ATS Thermal Imaging Probe, ATS Patient Interface Unit

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. March 21, 2018 Securus Medical Group, Inc. William J. Gorman Director of Quality and Regulatory Affairs 100 Cummings Center, Suite 215F Beverly, Massachusetts 01915 Re: K180148 Trade/Device Name: ATS Thermal Imaging Probe, ATS Patient Interface Unit Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 20, 2018 Received: February 21, 2018 Dear Mr. William J. Gorman: 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. {1}------------------------------------------------ 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 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. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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Sincerely, Tina Kiang s Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180148 Device Name ATS Thermal Imaging Probe, ATS Patient Interface Unit Indications for Use (Describe) The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring. The ATS Patient Interface Unit is intended to display continuous temperature measurements (C°) from the ATS Thermal Imaging Probe. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the Aurora Thermographic System (ATS) made up of the ATS Thermal Imaging Probe and the ATS Patient Interface Unit is provided below. ## 1) Submitter Securus Medical Group, Inc. 100 Cummings Center Suite 215F Beverly, MA 01915 978-317-0836 Phone: Contact: William J. Gorman Date Prepared: March 15, 2018 #### 2) Device | Trade name: | ATS Thermal Imaging Probe<br>ATS Patient Interface Unit | |-------------|---------------------------------------------------------| |-------------|---------------------------------------------------------| Clinical Electronic Thermometer Common name: #### Classification Number/ Classification name/Product code: Clinical Electronic Thermometers are Class II devices under 21 CFR § 880.2910 and are classified by the General Hospital Panel. Product code - FLL. #### 3) Predicate Device InfraRed Thermographic System (IRTS), (K152402). Reference Device: None #### 4) Device Description The Securus Aurora Thermographic System (ATS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on the Patient Interface Unit. Aurora Thermographic System (ATS) consists of two components: - A. ATS Thermal Imaging Probe - B. ATS Patient Interface Unit The ATS Thermal Imaging Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. This design is standard for esophageal temperature probes commonly used in the industry. In addition, the ATS Thermal Imaging Probe incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The ATS Patient Interface Unit displays temperature measurements (°C) from the ATS Thermal {4}------------------------------------------------ Imaging Probe. The ATS Patient Interface Unit has a Digital Video (DVI) port for streaming thermal image data to an auxiliary monitor (not offered with the system). ## 5) Indications for Use The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring. The ATS Patient Interface Unit is intended to display continuous esophageal temperature measurements (°C) from the ATS Thermal Imaging Probe. ## 6) Comparison of Technological Characteristics The proposed Aurora Thermographic System (ATS) is a modification of the Securus Infrared Thermographic System (IRTS). Both systems include a 9 French Clinical Thermometer designed to provide continuous direct mode esophageal temperature monitoring through the use of a standard T-type thermocouple. In addition, both systems incorporate the identical infrared thermographic technology for quantifying surface temperature changes in the esophagus. Infrared accuracy and resolution are unchanged. The indications for use, intended use, temperature measurement technology and route of administration remain identical for the two systems. The modifications involve hardware integration, software and packaging of the ATS Patient Interface Unit and ATS Thermal Imaging Probe. | Technological Characteristics Comparison Table | | | | |--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | ATS Thermal Imaging Probe<br>ATS Patient Interface Unit | IRTS System (K152402) | Discussion | | | Modified Device | Predicate Device | | | Intended Use | Continuous temperature monitoring of<br>the patient's esophagus. | Continuous temperature monitoring of<br>the patient's esophagus. | Identical | | Indications for Use | The ATS Thermal Imaging Probe<br><br>is intended for continuous esophageal<br>temperature monitoring.<br><br>The ATS Patient Interface Unit<br><br>is intended to display continuous<br>temperature measurements (C°) from<br>the ATS Thermal Imaging Probe. | The IRTS Probe<br><br>is intended for continuous esophageal<br>temperature monitoring.