(84 days)
Not Found
Not Found
No
The summary describes a physical restraint device with no mention of software, data processing, or AI/ML terms.
No
The device is intended to hinder egress or aid in patient positioning, which are functions of a restraint, not a therapeutic device.
No
The device is intended to hinder egress or aid in positioning a patient, which are functions related to patient restraint and support, not diagnosis. The description does not mention any function related to identifying, analyzing, or monitoring medical conditions.
No
The device description clearly outlines physical components like straps, buckles, and hardware used to secure the patient, indicating it is a physical restraint device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, genatric chair, or gurney." This describes a physical restraint or positioning device used on a patient.
- Device Description: The description details a physical product with straps and buckles used to secure a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
These products are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, genatric chair, or gurney
Product codes
Not Found
Device Description
The devices included in this 510(k) submission support the waist or torso area. The product is closed around the patient by encircling the hips, legs or chest. 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 or hardware (screws).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
waist or torso area, hips, legs or chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 27 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 vertically on each of the top three leaves of the clover. The word "Quality" is written in a cursive font at the bottom of the circle.
Posev Company
5635 Peck Road · Arcadia, California 91006-0020 U.S.A.
Customer Servic Toll Free: (800) 44-POSEY Tel: (818) 443-3143 Fax: (818) 443-5014
SAFETY AND EFFECTIVENESS SUMMARY
JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 18.1996
Phone # (818) 443-3143 FAX # (818) 443-5014
Reference Number: K963414
Trade Name: Protective Restraints Common Name: Belts Classification Name Protective Restraints
The devices included in this 510(k) submission support the waist or torso area. The product is closed around the patient by encircling the hips, legs or chest. 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 or hardware (screws).
These products are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, genatric chair, or gurney
The devices used for comparative purposes are identical to the belts 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 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 belts 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.