(128 days)
K830592A
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No
The summary describes a standard electronic thermometer system for temperature monitoring and does not mention any AI or ML capabilities.
No
The device is described as a thermometer system used to monitor tissue temperatures during therapeutic procedures, not to perform therapy itself.
Yes
Explanation: The device monitors tissue temperatures to avoid unintended tissue damage during various surgical procedures. This monitoring function provides information for diagnosis or to guide treatment decisions.
No
The device description explicitly mentions "thermocouple probes," which are hardware components used for temperature measurement. The system incorporates a user interface and works with these probes, indicating it is a system that includes both hardware and software, not a software-only device.
Based on the provided information, the Endocare Electronic Thermometer System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor tissue temperatures during thermotherapy, cryosurgery, or normal intra operative feedback." This describes a device used in vivo (within the living body) to measure a physiological parameter (temperature) during a medical procedure.
- Device Description: The description reinforces this by stating the probes are used for "intra-operative temperature monitoring."
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue samples) in vitro (outside the living body) to provide information about a patient's health. The description of the Endocare system does not mention any analysis of biological samples.
Therefore, the Endocare Electronic Thermometer System is a medical device used for in vivo temperature monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Endocare Electronic Thermometer System are designed for use in General Surgery, Urology, and Gynecology to monitor tissue temperatures during thermotherapy, cryosurgery, or normal intra operative feedback.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Temperature monitoring systems have been in the medical device market place for several decades. Endocare is introducing an Electronic Thermometer System that incorporates a flexible user interface for easy of use. The Temperature Monitoring System can be used with a variety of thermocouple probes. The probes can be used for intra-operative temperature monitoring to avoid unintended tissue damage.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Bailey BAT-8, K830592A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
AUG 15 1996
3. SAFETY AND EFFECTIVENESS SUMMARY
The Following is a summary of the safety and effectiveness of the Endocare Electronic Thermometer System.
1.0 General Information:
Device Name: Endocare Electronic Thermometer System Manufacturer: Endocare Inc. Sterigenics International Sterilizer:
2.0 Description
Temperature monitoring systems have been in the medical device market place for several decades. Endocare is introducing an Electronic Thermometer System that incorporates a flexible user interface for easy of use. The Temperature Monitoring System can be used with a variety of thermocouple probes. The probes can be used for intra-operative temperature monitoring to avoid unintended tissue damage.
3.0 Substantial Equivalence Support
The Endocare Electronic Thermometer System are designed for use in General Surgery, Urology, and Gynecology to monitor tissue temperatures during thermotherapy, cryosurgery, or normal intra operative feedback.
The Endocare Electronic Thermometer System has the same temperature measuring characteristics as current electronic thermometer systems.
The Endocare Electronic Thermometer System is substantially equivalent to the Bailey BAT-8 clinical monitoring thermometers and the Electromedics TM147T Temperature System. The Bailey BAT-8 clinical monitoring thermometers ( Pre-Medical Device Amendments of 1976) and the Electromedics TM147T Temperature Monitoring System (K#830592A) have been granted market clearance by the FDA .