Other than the fleece liner, all devices are intended to limit movement of severely agitated persons who may cause harm to themselves or to others if not restrained. The fleece liner is an accessory to reduce chatling when used with the silicone rubber cuff. Where locks are a part of the device, they are for the purpose of lessening the chance of unauthorized release.

Device Description

Silicone Rubber Cuff: The device is made of silicone rubber molded over a 0.015 inch mylar insert. A nickel plated oblong shaped steel loop is riveted on one end that can be inserted into one of 5 slots on the other end as the first step in securing
Disposable Fleece Liner: The disposable fleece liner is made of a soft, disposable fleece material that is designed to be placed over the cuff to reduce chafing.
Web Torso Restraint: The device is a 2 inch wide nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2 inch polyethylene side-release buckle with 2 inch slide bar, each attached 28 inches from the end.
Nylon Limb Holder: The device is a 2 inch wide nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2 inch polyethylene side-release buckle with 2 inch slide bar, each attached 14 inches (wrist) or 9 inches (ankle) from the center.
Vinyl Limb Holder: The device is a 2 inch wide vinyl strap with either two sewn on L-400 lock or two sewn-on 2 inch polyethylene side-release buckle with 2 inch slide bar, each attached 14 inches (wrist) or 9 inches (ankle) from the center.
Nylon Bed Restraints (Wrist): The device is attached to the bed frame using a 2 inch x 12 foot nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2 inch polyethylene side-release buckle with 2 inch slide bar, each attached 38 inches from each end. Two 2 inch x 12 inch (wrist) or two 2 inch x 14 inch (ankle) fleece-lined culls are sewn on to the 64 inch length of nylon webbing each either 14 inches (wrist) or 9 inches (ankle) from the center. The culls are available with a choice of 4 different types of closures: a 1 inch polyethylene side release buckle with 1 inch polyethylene slide bar, an L-400 lock, a 1 ½ inch double D ring buckle, or a polypropylene web buckle.
Nylon Torso Restraint: A 2 inch x 96 inch nylon webbing torso restraint is available in one size. The restraint is place over the chest or upper legs and secured to a bed with cither two L-400 lock buckles or two 2 inch polyethylene side-release buckle, each sewn 28 inches from the end. The restraint is optional for use with wrist restraints to prevent the restrained person from sitting up in the bed.
Nylon Transporter: This device consists of a 2 inch x 64 inch nylon webbing waist belt with two 2 inch x 12 inch nylon webbing wrist culls sewn on, the first 9 inches from the keeper, the second, 13 inches from the first. The waist belt is secured in back with a 2 inch polyethylene side release lock with 2 inch slider bar, the wrist cuffs are double secured with 4 1/4 inches of 1-1/2 inch hook and loop closure and twin D rings sewn onto the cuff along with a 1 inch x 18 inch black nylon webbing strap to cinch the D rings.

AI/ML Overview

I am sorry, but the provided text from K9603485 is a 510(k) Summary of Safety and Effectiveness for various protective restraints. It generally describes the devices, their intended use, and compares them to existing legally marketed devices.

This document does not contain information related to acceptance criteria, a study proving performance against such criteria, sample sizes for testing or training, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory compliance and equivalence to predicate devices, not on detailed performance studies with acceptance criteria.

Summary

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K9603485

了游

Image /page/0/Picture/1 description: The image shows the words "Humane Restraint" in a bold, sans-serif font. The words are stacked on top of each other, with "Humane" on the top line and "Restraint" on the bottom line. The text is black and the background is white. The dot on the i in Restraint is a circle.

NOV 22 1996

TAB F: 510(k) Summary of Safety and Effectiveness

Name, address, phone and fax numbers for person submitting the 510(k) notification:

Stacy Schultz, Product Manager Humane Restraint Company, Inc. 912 Waunakee, WI 53597 Phone: 1-800-356-7472 Fax: 1-608-849-6315

Contact Person: Stacy Schultz

Date summary was prepared: August 28, 1996

Device name:

Trade name(s):

Silicone Rubber Cuff Fleece Liner Web Torso Restraint Nylon Limb Holder Vinyl Limb Holder Nylon Bed Restraint (wrist) Nylon Torso Restraint Nylon Transporter
Common name: Same Classification name: Protective Restraint

Predicate device:

The fleece liners, silicone rubber cuffs, web torso restraints, nylon limb holders, vinyl limb holders, nylon bed restraints (wrist), nylon torso restraint, and nylon transporter, all legally marketed at this time. The devices described in this submission are our currently marketed products. This submission is in response to 61 FR 8431 -8439, Protective Restraints; Revocation of Exemptions From the 510(k) Premarket Notification Procedures and Current Good Manufacturing Practice Regulations.

