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.

Device Description

The QUANTIENTTM Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWireTM guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Relevant display data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Resting Full-Cycle Ratio (RFR) index, Pd/Pa and data from ECG.

Information on the display screen may also be transferred to the cathlab monitoring system or an offsite video monitor. Recorded procedures can be viewed on a PC, with application specific viewing software installed such as RadiView, for post procedural review and analysis.

Quantien allows for importing of a patient work list from the hospital DICOM system, exporting of recorded measurement data to DICOM or to an external server location or portable (USB) memory device.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the QUANTIEN™ Measurement System with Software Version 1.12.1. as presented in the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (Threshold)	Reported Device Performance (RFR-FFR Hybrid Method)
Diagnostic Accuracy	Not explicitly stated as a numerical threshold, but implicitly defined by the comparative equivalence to iFR-FFR.	93.6% [91.1%, 95.6%]
Percent Positive Agreement	Not explicitly stated as a numerical threshold.	91.3% [86.9%, 94.5%]
Percent Negative Agreement	Not explicitly stated as a numerical threshold.	95.8% [92.6%, 97.9%]
Positive Predictive Value (PPV)	Not explicitly stated as a numerical threshold.	95.2% [91.6%, 97.6%]
Negative Predictive Value (NPV)	Not explicitly stated as a numerical threshold.	92.3% [88.4%, 95.1%]
Diagnostic Accuracy Outside the Gray Zone	Not explicitly stated as a numerical threshold.	88.5% [84.1%, 92.0%]

Note: The acceptance criteria are implicitly defined by demonstrating equivalence to the iFR-FFR hybrid approach, which itself serves as a benchmark for diagnostic utility in assessing coronary artery disease. The study aims to show that the RFR-FFR hybrid method performs comparably to the established iFR-FFR method.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical value for the overall study. However, the results are presented with 95% confidence intervals, which usually implies a sufficient sample size was used for statistical significance.
- Data Provenance: Prospective study. The country of origin of the data is not specified in the provided document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications used to establish the ground truth.
- Instead, the "ground truth" for the comparison is RFR-FFR and iFR-FFR hybrid methods, where FFR is typically considered a reference standard in fractional flow reserve studies. The document does not describe an independent "expert consensus" or manual ground truth labeling for the images/data used. The comparison is between two algorithmic approaches.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe a specific adjudication method like 2+1 or 3+1. The study is a comparison of two physiological assessment methods (RFR-FFR vs. iFR-FFR), not a reader-based adjudication process for image interpretation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done to evaluate human reader improvement with AI assistance. This study focuses on the comparison of two physiological indices (RFR and iFR) against FFR as the reference, not on human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance metrics (Diagnostic Accuracy, Agreement, PPV, NPV) presented for "RFR-FFR" and "iFR-FFR" represent the standalone performance of these hybrid methods. They involve algorithmic computation and interpretation based on defined thresholds (e.g., RFR < 0.86 for positive, FFR ≤ 0.8 for positive). There isn't a human-in-the-loop element described in these performance metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference standard used in this comparative study is Fractional Flow Reserve (FFR), which is a widely accepted physiological measure for assessing the hemodynamic significance of coronary artery stenoses. The study compares the RFR-FFR and iFR-FFR hybrid approaches against this standard.
The sample size for the training set:
- The document states, "No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k)." This implies that the RFR algorithm and its established thresholds were likely developed and validated prior to this submission, possibly through other studies. Therefore, the training set size is not provided in this document as it pertains to development data that was not newly generated for this submission.
How the ground truth for the training set was established:
- Given the statement in point 7, the document does not describe how the ground truth for any training set was established for the RFR algorithm. The presented clinical testing is a validation study of the already established RFR method, not a development study.

Summary

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Image /page/0/Picture/0 description: The image contains 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, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

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.

