(188 days)
The primary use of the CIM, as an intermittent themmeter, is to take a patient's temperature at a single point in time. However, the instrument's Monitor mode also allows continuous monitoring of the patient's temperature. The CIM is a clinical grade thermometer. It is intended for use by healthcare practitioners only; typically in a hospital, clinic or mobile environment. It is not intended for lay or home use.
The Clinical Themometry Module is intended to be used for the intermittent determination of temperature in hypothermic normothermic of ebrildren or adults, In the Normal mode, oral use in compliant patients allowing maintenance of the sublingual picket for the temperature-taking cycle, enables the predictive algorithm to determine an accurate temperature in approximately 4 seconds. Rectal use results in a predictive temperature in approximately 10 seconds.
The CTM consists of an elongated metal heat-conductive probe connected to the multiparameter module (MPM) which may be used with the ESCORT® II Patient Monitor through a coiled cable. The probe contains a thermistor which conveys temperature information to the MPM for calculation of patient temperature which may be displayed on the ESCORT® II display panel.
Prior to use, the probe is inserted into a plastic probe cover. The cover offers no significant barrier to heat transfer from the patient to the probe body. The disposable nature of the probe cover prevents microbiological cross-contamination among patients such as might occur with a reusable probe.
Calculation of patient temperature may, in the normal mode, utilize algorithms which enable accurate temperature prediction within 3 to 10 seconds of probe placement.
Here's an analysis of the provided text regarding the K970011 Clinical Thermometry Module, focusing on acceptance criteria and supporting studies, formatted as requested:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance (CTM) | Predicate Device (SureTemp® & LifeSign®) |
|---|---|---|
| Display Temperature Range | 84.0°F to 108.8°F / 28.9°C to 42.2°C | 84.0°F to 108.8°F (SureTemp®), 84.0°F to 108.8°F (LifeSign®) |
| Laboratory Accuracy | ±0.2°F, in Monitor mode in a stirred water bath | ±0.2°F, in Monitor mode in a stirred water bath (SureTemp®), per ASTM E-1112-86 (LifeSign®) |
| Precision | 0.1°F / 0.1°C | 0.1°F / 0.1°C (SureTemp®), Not Specified (LifeSign®) |
| Operating Temperature Range | 60.8°F to 104°F / 16°C to 40°C | 60.8°F to 104°F (SureTemp®), 82°F to 104°F (LifeSign®) |
| Operating Humidity Range | 15% to 95%, non-condensing | 15% to 95%, non-condensing (SureTemp®), 15% to 90%, non-condensing (LifeSign®) |
| Storage Temperature Range | -4°F to 120°F / -20°C to 50°C | -4°F to 120°F (SureTemp®), -4°F to 122°F (LifeSign®) |
| Storage Humidity Range | 15% to 95%, non-condensing | 15% to 95%, non-condensing (SureTemp®), 15% to 90%, non-condensing (LifeSign®) |
| Bench Test - Environmental Data | Slope: 0.995, Y-Intercept: 0.0938, r: 0.999, SEE: 0.5246, Mean Error: 0.000, Std. Deviation: 0.0391 | (Not directly reported for predicate devices as comparative statistical analysis was against them) |
| Bench Test - Heat Well Data | Slope: 1.000, Y-Intercept: 0.000, r: 1.000, SEE: 0.000, Mean Error: 0.000, Std. Deviation: 0.000 | (Not directly reported for predicate devices as comparative statistical analysis was against them) |
2. Sample size used for the test set and the data provenance
The document describes "bench testing methods" used for device testing. It does not specify a sample size in terms of number of patients, readings, or specific data points for the test set. Instead, it relies on statistical analysis of temperature measurements.
- Data Provenance: The bench testing involved "making temperature measurements at operational environmental extremes of temperature and humidity" and "using a constant temperature source." This indicates the data was generated in a laboratory setting rather than from human subjects. The provenance is therefore considered retrospective/simulation based on laboratory conditions and not derived from clinical patient data or specific geographical regions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for the bench testing appears to be established by the "constant temperature source" and the predicate devices themselves, as the CTM was validated "against the predicate devices incorporating Diatek technology."
4. Adjudication method for the test set
There is no mention of an adjudication method for the test set. Since the testing involved bench comparisons to known standards (constant temperature source) and predicate devices, a human adjudication method was not applicable or described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a direct measurement instrument (thermometer), not an AI-assisted diagnostic tool that would involve human interpretation or "readers." Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance evaluation was implicitly done. The "bench testing methods" evaluated the CTM's accuracy and repeatability in a lab setting, comparing its measurements to known standards and predicate devices without human intervention in the measurement process. The predictive algorithm's performance (determining accurate temperature in approximately 4 seconds orally, 10 seconds rectally) is described as an inherent function of the device itself.
