(14 days)
Not Found
No
The device description and performance studies focus on standard temperature sensing technology and do not mention any AI or ML components or capabilities.
No.
The device's intended use is for continuous temperature monitoring, which is a diagnostic function rather than a therapeutic one.
No
The device is intended for continuous temperature monitoring, which is a measurement function, not a diagnostic one. It provides data (temperature readings) but does not interpret that data to identify a disease, condition, or state.
No
The device description explicitly lists hardware components: a touch-screen monitor, interconnect cable, and temperature probe. The performance studies also focus on the accuracy and response time of the physical probe and system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Device Function: The CIRCA Scientific Temperature Monitoring System measures temperature directly within the esophagus of a patient. This is an in vivo measurement (within a living organism), not an in vitro measurement (outside the body).
- Intended Use: The intended use is "continuous temperature monitoring" by placing a probe in the esophagus. This is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the device described is a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Esophageal Temperature Probe:
The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus.
Temperature Monitor:
Display continuous temperature measurement (°C) from 12-sensor temperature probe.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The CIRCA Scientific Temperature Monitoring System consists of: touch-screen monitor, interconnect cable, and temperature probe.
The monitor displays 12 temperature probe sensor readings (°C), the maximum temperature of all sensors, and contains an alarm system with user-selected levels.
The S-Cath™ Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode. The probe contains 12 thermistor sensors located along an scurve. The sensors measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.
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)
The following performance testing was performed per Standard ISO 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 to establish and compare performance characteristics to the predicate device:
- . Accuracy of the device.
- . Precision and repeatability of the device.
- . Time Response.
In addition, the device has been assessed against the standards below. The device has been tested and meets physical, operational, and biological specifications.
- . ISO 10993-1 / 2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- IEC 60601-1 / 1988 + Amendment 1 / 1991-11 + Amendment 2 / 1995 Medical electrical . equipment -- Part 1: General requirements for safety
- . IEC 60601-1-2 / Edition 3:2007-03 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests
- 1EC 60601-1-4 / 2000 Consol. Ed 1.1 Medical electrical equipment Part 1-4: General . requirements for safety - Collateral standard: Programmable electrical medical systems
- 1SO 15223-1 / First Edition:2007 Medical devices Symbols to be used with medical . device labels, labelling, and information to be supplied - Part 1: General requirements
- ISO 14971 / 2007 Medical devices Application of risk management to medical devices .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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
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
| 510(k) SUMMARY | |||
|---|---|---|---|
| AUG 3 1 2011 | K112376 | ||
| Submitter: | CIRCA Scientific, LLC | ||
| 14 Inverness Drive East, Suite H-240 | |||
| Englewood, CO 80112 | |||
| (303) 951-8767 | |||
| Date Prepared: | July 28, 2011 | ||
| Trade/Device Name: | S-Cath™ Esophageal Temperature Probe and Temperature | ||
| Monitoring System | |||
| Regulation Number: | 880.2910 | ||
| Regulation Name: | Clinical electronic thermometer | ||
| Regulatory Class: | Class II | ||
| Product Code: | FLL | ||
| Predicate Device: | Esophageal/Rectal Temperature Probe (510(k) K863646), | ||
| Temperature Monitor (510(k) K913083) |
DEVICE DESCRIPTION
The CIRCA Scientific Temperature Monitoring System consists of: touch-screen monitor, interconnect cable, and temperature probe.
Image /page/0/Figure/4 description: The image shows four different diagrams of equipment. The first two diagrams show the front and back views of a monitor. The third diagram shows a temperature probe, and the fourth diagram shows an interconnect cable. The diagrams are labeled with text.
Page 1 of 5 510(k) ___
1
The monitor displays 12 temperature probe sensor readings (°C), the maximum temperature of all sensors, and contains an alarm system with user-selected levels.
The S-Cath™ Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode. The probe contains 12 thermistor sensors located along an scurve. The sensors measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the monitor by using an interconnect cable. The 10Fr diameter probe is placed inside the esophagus.
INDICATIONS FOR USE
Esophageal Temperature Probe:
The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus.
Temperature Monitor:
Display continuous temperature measurement (°C) from 12-sensor temperature probe.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE
Legally Marketed Electronic Thermometer to Which Substantial Equivalence is Claimed: Smiths Medical Level 1® Esophageal/Rectal Temperature Probe (510(k) K863646), Smiths Medical Bi-Temp Temperature Monitor (510(k) K913083). The probe and monitor are originally listed under Respiratory Support Products, Inc. (RSP).
