QUANTIEN Measurement System

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February 28, 2019 St. Jude Medical (now Abbott Medical) Ka Zoua Xiong Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117 Re: K183099 Trade/Device Name: OUANTIEN Measurement System with Software Version 1,12,1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DSK Dated: January 29, 2019 Received: January 30, 2019 Dear Ka Zoua Xiong: 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. 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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 {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Stephen C. Browning -S5 for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K183099 Device Name QUANTIENTM Measurement System with Software Version 1.12.1 #### Indications for Use (Describe) The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. The QUANTIEN measurement system is intended for use in the catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <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}------------------------------------------------ # K183099 pg. 1 of 4 | 510(k) Summary | | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Per 21 CFR §807.92 | | | 510(k) Number | K183099 | | Date Prepared | 29 January 2019 | | Submitter Name &<br>Address | St. Jude Medical<br>One St. Jude Medical Drive<br>St. Paul, MN 55117 | | Contact Person | Ka Zoua Xiong<br>Senior Specialist, Regulatory Affairs<br>Phone: (651) 756-3903<br>Fax: (877) 497-0309<br>Email: kazoua.xiong@abbott.com | | Alternative Contact<br>Person | Marlene Peterson<br>Manager, Regulatory Affairs<br>Phone: (651) 756-3268<br>Fax: (651) 756-3301<br>Email: marlene.peterson@abbott.com | | Proprietary/Trade<br>Name | QUANTIENTTM Measurement System with Software Version 1.12.1 | | Common/Usual Name | QUANTIEN | | Product Classification<br>Code | Product Code: DQK<br>Subsequent Product Code: DSK | | Product Regulation<br>Number and Name | 21 CFR 870.1425, Programmable diagnostic computer<br>21 CFR 810.1110, Blood pressure computer | | Device Class | II | | Predicate Device | Primary: QUANTIENTTM Measurement System (K172182), cleared 18 August 2017<br>Secondary: Volcano iFR® Modality (K133323), cleared 14 March 2014 | | Device Description | The QUANTIENTTM Measurement System is a diagnostic computer designed to record,<br>compute, display and store data from PressureWireTM guidewire and other external<br>transducers. The information is displayed as graphs as well as numerical values on the<br>screen. Relevant display data includes: systolic, diastolic and mean blood pressure, heart<br>rate, Fractional Flow Reserve (FFR), Resting Full-Cycle Ratio (RFR) index, Pd/Pa and<br>data from ECG.<br><br>Information on the display screen may also be transferred to the cathlab monitoring<br>system or an offsite video monitor. Recorded procedures can be viewed on a PC, with<br>application specific viewing software installed such as RadiView, for post procedural<br>review and analysis.<br><br>Quantien allows for importing of a patient work list from the hospital DICOM system,<br>exporting of recorded measurement data to DICOM or to an external server location or<br>portable (USB) memory device. | | Indications for Use/<br>Intended Use | The QUANTIENTTM Measurement System is indicated to provide hemodynamic<br>information for use in the diagnosis and treatment of coronary or peripheral artery<br>disease.<br><br>The QUANTIENTTM Measurement System is intended for use in catheterization and<br>related cardiovascular specialty laboratories to compute, and display various<br>physiological parameters based on the output from one or more electrodes, transducers,<br>or measuring devices. | {4}------------------------------------------------ # K183099 # pg. 2 of 4 | The QUANTIENTM Measurement System is equivalent to the QUANTIENTM<br>Measurement System (K172182) in terms of the intended use, indications for use,<br>fundamental design, operational and technological characteristics (reference Table 1).