POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER

K963431 · Zimmer, Inc. · FMQ · Nov 6, 1996 · General Hospital

Device Facts

• Record ID: K963431
• Device Name: POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER
• Applicant: Zimmer, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease. Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances.

Device Story

Limb holders (foam, polyester pile, flannel) designed to secure patient limbs to prevent self-injury or injury to clinical staff. Used in clinical settings (hospitals, nursing homes) by healthcare personnel. Operation involves manual application of restraints to patient limbs. Output is physical restriction of movement. Intended to ensure patient safety during medical treatment or recovery. Not for violent patients requiring heavy-duty restraints.

Clinical Evidence

No clinical data; bench testing only. Devices have 20+ years of commercial distribution history.

Technological Characteristics

Materials: Foam, polyester pile, flannel. Form factor: Limb holders/restraints with quick-release buckles. ISO 9001 certified manufacturing.

Indications for Use

Indicated for restless, confused, elderly, or unsteady patients; patients with emotional/psychological disturbance, suicidal ideation, drug/alcohol abuse, seizure, cardiac arrest, post-op recovery, sedation, stroke, neuromuscular disorders, or Alzheimer's disease. Contraindicated for exceptionally violent patients.

Regulatory Classification

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.

Submission Summary (Full Text)

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K963431

Patient Care Division
200 West Ohio Avenue
P.O. Box 10
Dover, OH 44622-0010
Phone: [phone]

# 510(k) Summary of Safety and Effectiveness

Contact Information: Paula S. Osorio
Director, Quality Assurance & Regulatory Compliance
Zimmer Patient Care Division
200 West Ohio Avenue
Dover, Ohio U.S.A. 44622
Telephone [phone]
Fax [phone]

Preparation Date: August 30, 1996
Device Name(s): Limb Holders (protective restraints)
Proprietary Names: Foam Limb Holder w/Quick Release Buckle
Polyester Pile Wrist/Ankle Restraint
Soft Flannel Wrist/Ankle Restraint
Wrist Restraint, Universal
Classification Name: Protective Restraint
Comparison Device: Same as above.

Intended Use: "The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel.

The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease.

Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances."

Comparative Data: The devices used for comparative purposes are the limb holders as described in this submission. (See Tab G - June 14, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH - for rationale.)

These limb holders are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations, and they are legally marketed by Zimmer Patient Care Division as of the date of this submission, August 30, 1996. These limb holders have been manufactured and in commercial distribution for over 20 years.

The use of all patient restraints in nursing homes is subject to Health Care Financing Administration Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience.

ISO 9001 Certified
F-1
A Bristol-Myers Squibb Company

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F-2

Further, the "Revised Standards for Restraint and Seclusion", TX.7.1.3.2.4, 1996 Accreditation Manual for Hospitals, Volume 1, Joint Commission on Accreditation of Healthcare Organizations, applies 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. The application of these standards, along with public awareness, and health care provider training, have contributed significantly to ensuring that the least restrictive restraint is used and that restraints are used only when needed for proper medical treatment and that their use is under appropriate supervision.

In our experience, the most significant problems involving restraints are not due to design or materials used, but rather are attributed to misuse or misapplication.