(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.
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DEC 31 1996
InCare HOT/ICE Cold Therapy Shoulder Blanket
510(k) Summary
1. Submitter's name, Address and Contact Person
Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Contact Person Joseph S. Tokarz Manager, Regulatory Affairs (847)680-2849 Ph (847)918-3860 Fax
Date Summary Prepared - October 4, 1996
2. Name of Device:
InCare HOT/ICE System Shoulder Blankets
3. Name of Predicate Device(s)
InCare HOT/ICE System Shoulder Blankets (K931843)
4. Description of Device
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.
5. Statement of Intended Use
The InCare HOT/ICE System Shoulder Blanket is intended to provided hot/cold therapy for body surfaces.
6. Statement of Technological Characteristics of the Device
The subject devices are identical in intended use, size/shape and flow design to the predicate device, with the following exception, the proposed device is available with
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Holline
InCare HOT/ICE Cold Therapy Shoulder Blanket
detachable hook and loop securing straps that hold the blanket in place and allow for more flexibility in positioning the blanket.
7. Biocompatibility Assessment
Material Biocompatibility: 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. Each assessment was conducted based on principles and guidelines established by various governmental and standard setting organizations among these are the following:
- -- ISO 10993, International Standards Organization (ISO) Standard
- -- General Program Memorandum #G95-1, United States FDA Office of Device Evaluation
- -- United Stated Pharmacopeia (USP)
The materials used to construct the InCare HOT/ICE Cold Therapy Shoulder Blanket are considered biocompatible and appropriate for their intended use.
8. Conclusion
Based upon the information presented above it is concluded that the proposed InCare HOT/ICE Cold Therapy Shoulder Blanket is safe and effective for it's intended use and is substantially equivalent to the predicate 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.