(123 days)
This is a trick question. The provided text "Not Found" clearly indicates that there is no information about K/DEN numbers or predicate devices within the input. Therefore, I cannot identify or list any.
Not Found
No
The device description details a mechanical system for circulating cold water and does not mention any computational or algorithmic components indicative of AI/ML.
Yes
The device is described as an "application of ice after surgery or injury to reduce swelling and pain," which aligns with therapeutic purposes. It also lists predicate devices that are typically therapeutic cold therapy units.
No
The device is described as providing cold therapy (applying ice after surgery or injury to reduce swelling and pain), which is a treatment, not a diagnostic function. It circulates chilled water to a pad for therapeutic application.
No
The device description explicitly details hardware components including a tank, water 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:
- Intended Use: The intended use is described as "The application of ice after surgery or injury to reduce swelling and pain." This is a physical therapy or pain management application, not a diagnostic test performed on biological samples.
- Device Description: The device components (tank, pump, console, pad) and their function (circulating cold water) are consistent with a therapeutic device for applying cold therapy externally. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as reagents, assays, sample handling procedures, or analysis of biological markers.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Not Found
§ 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.
0
MAR - 8 990
k
L9SSOS7
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 purnp, 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 11-3-95
Dan W. Miller Director of Regulatory Affairs and Quality Assurance
Smith & Nephew DonJoy 510K Premarket Submission Page 18