(618 days)
No
The description focuses on standard temperature sensing technology (thermistors) and basic data display/storage. There is no mention of AI, ML, or any advanced algorithms for analysis or prediction.
No.
The device is solely for continuous temperature monitoring and visualization, without any stated therapeutic function or ability to treat a condition.
No
The device is a temperature monitoring system that measures and displays esophageal temperature. While temperature can be a diagnostic indicator, the device itself is described for "continuous detection, measurement and visualization" of temperature, not for making a diagnosis. The text explicitly states that its role in "reducing the risk of cardiac ablation-related esophageal injury has not been established" and its performance in "detecting esophageal temperature changes as a result of energy delivery... has not been evaluated," further indicating it's a monitoring tool, not a diagnostic one.
No
The device description explicitly states that the system consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the continuous detection, measurement, and visualization of esophageal temperature within the body.
- Mechanism: It uses temperature sensors (thermistors) placed inside the esophagus to directly measure temperature.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device is a medical device used for physiological monitoring in vivo (within a living organism), not for testing samples in vitro (outside the body).
N/A
Intended Use / Indications for Use
The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe.
The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
Product codes
FLL, IKD
Device Description
The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe.
The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with user-selected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive).
The S-CATH M Esophageal Temperature Probe provides continuous temperature measurement (℃) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadjusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located along an s-curve. The sensors measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.
The Probe is also equipped with 4 electrode sensors. By connecting the S-CATH M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for optimal placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating rooms and interventional electrophysiology rooms.
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)
The device was subjected to the following non-clinical testing to demonstrate that it performs as intended to the predicate device:
- In vitro cytotoxicity, sensitization, and intracutaneous reactivity
- ENDPOINT: Verifying the compliance of the esophageal probe to the requirements of ISO 10993-1 for the considered type and duration of contact.
- RESULT SUMMARY: Results of tests demonstrate that the sample can be considered non cytotoxic, not sensitizing, and meets the requirements of intracutatneous reactivity.
- Sterility
- ENDPOINT: Verifying the compliance of the esophageal probe to the requirements of sterilization according to standard ANSI/AAMI/ISO 11135.
- RESULT SUMMARY: Results of EO sterilization validation and tests demonstrate the device meets a Sterility Assurance Level (SAL) of 10-6.
- Software system tests
- ENDPOINT: Verifying the correct implementation of the software requirements according to standard IEC 62304.
- RESULT SUMMARY: Following completion of all software lifecycle activities, the software device does not have any unresolved anomalies (bugs or defects).
- All the applicable safety tests prescribed by the IEC 60601-1 standard
- ENDPOINT: Verifying the compliance of the system to the IEC 60601-1 standard.
- RESULT SUMMARY: The system passed all the applicable tests.
- All the applicable immunity and emission tests prescribed by the IEC 60601-1-2 standard
- ENDPOINT: Verifying the compliance of the system to the IEC 60601-1-2 standard.
- RESULT SUMMARY: The system passed all the applicable tests
- Accuracy and response time test
- ENDPOINT: Verifying the compliance of the system to the ISO 80601-2-56 standard.
- RESULT SUMMARY: The system accuracy and response time meets the requirements of the standard
- Mapping cable validation
- ENDPOINT: Verifying the compliance of the mapping cable to the ANSI/AAMI EC53:2013 standard.
- RESULT SUMMARY: The cable manufacturing process guarantees the compliance to the standard
- Performance test in the working environment
- ENDPOINT: Verifying the immunity of the system to the most common disturbances sources in the working environment, verifying the compatibility with 3D cardiac mapping systems.
- RESULT SUMMARY: The system is not affected by the noise sources in the working environment. The system is compatible with the following 3D cardiac mapping systems: EnSite NavX and CARTO 3
- Performance test in vivo (animal) setting
- ENDPOINT: Evaluate precision and accuracy of the electrode position detected by the 3D cardiac mapping system by measuring the distances between electrodes and control catheter tip on fluoroscopy and 3D cardiac mapping system.