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 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

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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

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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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K183099

pg. 1 of 4

510(k) Summary
Per 21 CFR §807.92
510(k) Number	K183099
Date Prepared	29 January 2019
Submitter Name &Address	St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN 55117
Contact Person	Ka Zoua XiongSenior Specialist, Regulatory AffairsPhone: (651) 756-3903Fax: (877) 497-0309Email: kazoua.xiong@abbott.com
Alternative ContactPerson	Marlene PetersonManager, Regulatory AffairsPhone: (651) 756-3268Fax: (651) 756-3301Email: marlene.peterson@abbott.com
Proprietary/TradeName	QUANTIENTTM Measurement System with Software Version 1.12.1
Common/Usual Name	QUANTIEN
Product ClassificationCode	Product Code: DQKSubsequent Product Code: DSK
Product RegulationNumber and Name	21 CFR 870.1425, Programmable diagnostic computer21 CFR 810.1110, Blood pressure computer
Device Class	II
Predicate Device	Primary: QUANTIENTTM Measurement System (K172182), cleared 18 August 2017Secondary: Volcano iFR® Modality (K133323), cleared 14 March 2014
Device Description	The QUANTIENTTM Measurement System is a diagnostic computer designed to record,compute, display and store data from PressureWireTM guidewire and other externaltransducers. The information is displayed as graphs as well as numerical values on thescreen. Relevant display data includes: systolic, diastolic and mean blood pressure, heartrate, Fractional Flow Reserve (FFR), Resting Full-Cycle Ratio (RFR) index, Pd/Pa anddata from ECG.Information on the display screen may also be transferred to the cathlab monitoringsystem or an offsite video monitor. Recorded procedures can be viewed on a PC, withapplication specific viewing software installed such as RadiView, for post proceduralreview and analysis.Quantien allows for importing of a patient work list from the hospital DICOM system,exporting of recorded measurement data to DICOM or to an external server location orportable (USB) memory device.
Indications for Use/Intended Use	The QUANTIENTTM Measurement System is indicated to provide hemodynamicinformation for use in the diagnosis and treatment of coronary or peripheral arterydisease.The QUANTIENTTM Measurement System is intended for use in catheterization andrelated cardiovascular specialty laboratories to compute, and display variousphysiological parameters based on the output from one or more electrodes, transducers,or measuring devices.

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K183099

pg. 2 of 4

The QUANTIENTM Measurement System is equivalent to the QUANTIENTMMeasurement System (K172182) in terms of the intended use, indications for use,fundamental design, operational and technological characteristics (reference Table 1).The QUANTIEN™ Measurement System is equivalent to the Philips' Volcano iFR®Modality (K133323) in terms of the pressure measurement modality for the RestingFull-Cycle Ratio index (reference Table 2).
Comparison ofSubject to PredicateDevice	Features	QUANTIENTM Measurement System(Subject Device)	QUANTIENTM Measurement System - K172182 (Predicate Device)
	Intended Use	The QUANTIEN™ system isintended for use in catheterizationand related cardiovascular specialtylaboratories to compute and displayvarious physiological parametersbased on the output from one or moreelectrodes, transducers or measuringdevices.	The QUANTIEN™ system isintended for use in catheterizationand related cardiovascular specialtylaboratories to compute and displayvarious physiological parametersbased on the output from one or moreelectrodes, transducers or measuringdevices.
	Indicationsfor Use/Intended Use	The QUANTIEN MeasurementSystem is indicated to providehemodynamic information for use inthe diagnosis and treatment ofcoronary or peripheral artery disease.QUANTIEN Measurement System isintended for use in catheterizationand related cardiovascular specialtylaboratories to compute and displayvarious physiological parametersbased on the output from one or moreelectrodes, transducers, or measuringdevices.	The QUANTIEN MeasurementSystem is indicated to providehemodynamic information for use inthe diagnosis and treatment ofcoronary or peripheral artery disease.QUANTIEN Measurement System isintended for use in catheterizationand related cardiovascular specialtylaboratories to compute and displayvarious physiological parametersbased on the output from one or moreelectrodes, transducers, or measuringdevices.
	Display	Backlit LCD display	Backlit LCD display
	DisplayFeatures	PressureWire™ distal (Pd) andproximal/aortic (Pa) pressure, MeanPd and Pa, Pd/Pa, RFR and ECG	PressureWire™ distal (Pd) andproximal/aortic (Pa) pressure, MeanPd and Pa, Pd/Pa and ECG
	Graphic UserInterface	Display data includes systolic,diastolic and mean blood pressure,heart rate, FFR, RFR, Pd/Pa, andECG	Display data includes systolic,diastolic and mean blood pressure,heart rate, FFR, Pd/Pa, and ECG.
	MeasurementModes	FFR and RFR	FFR
Table 2: QUANTIEN compared to Predicate (K133323)
	Features	QUANTIEN™ Measurement System(Subject Device)	Volcano iFR® Modality - K133323(Predicate Device)
	IntendedUse	The QUANTIEN™ system is intendedfor use in catheterization and relatedcardiovascular specialty laboratories tocompute and display variousphysiological parameters based on theoutput from one or more electrodes,transducers or measuring devices.	The Volcanos5TM/s5i/CORE/CORETM MobilePrecision Guided Therapy System isused for the qualitative andquantitative evaluation of vascularmorphology in the coronary arteriesand vessels of the peripheralvasculature. It is also indicated as anadjunct to conventional angiographicprocedures to provide an image ofvessel lumen and wall structures.The pressure feature is intended foruse in all blood vessels, includingcoronary and peripheral arteries, tomeasure intravascular blood pressureduring diagnostic angiography and/orinterventional procedures
	Indicationsfor Use	The QUANTIEN MeasurementSystem is indicated to providehemodynamic information for use inthe diagnosis and treatment ofcoronary or peripheral artery disease.QUANTIEN Measurement System isintended for use in catheterization andrelated cardiovascular specialtylaboratories to compute and displayvarious physiological parametersbased on the output from one or moreelectrodes, transducers, or measuringdevices.	The iFR® Modality of thes5/sSiCORE/CORE Mobile PrecisionGuided Therapy System is indicated inall blood vessels, including coronaryand peripheral arteries, to measureintravascular blood pressure duringdiagnostic angiography and/orinterventional procedures.The iFR® Modality is intended to beused in conjunction with currentlymarketed Volcano pressure wires.
	RelevantDisplayFeatures	RFR resting full cycle ratio	iFR instant wave free ratio
Summary on Non-Clinical Testing	Verification and Validation testing were completed to demonstrate safety andeffectiveness and ensure that the subject device performs as intended. Designverification and validation included the following:Software Verification and Validation – performed to ensure that the subjectdevice meets requirements and functions as intended Usability Study - performed to evaluate the usability and possible use errorsthat may lead to patient safety issues with the introduction of the new featureson the graphical user interface

