(81 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 performance metrics typically associated with AI/ML devices.
No
The device is intended to hinder egress or assist body alignment and secure a patient, rather than to treat a medical condition or provide therapy.
No
The device is intended to hinder egress and assist body alignment, which are support functions, not diagnostic. It does not mention any diagnostic capabilities such as detecting, analyzing, or identifying medical conditions or diseases.
No
The device description clearly indicates the product is a physical restraint made of fabric, straps, zippers, and buckles, which are hardware components.
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 a hospital bed, genatric chair, wheelchair, or gurney." This describes a physical restraint or positioning device used on a patient.
- Device Description: The description details a physical product that supports the torso and/or pelvic area and is secured to a bed or chair. This is consistent with a physical support or restraint device.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status through in vitro testing.
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 of a patient and/or assist body alignment in a hospital bed, genatric chair, wheelchair, or gurney.
Product codes
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Device Description
The devices included in this 510(k) submission support the torso and/or pelvic area. The product is closed around the patient by one or more of the following: a zipper, fabric alone, straps, or straps and buckles. 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, or straps and 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 and/or pelvic area
Indicated Patient Age Range
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Intended User / Care Setting
hospital bed, genatric chair, wheelchair, or gurney
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
J. T. Posey Co.
818 443 5064 P.09/11
Image /page/0/Picture/4 description: The image shows a black four-leaf clover inside of a circle. The clover has a stem that curves to the right. Below the clover, the word "Quality" is written in cursive.
Posev Comn
5635 Peck Road · Arcadia, California 91006-0020 U.S.A.
SAFETY AND EFFECTIVENESS SUMMARY
NOV 1 9 1996
Tal. 18181 443-3143
JT Posev 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: K963437
Trade Name: Protective Restraints Common Name: Pelvic Holders Classification Name: Protective Restraints
The devices included in this 510(k) submission support the torso and/or pelvic area. The product is closed around the patient by one or more of the following: a zipper, fabric alone, straps, or straps and buckles. 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, or straps and buckles.
These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, genatric chair, wheelchair, or gurney.
The devices used for comparative purposes are identical to the pelvic holders 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 pelvic holders 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.