(43 days)
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No
The 510(k) summary describes a physical restraint device made of cotton and steel fasteners, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as a "protective restraint device" used to "restrict patient upper body movements thereby enabling protection of the patient or others." It does not directly treat a disease or condition.
No
Explanation: The device is described as a "protective restraint device" used to restrict movement for protection, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical materials (cotton and steel fasteners), 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 "restrict patient upper body movements thereby enabling protection of the patient or others." This describes a physical restraint used on a living patient for safety purposes.
- Device Description: The description details a physical garment made of cotton and fasteners, designed to restrict movement.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment based on such analysis.
- Any laboratory or in-vitro procedures.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is a physical restraint applied externally to a patient.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Strait Jacket is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient upper body movements thereby enabling protection of the patient or others.
Product codes (comma separated list FDA assigned to the subject device)
80FMQ
Device Description
The DeRoyal Industries, Inc. Strait Jacket is a protective restraint device that is intended for medical purposes to restrict patient upper body movements thereby enabling protection of the patient or others.
Design Design/Materials Used/Physical Procerties: The DeRoyal Strait Jacket is designed similar to those marketed by other manufacturers. The Strait Jacket is primarily comprised of white armyduck cotton and steel nickel plated fasteners.
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
upper body
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
OCT 16 1996
DeRoyal Industries, Inc. Strait Jacket
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. Strait Jacket COMMON/USUAL NAME: Strait Jacket 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. Strait Jacket is a protective restraint device that is intended for medical purposes to restrict patient upper body movements thereby enabling protection of the patient or others.
Design Design/Materials Used/Physical Procerties: The DeRoyal Strait Jacket is designed similar to those marketed by other manufacturers. The Strait Jacket is primarily comprised of white armyduck cotton and steel nickel plated fasteners.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Strait Jacket is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient upper body movements thereby enabling protection of the patient or others.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of white armyduck cotton | |
| (pre-shrunk) | Same | |
| Size | Small, Medium, Large, and Extra-Large | Same |
| Intended Use | Restrict upper body movement | Same |
| Length of use | Short term use | Same |
| Level of Patient | ||
| Activity | Highly Agitated or Disoriented | Same |
| Aggressive | Same | |
| Patient requires physical control | Same |