K Number

Device Name

ESCORT II CLINICAL THERMOMETRY MODULE (CTM)

Manufacturer

MEDICAL DATA ELECTRONICS

Date Cleared

1997-07-09

(188 days)

Product Code

FLL

Regulation Number

880.2910

Intended Use

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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document mentions "predictive algorithm" but provides no details suggesting AI/ML, such as training data, test data, or specific AI/ML techniques. The description aligns with traditional algorithmic approaches for temperature prediction based on thermistor readings.

Therapeutic

The device is a clinical grade thermometer intended for measuring patient temperature, which is a diagnostic function, not a therapeutic intervention.

Diagnostic

The device is a clinical thermometer intended for measuring a patient's temperature, which is a vital sign. While vital signs are used in diagnosis, the device itself simply provides a measurement and does not interpret the measurement to provide a diagnosis of a disease or condition. Its primary functions are temperature determination and monitoring.

SaMD (Software as a Medical Device)

The device description explicitly states that the device consists of a physical probe with a thermistor connected to a multiparameter module and a patient monitor. This indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The described device is a clinical thermometer that measures a patient's body temperature directly. It does not analyze samples taken from the body.
Intended Use: The intended use is to measure and monitor a patient's temperature, which is a direct physiological measurement, not an in vitro test.

Therefore, the device described is a clinical thermometer, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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.

Product codes (comma separated list FDA assigned to the subject device)

FLL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral, Rectal

Indicated Patient Age Range

children or adults

Intended User / Care Setting

healthcare practitioners only; typically in a hospital, clinic or mobile environment. It is not intended for lay or home use.

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

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was performed:
Simple Linear Regression Analysis (Constant Temperature Source): Slope: 0.995, Y-Intercept: 0.0938, r: 0.999, SEE: 0.5246, Mean Error: 0.000, Std. Deviation: 0.0391.
Simple Linear Regression Analysis (Environmental Test Data): Slope: 1.000, Y-Intercept: 0.000, r: 1.000, SEE: 0.000, Mean Eerror: 0.000, Std. Deviation: 0.000.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

Not Found

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 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.

Summary

K970011

- - JUL - 9 - 9 - 1997

clinical thermometry module

510(K) SUBMISSION

510(K) SUMMARY

K970011

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, Predictive
Thermometer
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.

Device Description:

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:

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.

ITEM	CTM	CTM WITH YSI
Display
Temperature
Range	84.0°F to 108.8°F
28.9°C to 42.2°C	20° to 50°C	84.0 to 108.8°F
28.9 to 42.2°C	84.0 to 108.8°F
28.9 to 42.2°C
Laboratory
Accuracy	±0.2°F, in Monitor mode in a
stirred water bath	±0.1°C	±0.2°F, in Monitor mode in a
stirred water bath	per ASTM E-1112-86
Precision	0.1°F
0.1°C	Not Specified	0.1°F
0.1°C	Not Specified
Operating
Temperature
Range	60.8°F to 104°F
16°C to 40°C	5°C to 40°C	60.8°F to 104°F
16°C to 40°C	82°F to 104°F
10°C to 40°C
Operating
Humidity Range	15% to 95%,
non-condensing	0 to 90%, non-condensing	15% to 95%,
non-condensing	15% to 90%,
non-condensing
Storage
Temperature
Range	-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 Humidity
Range	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 AH
AC Main: 115/230VAC,
Selectable
48-62 Hz, Autosensing	Modular Batteries; 2 each,
12V, 2.3 AH
AC Main: 115/230VAC,
Selectable
48-62 Hz, Autosensing	AA, Alkaline	Lead Acid
	AC Current: 0.4A @ 115VAC
0.2 A @ 230VAC	AC Current: 0.4A @ 115VAC
0.2 A @ 230VAC	N/A	AC Current: 120 VAC
220-240 VAC
Battery
Operating Life	2.5 to 4 hours, depending on
monitor configuration	2.5 to 4 hours, depending on
monitor configuration	About 6000 readings	10 Hours, minimum

Device Testing:

Results of statistical analysis of the bench test data are contained in the following tables.

Simple Linear Regression Analysis:
Slope:
Y-Intercept:	0.995
0.0938	r:
SEE:	0.999
0.5246	Mean Error:	0.000
Std. Deviation:	0.0391
Environmental Test Data

Simple Linear Regression Analysis:
Slope:
Y-Intercept:	1.000
0.000	r:
SEE:	1.000
0.000	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.

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

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

5 1 O(k) Number (if known): K97001

Ocvice Name: ESCORT II CLINICAL THERMOMETRY MODULE (CIM)

Indications for Usc:

(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 _

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