(141 days)
Not Found
Not Found
No
The summary describes a physical restraint device with no mention of software, data processing, or AI/ML terms.
No.
The device is described as a "protective restraint device" used to limit limb movements for examination or protection, and it does not treat or cure any medical condition.
No
Explanation: The device is described as a "protective restraint device" used to "limit limb movements thereby enabling examination or protection of the patient or others." It does not actively diagnose any medical condition, but rather facilitates the examination process.
No
The device description explicitly details physical components like materials (kodel, nylon, flannel, blue purr, white webbing) and fasteners (hook and loop, 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The DeRoyal Disposable Limb Holder is a physical restraint device used to limit limb movement on the patient's body. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is to facilitate examination or protect the patient or others by limiting movement, not to diagnose or monitor a medical condition through laboratory testing.
Therefore, the description clearly indicates a physical medical device used for patient management, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Disposable Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination of the patient or others. The Disposable Limb Holder can be used with a gurney, bed, or stretcher.
Product codes
80FMQ
Device Description
The DeRoyal Industries, Inc. Disposable Limb Holder is a protective restraint device that is intended for medical purposes to limit limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Disposable Limb Holder is designed similar to those marketed by other manufacturers. The Disposable Limb Holder is primarily comprised of a kodel, nylon, flannel or blue purr material. The straps are made of white webbing. The fasteners are made of hook and loop or steel nickel plated buckles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
responsible licensed healthcare professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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. Disposable Limb Holder
510(k) Summary
JAN 22 1997
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
(423) 938-7828 TELEPHONE: DeRoyal Industries, Inc. NAME: Camille Matlock CONTACT: ADDRESS: 200 DeBusk Lane August 30, 1996 DATE OF PREPARATION: Powell, TN 37849
DEVICE NAMES
DeRoyal Industries, Inc. Disposable Limb Holder NAME: Disposable 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. Disposable Limb Holder is a protective restraint device that is intended for medical purposes to limit limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Disposable Limb Holder is designed similar to those marketed by other manufacturers. The Disposable Limb Holder is primarily comprised of a kodel, nylon, flannel or blue purr material. The straps are made of white webbing. The fasteners are made of hook and loop or steel nickel plated buckles.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Disposable Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination of the patient or others. The Disposable Limb Holder can be used with a gurney, bed, or stretcher.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of kodel, nylon, flannel or | |
| blue purr material. The straps are made of | ||
| white webbing. Fasteners include hook and | ||
| loop or buckles. | Same | |
| Size | Universal | Same |
| Vehicles for | ||
| Attachment | Gurney, Bed, or Stretcher | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient | ||
| Activity | Mildly to moderately agitated or disoriented | Same |