- RESULT SUMMARY: Data confirmed S-CATH M probe is visible on 3D cardiac mapping system with a determined precision and accuracy of 2.0 ± 1.2mm on CARTO 3 and 7.4 ± 5.3mm on EnSite NavX.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Accuracy: 0.3℃ within rated output range
- Precision and repeatability: 0.1℃
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2021
CIRCA Scientific, Inc. Fred Piazza Quality Assurance Manager 14 Inverness Drive East. Suite H-136 Englewood, Colorado 80112
Re: K200943
Trade/Device Name: Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL, IKD Dated: November 18, 2021 Received: November 19, 2021
Dear Fred Piazza:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200943
Device Name
CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System
Indications for Use (Describe)
The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophaged temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe.
The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
I. SUBMITTER
CIRCA Scientific, Inc. 14 Inverness Drive East, Suite H-136 Englewood, CO 80112 Phone: (303) 951-8767 Contact: Fred Piazza Date Prepared: November 18, 2021
II. DEVICE INFORMATION
Name of Device: CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System
Common or Usual Name: Clinical electronic thermometer
Classification Name: Clinical electronic thermometer (21 CFR 880.2910)
Regulatory Class: II
Product Code(s): FLL, IKD
Predicate Device: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, K192210
Reference Device: S-Cath Esophageal Temperature Probe and Temperature Monitoring Probe, K112376
III. DEVICE DESCRIPTION
The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe.
The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive).
The S-CATH M Esophageal Temperature Probe provides continuous temperature measurement (℃) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadjusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located along an s-curve. The sensors measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.
4
The Probe is also equipped with 4 electrode sensors. By connecting the S-CATH M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for optimal placement.
IV. INDICATIONS FOR USE
The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA S-CATH M Probe and is intended for the continuous detection, measurement and visualization (in ℃) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA S-CATH M Probe.
The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| ELEMENT OF
COMPARISON | SUBJECT DEVICE: CIRCA
S-CATH M Esophageal
Temperature Probe and
Temperature Monitoring
System | PREDICATE DEVICE:
K192210 FIAB-ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | COMMENTS |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermometer
type | Esophageal | Esophageal | Same |
| Product Code | FLL, IKD | FLL, IKD | Same |
| Regulation | 880.2910 Clinical Electronic
Thermometer
890.1175 Cable, Electrode | 880.2910 Clinical Electronic
Thermometer
890.1175 Cable, Electrode | Same |
| ELEMENT OF
COMPARISON | SUBJECT DEVICE: CIRCA
S-CATH M Esophageal
Temperature Probe and
Temperature Monitoring
System | PREDICATE DEVICE:
K192210 FIAB-ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | COMMENTS |
| Indications for
Use | The CIRCA Temperature
Monitoring System is
composed of CIRCA
Temperature Monitor and
CIRCA S-CATH M Probe
and is intended for the
continuous detection,
measurement and
visualization (in ℃) of
esophageal temperature. The
intended environments of use
are operating rooms and
interventional
electrophysiology rooms.
The CIRCA Monitor must be
used in conjunction with the
CIRCA S-CATH M Probe.
The role of esophageal
temperature monitoring using
this device in reducing the
risk of cardiac ablation-
related esophageal injury has
not been established. The
performance of the CIRCA
Temperature Monitoring
System in detecting
esophageal temperature
changes as a result of energy
delivery during cardiac
ablation procedures has not
been evaluated. | The ESOTEST MULTI
Temperature Monitoring
System is composed of
ESOTEST MULTI Monitor
and ESOTEST MULTI Probe
and is intended for the
continuous detection,
measurement and
visualization (in °C) of
esophageal temperature. The
intended environments of use
are operating rooms and
interventional
electrophysiology rooms. The
ESOTEST MULTI Monitor
must be used in conjunction
with the ESOTEST MULTI
Probe.
