QUANTIEN Measurement System

K172182 · St. Jude Medical (Now Part of the Abbott Medical) · DQK · Aug 18, 2017 · Cardiovascular

Device Facts

• Record ID: K172182
• Device Name: QUANTIEN Measurement System
• Applicant: St. Jude Medical (Now Part of the Abbott Medical)
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The QUANTIENT™ 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. The QUANTIENT™ system is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters with PressureWire™ guidewire.

Device Story

Diagnostic computer system for catheterization labs; records, computes, displays, and stores hemodynamic data. Inputs: signals from PressureWire™ guidewire and external pressure transducers; ECG data. Processing: calculates physiological parameters including systolic/diastolic/mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and Pd/Pa ratio. Output: graphical and numerical data displayed on backlit LCD; exportable to external hemodynamic recording systems, video monitors, or DICOM servers. Used by physicians to assess stenosis severity and guide therapeutic intervention. Benefits: provides objective hemodynamic information to support clinical decision-making regarding coronary or peripheral artery disease treatment.

Clinical Evidence

No new clinical testing performed. Equivalence to FFR and iFR established via existing clinical literature and public data.

Technological Characteristics

Diagnostic computer; backlit LCD display; inputs from PressureWire™ guidewire and external transducers; connectivity via DICOM, USB, and external hemodynamic recording system (HRS) interfaces; software-based data processing and display.

Indications for Use

Indicated for patients undergoing hemodynamic measurement of physiological parameters using PressureWire™ guidewire in catheterization and cardiovascular specialty laboratories for the diagnosis and treatment of coronary or peripheral artery disease.

Regulatory Classification

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.

Predicate Devices

• QUANTIENT™ Measurement System (K123984)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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.

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 and<br>Address: | St. Jude Medical (now part of Abbott Medical)<br>One St. Jude Medical Dr.<br>St. Paul, MN 55117 |
| Contact Person: | Julie Dalquist, RAC<br>Senior Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone]<br>[e-mail] |
| Proprietary Name: | QUANTIENTM Measurement System |
| Common/Usual Name: | Quantien |
| Product Classification<br>Code: | DQK |
| Product Regulation<br>Number and Name: | §870.1425, Programmable Diagnostic computer |
| Subsequent Code: | DSK |
| Product Regulation<br>Number 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 to<br>record, compute, display and store data from PressureWire™ guidewire and<br>other external transducers. The information is displayed as graphs as well as<br>numerical values on the screen. Data includes, but is not limited to: systolic,<br>diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR),<br>Pd/Pa, and data from ECG. |
| | Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure<br>to aortic pressure, measured during hyperemia. It provides the maximal blood<br>flow in the presence of a stenosis as a fraction of the achievable blood flow<br>that would exist in the hypothetical situation that the stenosis was not present.<br>The physician may use the FFR parameter, along with knowledge of patient<br>history, medical expertise and clinical judgment to determine if therapeutic<br>intervention is indicated. This functionality is achieved when the<br>QUANTIENT™ Measurement System is used in conjunction with the<br>manufacturer's distal intracoronary pressure transducer and a proximal aortic<br>pressure transducer. |
| | Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressure<br>measured at resting conditions. The physician may use Pd/Pa at rest, along<br>with knowledge of patient history, medical expertise and clinical judgment to<br>determine if additional measurement of FFR during hyperemia or therapeutic<br>intervention is indicated. |
| | Information on screen can also be transferred to an external hemodynamic<br>recording system (HRS) or to an external video monitor. Recorded procedures<br>can be viewed on a PC for post-procedural review and analysis with<br>application specific viewing software installed, such as RadiView™ software. |
| | Additional functions let you import a patient work list from the hospital DICOM<br>system, export recorded measurement data to DICOM or to an external server<br>location or save it to a USB memory stick. |
| Intended Use: | The QUANTIENT™ system is intended for use in catheterization and related<br>cardiovascular specialty laboratories to compute and display various<br>physiological parameters based on the output from one or more electrodes,<br>transducers or measuring devices.<br>The QUANTIENT™ system is indicated to provide hemodynamic information<br>for use in the diagnosis and treatment of patients that undergo measurement of<br>physiological 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 Subject<br>to Predicate Device: | The intended use and technological characteristics of the QUANTIENT™<br>Measurement System that is subject to this Special 510(k) submission are the<br>same as the predicate, as summarized in the following table. | | |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Characteristic | QUANTIENT™ Measurement<br>System (subject device) | QUANTIENT™ Measurement<br>System (predicate device) | |
| Intended Use | The QUANTIENT™ system is<br>intended for use in<br>catheterization and related<br>cardiovascular specialty<br>laboratories to compute and<br>display various physiological<br>parameters based on the output<br>from one or more electrodes,<br>transducers or measuring<br>devices.<br>The QUANTIENT™ system is<br>indicated to provide<br>hemodynamic information for<br>use in the diagnosis and<br>treatment of patients that<br>undergo measurement of<br>physiological parameters with<br>Pressure Wire™ guidewire. | The QUANTIENT™ system is<br>intended for use in<br>catheterization and related<br>cardiovascular specialty<br>laboratories to compute and<br>display various physiological<br>parameters based on the output<br>from one or more electrodes,<br>transducers or measuring<br>devices.<br>The QUANTIENT™ system is<br>indicated to provide<br>hemodynamic information for<br>use in the diagnosis and<br>treatment of patients that<br>undergo measurement of<br>physiological parameters with<br>PressureWire™ guidewire. | |
| Display | Backlit LCD | Backlit LCD | |
| Display<br>Features | PressureWire™ distal (Pd) and<br>proximal/aortic (Pa) pressure<br>Mean Pd and Pa | PressureWire™ distal (Pd) and<br>proximal/aortic (Pa) pressure<br>Mean Pd and Pa | |
| | Pd/Pa<br>ECG | Pd/Pa<br>ECG | |
| Summary on Non-<br>Clinical Testing: | No new non-clinical testing was completed, nor relied upon, in support of this<br>Special 510(k) submission. | | |
| Summary of Clinical<br>Testing: | No new clinical testing was completed in support of this Special 510(k)<br>submission. Physician use and data analysis was completed and published<br>publicly. Comparison to FFR was equivalent clinically, and comparison to<br>iFR (as per the guidelines) was shown equivalent in clinical literature and<br>publication. | | |
| Statement of<br>Equivalence: | The QUANTIENT™ Measurement System described in this Special 510(k)<br>submission is substantially equivalent to the currently-marketed predicate<br>device, based on comparisons of the device classifications, technological<br>characteristics, and intended use. | | |