OUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

QUANTIEN Measurement System is intended for use in 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 QUANTIENT™ Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes, but is not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Pd/Pa, and data from ECG.

Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure to aortic pressure, measured during hyperemia. It provides the maximal blood flow in the presence of a stenosis as a fraction of the achievable blood flow that would exist in the hypothetical situation that the stenosis was not present. The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. This functionality is achieved when the QUANTIENT™ Measurement System is used in conjunction with the manufacturer's distal intracoronary pressure transducer and a proximal aortic pressure transducer.

Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressure measured at resting conditions. The physician may use Pd/Pa at rest, along with knowledge of patient history, medical expertise and clinical judgment to determine if additional measurement of FFR during hyperemia or therapeutic intervention is indicated.

Information on screen can also be transferred to an external hemodynamic recording system (HRS) or to an external video monitor. Recorded procedures can be viewed on a PC for post-procedural review and analysis with application specific viewing software installed, such as RadiView™ software.

Additional functions let you import a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.

AI/ML Overview

This document describes the QUANTIENT™ Measurement System, a diagnostic computer designed to record, compute, display, and store data from PressureWire™ guidewire and other external transducers for the diagnosis and treatment of coronary or peripheral artery disease.

This 510(k) pertains to a Special 510(k) submission, meaning it compares a modified version of a device to an already cleared predicate device (QUANTIENT™ Measurement System, K123984). The focus is on demonstrating substantial equivalence, meaning the modified device has the same intended use and technological characteristics as the predicate, and does not raise new questions of safety and effectiveness.

1. A table of acceptance criteria and the reported device performance

Since this is a Special 510(k) submission for a substantially equivalent device, the performance acceptance criteria are implicitly those established for the original predicate device (K123984). The document explicitly states: "The intended use and technological characteristics of the QUANTIENT™ Measurement System that is subject to this Special 510(k) submission are the same as the predicate."

Therefore, the reported device performance for the subject device (K172182) is considered to be equivalent to the predicate device. The document does not provide a specific table of numerical acceptance criteria or performance metrics for the K172182 device itself, as the basis of this submission is equivalence to the predicate.

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (Subject Device K172182)
Ability to record, compute, display, and store data from PressureWire™ guidewire and other external transducers.	The device performs these functions, having the same technological characteristics as the predicate device.
Accurate display of systolic, diastolic, and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and Pd/Pa.	The device displays these parameters, which are considered equivalent to the predicate due to consistent technology.
Functional calculation and display of FFR.	The device calculates and displays FFR, used in conjunction with manufacturer's distal intracoronary pressure transducer and proximal aortic pressure transducer, equivalent to the predicate.
Functional calculation and display of Pd/Pa.	The device calculates and displays Pd/Pa, equivalent to the predicate.
Capability to transfer information to external hemodynamic recording systems or video monitors.	The device has this capability, equivalent to the predicate.
Capability to import patient work lists from hospital DICOM systems, export recorded measurement data to DICOM or external server, or save to USB.	The device has these capabilities, equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission." and "No new clinical testing was completed in support of this Special 510(k) submission."

Therefore, no new test set was used for this particular submission. The data provenance and sample size would refer to the testing done for the predicate device (K123984), which is not detailed in this document.

The document does mention: "Physician use and data analysis was completed and published publicly. Comparison to FFR was equivalent clinically, and comparison to iFR (as per the guidelines) was shown equivalent in clinical literature and publication." This indicates that previous clinical data support the use of the technology, but specific details on sample size, design, and provenance related to these publications are not provided within this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable to this Special 510(k) submission as no new testing was performed and no new ground truth was established for the subject device (K172182). The ground truth would have been established during the development and clearance of the predicate device (K123984), but details are absent here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new test set was used for this submission.

5. 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

Not applicable. The device is a diagnostic computer for physiological parameters, not an AI-assisted diagnostic tool for image interpretation or similar. The document does not mention any MRMC studies or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone system that computes and displays physiological parameters. It is "algorithm only" in the sense that it performs calculations based on transducer outputs without requiring direct human interpretation of raw signals for its primary function. However, the output (FFR, Pd/Pa values) is intended to be used by a physician "along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated." Therefore, it's a standalone measurement device providing data for human interpretation, rather than an "algorithm only" diagnostic system making a definitive diagnosis without human oversight.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the predicate device, the ground truth for physiological parameters (like blood pressure, FFR, Pd/Pa) would typically be established through comparison to established reference standards, often involving direct physical measurements or highly accurate invasive measurement techniques during clinical studies. The document states "Comparison to FFR was equivalent clinically, and comparison to iFR (as per the guidelines) was shown equivalent in clinical literature and publication," implying that clinical outcomes and established clinical guidelines serve as the ultimate ground truth for the utility of these parameters. Specific details of the ground truth used for the predicate device's validation are not provided in this document.

8. The sample size for the training set

Not applicable. This is a Special 510(k) for a device that computes physiological parameters, not a machine learning or AI device that requires a distinct "training set" in the conventional sense. The device's algorithms are based on established physiological principles and measurement techniques, not on learning from a dataset.

9. How the ground truth for the training set was established

Not applicable, as there isn't a training set in the context of this device's functionality. The "ground truth" for the device's calculations refers to the accuracy of its physiological measurements against accepted standards.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2017

St. Jude Medical Julie Dalquist Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117

Re: K172182

Trade/Device Name: OUANTIEN™ Measurement System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DSK Dated: July 18, 2017 Received: July 19, 2017

Dear Julie Dalquist:

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.

