(85 days)
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No
The device description and other sections do not mention any AI or ML components or functionalities. The device is a simple hot/cold therapy blanket that circulates water.
Yes
The device is intended to provide hot/cold therapy for body surfaces, which is a therapeutic function.
No
The device provides hot/cold therapy, which is a treatment, not a diagnostic function. It does not analyze data or identify medical conditions.
No
The device description clearly describes physical components (blankets, tubing, connectors, straps) and their function in circulating water for therapy, indicating it is a hardware device, not software-only.
Based on the provided information, the InCare HOT/ICE Cold Therapy Blankets are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide hot/cold therapy for body surfaces." 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.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVD devices are used to perform tests on specimens taken from the human body to provide information about a person's health. The InCare HOT/ICE Cold Therapy Blankets are applied externally to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The InCare HOT/ICE Cold Therapy Blankets are intended to provide hot/cold therapy for body surfaces.
Product codes
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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. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
body surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/0 description: The image shows a logo with a geometric shape on the left and the word "Hollinger" on the right. The geometric shape is a complex design made up of intersecting lines and squares. The word "Hollinger" is written in a simple, sans-serif font. The image is in black and white, and the text is slightly faded.
DEC 31 1996
InCare HOT/ICE Cold Therapy Blankets
510(k) Summarv
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 Fax (847)918-3860
Date Summary Prepared - October 4, 1996
2. Name of Device:
InCare HOT/ICE System Blankets
3. Name of Predicate Device(s)
InCare HOT/ICE System Blankets (K871962, K871963 and K833564) ImmobilICE Support Blankets
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. 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.
5. Statement of Intended Use
The InCare HOT/ICE Cold Therapy Blankets are intended to provide hot/cold therapy for body surfaces.
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Image /page/1/Picture/0 description: The image shows the Hollister logo. On the left is a black geometric shape that resembles a stylized cross or star. To the right of the shape is the word "Hollister" in a distressed, sans-serif font.
InCare HOT/ICE Cold Therapy Blankets
6. Statement of Technological Characteristics of the Device
The subject devices are identical in intended use, size/shape availability and flow design to the currently available InCare HOT/ICE Blankets (K871963 and K833564), with the following exceptions, the material used to construct the bladder has been changed to polyurethane to allow for more flexibility when applying the blanket and the blankets are available with detachable hook and loop securing straps that hold the blanket in place and allow for more flexibility in positioning the blankets.
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 Blankets 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 Blankets are safe and effective for their intended use and are substantially equivalent to the predicate devices.