(76 days)
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No
The device description and lack of mentions of AI, ML, or related concepts indicate a purely mechanical restraint device.
No.
The device is described as limiting limb or finger movement and securing patients to a bed or gurney, indicating it is a restraint device, not a therapeutic one. Its intended use is to limit movement, not to treat or alleviate a medical condition.
No
Explanation: The device is described as a product intended to limit limb or finger movement, secured to a bed or gurney. Its function is to restrain, not to diagnose or provide information about a patient's medical condition.
No
The device description clearly describes physical components (straps, buckles, rings, etc.) used to limit movement, indicating it is a hardware device, not software-only.
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 limb movement or finger movement in a hospital bed or gurney." This describes a physical restraint device used on a patient.
- Device Description: The description details how the device is applied to the patient's wrists, hands, or ankles and secured to a bed or gurney. This is consistent with a physical restraint.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information. The device's function is purely mechanical and related to patient management.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the bed or gurney via straps. These straps are securely connected to the bed, genatic chair, or wheelchair by one or more of the following: knots, corset buckles, keyed lock buckles, square rings, hook and loop, standard buckles, or quick release buckles.
These products are intended to limit limb movement or finger movement in a hospital bed or gurney.
Product codes
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Device Description
The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the bed or gurney via straps. These straps are securely connected to the bed, genatic chair, or wheelchair by one or more of the following: knots, corset buckles, keyed lock buckles, square 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
limbs, fingers, wrists, hands, ankles
Indicated Patient Age Range
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Intended User / Care Setting
hospital, 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
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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
T. T. Posey Co.
FI 133753
K96 3413
Image /page/0/Picture/4 description: The image shows a partial view of a document with the word "Posey" in large, bold font at the top. Below the word "Posey", the text "5635 Peck Road" is visible. The text is in a smaller font size compared to the word "Posey".
Customer Service
Toll Free: (800) 44-POSEY
Tel: (818) 443-3143
Fax: (818) 443-5014
SAFETY AND EFFECTIVENESS SUMMARY
NOV I 1 1996
JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 13, 1996
Phone # (818) 443-3143 (818) 443-5014 FAX #
Reference Number : K963413
Trade Name: Protective Restraints Common Name: Limb Holders Classification Name: Protective Restraints
The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the bed or gurney via straps. These straps are securely connected to the bed, genatic chair, or wheelchair by one or more of the following: knots, corset buckles, keyed lock buckles, square rings, hook and loop, standard buckles, or quick release buckles.
These products are intended to limit limb movement or finger movement in a hospital bed or gurney.
The devices used for comparative purposes are identical to the limb 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 limb 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.