(72 days)
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No
The description details a physical restraint device made of fabric and fasteners, with no mention of software, data processing, or any technology that would involve AI or ML.
No
The document describes a restraint device used to limit patient movement for examination or protection, which is not typically considered a therapeutic device.
No
The device is described as a restraint used to limit patient movement for safety or examination purposes, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical materials like cool knit, cotton, plaid tietex, polyester straps, nylon hook and loop, plastic, or 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "Criss-Cross Vest Restraint" intended to "limit patient movements thereby enabling examination or protection of the patient on others." This is a physical restraint device used externally on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on internal bodily processes.
Therefore, the DeRoyal Industries, Inc. Criss-Cross Vest Restraint falls under the category of a physical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Criss-Cross Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient on others. The Criss-Cross Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
Product codes
80FMQ
Device Description
The DeRoyal Industries, Inc. Criss-Cross Vest Restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others.
Device Design/Materials UsedPhysical Properties: The DeRoyal Criss-Cross Vest Restraint is designed similar to those marketed by other manufacturers. The Criss-Cross Vest Restraint is primarily comprised of cool knit, cotton, or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop, plastic, or steel nickel plated buckles.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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DeRoyal Industries, Inc. Criss-Cross Vest Restraint
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION 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: DeRoyal Industries, Inc. Criss-Cross Vest Restraint COMMON/USUAL NAME: Criss-Cross Vest Restraint 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. Criss-Cross Vest Restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others.
Device Design/Materials UsedPhysical Properties: The DeRoyal Criss-Cross Vest Restraint is designed similar to those marketed by other manufacturers. The Criss-Cross Vest Restraint is primarily comprised of cool knit, cotton, or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop, plastic, or steel nickel plated buckles.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Criss-Cross Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient on others. The Criss-Cross Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of plaid or white tietex, cotton flannel or | |
| polyester cool knit. The straps are made of polyester twill tape | ||
| and white webbing. Fasteners are made of hook and loop, | ||
| plastic, or steel nickel plated buckles. | Same | |
| Size | Small, Medium, Large, X-Large, XX-Large | Same |
| Vehicles for | ||
| Attachment | Bed or Wheelchair | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient | ||
| Activity | Mildly agitated or disoriented | Same |
| Reminder |