(62 days)
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No
The description focuses on mechanical components (tank, pump, console, pad) and temperature control, with no mention of AI, ML, or related concepts.
Yes
The device is intended to reduce swelling and pain after surgery or injury, which are therapeutic effects. The description also mentions it circulates cold water through a pad, indicating a direct application to the body for treatment, consistent with a therapeutic device.
No
The device is described as circulating cold water for treatment (reducing swelling and pain), not for identifying or diagnosing a medical condition.
No
The device description clearly outlines hardware components including a tank, pump, console, and pad, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is used for applying cold water externally to the body to reduce swelling and pain after surgery or injury. It involves a physical application of temperature, not the analysis of biological samples.
- Intended Use: The intended use is for a physical therapy/recovery application, not for diagnostic testing.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The device consists of a tank containing ice and 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5720 Water circulating hot or cold pack.
(a)
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.(b)
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.
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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 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.
Don W. Wible 1-2-52
Dan W. Miller Director of Regulatory Affairs and Quality Assurance
Smith & Nephew DonJoy 510K Premarket Submission Page 18