(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.
§ 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.