(68 days)
The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide. suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease. Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances. Finally, these restraints are labeled with the prescription legend, and thus. should only be used on the order of a physician.
Vest Restraints
This document is a 510(k) summary for medical device clearance, specifically for "Vest Restraints" manufactured by Zimmer Patient Care Division. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as one would expect for a diagnostic or AI-powered medical device.
Instead, this document is a summary for a clearance for a physical medical device (vest restraints) that was already legally marketed and whose only change was the addition of "color-coded banding." The focus of the document is on the device's intended use, comparison to existing devices, and compliance with regulations related to their use (such as those from the Health Care Financing Administration and the Joint Commission on Accreditation of Healthcare Organizations).
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, or details about standalone or MRMC studies, because none of that information is present in the provided text. The document does not describe any performance metrics that would typically require such studies for device clearance.
§ 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.