(84 days)
These products are intended to limit movement in a hospital patient.
The devices included in this 510(k) submission limit movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured around the patient via straps. These straps are secured behind the patient with either heavy duty corset buckles or heavy duty standard buckles.
I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) submission for "Straight Jackets" and primarily focuses on regulatory classification, common names, and a historical context of their marketing and exemption status.
Specifically, the text is a "SAFETY AND EFFECTIVENESS SUMMARY" but it does not include any performance data, clinical study results, or explicitly stated acceptance criteria for the device. It discusses the device's purpose (limiting patient movement) and its comparison to legally marketed devices (the manufacturer's own current products), but it does not detail any studies proving its safety or effectiveness in terms of measureable outcomes or performance metrics.
Therefore, I cannot provide any of the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or expert details for test sets.
- Adjudication methods.
- MRMC study details or effect sizes.
- Standalone performance studies.
- Types of ground truth used.
- Training set sample sizes or ground truth establishment methods.
The document is purely a regulatory statement about the device's status and comparison within the 510(k) framework, not a summary of performance studies.
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NOV 22 1996
Image /page/0/Picture/2 description: The image is a black and white logo for "Posey Quality". The logo is a circle with a four-leaf clover in the center. The word "Posey" is written twice in the clover, once on the top and once on the left side. The word "Quality" is written at the bottom of the circle.
· Arcadia California 91006-0020 U.S.A. 5635 Peck Road
Customer Service Toll Free: (800) 44-POSEY el: (818) 443-3143 Fax: (818) 443-5014
SAFETY AND EFFECTIVENESS SUMMARY
JT Posev Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 18, 1996
Phone # (818) 443-3143 (818) 443-5014 FAX # =
Reference Number: K963410
Trade Name: Straight Jackets Common Name: Straight Jackets Classification Name: Protective Restraints
The devices included in this 510(k) submission limit movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured around the patient via straps. These straps are secured behind the patient with either heavy duty corset buckles or heavy duty standard buckles.
These products are intended to limit movement in a hospital patient.
The devices used for comparative purposes are identical to the straight jackets as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is submitted in response to the agency's final rule published on March 4, 1996 in the Federal Register 21 CFR 880 and 21 CFR 890 Medical Devices, Protective Restraints - Revocation of Exemptions from 510(k) Pre-market Notification Procedures and Current Good Manufacturing Practice Requiation. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for comparison:
"Predicate device
FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for comparison purposes in their submissions. It would also be appropriate to reference any approved 510(k)s that manufacturers have submitted for their products."
The straight jackets are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission, August 30,1996. The limb holders have been manufactured and in commercial distribution for up to 20 years.
§ 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.