(119 days)
Not Found
No
The device description and performance studies focus on basic temperature sensing, display, and alarm functions, with no mention of AI/ML algorithms or data processing beyond simple threshold comparisons.
No.
The device is solely intended for monitoring esophageal temperature, not for treating any condition or disease.
No
The device is primarily for continuous esophageal temperature monitoring. While it provides data (temperature measurements) that a clinician might use, its direct function isn't to diagnose a disease or condition but rather to monitor a physiological parameter.
No
The device description explicitly lists hardware components: Monitor, Interconnect Cable, and Esophageal Probe. The performance studies also involve physical testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "continuous esophageal temperature monitoring." This involves measuring a physiological parameter (temperature) directly within the body.
- Device Description: The device measures temperature using sensors placed in the esophagus. This is a direct measurement of a physical property within the patient.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not process or analyze any biological specimens.
Therefore, the ESOTEST Probe and Monitor system is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical test were performed to support Substantial Equivalence and performance characteristics.
Tests performed according to FIAB internal protocol developed by following the guidelines of
- 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.
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 comparison instrument. Explored temperature range is 25-45°C.
3 ESOTEST Monitors with 3 Probes were used. The results were that for each tested thermometer (for each monitor for a total of 9 tested thermometers) none of the difference between reference and measured temperature exceed the device's accuracy. Concluded that the device ESOTEST Monitor with its ESOTEST Probe and their connecting cable is characterized by an accuracy of ±0,3℃ in the whole measurement range 25-45℃.
Repeatability: Purpose was to measure, in condition of repeatability, the precision of the thermometric chain and verify it does not exceed the displays resolution (0,1℃). 5 ESOTEST Monitors with Probes were used. Under repeatability conditions, 14 measurements were performed for each thermometer (for a total of 15 independent thermometers). Results confirmed that precision is in the specified limit (0,1℃).
Response time: Purpose was to 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). 6 ESOTEST Monitors and probes were used. 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 (approximately 1").
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.3℃
Precision and Repeatability: 0.1℃
Response Time: 1s
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.
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
§ 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
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.
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Carreland | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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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:
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|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
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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 |
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Sec.04 - 1/1 | |
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Kathleen | Digitally signed by Kathleen E. Fitzgerald DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=0010093027, cn=Kathleen E. Fitzgerald Date: 2013.02.26 11:40:17 -05'00' |
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Fitzgerald |