(72 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical restraint device with no mention of software, algorithms, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device's intended use is to limit pediatric patient movements for examination or protection, not to treat a disease, injury, or condition.
No
This device is a physical restraint used to limit patient movement for examination or protection, not to diagnose a medical condition.
No
The device description clearly states it is comprised of physical materials like flannel, cool knit, polyester straps, nylon hook and loop, and steel nickel plated buckles, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "limit pediatric patient movements thereby enabling examination or protection of others." This describes a physical restraint used on a patient.
- Device Description: The description details a physical vest made of fabric and straps, designed to restrict movement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a physical restraint used directly on a patient.
N/A
Intended Use / Indications for 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.
Product codes
80FMQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric patient, Infant, child (2-4)(4-6)(6-8)
Intended User / Care Setting
responsible licensed healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |