(81 days)
These products are intended to limit limb movement or finger movement in a hospital bed or crib.
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 hospital bed or crib via straps. These straps are securely connected to the hospital bed or crib by quick release knots or with the use of a safety pin.
This document describes an application for a 510(k) premarket notification for "Protective Restraints" (Pediatric limb holders) by J.T. Posey Co. It is a safety and effectiveness summary. The core of the submission emphasizes that the devices are identical to existing, legally marketed products by the same company, which were previously exempt from 510(k) procedures.
Given the nature of the document, which pertains to a premarket notification for a device that is identical to already marketed devices, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as typically understood for new or significantly modified medical devices that rely on performance metrics.
Here's why and what information is present:
- No Acceptance Criteria or Performance Study: The document explicitly states: "The devices used for comparative purposes are identical to the pediatric limb holders as described in this submission and produced or sold by the J.T. Posey Co." This means the submission is based on substantial equivalence to existing devices, not on a new performance study demonstrating specific acceptance criteria. The purpose of this 510(k) is a response to a regulatory change ("Revocation of Exemptions from 510(k) Premarket Notification Procedures") rather than a technological advance requiring new clinical evidence.
- "Predicate device" rationale: The document highlights that FDA indicated manufacturers could reference their current products as legally marketed devices for comparison. This is the entire basis of the submission.
- Device history: The limb holders have been manufactured and in commercial distribution for up to 20 years.
Therefore, I cannot fill in the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission is not about demonstrating new performance but rather establishing legal equivalence to existing, long-marketed products under new regulatory requirements.
§ 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.