(72 days)
Not Found
Not Found
No
The 510(k) summary describes a physical restraint device made of cool knit material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is described as a protective restraint used to limit patient movement for postural support, examination, or protection, not for treating a disease or condition.
No
The device is described as a restraint used to limit patient movement for postural support, examination, or protection, not to diagnose a condition.
No
The device description explicitly states it is comprised of "cool knit material," indicating it is a physical restraint and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The DeRoyal Super Security Restraint is a physical restraint device used to limit patient movement for postural support, examination, or protection. It is applied externally to the patient.
- Intended Use: The intended use is to physically restrain a patient, not to analyze biological samples.
The description clearly indicates a physical restraint device, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Super Security Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patients thereby providing postural support or enabling examination or protection of the patient or others. The Super Security Restraint is a protective restraint which can be used with a bed or wheelchair.
Product codes
80FMQ
Device Description
The DeRoyal Industries. Inc. Super Security Restraint device that is intended for medical purposes to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Super Security Restraint is designed similar to those marketed by other manufacturers. The Super Security Restraint is primarily comprised of cool knit material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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): 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.
Not Found
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.
Not Found
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).
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
DeRoyal Industries, Inc. Super Security Restraint
K 96 347/
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
DeRoyal Industries, Inc. (423) 938-7828 TELEPHONE: NAME: ADDRESS: 200 DeBusk Lane CONTACT: Camille Matlock DATE OF PREPARATION: August 30, 1996 Powell, TN 37849
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Industries, Inc. Super Security Restraint Security Restraint Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries. Inc. Super Security Restraint device that is intended for medical purposes to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Super Security Restraint is designed similar to those marketed by other manufacturers. The Super Security Restraint is primarily comprised of cool knit material.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Super Security Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patients thereby providing postural support or enabling examination or protection of the patient or others. The Super Security Restraint is a protective restraint which can be used with a bed or wheelchair.
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | The body is comprised of Cool Knit (polyester). | |
| The binding and straps are made of polyester. | Same | |
| Style Variations | Vest with Pelvic Holder or | |
| Vest Only | 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 | |
| Tendency to Leave Bed or Wheelchair | Same |