INCARE HOT/ICE SYSTEM SHOULDER BLANKET

K964057 · Hollister, Inc. · ILO · Dec 31, 1996 · Physical Medicine

Device Facts

• Record ID: K964057
• Device Name: INCARE HOT/ICE SYSTEM SHOULDER BLANKET
• 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 System Shoulder Blanket is intended to provided hot/cold therapy for body surfaces.

Device Story

Device consists of plastic blanket with integrated connector/tubing; circulates heated or chilled water via external pump; includes detachable hook and loop straps for positioning. Used in clinical or home settings; operated by patient or healthcare provider. Provides localized thermal therapy to shoulder surface to manage temperature-related treatment. Benefits include flexible positioning and consistent thermal delivery.

Clinical Evidence

No clinical data. Biocompatibility assessment performed per ISO 10993, FDA G95-1, and USP guidelines.

Technological Characteristics

Plastic blanket with integrated tubing/connector; circulating water thermal therapy; detachable hook and loop straps. Biocompatible materials per ISO 10993 and USP standards. Sterile product.

Indications for Use

Indicated for patients requiring hot or cold therapy applied to the shoulder surface of the body.

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 Shoulder Blankets (K931843)

Submission Summary (Full Text)

{0}

1<964057

DEC 31 1996

# InCare HOT/ICE Cold Therapy Shoulder Blanket

## 510(k) Summary

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

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

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

TEL [phone] FAX [phone]

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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.