<br>The QUANTIEN™ Measurement System is equivalent to the Philips' Volcano iFR®<br>Modality (K133323) in terms of the pressure measurement modality for the Resting<br>Full-Cycle Ratio index (reference Table 2). | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison of<br>Subject to Predicate<br>Device | Features | QUANTIENTM Measurement System<br>(Subject Device) | QUANTIENTM Measurement System - K172182 (Predicate Device) | | | Intended Use | The QUANTIEN™ system is<br>intended for use in catheterization<br>and related cardiovascular specialty<br>laboratories to compute and display<br>various physiological parameters<br>based on the output from one or more<br>electrodes, transducers or measuring<br>devices. | The QUANTIEN™ system is<br>intended for use in catheterization<br>and related cardiovascular specialty<br>laboratories to compute and display<br>various physiological parameters<br>based on the output from one or more<br>electrodes, transducers or measuring<br>devices. | | | Indications<br>for Use/<br>Intended Use | The QUANTIEN Measurement<br>System is indicated to provide<br>hemodynamic information for use in<br>the diagnosis and treatment of<br>coronary or peripheral artery disease.<br>QUANTIEN Measurement System is<br>intended for use in catheterization<br>and related cardiovascular specialty<br>laboratories to compute and display<br>various physiological parameters<br>based on the output from one or more<br>electrodes, transducers, or measuring<br>devices. | The QUANTIEN Measurement<br>System is indicated to provide<br>hemodynamic information for use in<br>the diagnosis and treatment of<br>coronary or peripheral artery disease.<br>QUANTIEN Measurement System is<br>intended for use in catheterization<br>and related cardiovascular specialty<br>laboratories to compute and display<br>various physiological parameters<br>based on the output from one or more<br>electrodes, transducers, or measuring<br>devices. | | | Display | Backlit LCD display | Backlit LCD display | | | Display<br>Features | PressureWire™ distal (Pd) and<br>proximal/aortic (Pa) pressure, Mean<br>Pd and Pa, Pd/Pa, RFR and ECG | PressureWire™ distal (Pd) and<br>proximal/aortic (Pa) pressure, Mean<br>Pd and Pa, Pd/Pa and ECG | | | Graphic User<br>Interface | Display data includes systolic,<br>diastolic and mean blood pressure,<br>heart rate, FFR, RFR, Pd/Pa, and<br>ECG | Display data includes systolic,<br>diastolic and mean blood pressure,<br>heart rate, FFR, Pd/Pa, and ECG. | | | Measurement<br>Modes | FFR and RFR | FFR | | Table 2: QUANTIEN compared to Predicate (K133323) | | | | | | Features | QUANTIEN™ Measurement System<br>(Subject Device) | Volcano iFR® Modality - K133323<br>(Predicate Device) | | | Intended<br>Use | The QUANTIEN™ system is intended<br>for use in catheterization and related<br>cardiovascular specialty laboratories to<br>compute and display various<br>physiological parameters based on the<br>output from one or more electrodes,<br>transducers or measuring devices. | The Volcano<br>s5TM/s5i/CORE/CORETM Mobile<br>Precision Guided Therapy System is<br>used for the qualitative and<br>quantitative evaluation of vascular<br>morphology in the coronary arteries<br>and vessels of the peripheral<br>vasculature. It is also indicated as an<br>adjunct to conventional angiographic<br>procedures to provide an image of<br>vessel lumen and wall structures.<br><br>The pressure feature is intended for<br>use in all blood vessels, including<br>coronary and peripheral arteries, to<br>measure intravascular blood pressure<br>during diagnostic angiography and/or<br>interventional procedures | | | Indications<br>for Use | The QUANTIEN Measurement<br>System is indicated to provide<br>hemodynamic information for use in<br>the diagnosis and treatment of<br>coronary or peripheral artery disease.