| ELEMENT OF COMPARISON | SUBJECT DEVICE | CLAIMED SE DEVICE |
|---|---|---|
| Thermometer type | Esophageal | Esophageal / Rectal |
| Intended Uses | Continuous patient temperature | |
| monitoring, designed for insertion | ||
| into the esophagus. | Continuous patient temperature | |
| monitoring, designed for insertion | ||
| into the esophagus, nasopharynx, | ||
| or rectum. | ||
| Labeling | Temperature Probe labeled for | |
| single-use. | ||
| Package label includes product | ||
| identification, lot number. | ||
| Instructions for use established. | Temperature Probe labeled for | |
| single-use. | ||
| Package label includes product | ||
| identification, lot number. | ||
| Instructions for use established. | ||
| Components | Temperature Probe(10Fr OD, | |
| 30.5" total length); | ||
| Interconnect Cable (10' Length); | ||
| Monitor (10.2" W x 7.8" H x | ||
| 3.25" D). | Temperature Probe (9Fr and 12Fr | |
| OD, 30.5" total length; | ||
| Interconnect Cable (length not | ||
| specified); | ||
| Monitor (6.1" W x 3.4" H x | ||
| 6.3" D). | ||
| Sensor | NTC Thermistor (accurate to ± | |
| 0.2ºC within temperature range) | NTC Thermistor (accurate to ± | |
| 0.2℃ within temperature range) | ||
| Signal processing and display | 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. | Actual temperature is a function | |
| of the thermistor resistance. | ||
| Temperature displayed in 0.1°C | ||
| increments. 2 inputs (2 probes) | ||
| available. 1 sensor per probe | ||
| displayed. | ||
| LCD Display includes user- | ||
| selected alarm limits. | ||
| Power requirements | 100 – 240 Vac | Alkaline D (4 batteries) |
| Materials (Patient Contacting) | Flexible Polyether and Rigid | |
| Polyamide PEBAX® | Polyvinyl Chloride (PVC) | |
| Temperature Range | 25°C to 45°C | 5°C to 45°C |
| Ambient Temperature | ||
| Environment | No special ambient temperature | |
| range is specified for the device. | No special ambient temperature | |
| range is specified for the device. | ||
| Accuracy | The accuracy within the rated | |
| output range in normal use is not | ||
| -greater-than-0.3°C.(ISO 80601-2-- | ||
| 56:2009 requirement for clinical | ||
| thermometers). | The accuracy within the rated | |
| output range in normal use is not | ||
| greater-than-0.3°C.(ISO 80601-2-- | ||
| 56:2009 requirement for clinical | ||
| thermometers). | ||
| Precision and Repeatability | 0.1°C | Not specified |
| Response Time | Heating transient response time is | |
| approximately 7 seconds and | ||
| cooling transient response time is | ||
| approximately 4.5 seconds. | ||
| (Note: time is for probe plunged | ||
| from reference water bath to a | ||
| water bath with a 2°C | ||
| differential.) | Heating transient response time is | |
| approximately 29 seconds and | ||
| cooling transient response time is | ||
| approximately 18 seconds. | ||
| (Note: time is for probe plunged | ||
| from reference water bath to a | ||
| water bath with a 2°C | ||
| differential.) | ||
| Other Capabilities | Device fully complies with IEC | |
| 60601-1:1988 + A1:1991 + | ||
| A2:1995. Electromagnetic | ||
| compatibility fully complies with | ||
| IEC 60601-1-2:2007. | Electrical leakage current of the | |
| device (sensor and PVC tube) | ||
| when used with Level 1 monitor | ||
| and cable, comply with IEC 601- | ||
| 1/EN 60601-1. | ||
| Comparison Discussion | The S-Cath Esophageal Temperature Probe and Monitor is | |
| substantially equivalent to the predicate Smiths Medical | ||
| Esophageal/Rectal Temperature Probe and Monitor for the following | ||
| elements: |
- Thermometer type;
- Intended uses;
- Labeling;
- Components;
- Sensor;
- Signal process and display;
- Temperature range;
- Ambient temperature environment; | |
2
3
| The following differences are noted but do not affect substantial
| equivalence of safety and effectiveness: |
|---|
| - Power requirements: SE device uses batteries while S-Cath |
| connects to hospital mains supply (100 – 240 Vac). It has |
| been evaluated to IEC 60601-1 and meets electrical safety |
| requirements. |
| - Materials (Patient Contacting): material of S-Cath PEBAX |
| was chosen for its flexibility and is used for other devices |
| such as urology catheter. It has been evaluated to ISO 10993- |
| 1 and meets biocompatibility requirements. |
| - Response Time: S-Cath provides a faster response time than |
| predicate device. |
NON-CLINICAL PERFORMANCE DATA
The following performance testing was performed per Standard ISO 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 to establish and compare performance characteristics to the predicate device:
- . Accuracy of the device.
- . Precision and repeatability of the device.
- . Time Response.
In addition, the device has been assessed against the standards below. The device has been tested and meets physical, operational, and biological specifications.
- . ISO 10993-1 / 2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- IEC 60601-1 / 1988 + Amendment 1 / 1991-11 + Amendment 2 / 1995 Medical electrical . equipment -- Part 1: General requirements for safety
- . IEC 60601-1-2 / Edition 3:2007-03 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests
- 1EC 60601-1-4 / 2000 Consol. Ed 1.1 Medical electrical equipment Part 1-4: General . requirements for safety - Collateral standard: Programmable electrical medical systems
- 1SO 15223-1 / First Edition:2007 Medical devices Symbols to be used with medical . device labels, labelling, and information to be supplied - Part 1: General requirements
- ISO 14971 / 2007 Medical devices Application of risk management to medical devices .
CLINICAL PERFORMANCE DATA
No clinical studies were performed to demonstrate substantial equivalence.
Page 4 of 5 510(k)
4
CONCLUSION OF SAFETY AND EFFECTIVENESS
The successful completion of:
- · accuracy, precision and repeatability, and time response performance tests;
- compliance to biological standard ISO 10993-1; and .
- compliance to electrical safety standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-4; .
demonstrate the safety and effectiveness of the CIRCA Scientific Esophageal Temperature Probe and Monitor when used for the defined indications for use, and demonstrate that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Circa Scientific, L.L.C C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street, NW Buffalo, Minnesota 55313
AUG 3 1 2011
Re: K112376
Trade/Device Name: S-Cath™ Esophageal Temperature Probe and Temperature Monitoring System Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: 11 Product Code: FLL Dated: August 16, 2011 Received: August 17, 2011
Dear Mr. Job:
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.
6
Page 2- Mr. Job
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/ucm 1 15809.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,
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K112374
Indications for Use:
Esophageal Temperature Probe:
The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus.
Temperature Monitor:
Display continuous temperature measurement (°C) from 12-sensor temperature probe.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Rly C. Chapman 8/31/4
Division Sign-Off) ୍ରvision of Anesthesiology, General Hospital ntection Control, Dental Devices
:10(k) Number: K112376
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