K Number
K963464
Device Name
RESTRAINT NET
Date Cleared
1996-11-12

(70 days)

Product Code
Regulation Number
880.6760
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DeRoyal Industries, Inc. Restraint Net is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient body movements thereby enabling protection of the patient or others. The Restraint Net/Bed is intended to be attached to a bed. The Restraint Net/Stretcher is intended to a stretcher.
Device Description
The DeRoyal Industries, Inc. Restraint Net is a protective restraint device that is intended for medical purposes to restrict patient body movements thereby enabling protection of the patient or others. Device Design/Materials Used/Physical Properties: The DeRoyal Restraint Net is designed similar to those marketed by other manufacturers. The Restraint Net is primarily comprised of white mesh.
More Information

Not Found

Not Found

No
The 510(k) summary describes a physical restraint device made of mesh, with no mention of software, algorithms, or any technology that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".

No.
The Restraint Net is described as a protective restraint device to restrict patient body movements for protection, not for treatment or therapy.

No

Explanation: The device description states its purpose is to restrict patient body movements for protection, not to diagnose a medical condition.

No

The device description explicitly states the device is comprised of "white mesh," indicating it is a physical product and 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 body movements thereby enabling protection of the patient or others." This is a physical restraint device used on a patient, not a device used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose or monitor a medical condition.
  • Device Description: The description confirms it's a "protective restraint device" made of "white mesh." This aligns with a physical restraint, not an IVD.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens.
    • Detecting or measuring substances in specimens.
    • Providing diagnostic information based on laboratory tests.

Therefore, the DeRoyal Industries, Inc. Restraint Net is a medical device, but it falls under the category of a physical restraint, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The DeRoyal Industries, Inc. Restraint Net is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient body movements thereby enabling protection of the patient or others. The Restraint Net/Bed is intended to be attached to a bed. The Restraint Net/Stretcher is intended to a stretcher.

Product codes

Not Found

Device Description

The DeRoyal Industries, Inc. Restraint Net is a protective restraint device that is intended for medical purposes to restrict patient body movements thereby enabling protection of the patient or others.

Device Design/Materials Used/Physical Properties: The DeRoyal Restraint Net is designed similar to those marketed by other manufacturers. The Restraint Net is primarily comprised of white mesh.

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

K 96 3464

DeRoyal Industries, Inc. Restraint Net

NOV 1 2 1996

510(k) Summarv

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: COMMON/USUAL NAME: CLASSIFICATION NAME (if known):

DeRoyal Industries. Inc. Restraint Net Restraint Net Restraint, Protective (80FMQ)

PREDICATE OR LEGALLY MARKETED DEVICES

J.T. Posey Company DeRoyal Industries, Inc.

DEVICE DESCRIPTION

The DeRoyal Industries, Inc. Restraint Net is a protective restraint device that is intended for medical purposes to restrict patient body movements thereby enabling protection of the patient or others.

Device Design/Materials Used/Physical Properties: The DeRoyal Restraint Net is designed similar to those marketed by other manufacturers. The Restraint Net is primarily comprised of white mesh.

DEVICE INTENDED USE

The DeRoyal Industries, Inc. Restraint Net is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient body movements thereby enabling protection of the patient or others. The Restraint Net/Bed is intended to be attached to a bed. The Restraint Net/Stretcher is intended to a stretcher.

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

CharacteristicDeRoyal DeviceOther Devices
MaterialsPrimarily comprised of white mesh, white
webbing straps (100% polyester), and steel
nickel plated fastenersSame
SizeUniversalSame
Vehicles for
AttachmentRestraint Net/Bed: BedSame
Restraint Net/Stretcher: StretcherSame
Length of useShort term useSame
Level of Patient
ActivityHighly Agitated or DisorientedSame
AggressiveSame
Patient requires physical controlSame