What is the FDA product code for ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM?

FLL. It is classified under 21 CFR 880.2910 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM

Q: Who is the manufacturer of ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM?

Fiab Spa filed the 510(k) submission for ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM (K123361).

K123361 · Fiab Spa · FLL · Feb 27, 2013 · General Hospital

Device Facts

Record ID	K123361
Device Name	ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
Applicant	Fiab Spa
Product Code	FLL · General Hospital
Decision Date	Feb 27, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2

Intended Use

ESOTEST Probe is intended for continuous esophageal temperature monitoring. ESOTEST Monitor is intended for display continuous temperature measurement (℃) from 3 sensors temperature probe.

Device Story

ESOTEST system monitors esophageal temperature; consists of monitor, interconnect cable, and 7Fr esophageal probe. Probe contains 3 thermocouple sensors for continuous temperature detection at 3 esophageal points. Monitor processes thermocouple voltage to display temperature on 3 LED displays; includes user-settable alarm thresholds with visual (flashing red LED) and audible (buzzer) alerts. Used in clinical settings by healthcare professionals. Provides real-time temperature data to assist clinical decision-making during procedures requiring thermal monitoring. Benefits patient by enabling continuous, accurate temperature tracking.

Clinical Evidence

Bench testing only. Evaluated accuracy, precision (repeatability), and response time against ISO 80601-2-56:2009 and NIST TN 1297 standards. Accuracy verified across 25-45°C range using 9 thermometers; precision verified via 14 measurements per thermometer (15 total); response time verified via 18 measurements per evaluation. All results met acceptance criteria.

Technological Characteristics

System uses 3 high-accuracy T-type thermocouple sensors. Materials: Polyurethane and Stainless Steel (AISI 304). Monitor features 3-digit 7-segment LED displays. Power: 100-120/230 Vac. Connectivity: Wired probe-to-monitor via interconnect cable. Compliance: UL60601-1:2006, IEC60601-1-2:2007. Sterilization: Not specified.

Indications for Use

Indicated for continuous esophageal temperature monitoring in patients requiring such monitoring. No specific age or gender restrictions provided. Contraindications not specified.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

S-Cath - Esophageal Temperature Probe and Temperature Monitoring System (K112376)

