(152 days)
No
The summary describes a device for cold therapy using circulating water and does not mention any AI or ML components or functionalities.
Yes
The device is intended to provide cold therapy to body surfaces and is evaluated for its ability to cool the test subject's skin, which are therapeutic functions.
No
Explanation: The device is described as providing cold therapy for treatment purposes, not for diagnosing medical conditions. It circulates chilled water to reduce skin temperature.
No
The device description explicitly mentions "solid state electronics" and the mechanism of action involves pumping and circulating chilled water through a plastic blanket, indicating a hardware component is essential to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide cold therapy to body surfaces by circulating chilled water through a blanket secured to the patient's anatomy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the mechanism of delivering cold therapy to the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The InCare HOT/ICE Lite Machine is intended to provide cold therapy to body surfaces by pumping and circulating chilled water through a plastic blanket that has been secured to the patient's anatomy.
Product codes
Not Found
Device Description
The InCare HOT/ICE Lite Machine incorporates state of the art technology with solid state electronics. The device is designed to deliver cold therapy to a localized area. This is accomplished by circulating cold water through a plastic blanket or bag that has been secured to the patient's anatomy. The device is intended to be used in an institution or home environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
institution or home environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The InCare HOT/ICE Lite Machine with a HOT/ICE blanket was evaluated for its ability to cool the test subjects skin as measured by a temperature probe on the skin surface. Skin temperature was recorded over a specific period of time. The results indicated that the InCare HOT/ICE Lite Machine in its ability to reduce patient skin temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Hollister Incorporated InCare HOT/ICE Lite Machine
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Contact Person Joseph S. Tokarz Manager, Regulatory Affairs Phone (847)680-2849 (847)918-3860 Fax
Date Summary Prepared - June 26, 1996
2. Name of Device:
InCare HOT/ICE Lite Machine
3. Name of Predicate Device(s)
| a. InCare | HE500 | (K830757) |
|---|---|---|
| b. InCare | System 3 | (K915196) |
4. Description of Device
The InCare HOT/ICE Lite Machine incorporates state of the art technology with solid state electronics. The device is designed to deliver cold therapy to a localized area. This is accomplished by circulating cold water through a plastic blanket or bag that has been secured to the patient's anatomy. The device is intended to be used in an institution or home environment.
5. Statement of Intended Use
The InCare HOT/ICE Lite Machine is intended to provide cold therapy to body surfaces by pumping and circulating chilled water through a plastic blanket that has been secured to the patient's anatomy.
6. Statement of Technological Characteristics of the Device
On the following page is a comparison of the technical specifications of the InCare HOT/ICE Lite Machine and the predicate devices.
1
Hollister Incorporated InCare HOT/ICE Lite Machine
| Features/Specs | Proposed device
InCare HOT/ICE Lite | InCare HE500
K830757 | InCare System 3
K915196 |
|------------------------------------------------------|-------------------------------------------|-------------------------------------------|------------------------------|
| Intended to provide cold
therapy to body surfaces | Yes | Yes | Yes |
| Solution Flow Rates
GPH=gallons per hour | 4 GPH (nominal) | 15 GPH (nominal) | 19 GPH (nominal) |
| Operating Pressure
PSI=pounds per square
inch | 3.5 PSI (nominal) | 2.5 PSI (nominal) | 4.8 PSI (nominal) |
| Liquid media | Water / Alcohol | Water / Alcohol | Water / Alcohol |
| Liquid Capacity | 500 ml = 350 ml Water +
150 ml Alcohol | 500 ml = 350 ml Water +
150 ml Alcohol | 650 ml water/alcohol |
| Therapy temperature
range | 50° to 72° F
10° to 22° C | 40° to 150° F
4° to 40° C | 40° to 150° F
4° to 40° C |
| Weight | approx 7.1 lbs | approx 20 lbs | 32 lbs (approximate) |
| Power Supply | 120VAC, 136 watts,
50/60Hz | 115 V, 60 Hz, 3 AMPS | 115 VAC, 60 Hz 3 AMPS |
7. Performance Testing
The InCare HOT/ICE Lite Machine with a HOT/ICE blanket was evaluated for its ability to cool the test subjects skin as measured by a temperature probe on the skin surface. Skin temperature was recorded over a specific period of time. The results indicated that the InCare HOT/ICE Lite Machine in its ability to reduce patient skin temperature.
8. Conclusion
The InCare HOT/ICE Lite Machine is substantially equivalent to the predicate devices and is safe and effective for its intended use.
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