(141 days)
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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" used to limit movement for examination or protection, not for treating a disease or condition.
No
The device is described as a "protective restraint" used to limit movement for "examination or protection of the patient or others," not to diagnose a condition.
No
The device description explicitly states it is comprised of physical materials like tietex, polyester straps, nylon hook and loop, and plastic, 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 movements thereby enabling examination or protection of the patient or others." This describes a physical restraint used on a patient.
- Device Description: The description details a physical garment made of fabric and straps, designed to be used with a bed or wheelchair.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside of the living body).
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a physical restraint used for patient management and safety.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the Tuxedo Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
Product codes
80FMO
Device Description
The DeRoyal Industries, Inc. Tuxedo Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others.
Device Designition Undering: The DeRoyal Tuxedo Vest Restraint is designed similar to those marketed by other manufacturers. The Tuxedo Restraint is primarily comprised of white or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop or plastic.
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
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
K963474
Jan. 22, 1997
DeRoyal Industries, Inc. Tuxedo Vest Restraint
510(k) Summarv
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: DeRoyal Industries, Inc. 200 DeBusk Lane ADDRESS: 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): DeRoval Industries. Inc. Tuxedo Vest Restraint Tuxedo Vest Restraint Restraint, Protective (80FMO)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Tuxedo Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others.
Device Designition Undering: The DeRoyal Tuxedo Vest Restraint is designed similar to those marketed by other manufacturers. The Tuxedo Restraint is primarily comprised of white or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop or plastic.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the Tuxedo 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 and polyester | |
| straps. Fasteners are made of hook and loop or plastic. | Same | |
| Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX-Large | Same |
| Vehicles for Attachment | Bed or Wheelchair | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Moderately agitated or disoriented | |
| Prone to sliding | ||
| Actively trying to get out of bed or wheelchair | Same |