Device Description:

Silicone Rubber Cuff: The device is made of silicone rubber molded over a 0.015 ટી. inch mylar insert. A nickel plated oblong shaped steel loop is riveted on one end that can be inserted into one of 5 slots on the other end as the first step in securing
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Nylon Bed Restraints (Wrist): The device is attached to the bed frame using a 2" x に 12 foot nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2" polyethylene side-release buckle with 2" slide bar, each attached 38" from each end. Two 2" x 12" (wrist) or two 2" x 14" (ankle) fleece-lined culls are sewn on to the 64" length of nylon webbing each either 14" (wrist) or 9" (ankle) from the center. The culls are available with a choice of 4 different types of closures: a 1" polyethylene side release buckle with 1" polyethylene slide bar, an L-400 lock, a I ½" double D ring buckle, or a polypropylene web buckle.
Nylon Torso Restraint: A 2" x 96" nylon webbing torso restraint is available in tic one size. The restraint is place over the chest or upper legs and secured to a bed with cither two L-400 lock buckles or two 2" polyethylene side-release buckle, each sewn 28" from the end. The restraint is optional for use with wrist restraints to prevent the restrained person from sitting up in the bed.
Nylon Transporter: This device consists of a 2" x 64" nylon webbing waist belt ﺷ with two 2" x 12" nylon webbing wrist culls sewn on, the first 9" from the keeper, the second, 13" from the first. The waist belt is secured in back with a 2" polyethylene side release lock with 2" slider bar, the wrist cuffs are double secured with 4 1/4 inches of 1-1/2" hook and loop closure and twin D rings sewn onto the cuff along with a 1" x 18" black nylon webbing strap to cinch the D rings.

Intended Use:

The following chart describes the device applications. >

Humane Restraint Company Summary of Safety and Effectiveness Various Protective Restraints Page 3 of 6

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dications for use (continu

DEVICE	LOCKS		APPLICATIONAMBULATORY				BED			NOTES	CATALOGPAGE #	DEVICE	YEARS
	WITH	WITHOUT	WRISTTO WRIST	ANKLETO ANKLE	WRISTTO BED	ANKLETO BED	TORSOTO BED					Silicone Rubber Cuff	1
SiliconeRubberCuff*	N/A	N/A	X	X	X	X		To be used with locking ornon-locking leather belts(pre-1976) and torso and/orchest restraints and/oroptional fleece liners **	2	Disposable Fleece Liner	1
Web TorsoRestraint	X	X					X(waist)	Optional use with limbholders	12	Web Torso Restraint	19
Nylon LimbHolder	X	X						Optional use with chest ortorso restrains	9	Nylon Limb Holder	1
Vinyl LimbHolder	X	X			X	X		Optional to use with chestor torso restraints	9	Vinyl Limb Holder	4
Nylon BedRestraints	X	X			X	X		May be used with optionalnylon chest restrain	9	Nylon Bed Restraint (wrist)	4
Nylon TorsoRestrain	X	X					X(chest andupper leg)	Optional to use with nylonbed restraint system	9	Nylon Torso Restraint:	4
NylonTransporter		X	X	X					15	Nylon Transporter	5

Humane Restraint Company
Summary of Safety and Effectiveness
Various Protective Restraints
Page 4 of 6

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Comparative information:

The devices used for comparative purposes are exactly the same as devices currently marketed by the Humane Restraint Company and as described in this submission.

These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by the Humane Restraint Company as of the date of this submission. The Humane Restraint Company has hecn manufacturing and commercially distributing these devices for the number of years as follows:

In addition to the devices listed and described in this submission, the Humane Restraint Company has been marketing devices with similar in designs but using different materials for more than 20 years. We have had no reports of injury for any of our products.

These restraint are intended and labeled for prescription use. The devices are not intended for lay use. The health care facilities where our devices are used are subject to the Health Care Financing Administration (HCFA) rules and usually meet accreditation standards. HCTA rules governing appropriate use of these devices and accreditation standards specifying conditions for device use and required personnel training provide controls necessary to ensure that the devices are used correctly. The application of these standards along with public awareness, and health care provider training have contributed significantly to ensuring that the least restraint is used, that restraints are used only when needed for proper medical treatment, and that their use is under appropriate supervision.

Use Restrictions for Restraints

The use of all patient restraints is subject to Health Care Financing Administration's Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience and specify that the patient situation be evaluated to assure that the least restrictive restraint is used.

Himane Restraint Company Summary of Safety and Effectiveness Various Protective Restraints Page 5 of 6

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Accreditation Training Requirements

Further, the "Revised Standards for Restraint and Scclusion", TX.7.1.3.2.4, 1996 Accreditation Manual for Hospitals, Volume 1, Joint Commission on Accreditation of I Icalthcare Organizations apply to all organizations accredited under the 1996 AMH, Volume 1, the Comprehensive Accreditation Manual for Ambulatory Care, and the Accreditation Manual for Mental Health, Chemical Dependency, and Mental Retardation-Developmental Disabilities.

These standards require that restraint be used correctly by competent trained staff. Organizations must identify, educate and determine competency of those staff members who apply or remove restraints and that the training consist of frequently repeated inservice education, including an understanding of manufacturers instructions for use of restraint device.

Humane Restraint Company Summary of Safety and Effectiveness Various Protective Restraints Page 6 of 6

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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.