<br><br>The IRTS Patient Monitoring Unit<br>(PMU) with Patient Interface Unit<br>(PIU)<br><br>is intended to display continuous<br>temperature measurements (C°) from<br>the IRTS Thermal Imaging Probe. | Identical | | System Components | Temperature Probe 9 French<br>Patient Interface Unit (PIU) | Temperature Probe 9 French<br>Patient Interface Unit (PIU)<br>Patient Monitoring Unit (PMU) | Similar | | Probe Sterility | Provided non-sterile | Provided non-sterile | Identical | | Route of Insertion | Oral or Nasal | Oral or Nasal | Identical | | Probe Material<br>(patient contact) | Polyethylene and Polyethylene<br>copolymer with BaSO4 | Polyethylene and platinum | Similar | | Technological Characteristics Comparison Table | | | | | | ATS Thermal Imaging Probe<br>ATS Patient Interface Unit | IRTS System (K152402) | Discussion | | | Modified Device | Predicate Device | | | Probe Size | 9 French catheter | 9 French catheter | Identical | | Probe Length | 108 cm length | 150 cm length | Similar | | Temperature<br>Precision and<br>Resolution | 0.1° C | 0.1° C | Identical | | Temperature Sensor | Type-T thermocouple | Type-T thermocouple | Identical | | Thermocouple<br>Sensor Signal<br>Processing and<br>Display | Temperature is a function of<br>thermocouple voltage<br>Temperature displayed in 0.1° C<br>increments | Temperature is a function of<br>thermocouple voltage<br>Temperature displayed in 0.1° C<br>increments | Identical | | Thermocouple<br>Sensor Range | 25° - 45° C | 25° - 45° C | Identical | | Thermocouple<br>Sensor Accuracy | ± 0.3° C<br>tested in accordance with ISO 80601-2-56 | ± 0.3° C<br>tested in accordance with ISO 80601-2-56 | Identical | | Transient Response<br>Time of<br>Temperature Sensor | Both heating transient response time<br>and cooling transient response time are<br>less than 2.5 seconds: time for probe<br>plunged from reference bath to a water<br>bath with a 2° C differential.<br>Tested in accordance with ISO 80601-<br>2-56 | Both heating transient response time<br>and cooling transient response time are<br>less than 2.5 seconds: time for probe<br>plunged from reference bath to a water<br>bath with a 2° C differential.<br>Tested in accordance with ISO 80601-<br>2-56 | Identical | | Infrared Detector<br>Technology | Stirling cooled MCT | Stirling cooled MCT | Identical | | Infrared Signal<br>Processing and<br>Display | Relative display of color graphical<br>image representing infrared radiation<br>emitted from the body. | Relative display of color graphical<br>image representing infrared radiation<br>emitted from the body. | Identical | | Infrared<br>Temperature Range | Rated Output Range: -10°C to +70°C<br>Extended Output Range -20°C to -10°C<br>Spectral response 8-14µm | Rated Output Range: 35° to 60°C<br>No extended output range offered<br>Spectral response 8-11µm | Similar | | Infrared<br>Temperature<br>Accuracy | ± 2°C in the Rated Output Range | ± 2°C in the Rated Output Range | Identical | | Technological Characteristics Comparison Table | | | | | | ATS Thermal Imaging Probe<br>ATS Patient Interface Unit<br>Modified Device | IRTS System (K152402)<br>Predicate Device | Discussion | | Infrared<br>Temperature<br>Resolution | 0.1°C | 0.1° C | Identical | | Infrared Image<br>Field of View | 360° | 360° | Identical | | Thermal Image Size | 128 x 60 array | 128 x 60 array | Identical | | Power Supply | 100-240 Vac AC integrated power<br>supply 24 VDC | 100-240 Vac AC adaptor power supply<br>24 VDC | Identical | | Electrical Safety<br>and<br>Electromagnetic<br>Compatibility | Fully complies with IEC<br>60601-1:2005 +A1:2012<br>IEC 60601-1-2:2014 | Fully complies with IEC<br>60601-1:2005 +A1:2012<br>IEC 60601-1-2:2007 | Identical | | Data Output | Data provided to a monitor for display. | Data provided to a monitor for display. | Identical | {5}------------------------------------------------ {6}------------------------------------------------ The subject Aurora Thermographic System (ATS) is identical to the predicate device in the following areas: - Identical Indications for Use and Intended Use ● - Identical temperature monitoring technology - Identical catheter diameter and route of administration ● - Identical accuracy, resolution and response time ● The primary differences between the proposed Aurora Thermographic System (ATS) and its predicate are the integration of two electronic devices into a single unit package and the related ATS Thermal Imaging Probe changes. The predicate system includes 3 components. - IRTS Thermal Imaging Probe - IRTS Patient Monitoring Unit ● - IRTS Patient Interface Unit ● The modified Aurora Thermographic System (ATS) includes 2 components. - ATS Thermal Imaging Probe ● - ATS Patient Interface Unit ● The ATS Thermal Imaging Probe incorporates a modification of the connection to the ATS Patient Interface Unit. The predicate IRTS Thermal Imaging Probe has two separate connectors, one for the thermocouple and one for the infrared measurement. The modified ATS Thermal Imaging Probe integrates the same thermocouple connector with the infrared connector to form a single connection. The ATS Thermal Imaging Probe length has been shortened from 150 cm to 108 cm. {7}------------------------------------------------ The infrared temperature range reported to the user has been modified from 35° - 60°C to -20°C -70°C. The infrared detector is unchanged and collects the same infrared energy as the predicate. The modified ATS Patient Interface Unit software allows more infrared data to be displayed. The impact of each modification has been evaluated using the Securus Risk Management and Design Control systems. Each modification was considered for its impact. All verification testing (non-clinical, performance, and software validation) has been repeated to provide assurance that the modifications did not affect system performance. Both systems have been validated using FDA recognized consensus standard ISO 80601-2-56:2017, Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. Thus, the differences between the systems do not raise new questions for the subject device. #### 7) Non Clinical Testing & Performance Data A risk analysis was performed to identify risks associated with the device modifications. Verification and validation testing has been performed to demonstrate that identified risks have been mitigated. This