(62 days)
The Morrison Medical Wrist Restraint is intended to be a protective limb restraint that limits 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 positions.
The Morrison Medical Wrist Restraint is constructed of a nylon woven webbing and metal D-Ring. There is nylon hook and loop material sewn onto the nylon webbing. This nylon hook and loop combination is intended to secure the wrist restraint to the patient. The Wrist Restraint is intended to restrain the patient to a chair, cot or stretcher.
This document is a 510(k) premarket notification for a medical device (Morrison Medical Wrist Restraint). It states that the device is identical in intended use, design, materials, manufacturing process, physical and mechanical specifications, and issues of safety and effectiveness to a predicate device, with the only difference being revised labeling.
Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for the following reasons:
- No new studies were performed or are described. The submission relies on substantial equivalence to a predicate device, meaning it asserts that the new device performs as safely and effectively as a device already on the market without needing new performance studies.
- No specific acceptance criteria are defined for device performance. Since no new performance studies were conducted, there are no new acceptance criteria or reported device performance metrics.
- The document focuses on substantial equivalence, not de novo performance testing.
In situations like this 510(k) submission, the "study" proving the device meets acceptance criteria is often the demonstration of its substantial equivalence to a legally marketed predicate device, which inherently means it meets the safety and effectiveness standards previously established for the predicate. However, this submission does not detail those predicate device studies or criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a stylized black shape on the left, resembling a triangle with a cutout. To the right of the shape, the words "MORRISON MEDICAL PRODUCTS" are stacked in three lines, with each word in bold, sans-serif font. The overall design is simple and professional.
Image /page/0/Picture/2 description: The image contains a handwritten alphanumeric string. The string appears to be "K9603419". The characters are written in a cursive style with thick strokes, and the overall impression is that of a quickly written note or label.
Morrison Medical Products Wrist 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 28, 1996
2. Name of Device:
Morrison Medical Wrist Restraint
3. Name of Predicate Device(s)
Morrison Medical Wrist Restraint
4. Description of Device
The Morrison Medical Wrist Restraint is constructed of a nylon woven webbing and metal D-Ring. There is nylon hook and loop material sewn onto the nylon webbing. This nylon hook and loop combination is intended to secure the wrist restraint to the patient. The Wrist Restraint is intended to restrain the patient to a chair, cot or stretcher.
5. Statement of Intended Use
The Morrison Medical Wrist Restraint is intended to be a protective limb restraint that limits 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 positions.
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.
Page 18
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a black geometric shape on the left, resembling an abstract letter "M" or an arrow pointing upwards. To the right of the shape, the words "MORRISON MEDICAL PRODUCTS" are stacked in three lines, with each word in bold, sans-serif font. The overall design is simple and professional, conveying a sense of reliability and expertise in the medical field.
Morrison Medical Products Wrist Restraint
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 Wrist Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.
Page 19
§ 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.