(64 days)
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard.
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard. The straps are constructed of an acrylic coated polyester woven material with an adhesive band on each end of the strap. The patient is secured to the backboard by lying the strap across the patient's body and peeling the release paper from the strap. The strap is woven through the hand hold in the backboard and stuck back onto the polyester strap. After use the strap is cut off with scissors.
This document is a 510(k) premarket notification for a disposable restraint strap, not a study evaluating a device's performance against acceptance criteria using statistical methods. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement.
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." The only difference is revised product labeling.
This implies that the device's safety and effectiveness are established by its substantial equivalence to a predicate device, not through a new study with specific performance acceptance criteria.
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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 simple, sans-serif font and is all in black.
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Morrison Medical Products Disposable Restraint Strap
Safety and Effectiveness Summary
1. Submitter's name. Address and Contact Person
Contact Person Submitter Joseph S. Tokarz; Manager, Regulatory Affairs Morrison Medical Products Hollister Incorporated 610 W. Town Street Columbus. OH 43215-4446 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax: (847)918-3860 Ph:
Date Summary Prepared - August 29, 1996
2. Name of Device:
Morrison Medical Disposable Restraint Strap
3. Name of Predicate Device(s)
Morrison Medical Disposable Restraint Strap
4. Description of Device
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard. The straps are constructed of an acrylic coated polyester woven material with an adhesive band on each end of the strap. The patient is secured to the backboard by lying the strap across the patient's body and peeling the release paper from the strap. The strap is woven through the hand hold in the backboard and stuck back onto the polyester strap. After use the strap is cut off with scissors.
5. Statement of Intended Use
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard.
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.
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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 "M" on the left, with the words "MORRISON MEDICAL PRODUCTS" stacked in three lines on the right. The font is bold and sans-serif, and the entire logo is in black and white.
Morrison Medical Products Disposable Restraint Strap
7. Biocompatibility
The materials used to manufacture this device are identical to a similar marketed device under comparable conditions of use. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in this device.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Morrison Medical Disposable Restraint Strap 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.