(122 days)
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No
The summary describes a physical restraint device with no mention of software, data processing, or any technology related to AI or ML.
No.
The device is described as a "protective restraint device" intended to "limit patient movements," which is not a therapeutic function but rather a safety or management function.
No
The device is described as a "protective restraint device" used to limit patient movements for examination or protection, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical materials like nylon, polyester, and cotton flannel, 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 clearly states that the device is used to "limit patient movements thereby enabling examination or protection of the patient or others." This describes a physical restraint used on a patient, not a test performed on a sample taken from the body.
- Device Description: The description details a "protective restraint device" made of "nylon or polyester seat belt webbing and cotton flannel." This is a physical device applied externally to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information about a patient's health status through laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DeRoyal Industries, Inc. Roll Belt does not fit this description.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Roll Belt 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 or others. The DeRoyal Industries, Inc. Roll Belt is intended to be used with a bed.
Product codes
80FMQ
Device Description
The DeRoyal Industries, Inc. Roll Belt is a protective restraint device that is intended for medical purposes to limit patient movements so that the patient remains in the bed while allowing the patient to move from side to side thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Roll Belt is designed similar to those marketed by other manufacturers. The Roll Belt is primarily comprised of nylon or polyester seat belt webbing and cotton flannel.
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
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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
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
K963467
JAN. 3, 1997
DeRoyal Industries, Inc. Roll Belt
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
DeRoyal Industries, Inc. NAME: 200 DeBusk Lane ADDRESS: Powell, TN 37849
TELEPHONE: CONTACT: DATE OF PREPARATION: (423) 938-7828 Camille Matlock August 30, 1996
DEVICE NAMES
DeRoyal Industries, Inc. Roll Belt NAME: Roll Belt COMMON/USUAL NAME: CLASSIFICATION NAME (if known): Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posev Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Roll Belt is a protective restraint device that is intended for medical purposes to limit patient movements so that the patient remains in the bed while allowing the patient to move from side to side thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Roll Belt is designed similar to those marketed by other manufacturers. The Roll Belt is primarily comprised of nylon or polyester seat belt webbing and cotton flannel.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Roll Belt 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 or others. The DeRoyal Industries, Inc. Roll Belt is intended to be used with a bed.
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of nylon or polyester seat | |
| belt webbing. Materials also include cotton | ||
| flannel and foam rubber for soft padding. | ||
| Fasteners are either a hook and loop or a | ||
| buckle. | Same | |
| Size | Small, Medium, and Large | Same |
| Vehicles for | ||
| Attachment | Bed | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient | ||
| Activity | Mildly Agitated or disoriented | Same |
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
Image /page/0/Picture/19 description: The image shows a handwritten text that appears to be a signature or initials. The characters are stylized and connected, with thick strokes forming the letters. The overall impression is that of a quick, cursive signature.