(81 days)
The InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is intended to provide hot/cold therapy for body surfaces.
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 Foot/Ankle surface of the body. Detachable hook and loop securing straps allow for more flexibility in positioning the blanket onto the Foot/Ankle. The proposed HOT/ICE System Foot/Ankle 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 document is a 510(k) summary for the InCare HOT/ICE Cold Therapy Foot/Ankle Blanket. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical trial or performance study comparing it against predefined metrics.
Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed device (K931843). This is a common pathway for medical device clearance in the US, where the company argues that its new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical performance studies to meet new acceptance criteria.
The key points from the document regarding substantial equivalence are:
- Technological Characteristics: The proposed device is "identical in intended use, size/shape and flow design to the predicate device, with the following exception, the proposed device is available with detachable hook and loop securing straps that hold the blanket in place and allow for more flexibility in positioning the blanket." This indicates minor design changes rather than fundamental operational differences.
- Biocompatibility Assessment: The document states that "Issues of biomaterial safety or biocompatibility have been addressed based upon the biomaterial history or in separate in-vitro or in-vivo evaluations using licensed commercial reference laboratories." It concludes that "The materials used to construct the InCare HOT/ICE Cold Therapy Foot/Ankle Blanket are considered biocompatible and appropriate for their intended use." This is about material safety, not performance.
- Conclusion: "Based upon the information presented above it is concluded that the proposed InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is safe and effective for it's intended use and is substantially equivalent to the predicate device."
Therefore, I cannot provide the requested information because the document does not describe acceptance criteria, a performance study, sample sizes, ground truth establishment, or expert involvement in the way a clinical study or AI/algorithm performance validation would. The device's approval is based on its similarity to an already approved device.
§ 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.