(73 days)
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 Morrison Medical Products 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 - 11/2" x 18" Series 1160 - 11/2 x 30"
The provided document is a 510(k) summary for the "Morrison Medical Products Cinch Strap with Buckle." This document does not contain information about acceptance criteria, device performance studies, or any of the other specific details requested in the prompt related to evaluating the performance of a device using statistical methods, human readers, or AI.
The document states that "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." It also mentions "The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements."
Therefore, I cannot extract the requested information from the provided text. The document's purpose is to demonstrate substantial equivalence to a predicate device, not to present a new performance study with acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for Morrison Medical Products. The logo consists of a large, stylized letter "M" on the left, followed by the words "MORRISON", "MEDICAL", and "PRODUCTS" stacked vertically on the right. The text is in a bold, sans-serif font and is aligned to the left.
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 | Joseph S. Tokarz, Manager, Regulatory Affairs |
| 610 W. Town Street | Hollister Incorporated |
| Columbus, OH 43215-4446 | 2000 Hollister Drive |
| Libertyville, IL 60048 | |
| Ph: (847)680-2849, Fax: (847)918-3860 |
Date Summary Prepared - August 23, 1996
- 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 - 11/2" x 18" Series 1160 - 11/2 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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Image /page/1/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a large, stylized letter "M" on the left, followed by the words "MORRISON", "MEDICAL", and "PRODUCTS" stacked vertically on the right. The text is in a bold, sans-serif font.
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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§ 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.