(84 days)
These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, geriatric chair, wheelchair, or gurney,
The devices included in this 510(k) submission support the torso area. The product is closed around the patient by one or more of the following: criss crossing the fabric and straps, a zipper, hook and loop, or tie strings. The product is secured to the bed geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles.
This document is a 510(k) summary for protective restraints (jackets and vests) manufactured by JT Posey Company. It describes the device, its intended use, and the regulatory context for its submission. However, it does not contain the specific information requested about acceptance criteria, device performance, study details, or ground truth establishment.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details based on the provided text.
The document states that the devices used for comparative purposes are "identical to the jackets and vests as described in this submission and produced or sold by the J.T. Posey Co." and that these products 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." This indicates that the submission is primarily for regulatory compliance of existing products rather than providing new performance data from a specific study designed to meet new acceptance criteria.
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NOV 22 1996
Image /page/0/Picture/1 description: The image is a black and white logo for "Posey Quality". The logo is a circle with a four-leaf clover inside. The word "POSEY" is written three times on the clover, once on the top leaf, once on the left leaf, and once on the right leaf. The word "Quality" is written at the bottom of the circle.
Posev Comnanv
5635 Peck Road · Arcadia, California 91006-0020 U.S.A.
Toll Free: (800) 44-POSF Tel. (818) 443-3143
SAFETY AND EFFECTIVENESS SUMMARY
JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe Ceneral Manager August 30, 1996 Revised: November 18, 1996
Phone # (818) 443-3143 (818) 443-5014 FAX # #
Reference Number: K963442
Trade Name: Protective Restraints Common Name: Jackets and Vests Classification Name: Protective Restraints
The devices included in this 510(k) submission support the torso area. The product is closed around the patient by one or more of the following: criss crossing the fabric and straps, a zipper, hook and loop, or tie strings. The product is secured to the bed geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles.
These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, geriatric chair, wheelchair, or gurney,
The devices used for comparative purposes are identical to the jackets and vests as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is submitted in response to the aqency'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 Regulation. 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 jackets and vests 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.