Related Devices

K112376 — S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM · Circa Scientific, LLC · Aug 31, 2011
K180047 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System · Fiab Spa · Nov 8, 2018
K192210 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System · Fiab Spa · Oct 10, 2019
K200943 — Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System · Circa Scientific, LLC · Dec 17, 2021
K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System · Circa Scientific, Inc. · May 25, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ K 123361 # FEB 2 7 2013 | 510(k) Summary | Image: FIAB logo | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|------------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2013/02/21 | 510(k) notification – Section 05 | ## Section 05 ## 510(k) Summary | This document was prepared on 2012/11/07 and reviewed on 2013/02/21 | | | |---------------------------------------------------------------------|--------------------------------|---| | Section 05 | | 1 | | 510(k) Summary | | 1 | | 1. | Submitter | 1 | | 2. | Device name and classification | 1 | | 3. | Predicates | 2 | | 4. | Device description | 2 | | 5. | Indications for use | 3 | | 6. | Comparison to predicate | 4 | | 7. | Non-clinical performance data | 6 | | 8. | Conclusion | 7 | #### Submitter 1. Fiab SpA Via Costoli, 4 50039 Vicchio Florence - Italy Tel : (39) 055 849 79 216 Fax: (39) 055 849 79 87 Contact: Silvia Calabrò, Official Correspondent Email: silvia@fiab.it; regulatory(@fiab.it #### Device name and classification 2. ESOTEST Esophageal Temperature Probe and Temperature Monitoring System. Regulation description: Clinical electronic thermometer, Product code: FLL, Regulation number: 880.2910, Device class: II, There were no prior submissions addressed to FDA related to device in object of present submission. - | 11 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 10-4000 AL-4000 - A 40 10-46-44 | THE COLLECTION | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | {1}------------------------------------------------ | 510(k) Summary | Image: FIAB logo | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|------------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2013/02/21 | 510(k) notification - Section 05 | | | | | #### 3. Predicates Lawfully marketed device to which is claimed equivalence: S-Cath - Esophageal Temperature Probe and Temperature Monitoring System, K112376 #### 4. Device description ESOTEST Esophageal Temperature Probe and Temperature Monitoring System consists of following main parts (on parenthesis is reported FIAB model and reference): - Monitor (ESOTEST PLUS 7717, 30110), - Interconnect Cable (F5406/TER), - Esophageal Probe (26155S/US). {2}------------------------------------------------ | 510(k) Summary | Image: FIAB logo | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|------------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2013/02/21 | 510(k) notification – Section 05 | Image /page/2/Figure/1 description: The image shows four different parts of an ESOTEST system. The first part is the monitor, which is shown from the front and back. The other parts are the temperature probe and the interconnect cable. Fig.1: ESOTEST parts. Monitor shows, on 3 separate led displays, the temperature detected by 3 thermocouple sensors placed in the esophageal probe. The incorporated alarm system allows the operator to set a threshold of adequate temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm. Esophageal probe is a Ø7Fr lead intended to continuous detection of esophageal temperature at three different points of esophagus. Temperature is get by 3 thermocouple sensors. Esophageal probe is connected to the monitor by interconnect cable. #### ર. Indications for use ESOTEST Probe is intended for continuous esophageal temperature monitoring. ESOTEST Monitor is intended for display continuous temperature measurement (℃) from 3 sensors temperature probe. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ A STATE A CONSTITUTION AND A CONSTITUTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CON | - 4 -- 4 400 ---- 1 10 t 1 1 | A Comments of Children Comments of Children No. of Cattle. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | -4-440-4-4 A STATE AND THE FORM OF CHANGE OF CHARACT AND THE FORM OF CHANGE OF THE CHANGE OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM Carreland | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ And Canadian Canada Career of | {3}------------------------------------------------ | 510(k) Summary | Image: FIAB logo | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|------------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2013/02/21 | 510(k) notification - Section 05 | #### Comparison to predicate 6. ESOTEST Esophageal Temperature Probe and Temperature Monitoring System have the same intended use as the predicate and do not imply new technological characteristics. Bench testing contained in this submission demonstrate that any differences in their technological characteristics and performance specifications do not raise any new questions of safety or effectiveness. Thus FIAB ESOTEST is substantially equivalent to the predicate device S-Cath. | Feature | Device under submisison FIAB - ESOTEST | Predicate S-Cath | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Thermometer type | esophageal | esophageal | | Intended Uses | continuous temperature monitoring of patient's esophagus | continuous patient temperature monitoring, designed for insertion into esophagus | | Labelling | Package label: includes product identification, lot number. Instructions for use: established. Temperature probe: labelled for single use | Package label: includes product identification, lot number. Instructions for use: established. Temperature probe: labelled for single use | | Components | temperature probe interconnect cable monitor | temperature probe interconnect cable monitor | | Temperature measurement range [°C] | 25-45 | 25-45 | | Number of temperature sensors | 3 | 12 | | Temperature sensor type | high accuracy thermocouple T type (accuracy ±0,3°C) | NTC thermistor (accuracy ±0,2°C) | | Measurement presentation | 3 led display | LCD monitor | | Display specification | 5 digit, 7-segment, 14 mm LED | n.a. | | Alarm temperature range [°C] | 36-41 | 0-90 | | Alarm signal | visual (flashing red led) audible (intermittent buzzer) | visual and audible | | Control interface | UP and DOWN on/off volume knob | touch screen monitor | | Power requirements | 100-120/230 Vac | 100-240 Vac | Sec.05 - 4/8 {4}------------------------------------------------ | 510(k) Summary | Image: FIAB logo | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|------------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2013/02/21 | 510(k) notification - Section 05 | | Feature | Device under submisison FIAB - ESOTEST | Predicate S-Cath | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Monitor classification | I, CF, defib protected | I,BF, defib protected | | Dimensions [cm] | monitor: 36,7x24,9x11,0 interconnect cable (length): 250 temperature probe (length and diameter): 95; Ø7Fr | monitor: 26x20x8,2 interconnect cable (length): 305 temperature probe (length and diameter): 77,5; Ø10Fr | | Introduction | esophageal (nose/throat) | esophageal | | Signal processing and display | Actual temperature is a function of the thermocouple voltage. Temperature displayed in 0,1°C increments. 