K970533 · Smith & Nephew, Inc. · ILO · Apr 15, 1997 · Physical Medicine
Device Facts
Record ID
K970533
Device Name
MODEL 1100 COLD THERAPY DEVICE
Applicant
Smith & Nephew, Inc.
Product Code
ILO · Physical Medicine
Decision Date
Apr 15, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.5720
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The application of ice after surgery or injury to reduce swelling and pain is a well established treatment with well know indications and contraindications. Devices approved for market, such as the Breg Inc. Polar Care 500, the Burke/Nutech Inc. Sports Therapy 1000, and the Smith & Nephew DonJoy, Inc. Model 1100 device, are essentially more convenient and safer means to apply ice.
Device Story
Cold therapy device; consists of ice/water tank, submerged water pump, console for temperature control/indication, and circulation pad. Pump circulates chilled water through insulated tubing to pad. Console positioned along tubing for patient access. Device provides safer, controlled temperature application compared to static ice bags; allows temperatures above 32F (0C) for extended treatment. Used in clinical or home settings; operated by patient or clinician. Benefits include reduced swelling and pain management.
Clinical Evidence
No clinical data provided. Safety and effectiveness supported by established clinical literature on cold therapy benefits and comparison to legally marketed predicate devices.
Technological Characteristics
System includes water tank, pump, console, and circulation pad. Leakage current limit: 100uA. Temperature control mechanism included. Non-software based.
Indications for Use
Indicated for patients requiring cold therapy post-surgery or post-injury to reduce swelling and pain.
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
Breg Inc. Polar Care 500
Burke/Nutech Inc. Sports Therapy 1000
Smith & Nephew DonJoy, Inc. Model 1100
Submission Summary (Full Text)
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L. SUMMARY OF SAFETY AND EFFECTIVENESS
APR 15 1997
K970533
The application of ice after surgery or injury to reduce swelling and pain is a well established treatment with well know indications and contraindications. Devices approved for market, such as the Breg Inc. Polar Care 500, the Burke/Nutech Inc. Sports Therapy 1000, and the Smith & Nephew DonJoy, Inc. Model 1100 device, are essentially more convenient and safer means to apply ice. More convenient because of less bulk for example, and safer because the treatment temperature can be set above the melting temperature of ice, 32F (0C), allowing extended safe treatment. A bag of ice in contrast, will necessarily be at 32F (0C) without option.
The device consists of a tank containing ice and water, a water pump to circulate cold water, a console containing a means to control and indicate temperature and a pad through which the cold water circulates. The pump, contained in a waterproof case, is submerged in the ice water bath and connected to the console via insulated tubing through which the chilled water flows to and from the pad. The console is located along this tubing about halfway between the pad and the water bath for easy access by the patient. Leakage current for the device shall not exceed 100uA.
To our knowledge, no new safety issues regarding the use of these and like devices approved for market, have been raised. To the contrary, the literature continues to study the benefits of cold therapy. Some recent publications follow:
Bert, Stark, Maschka, Chock. The Effect of Cold Therapy on Morbidity Subsequent to Arthroscopic Lateral Retinacular Release, Orthopaedic Review, Vol. XX, No. 9, September 1991
Ho, Coel, Kagawa, Richardson. The Effect of Ice on Blood Flow and Bone Metabolism in Knees, The American Journal of Sports Medicine, Vol. 22, No. 4, 1994
Ho, Illgen, Meyer, Comparison of Various Icing Times in Decreasing Bone Metabolism and Blood Flow in the Knee, The American Journal of Sports Medicine, Vol. 23, 1995
Grana WA, Cold Modalities (Chapter 7) in: Orthopedic Sports Medicine, Ed. Delee, Drez Vol 1, 1994
Smith & Nephew DonJoy Inc.
Dan W. Miller
Director of Regulatory Affairs and Quality Assurance
Smith & Nephew DonJoy 510K Premarket Submission
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