INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)

K964006 · Hollister, Inc. · ILO · Dec 31, 1996 · Physical Medicine

Device Facts

• Record ID: K964006
• Device Name: INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
• Applicant: Hollister, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Dec 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InCare HOT/ICE Cold Therapy Blankets are intended to provide hot/cold therapy for body surfaces.

Device Story

Device consists of plastic blankets with integrated connector/tubing; circulates heated or chilled water from compatible InCare HOT/ICE system pumps to body surfaces. Used in clinical or home settings by caregivers or patients. Polyurethane bladder construction provides increased conformity and flexibility. Available in sterile and non-sterile versions; optional hook and loop straps secure blanket to patient. Therapy delivery aids in localized temperature management; provides therapeutic benefit through thermal regulation of body surfaces.

Clinical Evidence

No clinical data provided. Biocompatibility assessment conducted via in-vitro and in-vivo evaluations following ISO 10993, FDA G95-1, and USP guidelines.

Technological Characteristics

Polyurethane bladder; circulating water thermal therapy system; compatible with existing InCare HOT/ICE pumps; includes connector/tubing and optional hook and loop straps; available in sterile/non-sterile configurations. Biocompatibility per ISO 10993 and USP.

Indications for Use

Indicated for patients requiring hot or cold therapy applied to various body surfaces.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• InCare HOT/ICE System Blankets (K871962)
• InCare HOT/ICE System Blankets (K871963)
• InCare HOT/ICE System Blankets (K833564)
• ImmobilICE Support Blankets

Submission Summary (Full Text)

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K 964006
DEC 31 1996

# InCare HOT/ICE Cold Therapy Blankets

## 510(k) Summary

### 1. Submitter's name, Address and Contact Person

| Submitter | Contact Person |
| --- | --- |
| Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048 | Joseph S. Tokarz
Manager, Regulatory Affairs
Ph [phone]
Fax [phone] |
| 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)<br/>
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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Hollister

# 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 (K871962, 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.

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