(84 days)
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No
The description focuses on mechanical attachment points for restraints and does not mention any computational or data-driven features indicative of AI/ML.
No
The devices facilitate attachment of other devices that aid in positioning or hinder egress, but the devices themselves are not directly therapeutic.
No
Explanation: The provided text describes devices that facilitate the attachment of protective restraints to vehicles for positioning or hindering egress of patients. There is no mention of the device being used to diagnose any medical condition or disease.
No
The device description clearly states it facilitates attachment of protective restraint devices to vehicles and provides anchor points, indicating a physical hardware component. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device's purpose is to "facilitate attachment of protective restraint devices to vehicles" (beds, chairs, wheelchairs, gurneys) to "hinder egress or aid in positioning of a patient." This is a mechanical function related to patient restraint and positioning, not the analysis of biological samples.
- Device Description: The description reinforces the mechanical nature of the device, focusing on providing "anchor points" and "adapting protective restraints."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
Therefore, the device described is a medical device, but it falls under the category of patient restraint or positioning accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The devices included in this 510(k) submission facilitate attachment of protective restraint devices to vehicles. These devices provide anchor points for tying quick release knots and/or adapts protective restraints with quick release buckles. The products are then secured to the bed, geriatric chair, or wheelchair via the accessory device. The accessory devices attach directly to the vehicle.
These products are facilitate attachment of devices that are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gumey.
Product codes
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Device Description
The devices included in this 510(k) submission facilitate attachment of protective restraint devices to vehicles. These devices provide anchor points for tying quick release knots and/or adapts protective restraints with quick release buckles. The products are then secured to the bed, geriatric chair, or wheelchair via the accessory device. The accessory devices attach directly to the vehicle.
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
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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 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
NOV 22 1996
Image /page/0/Picture/1 description: The image is a black and white logo. The logo is a circle with a four-leaf clover inside. The word "Quality" is written in cursive below the clover. The clover has the letters "PCCY" written on each of the leaves.
Posey Company
Customer Service oll Free: (800) 44-POSE) Tel: (818) 443-3143 x (818) 443-5014
5635 Peck Road • Arcadia, California 91006-0020 U.S.A.
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: K963436
Trade Name: Protective Restraints Common Name: Restraint Accessories Classification Name: Protective Restraints
The devices included in this 510(k) submission facilitate attachment of protective restraint devices to vehicles. These devices provide anchor points for tying quick release knots and/or adapts protective restraints with quick release buckles. The products are then secured to the bed, geriatric chair, or wheelchair via the accessory device. The accessory devices attach directly to the vehicle.
These products are facilitate attachment of devices that are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gumey.
The devices used for comparative purposes are identical to the restraint accessories as described in this submission and produced or sold by the J.T. Posev Co. This premarket 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) Premarket 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 restraint accessories 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.