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K183099
pg. 3 of 4

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K183099 pg. 4 of 4

Summary of ClinicalTesting	No new clinical testing was completed, nor relied upon, in support of this Traditional510(k). However, a prospective study was performed to determine the diagnostic utilityof RFR for the physiological assessment of coronary artery disease in real worldpatients. The results of the study showed equivalence between resting full-cycle ratio(RFR) and instantaneous wave-free ratio (iFR).
	RFR-FFR Hybrid Method Result Interpretation
	The following gray zone and criteria for determining positive (ischemia causing) andnegative (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)
	Summary of RFR Validation Study
	The results of the prospective validation study showed comparable diagnostic accuracy,percent positive agreement, percent negative agreement, PPV, and NPV values betweenthe 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%[91.1%, 95.6%]	92.2%[89.5%, 94.4%]
Percent Positive Agreement	91.3%[86.9%, 94.5%]	88.8%[84.1%, 92.5%]
Percent Negative Agreement	95.8%[92.6%, 97.9%]	95.4%[92.1%, 97.6%]
PPV	95.2%[91.6%, 97.6%]	94.7%[90.9%, 97.2%]
NPV	92.3%[88.4%, 95.1%]	90.2%[86.1%, 93.5%]
Diagnostic Accuracy Outside the Grey Zone	88.5%[84.1%, 92.0%]	86.8%[82.4%, 90.4%]
Lesions free from Hyperemic Agents	55.5%[51.0%, 59.9%]	58.9%[54.4%, 63.2%]
Patients free from Hyperemic Agents	50.8%[46.0%, 55.6%]	54.3%[49.5%, 59.1%]
Statement ofEquivalence	The QUANTIENT™ Measurement System with Software v1.12.1 is equivalent to theQUANTIENT™ Measurement System (K172182) in terms of the intended use,indications for use, fundamental design, operational and technological characteristics.
	The QUANTIENT™ Measurement System with Software v1.12. is equivalent to thePhilips' Volcano iFR® Modality (K133323) in terms of the pressure measurementmodality for the Resting Full-Cycle Ratio index.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).