(84 days)
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No
The device description focuses on physical restraints and support, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
Explanation: The device is intended to hinder egress and assist body alignment, which are functions related to patient restraint and support, not therapeutic treatment or diagnosis.
No
The device is intended to hinder egress and assist body alignment, not to diagnose medical conditions.
No
The device description clearly describes physical components like fabric, straps, zippers, buckles, and tie strings, which are 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 "hinder egress of a patient and/or assist body alignment" in various patient care settings. This describes a physical restraint or positioning device, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a physical product that supports the torso and is secured to a bed or chair. This aligns with a physical medical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic or monitoring information based on biological analysis
Therefore, this device falls under the category of a physical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, geriatric chair, wheelchair, or gurney,
Product codes
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Device Description
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.
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
torso area
Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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/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.