The role of esophageal
temperature monitoring using
this device in reducing the
risk of cardiac ablation-
related esophageal injury has
not been established. The
performance of the ESOTEST
MULTI system in detecting
esophageal temperature
changes as a result of energy
delivery during cardiac
ablation procedures has not
been evaluated. | Same (except for the
trade name) |
| Components | Temperature probe, Patient
cable, Monitor. The package
includes an external power
supply and hospital-grade
power cord. Optional
component: Mapping
Interconnect Cable | Temperature probe, Patient
cable, Monitor. The package
includes an external power
supply and an equipotential
cable. Optional component:
ESOTEST MULTI
ADAPTER CABLE | Similar, predicate
device includes
additional
equipotential cable.
Equipotential cable is
not required per IEC
60601-1; it is an
accessory provided
by predicate
manufacturer. |
| ELEMENT OF
COMPARISON | SUBJECT DEVICE: CIRCA
S-CATH M Esophageal
Temperature Probe and
Temperature Monitoring
System | PREDICATE DEVICE:
K192210 FIAB-ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | COMMENTS |
| Temperature
measurement
range (°C) | 0 - 45 | 0 - 75 | Rated output range is
lower for the subject
device. Consensus
standard ISO 80601-
2-56 states in section
201.12.1.101: The
output temperature of
clinical thermometers
should cover the
minimum rated output
range from 34,0 °C to
43,0 °C. |
| Number of
temperature
sensors | 12 | 5 or 7 | Subject device has
more sensors
allowing additional
coverage within the
esophageal area. |
| Temperature
sensor type | NTC Thermistor
(system accuracy ± 0.3ºC) | T-type thermocouple (system
accuracy ± 0.3°C) | Similar, a thermistor
is a temperature-
sensitive resistor,
whilst a thermocouple
generates a voltage
proportional to the
temperature. The
same accuracy is
ensured by the
respective signal
process and display. |
| Measurement
presentation /
User Interface | LCD monitor
Touch screen monitor | LCD monitor
Touch screen monitor | Same |
| Alarm
temperature
range (°C) | Upper threshold (Alarm and
Warning High)
Lower Threshold (Alarm and
Warning Low)
Low threshhold cannot be set
higher than upper threshold. | 37-41 upper threshold (Tmax)
12-24 lower threshold (Tmin) | Similar, subject
device allows user to
select values within
the same ranges. |
| Alarm signal | Visual (flashing yellow or red
on the LCD display)
Audible (intermittent sound) | Visual (flashing red circles on
the LCD display)
Audible (intermittent sound) | Similar, subject
device includes
yellow visual for
warning level and red
for alarm level. |
| Power
requirements | 100 - 240 Vac | 100 - 240 Vac | Same |
| ELEMENT OF
COMPARISON | SUBJECT DEVICE: CIRCA
S-CATH M Esophageal
Temperature Probe and
Temperature Monitoring
System | PREDICATE DEVICE:
K192210 FIAB-ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | COMMENTS |
| Monitor
classification | Class I Medical Electrical
Equipment
Type CF Applied Part,
Defibrillation-Proof | Class I Medical Electrical
Equipment
Type CF Applied Part.
Defibrillation-Proof | Same |
| Dimensions
(cm) | Monitor: 26W x 19H x 9D
Patient cable length: 460
Temperature Probe: 65L;
10Fr | Monitor: 34W x 25H x 6.5D
Patient cable length: 290
Temperature probe: 83L; 7Fr
body, 11Fr sensors | Similar in size, minor
differences that do
not affect device
placement or use. |
| Introduction | Esophageal (nose / throat) | Esophageal (nose / throat) | Same |
| Signal
processing and
display: | Actual temperature is a
function of the thermistor
resistance.
Temperature displayed in
0.1℃ increments. 1 input
(single probe) available.
12 sensors per probe
measurements and user-
selected alarm limits are
displayed on LCD monitor. | Actual temperature is a
function of the thermocouple
voltage.
Temperature displayed in
0.1℃ increments. 1 input
(single probe) available.
5/7
sensors per probe
measurements and user-
selected alarm limits are
displayed on LCD monitor. | Similar, temperature
sensor technology
(thermocouple and
thermistor) are
standard for
temperature
measurement. The
same accuracy is
ensured.
