(76 days)
The devices included in this 510(k) submission provide anterior postural support, The products are inserted into the arms of the wheelchair compressing the foam and releasing it once in position. If the patient cannot easily self release the product, it may be considered a restraint. These products are intended to provide postural support and a surface for activities,
The devices included in this 510(k) submission provide anterior postural support, The products are inserted into the arms of the wheelchair compressing the foam and releasing it once in position. If the patient cannot easily self release the product, it may be considered a restraint.
The provided text is a Safety and Effectiveness Summary for a medical device (Posey® Hugger) submitted to the FDA in 1996. It focuses on device classification, intended use, and substantial equivalence to legally marketed predicate devices, primarily for regulatory purposes.
Crucially, this document does not contain information about a study that measures the device's performance against specific acceptance criteria in the context of typical AI/software-as-a-medical-device (SaMD) performance evaluations. The "Safety and Effectiveness Summary" in this context refers to regulatory compliance and demonstrating substantial equivalence to existing devices, not a clinical performance study with statistical metrics.
Therefore, I cannot provide the requested information, such as acceptance criteria, reported device performance metrics (like sensitivity, specificity, AUC), sample sizes, ground truth methodology, or details about expert involvement, because these types of studies were not conducted or described in this document.
The relevant information from the document related to "effectiveness" pertains to its function as a postural support and a surface for activities, and its regulatory status as an exempt device. The "comparison" mentioned is purely for demonstrating substantial equivalence to existing, legally marketed J.T. Posey Co. huggers, not for evaluating a new device's performance against clinical endpoints.
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J. T. Posey Co.
Posev Con
818 443 5064 P. 02/03
Customer Service
Toll Free: (800) 44-PC
Tel: (818) 443-314
Fax: (618) 443-501
5635 Peck Road · Arcadia, California 91006-0020 U.S.A.
NOV 14 1996
SAFETY AND EFFECTIVENESS SUMMARY
JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 13, 1996
Phone # (818) 443-3143 FAX # (818) 443-5014
Reference Number: K963409
Trade Name: Posey® Hugger Common Name: Hugger Classification Name: Wheelchair Accessory
The devices included in this 510(k) submission provide anterior postural support, The products are inserted into the arms of the wheelchair compressing the foam and releasing it once in position. If the patient cannot easily self release the product, it may be considered a restraint.
These products are intended to provide postural support and a surface for activities,
The devices used for comparative purposes are identical to the huggers as described in this submission and produced or sold by the J.T. Posey Co. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for companson:
"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 huggers are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Company as of the date of this submission, August 30,1996.
§ 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.