DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT by DEPUY, INC.

The DePuy OrthoTech Heavy Duty Vest Restraint is intended to limit body movement and provide support for patients in chairs, wheelchairs and beds who (a) may be susceptible to lifethreatening falls, (b) may be suicidal, or (c) are aggressive.

Device Description

The body of the vest restraint is constructed from three main pattern pieces, two front panels and a back panel which are cut from polyester mesh fabric. The vest comes equipped with four pairs of long straps which are used for securing the patient to the chair, wheelchair or bed. The subject vest restraint is supplied in five sizes from X-small to X-large to fit chests from 28" to 56". It may be hand washed in warm water and air dried.

AI/ML Overview

The provided document K971742 is a 510(k) premarket notification for a medical device (DePuy OrthoTech Heavy Duty Vest Restraint). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.

The "Basis of Substantial Equivalence" section explicitly states that the device is considered substantially equivalent based on similarities in design, construction, materials, and intended uses to previously cleared devices. This means the device's "performance" is implicitly considered acceptable because it is similar to other devices already on the market.

Here's a breakdown of why each point of your request cannot be fulfilled by this document:

A table of acceptance criteria and the reported device performance: Not applicable. The document doesn't define specific performance criteria for the device beyond its intended use, nor does it report any testing against such criteria.
Sample sized used for the test set and the data provenance: Not applicable. No test set or study data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process is described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical restraint, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical restraint, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. No machine learning or algorithm training is involved.
How the ground truth for the training set was established: Not applicable.

In summary, the K971742 document is a regulatory submission for a physical medical device based on substantial equivalence, and it does not involve the type of performance data and study methodologies typically associated with digital health technologies or AI/ML devices that would require the information outlined in your request.

Summary

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K971742

SAFETY AND EFFECTIVENESS SUMMARY

JUL 2 4 1997

NAME OF FIRM:	DePuy, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988FDA Registration No.: 1818910
FIRM CONTACT:	Arlene Saull, RACManager, Medical Device SubmissionsDePuy Orthopaedics, Inc. (a subsidiary of DePuy, Inc.)700 Orthopaedic DriveWarsaw, IN 46581-0988
TRADE NAME:	DePuy OrthoTech Heavy Duty Vest Restraint
COMMON NAME:	Protective Restraints
CLASSIFICATION:	Class I per 21 CFR, 880.6760 Protective Restraint
DEVICE PRODUCT CODE:	80 FMQ Restraint, Protective
SUBSTANTIALLY EQUIVALENT DEVICES:

SUBSTANTIALLY EQUIVALENT DEVICES

Zimmer Heavy Duty Vest Restraint, and DePuy Vest Restraint with Sleeves (K963393)

DEVICE DESCRIPTION AND INTENDED USE:

BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on their similarities in design, construction, materials, and intended uses, DePuy, Inc. considers the subject DePuy OrthoTech Heavy Duty Vest Restraint as substantially equivalent to the DePuy Mesh Vest Restraint with Sleeves which was cleared by FDA in 510(k) K963393 and the Zimmer Inc. Heavy Duty Vest Restraint.

Heavy Duty Vest Restraints

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines beneath them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Arlene C. Saull Manager, Medical Device Submission DePuy, Incorporated_______ 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

JUL 2 4 1997

K971742 Re : DePuy Orthotech Heavy Duty Vest Restraint Trade Name: Regulatory Class: I Product Code: FMQ Dated: May 9, 1997 Received: May 12, 1997

Dear Ms. Saull:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Saull

through 542 of the Act for devices under the Electronic enroagle Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. JThe FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely Yours,

A. Ulatowski Time Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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INDICATIONS

510(k) Number (if known)_K971742

Device Name_DePuy OrthoTech Heavy Duty Vest Restraint

Indications for Use:

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============================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation (Division Sign-Off) Division of Dental. and General Hospit 510(k) Number Prescription Use_ OR Over-the-Counter Use -------(Per 21 CFR 801.109)

Heavy Duty Vest Restraints

Regulation Number and Section

§ 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.