Subject device has 5
more sensors per
probe and therefore
displays 12
temperatures. |
| Patient
contacting
materials | Flexible Polyether and Rigid
Polyamide PEBAX®
Tecothane® Urethane and
Gold Electrode Bands | Polyurethane and Stainless
Steel (SST) AISI 304 | Similar, both use
thermoplastics and
metals commonly
used for medical
device applications.
To bridge the
difference, subject
device was tested
under ISO 10993-1. |
| Operating
conditions | 0°C to 40°C
Non-condensed relative
humidity: 30% to 75% | +10°C to +40°C
Non-condensed relative
humidity: 30% to 75% | Similar, subject
monitor has a lower
limit; devices are
used in the same
hospital setting. |
| Accuracy | 0.3℃ within rated output
range (ISO 80601-2-56
requirements for clinical
thermometers) | 0.3℃ within rated output
range (ISO 80601-2-56
requirements for clinical
thermometers) | Same |
| Precision and
repeatability
(°C) | 0.1 | 0.1 | Same |
| ELEMENT OF
COMPARISON | SUBJECT DEVICE: CIRCA
S-CATH M Esophageal
Temperature Probe and
Temperature Monitoring
System | PREDICATE DEVICE:
K192210 FIAB-ESOTEST
MULTI Esophageal
Temperature Probe and
Temperature Monitoring
System | COMMENTS |
| Response time | Heating transient response
time is approximately six
seconds and cooling transient
response time is
approximately eight and a
half seconds.
Response time is for probe
plunged from reference water
bath to a water bath with a
2°C differential, ISO 80601-
2-56 requirements for clinical
thermometers. | Both heating and cooling
response time are
approximately 1 second.
Response time is defined as
the mean value of the
measured time intervals
associated to temperature
increase (tr) or to temperature
difference (tf) necessary to
cover 63.3% of the total
temperature excursion. | Response time testing
between FIAB
ESOTEST and
CIRCA S-CATH M
using the same test
methodology was
conducted. The
actual testing showed
substantial
equivalence, with the
predicate device
heating transient
response time an
average of only 2
seconds faster and
also cooling transient
response time an
average of 2 seconds
faster. |
| Probe
sterilization | ETO Sterilized | ETO Sterilized | Same |
| Biocompatibility
of the patient
contacting part | Compliance to ISO 10993-1 | Compliance to ISO 10993-1 | Same |
| Software | Compliance to IEC 62304 | Compliance to IEC 62304 | Same |
| Electrical safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 | Same |
| EMC | Compliance to IEC 60601-1-
2 | Compliance to IEC 60601-1-
2 | Same |
| Performance
bench testing | Compliance to ISO 80601-2-
56 | Compliance to ISO 80601-2-
56 | Same |
5
6
7
8
Substantial Equivalence Discussion:
Esophageal temperature monitoring using standard temperature sensor technology (thermocouple or thermistor) is the technological principle for both the subject and predicate devices.
The subject device has the same intended use as the predicate device, which is legally marketed. The subject device (CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System) and the predicate device (ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, K192210) are similar in the following areas:
- Indications for use ●
- Components
9
- Temperature monitoring technology and monitor display
- . Probe diameter and rout of administration
- Accuracy, precision and repeatibility
Both systems have been evaluated to FDA recognized consensus standards in the areas of biocompatibility, sterilization, software, electrical safety, EMC, and performance for clinical electronic thermometers.
Due to the difference in shape of the subject device compared to the predicate device, Circa is using a reference device (S-Cath Esophageal Temperature Probe and Temperature Monitoring System (K112376)) to address the safety and effectiveness of the new technological characteristic when compared to the predicate device.
The s-curve shape of the subject device has been reviewed and cleared in a similar device, S-Cath Esophageal Temperature Probe and Temperature Monitoring System (K112376). The S-Cath Esophageal Temperature Probe and Temperature Monitoring System is intended for continuous temperature monitoring and is designed for placement in the esophagus. The Probe evaluated the impact the s-curve shape had on performance time, accuracy, precision, and repeatibility. Performance testing was conducted per Standard 80601-2-56 / First Edition 2009-10-01 Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. Results for the reference device and its predicate device showed that the s-curve shape provided a faster response time.