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

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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.G. Wilhelm
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) K172182

Device Name Quantien Measurement System

Indications for Use (Describe)

OUANTIEN 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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ST. Jude Medical

St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 USA Main 651 756 2000

6. 510(k) Summary

The 510(k) Summary is provided below, as required by 21 CFR 807.92(c).

510(k) Number	K172182
Date Prepared:	August 18, 2017
Submitter Name andAddress:	St. Jude Medical (now part of Abbott Medical)One St. Jude Medical Dr.St. Paul, MN 55117
Contact Person:	Julie Dalquist, RACSenior Regulatory Affairs SpecialistPhone (651) 756-3501Fax (651) 756-3298jdalquist@sjm.com
Proprietary Name:	QUANTIENTM Measurement System
Common/Usual Name:	Quantien
Product ClassificationCode:	DQK
Product RegulationNumber and Name:	§870.1425, Programmable Diagnostic computer
Subsequent Code:	DSK
Product RegulationNumber and Name:	§870.1110, Blood Pressure computer
Device Class:	II
Predicate Device:	QUANTIENTM Measurement System (K123984)
Device Description:	The QUANTIENT™ Measurement System is a diagnostic computer designed torecord, compute, display and store data from PressureWire™ guidewire andother external transducers. The information is displayed as graphs as well asnumerical values on the screen. Data includes, but is not limited to: systolic,diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR),Pd/Pa, and data from ECG.
	Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressureto aortic pressure, measured during hyperemia. It provides the maximal bloodflow in the presence of a stenosis as a fraction of the achievable blood flowthat would exist in the hypothetical situation that the stenosis was not present.The physician may use the FFR parameter, along with knowledge of patienthistory, medical expertise and clinical judgment to determine if therapeuticintervention is indicated. This functionality is achieved when theQUANTIENT™ Measurement System is used in conjunction with themanufacturer's distal intracoronary pressure transducer and a proximal aorticpressure transducer.
	Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressuremeasured at resting conditions. The physician may use Pd/Pa at rest, alongwith knowledge of patient history, medical expertise and clinical judgment todetermine if additional measurement of FFR during hyperemia or therapeuticintervention is indicated.
	Information on screen can also be transferred to an external hemodynamicrecording system (HRS) or to an external video monitor. Recorded procedurescan be viewed on a PC for post-procedural review and analysis withapplication specific viewing software installed, such as RadiView™ software.
	Additional functions let you import a patient work list from the hospital DICOMsystem, export recorded measurement data to DICOM or to an external serverlocation or save it to a USB memory stick.
Intended Use:	The QUANTIENT™ system is intended for use in catheterization and relatedcardiovascular specialty laboratories to compute and display variousphysiological parameters based on the output from one or more electrodes,transducers or measuring devices.The QUANTIENT™ system is indicated to provide hemodynamic informationfor use in the diagnosis and treatment of patients that undergo measurement ofphysiological parameters with PressureWire™ guidewire.

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St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 USA Main 651 756 2000

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K172182

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St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 USA Main 651 756 2000

Comparison of Subjectto Predicate Device:	The intended use and technological characteristics of the QUANTIENT™Measurement System that is subject to this Special 510(k) submission are thesame as the predicate, as summarized in the following table.
Characteristic	QUANTIENT™ MeasurementSystem (subject device)	QUANTIENT™ MeasurementSystem (predicate device)
Intended Use	The QUANTIENT™ system isintended for use incatheterization and relatedcardiovascular specialtylaboratories to compute anddisplay various physiologicalparameters based on the outputfrom one or more electrodes,transducers or measuringdevices.The QUANTIENT™ system isindicated to providehemodynamic information foruse in the diagnosis andtreatment of patients thatundergo measurement ofphysiological parameters withPressure Wire™ guidewire.	The QUANTIENT™ system isintended for use incatheterization and relatedcardiovascular specialtylaboratories to compute anddisplay various physiologicalparameters based on the outputfrom one or more electrodes,transducers or measuringdevices.The QUANTIENT™ system isindicated to providehemodynamic information foruse in the diagnosis andtreatment of patients thatundergo measurement ofphysiological parameters withPressureWire™ guidewire.
Display	Backlit LCD	Backlit LCD
DisplayFeatures	PressureWire™ distal (Pd) andproximal/aortic (Pa) pressureMean Pd and Pa	PressureWire™ distal (Pd) andproximal/aortic (Pa) pressureMean Pd and Pa
	Pd/PaECG	Pd/PaECG
Summary on Non-Clinical Testing:	No new non-clinical testing was completed, nor relied upon, in support of thisSpecial 510(k) submission.
Summary of ClinicalTesting:	No new clinical testing was completed in support of this Special 510(k)submission. Physician use and data analysis was completed and publishedpublicly. Comparison to FFR was equivalent clinically, and comparison toiFR (as per the guidelines) was shown equivalent in clinical literature andpublication.
Statement ofEquivalence:	The QUANTIENT™ Measurement System described in this Special 510(k)submission is substantially equivalent to the currently-marketed predicatedevice, based on comparisons of the device classifications, technologicalcharacteristics, and intended use.

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).