K955057 · Smith and Nephew Donjoy, Inc. · ILO · Mar 8, 1996 · Physical Medicine
Device Facts
Record ID
K955057
Device Name
MODEL 1100 COLD THERAPY DEVICE
Applicant
Smith and Nephew Donjoy, Inc.
Product Code
ILO · Physical Medicine
Decision Date
Mar 8, 1996
Decision
SN
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, submersible water pump, console with temperature control/indicator, and circulation pad. Pump circulates chilled water through pad; console positioned along tubing for patient access. Device allows temperature settings above 32F (0C) for safer, extended treatment compared to ice bags. Used in clinical or home settings; operated by patient or clinician. Output is localized cold therapy to affected area; aids in pain management and swelling reduction.
Clinical Evidence
No clinical data provided. Relies on established literature regarding the benefits of cold therapy for post-surgical and injury-related morbidity, blood flow, and bone metabolism.
Technological Characteristics
System includes water tank, submersible pump, console, and circulation pad. Leakage current limit: 100uA. Temperature control mechanism allows settings above 32F (0C). Insulated tubing connects components.
Indications for Use
Indicated for patients requiring cold therapy to reduce swelling and pain following surgery or injury.
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.
Reference Devices
Breg Inc. Polar Care 500
Burke/Nutech Inc. Sports Therapy 1000
Smith & Nephew DonJoy, Inc. Model 1100
Submission Summary (Full Text)
{0}
MAR - 8 1996
K9SS057
# L. SUMMARY OF SAFETY AND EFFECTIVENESS
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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