Because more sensors are placed along the s-curve shape of the device to cover the geometry, the distance between each sensor is closer for the subject device than for the predicate device. The number of sensors are much like that for the reference device. Therefore, the s-curve shape is as safe and effective and does not raise different questions of safety and effectiveness.
VI. NON-CLINICAL PERFORMANCE DATA
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. Performance, labeling, electrical, biocompatibility, and sterilization testing of the subject device was conducted based on the risk analysis and on the requirements of recognized standards and FDA guidance documents.
The device was subjected to the following non-clinical testing to demonstrate that it performs as intended to the predicate device:
| TEST NAME | ENDPOINT | RESULT SUMMARY |
|---|---|---|
| In vitro cytotoxicity, | ||
| sensitization, and | ||
| intracutaneous reactivity | Verifying the compliance of the | |
| esophageal probe to the | ||
| requirements of ISO 10993-1 for the | ||
| considered type and duration of | ||
| contact. | Results of tests demonstrate that the | |
| sample can be considered non | ||
| cytotoxic, not sensitizing, and meets | ||
| the requirements of intracutatneous | ||
| reactivity. | ||
| TEST NAME | ENDPOINT | RESULT SUMMARY |
| Sterility | Verifying the compliance of the | |
| esophageal probe to the | ||
| requirements of sterilization | ||
| according to standard | ||
| ANSI/AAMI/ISO 11135. | Results of EO sterilization validation | |
| and tests demonstrate the device | ||
| meets a Sterility Assurance Level | ||
| (SAL) of 10-6. | ||
| Software system tests | Verifying the correct | |
| implementation of the software | ||
| requirements according to standard | ||
| IEC 62304. | Following completion of all software | |
| lifecycle activities, the software | ||
| device does not have any unresolved | ||
| anomalies (bugs or defects). | ||
| All the applicable safety | ||
| tests prescribed by the IEC | ||
| 60601-1 standard | Verifying the compliance of the | |
| system to the IEC 60601-1 standard. | The system passed all the applicable | |
| tests. | ||
| All the applicable | ||
| immunity and emission | ||
| tests prescribed by the IEC | ||
| 60601-1-2 standard | Verifying the compliance of the | |
| system to the IEC 60601-1-2 | ||
| standard. | The system passed all the applicable | |
| tests | ||
| Accuracy and response | ||
| time test | Verifying the compliance of the | |
| system to the ISO 80601-2-56 | ||
| standard. | The system accuracy and response | |
| time meets the requirements of the | ||
| standard | ||
| Mapping cable validation | Verifying the compliance of the | |
| mapping cable to the ANSI/AAMI | ||
| EC53:2013 standard. | The cable manufacturing process | |
| guarantees the compliance to the | ||
| standard | ||
| Performance test in the | ||
| working environment | Verifying the immunity of the | |
| system to the most common | ||
| disturbances sources in the working | ||
| environment, verifying the | ||
| compatibility with 3D cardiac | ||
| mapping systems. | The system is not affected by the | |
| noise sources in the working | ||
| environment. The system is | ||
| compatible with the following 3D | ||
| cardiac mapping systems: EnSite | ||
| NavX and CARTO 3 | ||
| Performance test in vivo | ||
| (animal) setting | Evaluate precision and accuracy of | |
| the electrode position detected by | ||
| the 3D cardiac mapping system by | ||
| measuring the distances between | ||
| electrodes and control catheter tip on | ||
| fluoroscopy and 3D cardiac mapping | ||
| system. | Data confirmed S-CATH M probe is | |
| visible on 3D cardiac mapping | ||
| system with a determined precision | ||
| and accuracy of 2.0 ± 1.2mm on | ||
| CARTO 3 and 7.4 ± 5.3mm on | ||
| EnSite NavX. |
10
VII. CONCLUSIONS
Based on the performance testing, comparison and analysis in the submission, the subject device is substantially equivalent to the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K192210).