(188 days)
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No
The description details a simple water circulation system for cold therapy, with no mention of AI, ML, or any computational analysis of data.
Yes
The device is intended to provide cold temperature therapy to temporarily assist in the localized reduction of minor swelling and pain, which are therapeutic effects.
No
This device is described as a "Water Circulating Treatment System" used to provide "cold temperature therapy intended to temporarily assist in the localized reduction of minor swelling and pain." It does not detect, diagnose, or monitor a medical condition.
No
The device description explicitly lists multiple hardware components: a reservoir module, a DC pump, a wall-mounted power supply, a plastic/foam pad, and a carrying case. This 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 clearly states that the device is used to provide cold temperature therapy by circulating water through a pad placed on a mattress. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the components of a system designed for circulating water for temperature therapy. There are no components or functions related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVDs, such as:
- Analysis of biological samples
- Detection or measurement of analytes
- Diagnostic purposes (identifying diseases, conditions, etc.)
- Calibration or quality control procedures for diagnostic tests
The device is designed to provide a physical therapy (cold therapy) to the user, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
ILO
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
0
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 number |
| 42000, manufactured and marketed by InCare Medical | |
| Products, a division of Hollister Inc., 2000 Hollister Drive, | |
| Libertyville, IL 60048. | |
| Device Description: | 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. | |
| Intended Use: | 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. | |
| Clinical and Non-Clinical | |
| Similarities and Differences: | The Therapy Concepts, Inc. Water Circulating Treatment |
| System and the InCare Medical Products, Inc. HOT/ICE | |
| Cold Therapy Cooler System are substantially equivalent | |
| since they both provide cold temperature therapy to | |
| temporarily assist in the localized reduction of minor | |
| swelling and pain. |