testing demonstrates that the modified ATS Thermal Imaging Probe and the ATS Patient Interface Unit is substantially equivalent to the predicate. | Device Modification | Associated Risk | Verification / Validation<br>Method | Acceptance<br>Criteria | Results | |----------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | ATS Thermal Imaging Probe Modifications | | | | | | Two connectors combined<br>into one handle. | Electrical connections not<br>adequate -<br>Accuracy thermocouple | Testing in accordance with ISO<br>80601-2-56 second Edition 2017-<br>03: Medical electrical equipment -<br>Part 2-56. | Accuracy $\pm$ 0.3° C<br>across the rated output<br>range. | All samples tested met<br>the accuracy<br>acceptance criteria $\pm$<br>0.3° C . | | Two connectors combined<br>into one handle. | Electrical connections not<br>adequate -<br>Response time<br>thermocouple | Testing in accordance with ISO<br>80601-2-56 second Edition 2017-<br>03: Medical electrical equipment -<br>Part 2-56. | Response time same as<br>predicate, < 2.5<br>seconds average | Test results met the<br>acceptance criteria <<br>2.5 seconds average. | | Two connectors combined<br>into one handle. | Optical connections not<br>adequate.<br>Performance compromised<br>- IR Accuracy | IR Temperature Accuracy tests<br>and IR characterization testing<br>over the rated temperature range. | IR Temperature<br>Accuracy equivalent to<br>predicate across rated<br>output range $\pm$ 2°C. | All samples tested met<br>the acceptance criteria<br>$\pm$ 2°C across rated<br>output range. | | Two connectors combined<br>into one handle. | Mechanical connections not<br>adequate - modified<br>connections break | Tensile test all joints. | All connections and<br>joints must withstand<br>3.37 lbs | All connections and<br>joints exceed 3.37 lbs<br>tensile strength. | | Distal tip modified to<br>include BaSO4 filler. | Biocompatibility<br>compromised by<br>modification. | Testing based on ISO 10993-<br>1:2009 Biological evaluation of<br>medical devices - Part 1:<br>Evaluation and testing within a<br>risk management process, the<br>following tests are recommended:<br>• Cytotoxicity<br>• Sensitization<br>• Irritation/Intracutaneous<br>Reactivity | Test results must<br>provide assurance of<br>biocompatibility when<br>tested in accordance<br>with ISO 10993-<br>1:2009. | All test results provide<br>assurance of<br>biocompatibility in<br>accordance with ISO<br>10993-1:2009. | | ATS Patient Interface Unit Modifications – Housing & Circuit Boards | | | | | | Housing (packaging)<br>modified to new form<br>factor to accommodate | Modifications compromise<br>EMC compatibility | Testing in accordance with<br>IEC 60601-1-2 Edition 4.0: 2014-<br>02 Medical electrical equipment - | Must comply with<br>recognized consensus<br>standard for | Testing performed at<br>certified test facility. | {8}------------------------------------------------ | Device Modification | Associated Risk | Verification / Validation<br>Method | Acceptance<br>Criteria | Results | |----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | touch screen and single<br>probe connection. | | Part 1-2: General requirements for<br>basic safety and essential<br>performance - Collateral standard:<br>Electromagnetic disturbances -<br>Requirements and tests (4th<br>Edition). | Electromagnetic<br>compatibility | Compliance confirmed. | | Housing (packaging)<br>modified to new form<br>factor to accommodate<br>touch screen and single<br>probe connection. | Modifications compromise<br>electrical safety | Testing in accordance with IEC<br>60601-1:2005 + A1:2012(E),<br>Medical electrical equipment -<br>Part 1: General requirements for<br>basic safety and essential<br>performance. | Must comply with<br>recognized consensus<br>standard for electrical<br>safety. | Testing performed at<br>certified test facility.<br>Compliance confirmed. | | Circuit boards modified to<br>accommodate modified<br>housing, single probe<br>connection and touch<br>screen. | Modifications compromise<br>performance | All accuracy testing repeated (see<br>sections above).<br>Software validation testing covers<br>all system functional requirements<br>(see software below). | The ATS Patient<br>interface unit must<br>meet all performance<br>criteria and must<br>support all software<br>functions. | All accuracy testing<br>meets criteria (see<br>sections above).<br>Software validation<br>testing meets all<br>acceptance criteria (see<br>below) | | ATS Patient Interface Unit Modifications - Software | | | | | | Software modified<br>accommodate modified<br>circuit boards, single probe<br>connection and touch<br>screen. | Software performance<br>compromised by<br>modification. | The software has been developed<br>and validated in accordance with<br>medical device standards including<br>ANSI/AAMI/IEC 62304:2006<br>Medical device software -<br>Software life cycle processes.<br>Complete software validation<br>testing performed including 100%<br>functional testing. | Software must perform<br>100% of functional<br>requirements in<br>accordance with the<br>requirements<br>specifications. | Software validation<br>confirms compliance<br>with all requirements<br>specifications. | ## 8) Conclusions A risk analysis was performed to identify risks associated with the device modifications. Verification and validation testing has been performed to demonstrate that the identified risks have been mitigated. This testing demonstrates that the modified ATS Thermal Imaging Probe and ATS Patient Interface Unit is substantially equivalent to the predicate.