(83 days)
The InCare HOT/ICE System Shoulder Blanket is intended to provided hot/cold therapy for body surfaces.
Hollister Incorporated, through its InCare division, currently markets the HOT/ICE System which is intended to provide hot/cold therapy for body surfaces. The HOT/ICE System products operate by pumping heated or chilled water through a plastic blanket.
The proposed devices consist of a connector/tubing that is an integral part of the plastic blanket where warm or cold water is circulated through and is intended to be used for the delivery of hot or cold therapy to the shoulder surface of the body. Detachable hook and loop securing straps allow for more flexibility in positioning the blanket onto the shoulder.
The proposed HOT/ICE System Shoulder Blanket can be used with all of the circulating pumps within the InCare HOT/ICE System and is available as a sterile product.
The provided text is a 510(k) summary for the InCare HOT/ICE Cold Therapy Shoulder Blanket. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, a standalone study with specific performance metrics, or details about ground truth, training sets, or expert involvement in establishing performance.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Information about experts, adjudication methods, or ground truth establishment.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone performance study with quantifiable results.
- Details regarding a training set.
The 510(k) summary primarily functions by asserting that the new device is "substantially equivalent" to a previously cleared device (the predicate device) based on similar intended use, technological characteristics, and safety (including biocompatibility). It aims to show that the new device doesn't raise new questions of safety or effectiveness.
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.