(72 days)
The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard.
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher frame and secured with the Hook and Loop to allow for quick and easy application and release.
The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies for the Morrison Medical Products Best Strap Restraint.
The document is a "Safety and Effectiveness Summary" for a 510(k) submission, primarily focusing on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and technological characteristics, and states that there are no changes to the device itself but only to the labeling to comply with regulatory guidance. It also briefly mentions biocompatibility.
Therefore, I cannot fulfill the request to build a table of acceptance criteria and reported device performance or provide details on the studies as the information is not present in the given text.
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Image /page/0/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" stacked on top of "MEDICAL" and "PRODUCTS" on the right. The text is in a bold, sans-serif font.
Morrison Medical Products Best Strap Restraint
Safety and Effectiveness Summary
1. Submitter's name. Address and Contact Person
Submitter Morrison Medical Products 610 W. Town Street Columbus, OH 43215-4446 Contact Person Joseph S. Tokarz: Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849. Fax: (847)918-3860 Ph:
Date Summary Prepared - August 23, 1996
2. Name of Device:
Best Strap Restraint
3. Name of Predicate Device(s)
Best Strap Restraint
4. Description of Device
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher frame and secured with the Hook and Loop to allow for quick and easy application and release.
5. Statement of Intended Use
The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard.
6. Statement of Technological Characteristics of the Device
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher
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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 Best Strap Restraint
frame and secured with the Hook and Loop to allow for quick and easy application and release.
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. 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 Morrison Medical Best Strap Restraint 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.