(84 days)
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Not Found
No
The device description and other sections do not mention any AI or ML components or functionalities. The device is described as a physical restraint system.
No
The device is intended to limit movement in hospital patients, which serves a restrictive or safety purpose rather than providing therapy for a medical condition.
No
Explanation: The device is intended to limit movement in a patient, which is a therapeutic or restraint function, not a diagnostic one. It does not gather information about a patient's health condition.
No
The device description clearly indicates a physical product (straps, buckles) used to limit patient movement, which is hardware, 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 "limit movement in a hospital patient." This is a physical intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical restraint system applied externally to the patient's wrists, hands, or ankles. This is not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
These products are intended to limit movement in a hospital patient.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
wrists, hands, or ankles
Indicated Patient Age Range
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Intended User / Care Setting
hospital patient
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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.