INCARE HOT/ICE LITE MACHINE

{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 (847)680-2849 Fax (847)918-3860 | 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