Mittens are primarily comprised of 100% polyester and cotton with hook and loop fasteners.
DEVICE INTENDED USE
The DeRoval Industries. Inc. Pediatric Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient finger, hand, and/or limb movements thereby enabling examination or protection of the patient or others. The Pediatric Mittens can be attached to a bed or used alone.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of 100% polyester cool knit, blue purr, and 100 % cotton white twill tape. Fasteners are made of hook and loop. | Same |
| Size | Infant and child | Same |
| Vehicles for Attachment | Attachment to bed is optional, if needed | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Finger, hand, or limb interference by pediatric patient | 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.