CINCH STRAP WITH BUCKLE

K963370 · Morrison Medical Products · FMQ · Nov 8, 1996 · General Hospital

Device Facts

• Record ID: K963370
• Device Name: CINCH STRAP WITH BUCKLE
• Applicant: Morrison Medical Products
• Product Code: FMQ · General Hospital
• Decision Date: Nov 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Indications for Use

The Morrison Medical Products Cinch Strap with Buckle is intended to limit the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting position. The device is also intended to be used as an assist in securing equipment.

Device Story

Cinch Strap with Buckle; nylon hook and loop material; heat-sealed nylon hook end. Used to limit patient movement or secure equipment. Applied by clinicians in clinical settings. Provides physical restraint or equipment stabilization. Benefits include patient/staff safety and equipment security.

Clinical Evidence

Bench testing only; no clinical data presented. Biocompatibility review of materials indicated low potential for adverse reaction.

Technological Characteristics

Nylon hook and loop material; heat-sealed construction. Available in sizes 1" x 42", 1.5" x 18", and 1.5" x 30".

Indications for Use

Indicated for patients requiring movement limitation for treatment, examination, or protection of the patient or others; applicable for patients in supine or sitting positions; also indicated for securing medical equipment.

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

• Cinch Strap with Buckle

Submission Summary (Full Text)

{0}

MORRISON MEDICAL PRODUCTS
K 963370

# Morrison Medical Products
## Cinch Strap with Buckle

NOV - 8 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 23, 1996

## 2. Name of Device:
Cinch Strap with Buckle

## 3. Name of Predicate Device(s)
Cinch Strap with Buckle

## 4. Description of Device
The Morrison Medical Products Cinch Strap with Buckle is intended to limit a patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting position. The device is also intended to be used as an assist in securing equipment.

The Cinch Strap with Buckle is constructed of a nylon hook and loop material. Heat Sealed to one end is a nylon hook material that is used to secure the patient or equipment in the Cinch Strap with Buckle. The Cinch Strap with Buckle is available in the following sizes:

- Series 1142 - 1" x 42"
- Series 1150 - 1½" x 18"
- Series 1160 - 1½ x 30"

## 5. Statement of Intended Use
The Morrison Medical Products Cinch Strap with Buckle is intended to limit the patient’s movement to the extent necessary for treatment, examination, or protection of the patient

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

{1}

MORRISON MEDICAL PRODUCTS

# Morrison Medical Products
## Cinch Strap with Buckle

or others. The device can be used in the supine or sitting position. The device is also intended to be used as an assist in securing equipment.

## 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

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

## 8. Conclusion

Based upon the information presented above it is concluded that the proposed Morrison Medical Products Cinch Strap with Buckle is safe and effective for its intended use and is substantially equivalent to the predicate device.

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