<br><br>QUANTIEN Measurement System is<br>intended for use in catheterization and<br>related cardiovascular specialty<br>laboratories to compute and display<br>various physiological parameters<br>based on the output from one or more<br>electrodes, transducers, or measuring<br>devices. | The iFR® Modality of the<br>s5/sSiCORE/CORE Mobile Precision<br>Guided Therapy System is indicated in<br>all blood vessels, including coronary<br>and peripheral arteries, to measure<br>intravascular blood pressure during<br>diagnostic angiography and/or<br>interventional procedures.<br><br>The iFR® Modality is intended to be<br>used in conjunction with currently<br>marketed Volcano pressure wires. | | | Relevant<br>Display<br>Features | RFR resting full cycle ratio | iFR instant wave free ratio | | Summary on Non-<br>Clinical Testing | Verification and Validation testing were completed to demonstrate safety and<br>effectiveness and ensure that the subject device performs as intended. Design<br>verification and validation included the following:<br>Software Verification and Validation – performed to ensure that the subject<br>device meets requirements and functions as intended Usability Study - performed to evaluate the usability and possible use errors<br>that may lead to patient safety issues with the introduction of the new features<br>on the graphical user interface | | | {5}------------------------------------------------ K183099 pg. 3 of 4 {6}------------------------------------------------ ### K183099 pg. 4 of 4 | Summary of Clinical<br>Testing | No new clinical testing was completed, nor relied upon, in support of this Traditional<br>510(k). However, a prospective study was performed to determine the diagnostic utility<br>of RFR for the physiological assessment of coronary artery disease in real world<br>patients. The results of the study showed equivalence between resting full-cycle ratio<br>(RFR) and instantaneous wave-free ratio (iFR). | | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | | <b>RFR-FFR Hybrid Method Result Interpretation</b> | | | | The following gray zone and criteria for determining positive (ischemia causing) and<br>negative (non-ischemia causing) were used for RFR result interpretation: | | | | RFR < 0.86: Positive (ischemia causing) 0.86 ≤ RFR ≤ 0.93: Gray zone, decision will be based on FFR FFR ≤ 0.8: Positive (ischemia causing) FFR > 0.8: Negative (non-ischemia causing) RFR > 0.93: Negative (non-ischemia causing) | | | | <b>Summary of RFR Validation Study</b> | | | | The results of the prospective validation study showed comparable diagnostic accuracy,<br>percent positive agreement, percent negative agreement, PPV, and NPV values between<br>the RFR-FFR and iFR-FFR hybrid approaches (reference Table 3). | | | | Table 3: Summary of RFR Validation Results | | | | RFR-FFR | iFR-FFR | | Diagnostic Accuracy | 93.6%<br>[91.1%, 95.6%] | 92.2%<br>[89.5%, 94.4%] | | Percent Positive Agreement | 91.3%<br>[86.9%, 94.5%] | 88.8%<br>[84.1%, 92.5%] | | Percent Negative Agreement | 95.8%<br>[92.6%, 97.9%] | 95.4%<br>[92.1%, 97.6%] | | PPV | 95.2%<br>[91.6%, 97.6%] | 94.7%<br>[90.9%, 97.2%] | | NPV | 92.3%<br>[88.4%, 95.1%] | 90.2%<br>[86.1%, 93.5%] | | Diagnostic Accuracy Outside the Grey Zone | 88.5%<br>[84.1%, 92.0%] | 86.8%<br>[82.4%, 90.4%] | | Lesions free from Hyperemic Agents | 55.5%<br>[51.0%, 59.9%] | 58.9%<br>[54.4%, 63.2%] | | Patients free from Hyperemic Agents | 50.8%<br>[46.0%, 55.6%] | 54.3%<br>[49.5%, 59.1%] | | Statement of<br>Equivalence | The QUANTIENT™ Measurement System with Software v1.12.1 is equivalent to the<br>QUANTIENT™ Measurement System (K172182) in terms of the intended use,<br>indications for use, fundamental design, operational and technological characteristics. | | | | The QUANTIENT™ Measurement System with Software v1.12. is equivalent to the<br>Philips' Volcano iFR® Modality (K133323) in terms of the pressure measurement<br>modality for the Resting Full-Cycle Ratio index. | |