(83 days)
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No
The description focuses on a simple hot/cold therapy system using circulating water and a blanket, with no mention of AI or ML technologies.
Yes.
The device provides hot/cold therapy for body surfaces, which is a therapeutic intervention aimed at alleviating pain, reducing swelling, or relaxing muscles.
No
Explanation: The device is described as providing hot/cold therapy for body surfaces, specifically the shoulder, which is a therapeutic function, not a diagnostic one. It does not identify or analyze diseases or conditions.
No
The device description clearly states it is a "plastic blanket" with "connector/tubing" and "detachable hook and loop securing straps," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide hot/cold therapy for body surfaces, specifically the shoulder. This is a therapeutic application, not a diagnostic one.
- Device Description: The device works by circulating heated or chilled water through a blanket applied to the body. This is a physical therapy method, not a method for examining specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, the InCare HOT/ICE System Shoulder Blanket falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The InCare HOT/ICE System Shoulder Blanket is intended to provided hot/cold therapy for body surfaces.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder surface of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
InCare HOT/ICE System Shoulder Blankets (K931843)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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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Image /page/1/Picture/0 description: The image shows a black and white symbol that resembles a stylized cross or asterisk. The symbol is composed of thick, intersecting lines that create a symmetrical pattern. The central area of the symbol is open, forming a square-like space. The overall design is bold and geometric.
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.