(188 days)
The Therapy Concepts Water Circulating Treatment System will be used to pump chilled or room temperature water through a plastic pad that is placed on a mattress underneath the user and in so doing, will provide cold temperature therapy intended to temporarily assist in the localized reduction of minor swelling and pain. Pre-chilled water will be provided by adding ice cubes and water to the reservoir. The cooling rate is adjusted by adjusting the rate of flow of the water through the plastic pad.
The Therapy Concepts Water Circulating Treatment System will consist of five discreet modules. A reservoir module holding 1.5 liters of water. A low voltage DC pump with integral connection tubing. A wall mounted power supply to provide 7,5 volts DC to power the pump. A plastic/foam pad with connecting tubing, containing channels through which water is circulated and a form fitted sewn nylon carrying case.
The provided text is a summary of safety and effectiveness for a medical device submitted in 1996. It describes the device, its intended use, and its predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.
Therefore, I cannot fulfill your request for that information based on the input provided. The text focuses on the device description and substantial equivalence, not on performance testing or clinical study results.
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OCT 3 1 1996
1961621 Section 10 - Summary of Safety and Effectiveness
| Date of Preparation: | October 29, 1996 |
|---|---|
| Device Name: | Therapy Concepts Water Circulating Treatment System |
| Classification Name: | Pack, Hot or Cold Water, Circulating - 89 ILO |
| Manufacturer: | Therapy Concepts, Inc. located at 11445 Moog Drive, St.Louis, MO 63146 (314) |
| Predicate Device: | HOT/ICE Cold Therapy Cooler System, catalog number42000, manufactured and marketed by InCare MedicalProducts, a division of Hollister Inc., 2000 Hollister Drive,Libertyville, IL 60048. |
| Device Description: | The Therapy Concepts Water Circulating TreatmentSystem will consist of five discreet modules. A reservoirmodule holding 1.5 liters of water. A low voltage DCpump with integral connection tubing. A wall mountedpower supply to provide 7,5 volts DC to power the pump.A plastic/foam pad with connecting tubing, containingchannels through which water is circulated and a formfitted sewn nylon carrying case. |
| Intended Use: | The Therapy Concepts Water Circulating TreatmentSystem will be used to pump chilled or room temperaturewater through a plastic pad that is placed on a mattressunderneath the user and in so doing, will provide coldtemperature therapy intended to temporarily assist in thelocalized reduction of minor swelling and pain. Pre-chilledwater will be provided by adding ice cubes and water tothe reservoir. The cooling rate is adjusted by adjustingthe rate of flow of the water through the plastic pad. |
| Clinical and Non-ClinicalSimilarities and Differences: | The Therapy Concepts, Inc. Water Circulating TreatmentSystem and the InCare Medical Products, Inc. HOT/ICECold Therapy Cooler System are substantially equivalentsince they both provide cold temperature therapy totemporarily assist in the localized reduction of minorswelling and pain. |
§ 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.