(141 days)
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Not Found
No
The 510(k) summary describes a physical restraint device made of traditional materials and does not mention any software, algorithms, or AI/ML related terms.
No
Explanation: This device is a restraint for limiting limb movements for examination or protection, not for treating a disease or condition.
No
Explanation: The device is a restrictive limb holder designed to limit patient limb movements for examination or protection, not to diagnose a medical condition.
No
The device description explicitly states it is comprised of physical materials like leather, neoprene, kodel, nylon, polyester, delrin, and steel, indicating it is a physical hardware 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 perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The DeRoyal Restrictive Limb Holder is described as a "protective restraint device" intended to "substantially limit patient limb movements." Its purpose is for "examination or protection of the patient or others."
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test on the patient's body fluids or tissues.
The device's function is purely physical restraint for safety and examination purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Restrictive Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to substantially limit patient limb movements thereby enabling examination or protection of the patient or others. The Restrictive Limb Holder can be used with a gurney, bed, or stretcher.
Product codes
80FMQ
Device Description
The DeRoyal Industries, Inc. Restrictive 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 Restrictive Limb Holder is designed similar to those marketed by other manufacturers. The Restrictive Limb Holder is primarily comprised of leather, neoprene, and soft kodel with nylon or polyester webbing straps. The types of fasteners include hook and loop, delrin, and various types that are steel nickel plated.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
limb movements
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)
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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
JAN 22 1997
K9653468
DeRoyal Industries, Inc. Restrictive Limb Holder
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 | CONTACT: | Camille Matlock |
| Powell, TN 37849 | DATE OF PREPARATION: | August 30, 1996 |
DEVICE NAMES
DeRoyal Industries, Inc. Restrictive Limb Holder NAME: COMMON/USUAL NAME: Restrictive Limb Holder Restraint, Protective (80FMQ) CLASSIFICATION NAME (if known):
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Restrictive 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 Restrictive Limb Holder is designed similar to those marketed by other manufacturers. The Restrictive Limb Holder is primarily comprised of leather, neoprene, and soft kodel with nylon or polyester webbing straps. The types of fasteners include hook and loop, delrin, and various types that are steel nickel plated.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Restrictive Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to substantially limit patient limb movements thereby enabling examination or protection of the patient or others. The Restrictive Limb Holder can be used with a gurney, bed, or stretcher.
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of leather, neoprene, and | |
| soft kodel material with webbing straps. The | ||
| types of fasteners include hook and loop, delrin, | ||
| and various types that are steel nickel plated | 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 | Highly agitated or violent | Same |