(163 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical restraint device made of straps and fasteners, with no mention of software, data processing, or any technology that would involve AI or ML.
No
The device is described as a "protective restraint device" used to limit limb movements for examination or protection, not for treating a disease or condition.
No
The device is described as a "protective restraint device" used to limit limb movements "thereby enabling examination of the patient or others." It does not detect, diagnose, or monitor any medical condition.
No
The device description explicitly states it is comprised of "polyester straps with hook and loop fasteners," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DeRoyal Pediatric Limb Holder is a physical restraint device used to limit patient movement. It does not involve testing samples from the body.
- Intended Use: The intended use is to limit limb movements for examination or protection, not for diagnostic testing.
- Device Description: The description focuses on the physical components and function of a restraint device.
Therefore, the DeRoyal Pediatric Limb Holder falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Pediatric Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient limb movements thereby enabling examination of the patient or others. The Pediatric Limb Holder can be used with an OR table, gurney, bed, or stretcher.
Product codes
Not Found
Device Description
The DeRoyal Industries, Inc. Pediatic Limb Holder is a protective restraint device that is intended for medical purposes to limit pediatric patient limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials UsedPhysical Properties: The DeRoyal Pediatric Limb Holder is designed similar to those marketed by other manufacturers. The Pediatic Limb Holder is primarily comprised of polyester straps with hook and loop fasteners.
Materials: Primarily comprised of 100% polyester twill tape and white webbing. Materials also include blue purr foam or white kodel. Fasteners are made of hook and loop.
Size: Infant, child, teen
Vehicles for Attachment: OR Table, gurney, bed, or stretcher
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb
Indicated Patient Age Range
pediatric
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 Limb Holder
FEB 1 3 1997
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
| NAME: | DeRoyal Industries, Inc. | TELEPHONE: | (423) 938-7828 |
|---|---|---|---|
| ADDRESS: | 200 DeBusk Lane | ||
| Powell, TN 37849 | CONTACT: | Camille Matlock | |
| DATE OF PREPARATION: | August 30, 1996 |
DEVICE NAMES
DeRoyal Industries, Inc. Pediatric Limb Holder NAME: Pediatric Limb Holder COMMON/USUAL NAME: CLASSIFICATION NAME (if known): Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Pediatic Limb Holder is a protective restraint device that is intended for medical purposes to limit pediatric patient limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials UsedPhysical Properties: The DeRoyal Pediatric Limb Holder is designed similar to those marketed by other manufacturers. The Pediatic Limb Holder is primarily comprised of polyester straps with hook and loop fasteners.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Pediatric Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient limb movements thereby enabling examination of the patient or others. The Pediatric Limb Holder can be used with an OR table, gurney, bed, or stretcher.
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of 100% polyester twill | |
| tape and white webbing. Materials also include | ||
| blue purr foam or white kodel. Fasteners are | ||
| made of hook and loop. | Same | |
| Size | Infant, child, teen | Same |
| Vehicles for Attachment | OR Table, gurney, bed, or stretcher | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Limb Interference by Pediatric Patient | Same |