INCARE HOT/ICE LITE MACHINE

K962537 · Hollister, Inc. · ILO · Nov 27, 1996 · Physical Medicine

Device Facts

• Record ID: K962537
• Device Name: INCARE HOT/ICE LITE MACHINE
• Applicant: Hollister, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InCare HOT/ICE Lite Machine is intended to provide cold therapy to body surfaces by pumping and circulating chilled water through a plastic bag or plastic blanket that has been secured to the patient’s anatomy.

Device Story

Device provides localized cold therapy; circulates chilled water/alcohol mixture through plastic blanket or bag secured to patient anatomy. Used in institutional or home environments. Solid-state electronics control pump and circulation. Healthcare provider or patient secures blanket; device maintains therapy temperature range (50° to 72° F). Output is cooling of localized skin surface; intended to reduce skin temperature for therapeutic benefit.

Clinical Evidence

Bench testing only. Evaluation of skin cooling ability performed using temperature probe on test subjects' skin surface over a specific period. Results confirmed device efficacy in reducing patient skin temperature.

Technological Characteristics

Solid-state electronics; 120VAC, 136 watts, 50/60Hz power supply. Liquid media: water/alcohol mixture (500 ml capacity). Nominal flow rate: 4 GPH; nominal operating pressure: 3.5 PSI. Therapy temperature range: 50° to 72° F (10° to 22° C). Weight: approx 7.1 lbs. Form factor: portable unit for institutional/home use.

Indications for Use

Indicated for patients requiring localized cold therapy to 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 HE500 (K830757)
• InCare System 3 (K915196)

Submission Summary (Full Text)

{0}

NOV 27 1996

Hollister Incorporated InCare HOT/ICE Lite Machine

K962537

# Safety and Effectiveness 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
Phone [phone]
Fax [phone] |

Date Summary Prepared - June 26, 1996

## 2. Name of Device:

InCare HOT/ICE Lite Machine

## 3. Name of Predicate Device(s)

a. InCare HE500 (K830757)
b. InCare System 3 (K915196)

## 4. Description of Device

The InCare HOT/ICE Lite Machine incorporates state of the art technology with solid state electronics. The device is designed to deliver cold therapy to a localized area. This is accomplished by circulating cold water through a plastic blanket or bag that has been secured to the patient’s anatomy. The device is intended to be used in an institution or home environment.

## 5. Statement of Intended Use

The InCare HOT/ICE Lite Machine is intended to provide cold therapy to body surfaces by pumping and circulating chilled water through a plastic bag or plastic blanket that has been secured to the patient’s anatomy.

## 6. Statement of Technological Characteristics of the Device

On the following page is a comparison of the technical specifications of the InCare HOT/ICE Lite Machine and the predicate devices.

{1}

Hollister Incorporated
InCare HOT/ICE Lite Machine

| Features/Specs | Proposed device
InCare HOT/ICE Lite | InCare HE500
K830757 | InCare System 3
K915196 |
| --- | --- | --- | --- |
| Intended to provide cold therapy to body surfaces | Yes | Yes | Yes |
| Solution Flow Rates
GPH=gallons per hour | 4 GPH (nominal) | 15 GPH (nominal) | 19 GPH (nominal) |
| Operating Pressure
PSI=pounds per square inch | 3.5 PSI (nominal) | 2.5 PSI (nominal) | 4.8 PSI (nominal) |
| Liquid media | Water / Alcohol | Water / Alcohol | Water / Alcohol |
| Liquid Capacity | 500 ml = 350 ml Water +
150 ml Alcohol | 500 ml = 350 ml Water +
150 ml Alcohol | 650 ml water/alcohol |
| Therapy temperature range | 50° to 72° F
10° to 22° C | 40° to 150° F
4° to 40° C | 40° to 150° F
4° to 40° C |
| Weight | approx 7.1 lbs | approx 20 lbs | 32 lbs (approximate) |
| Power Supply | 120VAC, 136 watts,
50/60Hz | 115 V, 60 Hz, 3 AMPS | 115 VAC, 60 Hz 3 AMPS |

## 7. Performance Testing

The InCare HOT/ICE Lite Machine with a HOT/ICE blanket was evaluated for its ability to cool the test subjects skin as measured by a temperature probe on the skin surface. Skin temperature was recorded over a specific period of time. The results indicated that the InCare HOT/ICE Lite Machine in its ability to reduce patient skin temperature.

## 8. Conclusion

The InCare HOT/ICE Lite Machine is substantially equivalent to the predicate devices and is safe and effective for its intended use.

37