(85 days)
The InCare HOT/ICE Cold Therapy Blankets are intended to provide 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. The proposed HOT/ICE System blankets are intended to be used for the delivery of hot or cold therapy to various body surfaces. The devices are available in various sizes to accommodate a wide range of body surfaces and depending on the caregivers preference, with or without straps to secure the device to the patient. Hook and loop securing straps allow for more flexibility in positioning the blankets. The material used to construct the bladder has been changed to polyurethane to allow for more conformity when applying the blanket. The proposed HOT/ICE System Blankets can be used with all of the circulating pumps within the InCare HOT/ICE System and are available in sterile and non-sterile versions.
This K964006 510(k) summary is for the InCare HOT/ICE Cold Therapy Blankets. It does not contain information about acceptance criteria or a study demonstrating device performance as would typically be found for a diagnostic or AI-based device.
Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices for a medical device that delivers hot/cold therapy. The key elements for this type of device and submission are:
- Intended Use: Providing hot/cold therapy for body surfaces.
- Technological Characteristics: The primary changes are the use of polyurethane for the bladder material (for flexibility) and the addition of detachable hook and loop straps. The flow design, sizes, and intended use are identical to predicate devices.
- Biocompatibility Assessment: This is the equivalent of "acceptance criteria" for material safety. The device materials were assessed for biocompatibility based on ISO 10993, FDA G95-1, and USP standards. The conclusion is that the materials are biocompatible and appropriate for their intended use.
- Substantial Equivalence: The ultimate "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.
Therefore, I cannot provide the requested table or detailed study information because the provided text for this 510(k) summary does not include it. This type of submission relies on demonstrating similarity to existing devices and material safety, rather than a performance study against specific acceptance criteria like a diagnostic device would.
If this were a submission for a diagnostic device or an AI-based system, the requested information would be crucial. However, for a therapy blanket, the concerns and supporting data are different.
§ 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.