7. The type of ground truth used
The ground truth used for the bench testing was:
- Known constant temperature sources: Implicit in "using a constant temperature source."
- Measurements from predicate devices: The CTM was validated "against the predicate devices incorporating Diatek technology." This means the predicate devices' measurements served as a reference for accuracy.
8. The sample size for the training set
The document describes a 510(k) submission for a medical device (thermometer), not an AI/machine learning model that typically requires a distinct "training set." Therefore, there is no mention of a training set sample size. The CTM's algorithms would have been developed and tested by the manufacturer during its design phase, but this is not referred to as a "training set" in the context of this submission.
9. How the ground truth for the training set was established
As there is no explicit mention of a "training set" in the context of this 510(k) submission, the method for establishing its ground truth is not provided. The device's underlying algorithms would have been designed based on established thermometry principles and validated through internal development testing, likely using similar methods to the bench tests described for the 510(k) submission.
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clinical thermometry module
510(K) SUBMISSION
510(K) SUMMARY
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Image /page/1/Picture/1 description: The image shows a logo with the letters "MDE" in bold, stylized font. Above the letters is a graphic of horizontal lines and a lightning bolt shape, all enclosed in a rounded rectangle. Below the logo, the words "510(k) Summary" and "Innovations" are printed in a smaller font. The text is slightly blurred, suggesting it may be part of a document or advertisement.
ESCORT® Il Clinical Thermometry Module
Submitted by:
David M. Trueblood Regulatory Affairs Manager Medical Data Electronics 12720 Wentworth Street Arleta, California 91331
Telephone: 818-768-6411 Contact: David M. Trueblood
Date Prepared: December 31, 1996
Device Name:
| Trade Name: | ESCORT® II Clinical Thermometry Module (CTM) |
|---|---|
| Common/Usual Name: | Thermometer, Electronic Thermometer, PredictiveThermometer |
| Classification Name: | Thermometer, Electronic, Clinical |
Substantial Equivalence:
The Clinical Thermometry Module (CTM) for the ESCORT® II Patient Monitor is substantially equivalent to the ESCORT II Patient Monitor with Yellow Springs Instruments (YSI) temperature measurement capability, to the Diatek® SureTemp® Thermometer System and to the Welch Allyn LifeSign® Critical Vital Signs Monitor (CVSM). The MDE Clinical Thermometry Module has the same intended use, has the same or equivalent design, materials, method of action and labeling and, therefore, is substantially equivalent to these and other clinical electronic thermometers currently distributed commercially in the United States. Temperature channels are factory-configured, as are all parameters contained in the MDE Multiparameter Module (MPM). Since hardware, software and function are identical in the CTM to those incorporated in the MPM, the CVSM and in the SureTemp®, which have all been previously granted marketing clearance by FDA, substantial equivalence to these devices is assured and claimed.
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Device Description:
The CTM consists of an elongated metal heat-conductive probe connected to the multiparameter module (MPM) which may be used with the ESCORT® II Patient Monitor through a coiled cable. The probe contains a thermistor which conveys temperature information to the MPM for calculation of patient temperature which may be displayed on the ESCORT® II display panel.
Prior to use, the probe is inserted into a plastic probe cover. The cover offers no significant barrier to heat transfer from the patient to the probe body. The disposable nature of the probe cover prevents microbiological cross-contamination among patients such as might occur with a reusable probe.
Calculation of patient temperature may, in the normal mode, utilize algorithms which enable accurate temperature prediction within 3 to 10 seconds of probe placement.
Intended Use:
The Clinical Themometry Module is intended to be used for the intermittent determination of temperature in hypothermic normothermic of ebrildren or adults, In the Normal mode, oral use in compliant patients allowing maintenance of the sublingual picket for the temperature-taking cycle, enables the predictive algorithm to determine an accurate temperature in approximately 4 seconds. Rectal use results in a predictive temperature in approximately 10 seconds.
Comparison to Predicate Devices:
The Clinical Thermometry Module for use with the ESCORT II Patient Monitor is shown to demonstrate substantial equivalence to the ESCORT II Patient Monitor with YSI temperature measurement technology, to the Diatek® SureTemp® Thermometer System and the Welch Allyn LifeSign® Critical Vital Signs Monitor (CVSM).
The following table summarizes the characteristics of the four electronic thermometers.