1 input (single probe) available 3 sensors per probe measurements and user-selected alarm limit are displayed on LED Displays. | Actual temperature is a function of the thermistor resistance. Temperature displayed in 0,1°C increments. 1 input (single probe) available 12 sensors per probe displayed LCD Display includes user-selected alarm limits. | | Materials (patient contacting) | Polyurethane and Stainless Steel (SST) AISI 304 | Flexible Polyether and Rigid Polyamide (PEBAX) | | Ambient temperature environment | no special ambient temperature range is specified for the device | no special ambient temperature range is specified for the device | | Accuracy [°C] | within rated output range in normal use is not greater than 0,3°C (ISO 80601-2-56:2009 requirements for clinical thermometers) | within rated output range in normal use is not greater than 0,3°C (ISO 80601-2- 56:2009 requirements for clinical thermometers) | | Precision and repeatibility [°C] | 0,1 | 0,1 | | Response time | Both heating transient response time and cooling transient response time are approximately 1"; time is for probe plunged from reference bath to a water bath with a 2°C differential. | Heating transient response time is 7" and cooling transient response time is approximately 4.5" (time is for probe plunged from reference bath to a water bath with a 2°C differential) | | Other capabilities | Device fully complies with UL and IEC (electrical, EMC): UL60601-1:2006 IEC60601-1-2: 2007 UL listing: FIAB SPA: Medical equipment PIDF (UL File # E324758) | Device fully complies with IEC (electrical, EMC): IEC60601-1:1998+A1+A2; IEC60601-1-2:2007 | : Tab.1: Comparison table. | September 19, 2011 11:30 AND AND AND AND AND AND AND AND AND AND AND AND AND A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A BREAD A | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ = 10 5 ﺍﻟﺘﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | Concession, Corporation Company Concession, | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | . Comment ACCRECTION | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Carrely Concession | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ program and the comments of the first and the first and the comments of the comments of the comments of the comments of the comments of the comments of the first of the first | · {5}------------------------------------------------ | 510(k) Summary | Image: FIAB logo | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|------------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2013/02/21 | 510(k) notification – Section 05 | #### 7. Non-clinical performance data In order to support Substantial Equivalence and performance characteristics of ESOTEST, non-clinical test were performed; the detailed description is reported on Section 18. Following it is reported a brief description of the tests, including purpose, measurement protocols and layouts, and the acceptance criteria for each parameter under test; the materials and the instruments used; the measurements results; the values of the parameters attributed to the devices as confirmed by the compliance to the specified criteria. Performance characteristics that are evaluated were obtained from FDA guidance: "Guidance on the content of premarket notification [510(K)] submission for clinical electronic thermometers" [March 1993] and performed according to FIAB internal protocol developed by following the guidelines of the technical standards: - ISO 80601-2-56:2009 Medical electrical equipment. Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - NIST Technical Note 1297: 1994 Edition Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results. | Characteristic | ESOTEST requirement | Reference | |-----------------------------------------|------------------------|--------------------------------------------------------------------------------------| | Accuracy of the device | ±0,3℃ | ISO 80601-2-56 – 201.101.2 Laboratory accuracy | | Precision in condition of repeatability | 0,1℃ | NIST TN 1296 - Appendix D | | Response Time | 1s | ISO 80601-2-56 – 201.101.3 Time response for a continuous clinical thermometer | Performance characteristics that were evaluated are in the following table: Thermometric chain of the devices under test The esophageal temperature measurement process is realized through a thermometric chain resulting by 3 elements: ESOTEST Probe, interconnect cable for the connection of probe to the monitor and the ESOTEST Monitor itself. Since the ESOTEST system has 3 independent thermometers and independent connection to the sensor in the probe for each device there are 3 independent thermometric chain that work at the same time. ### Tests performed Accuracy: ESOTEST's accuracy was verified comparing temperature measurements performed by each of three thermometers present in the device with temperature measured by a reference thermometer. A reference thermometric chain, consisting in a reference probe (Pt100) and a reference thermometer, both calibrated, was used as | Carrely Concession CONCELLA | --------------------------------------------------------------------- | -------- | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The Comment of Children Career of Children | | {6}------------------------------------------------ | 510(k) Summary | | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|----------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2013/02/21 | 510(k) notification – Section 05 | comparison instrument in order to evaluate the difference between the values of the same temperature, measured by the two chains. Explored temperature range is 25-45°C. The measurements was performed in order to verify that thermometric chain realized with ESOTEST System (connecting cable, connectors and internal wiring employed for the assembly of ESOTEST System), ensure the accuracy requirements of the reference standard, as well as the predicate device's performances (±0.3℃). For the tests were used 3 ESOTEST Monitor with 3 Probes, a thermostatic bath and a reference thermometer with probe. Based on a considerable number of measurements, the results were that for each tested thermometers for each monitor for a total of 9 tested thermometers) none of the difference between reference and measured temperature exceed the device's accuracy. Then it was possible to conclude that the device ESOTEST Monitor with his ESOTEST Probe and their connecting cable is characterized by an accuracy of ±0,3℃ in the whole measurement range 25-45℃. Repeatibility: The purpose of this test is to measure, in condition of repeatability, the precision of the thermometric chain previously described and verify that it do not exceeds the displays resolution (0,1℃). For the tests were used 5 ESOTEST Monitor with Probe a thermostatic bath and a reference thermometer with probe. Under repeatibility conditions were performed 14 measurements for each thermometer (for a total of 15 independent thermometers) and results obtained confirmed that precision is in the specified limit (0,1℃). Response time: the purpose of this test is measure rise and fall times of the values displayed by ESOTEST Monitor in reply to temperature variations sensed by ESOTEST Probe, and verify that these response times do not exceed the limits established (1,6s). For the test were used 6 ESOTEST Monitor and probe, 1 thermostatic bath, 1 adiabatic bottle, 2 reference thermometers, 1 video camera. Following procedure was followed: a bath is at a certain temperature (T) and the other one is maintained at a greater temperature (T+2°C). For the rise time: after thermal stabilization in the thermostatic baths at lower temperature probe was plunged in the thermostatic bath at upper temperature. Rise time is obtained measuring elapsed time from plunging of probe in the upper bath to the achievement of final temperature. For the fall time it was repeated same procedure from upper to lower bath. Rise and fall times were evaluated through a statistically significant and independent number of measurements (18 for each evaluation). Results confirmed that rise and fall times are in the expected range. #### Conclusion 8. : The following data have been considered from devices comparison (ESOTEST Esophageal Temperature Probe and Temperature Monitoring System vs S-Cath - Esophageal Temperature Probe and Temperature Monitoring System) and from performance testing, in order to demonstrate Substantial Equivalence: | -- 14-25-4-4-4-4-4-4-5-50-50-50- | A CONSULTION CONTRACT CARTS CONTACT CARTS CONTACT CARTS CONTACT CARTS CONTACT CARTS CONTACT CARTS CONTACT CARTS CONTACT CARTS CONTACT CARTS CONTACT CARTS CONTACT CARTS CONTAC ומים מועד מיני מורג מורג יוצר מירי רומו למודד בין מערי היינו בין אין אין אין אין אין אין אין אין אין אין ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | Company of Children College of Children | {7}------------------------------------------------ | 510(k) Summary | Image: FIAB logo | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|------------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2013/02/21 | 510(k) notification - Section 05 | - the same intended use and site application (temperature monitoring of patient's esophagus); the same components of monitoring system (probe, interconnect cable, monitor); - similarity of technical/physical features (in terms of procedure of use); - the same temperature measurement range (25-45 ℃); - the same accuracy of measurement (±0,3℃ in the whole measurement range); ﺖ the same precision and repeatibility (0.1℃); - a faster response time (1" for both heating and cooling transient response time). - According to these data we can finally conclude that the temperature measurement system composed of ESOTEST Monitor, ESOTEST Probe and their connecting cable, is substantially equivalent to the predicate device in terms of performances, usage characteristics, safety of use. The differences with the predicate device do not affect substantial equivalence of performances and do not raise any new safety concern. Sec.05 - 8/8 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 ### February 27, 2013 Ms. Silvia Calabrò FIAB SpA Official Correspondent Via P. Costoli, 4 50039 Vicchio Florence Italy ### Re: K123361 Trade/Device Name: Esophageal Temperature Probe and Temperature Monitoring System Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic thermometer Regulatory Class: II Product Code: FLL Dated: January 10, 2013 Received: January 18, 2013 ### Dear Ms. Calabrò: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class.II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {9}------------------------------------------------ Page 2 - Ms. Calabrò Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Image /page/9/Picture/6 description: The image contains a signature that appears to read "for Ruth urowitz". The signature is stylized with looping lines and overlapping characters, making it somewhat difficult to decipher. The background behind the signature is patterned, with geometric shapes and lines that add visual complexity to the image. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ### Enclosure {10}------------------------------------------------ | Indications for Use | Image: FIAB logo | FIAB spa Vicchio, ITALY | |------------------------------------------------------------------------------|------------------|----------------------------------| | ESOTEST Esophageal Temperature Probe and Temperature Monitoring System | 2012/10/15 | 510(k) notification - Section 04 | ### Section 04 ### Indications for Use 510(k) Number (if known): - 11/23 צל 1 Device Name: ESOTEST Esophageal Temperature Probe and Temperature Monitoring System Indications For Use: #### ESOTEST Probe Esotest probe is intended for continuous esophageal temperature monitomig. ### ESOTEST Monitor . Esotest monitor is intended for display continuous temperature measurement (°C) from 3 sensors temperature probe. Prescription Use __ X_________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | 510(k) Number: | 413361 | |----------------|--------| |----------------|--------| | | Sec.04 - 1/1 | |--|--------------| |--|--------------| | Kathleen | <div style="font-size: small;">Digitally signed by Kathleen E. Fitzgerald</div> <div style="font-size: x-small;">DN: c=US, o=U.S. Government, ou=HHS,</div> <div style="font-size: x-small;">ou=FDA, ou=People,</div> <div style="font-size: x-small;">0.9.2342.19200300.100.1.1=0010093027,</div> <div style="font-size: x-small;">cn=Kathleen E. Fitzgerald</div> <div style="font-size: x-small;">Date: 2013.02.26 11:40:17 -05'00'</div> | |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fitzgerald | |