ANKLE RESTRAINT SYSTEM

K963416 · Morrison Medical Products · FMQ · Nov 6, 1996 · General Hospital

Device Facts

• Record ID: K963416
• Device Name: ANKLE RESTRAINT SYSTEM
• Applicant: Morrison Medical Products
• Product Code: FMQ · General Hospital
• Decision Date: Nov 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Indications for Use

The Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a cot or stretcher. The Ankle Restraint System is intended to secure the patient’s ankles by keeping them in a fixed position.

Device Story

Ankle restraint system for patient control; secures ankles in fixed position on cot or stretcher. Consists of two ankle cuffs attached to 17-inch nylon security strap; nylon hook and loop closures. Used by healthcare providers in clinical or transport settings to prevent patient movement. Benefits include patient safety and controlled positioning.

Clinical Evidence

No clinical data; bench testing/biocompatibility assessment only. Materials identical to predicate with no history of adverse skin irritation reports.

Technological Characteristics

Materials: nylon woven webbing. Components: two ankle restraints, 17-inch security strap, hook and loop closures. Mechanical restraint system; no energy source or software.

Indications for Use

Indicated for patients requiring physical restraint/control while positioned on a cot or stretcher.

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.

Predicate Devices

• Ankle Restraint System

Submission Summary (Full Text)

{0}

MORRISON MEDICAL PRODUCTS
196346
Morrison Medical Products
Ankle Restraint System
NOV - 6 1996

# Safety and Effectiveness Summary

## 1. Submitter's name, Address and Contact Person

| Submitter | Contact Person |
| --- | --- |
| Morrison Medical Products
610 W. Town Street
Columbus, OH 43215-4446 | Joseph S. Tokarz, Manager, Regulatory Affairs
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
Ph: [phone], Fax: [phone] |
| Date Summary Prepared - | August 26, 1996 |

## 2. Name of Device:
Ankle Restraint System

## 3. Name of Predicate Device(s)
Ankle Restraint System

## 4. Description of Device
In recent years there has been considerable effort in the health care community to assure that restraints are used only when needed, usually with patient consent and that the least restrictive restraint be used. Morrison Medical Products has developed the Ankle Restraint System to help serve in this purpose. The Ankle Restraint System is designed for situations requiring patient control. The Ankle Restraint System is a restraint system that secures the patient’s ankles in a fixed position. It consists of two individual ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed using a nylon woven webbing that is 2 inches wide and 17 inches long. Straps attached to both ends of the security strap secure the ankle restraint system to a cot or stretcher. The individual ankle restraints are also constructed using a nylon woven webbing. A nylon hook and loop closure is secured to the webbing and is used to securely close the ankle restraint.

## 5. Statement of Intended Use
The Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a cot or stretcher. The Ankle Restraint System is intended to secure the patient’s ankles by keeping them in a fixed position.

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610 WEST TOWN STREET
COLUMBUS, OH 43215
FAX 614•469•96•96
614-461-4400

{1}

M

MORRISON MEDICAL PRODUCTS

# Morrison Medical Products
## Ankle Restraint System

### 6. Statement of Technological Characteristics of the Device

The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency’s labeling requirements set forth in the draft “Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints” dated December 1995.

### 7. Biocompatibility Assessment

The subject devices are identical in component materials to the predicate devices. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction.

### 8. Conclusion

Based upon the information presented above it is concluded that the proposed Ankle Restraint System is safe and effective for its intended use and is substantially equivalent to the predicate device.

Page 20

610 WEST TOWN STREET

COLUMBUS, OH 43215

FAX 614•469•96•96

614-461-4400