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| ITEM | CTM | CTM WITH YSI | SURETEMP® | LIFESIGN® |
|---|---|---|---|---|
| DisplayTemperatureRange | 84.0°F to 108.8°F28.9°C to 42.2°C | 20° to 50°C | 84.0 to 108.8°F28.9 to 42.2°C | 84.0 to 108.8°F28.9 to 42.2°C |
| LaboratoryAccuracy | ±0.2°F, in Monitor mode in astirred water bath | ±0.1°C | ±0.2°F, in Monitor mode in astirred water bath | per ASTM E-1112-86 |
| Precision | 0.1°F0.1°C | Not Specified | 0.1°F0.1°C | Not Specified |
| OperatingTemperatureRange | 60.8°F to 104°F16°C to 40°C | 5°C to 40°C | 60.8°F to 104°F16°C to 40°C | 82°F to 104°F10°C to 40°C |
| OperatingHumidity Range | 15% to 95%,non-condensing | 0 to 90%, non-condensing | 15% to 95%,non-condensing | 15% to 90%,non-condensing |
| StorageTemperatureRange | -4°F to 120° F-20°C to 50°C | -40°C to +70°C | -4°F to 120° F-20°C to 50°C | -4°F to 122° F-20°C to 50°C |
| Storage HumidityRange | 15% to 95%,non-condensing | 10 to 100%, non-condensing | 15% to 95%,non-condensing | 15% to 90%,non-condensing |
| Power Source | Modular Batteries; 2 each,12V, 2.3 AHAC Main: 115/230VAC,Selectable48-62 Hz, Autosensing | Modular Batteries; 2 each,12V, 2.3 AHAC Main: 115/230VAC,Selectable48-62 Hz, Autosensing | AA, Alkaline | Lead Acid |
| AC Current: 0.4A @ 115VAC0.2 A @ 230VAC | AC Current: 0.4A @ 115VAC0.2 A @ 230VAC | N/A | AC Current: 120 VAC220-240 VAC | |
| BatteryOperating Life | 2.5 to 4 hours, depending onmonitor configuration | 2.5 to 4 hours, depending onmonitor configuration | About 6000 readings | 10 Hours, minimum |
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Device Testing:
Bench testing methods were utilized to confirm the accuracy and repeatability of the as referenced to the predicate devices containing the Diatek clinical electronic thermometer technology. The intent of the bench tests was: 1.) To exercise the CTM by making temperature measurements at operational environmental extremes of temperature and humidity to ensure system performance comparable to the predicate devices incomorating Diatek technology and, 2.) To validate the CTM against the predicate devices incorporating Diatek technology using a constant temperature source.
Results of statistical analysis of the bench test data are contained in the following tables.
| Simple Linear Regression Analysis: | |||||
|---|---|---|---|---|---|
| Slope:Y-Intercept: | 0.9950.0938 | r:SEE: | 0.9990.5246 | Mean Error: | 0.000 |
| Std. Deviation: | 0.0391 | ||||
| Environmental Test Data | |||||
| Simple Linear Regression Analysis: | |||||
| Slope:Y-Intercept: | 1.0000.000 | r:SEE: | 1.0000.000 | Mean Eerror: | 0.000 |
| Std. Deviation: | 0.000 | ||||
| Heat Well Test Data |
Conclusions of Bench Tests:
Results of bench testing confirm the accuracy of the CTM relative to two predicate devices utilizing the same proprietary technology. The results support the substantial equivalence claim for the CTM.
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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's head is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David M. Trueblood 'Requlatory Affairs Manager Medical Data Electronics, Incorporated 12720 Wentworth Street Arleta, California 91331
JUL - 9 1997 - 9 1997
Re : K970011 Trade Name: Escort II Clinical Thermometry Module (CTM) Regulatory Class: II Product Code: FLL Dated: April 9, 1997 Received: April 10, 1997
Dear Mr. Trueblood:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as sat forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
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Page 2 - Mr. Trueblood
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5 1 O(k) Number (if known): K97001
Ocvice Name: ESCORT II CLINICAL THERMOMETRY MODULE (CIM)
Indications for Usc:
The primary use of the CIM, as an intermittent themmeter, is to take a patient's temperature at a single point in time. However, the instrument's Monitor mode also allows continuous monitoring of the patient's temperature. The CIM is a clinical grade thermometer. It is intended for use by healthcare practitioners only; typically in a hospital, clinic or mobile environment. It is not intended for lay or home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CORH, Office of Device Evaluation (ODE)
(Division Sign-Off) Putriceci Cucente
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K970011
11 asseription Lise _ iPor 21 CER 001.1091
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Over. The-Counter Use _
įOplionai Formai 1-2-96j
§ 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.