QUANTIEN 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

QUANTIEN Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire (K113584, K080813, K062769) and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR) and data from ECG.

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

Additional functions allow for import of 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

The provided text describes the QUANTIEN™ Measurement System and its 510(k) submission, focusing primarily on its intended use, technical characteristics, and substantial equivalence to a predicate device. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample size or data provenance for a test set.
Details on experts used for ground truth establishment.
Adjudication methods.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
The type of ground truth used (beyond implying physiological parameters).
Sample size for the training set.
How ground truth for the training set was established.

The document focuses on explaining that the QUANTIEN™ Measurement System "meets the design inputs and raises no new safety or efficacy concerns" and is "substantially equivalent to the marketed predicate device, RadiAnalyzer Xpress (K092105)." This implies that the acceptance criteria are met by demonstrating equivalence and adherence to design specifications, but the specific criteria and performance figures are not detailed.

Given the limitations of the provided text, I can only provide information based on what is available.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the QUANTIEN™ Measurement System emphasizes that the device meets its design inputs and is substantially equivalent to its predicate device, the RadiAnalyzer® Xpress (K092105). This implies that the acceptance criteria for the QUANTIEN™ system are largely based on demonstrating that it performs comparably to the predicate device in its intended function of recording, computing, displaying, and storing physiological data, including Fractional Flow Reserve (FFR), without introducing new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a specific table of acceptance criteria or reported device performance metrics for the QUANTIEN™ Measurement System. The core claim is that it "meets the design inputs" and is substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance

The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study. The 510(k) submission primarily relies on technical characteristics, intended use, operational characteristics, and fundamental design similarities to the predicate device for demonstrating substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

The document does not describe an MRMC comparative effectiveness study nor does it mention AI assistance. The QUANTIEN™ Measurement System is described as a diagnostic computer for physiological measurements, not an AI-assisted diagnostic tool.

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

The document does not describe a standalone algorithm performance study. The device is intended to "compute and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices," implying human interaction in its use and interpretation.

7. The type of ground truth used

While not explicitly stated as "ground truth," the device's function is to "compute and display various physiological parameters." The implication is that the accuracy of these computed physiological parameters against established physiological measurement methods would serve as the ground truth for its performance. The document mentions "output from one or more electrodes, transducers or measuring devices" as the input, which suggests the ground truth would be against the direct measurements from these established sensors.

8. The sample size for the training set

The document does not specify a training set sample size.

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

The document does not provide information on how ground truth for a training set was established.

Summary

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ST. JUDE MEDICAL
MORE CONTROL LESS RISK

St Jude Medical Systems Palmbladsgatan 10 Box 6350, SE-751 35 Uppsal +46 (0)18 161000 +46 (0)18 161099

Corporate ID no: 556335-9446

Attachment 4

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements in 21 CFR §807.92

Submitted by:

St. Jude Medical Systems AB Palmbladsgatan 10, Box 6350 SE-751 35 Uppsala, Sweden Phone:+46 18 161000

Contact Person:	Anna-Lisa Tiensuu
Date Prepared:	December 18, 2012
Proprietary Name:	QUANTIENT™ Measurement System
Common Name:	QUANTIEN
Classification Name:	§870.1425, Programmable diagnostic computer
Predicate Device:	RadiAnalyzer® Xpress K092105

Description of the Device:

Intended Use of the Device:

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.

MAR 2 8 2013

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T. JUDE MEDICAL

St. Jude Medical Systems AB Palmbladsgatan 10 Box 6350, SE-751 35 Uppsala Sweden Tel +46 (0)18 161000 ax +46 (0)18 161099

Corporate ID no: 556335-9446

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

Technical Characteristics:

The reason for the device modification is that some components in RadiAnalyzer Xpress have reached end of life because of technological advancements (e.g., design of electronic components). In addition, user/market feedback has been addressed to improve the usability of the device in the intended environment (catheterization laboratories), and data connectivity (e.g. DICOM, USB, network).

The subject device, Quantien Measurement System, meets the design inputs and raises no new safety or efficacy concerns.

Quantien Measurement System is determined to be substantially equivalent to the marketed predicate device, RadiAnalyzer Xpress (K092105). The substantial equivalence is based on the similarities in intended use, operational characteristic and the same fundamental design and technology as the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 28, 2013

St. Jude Medical Systems AB c/o Ms. Anna-Lisa Tiensuu Palmbladsgatan 10 Box 6350 Uppsala SE-751 35 Sweden

Re: K123984

Trade/Device Name: QUANTIEN™ Measurement System Regulatory Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (Two) Product Code: DQK, DSK Dated: February 28, 2013 Received: March 1, 2013

Dear Ms. Tiensuu:

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.

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Page 2 - Ms. Anna-Lisa Tiensuu

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen=P.Faris -S

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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K123984

Attachment 2

Indication for Use Statement

510(k) Number:

Device Name:

QUANTIENTM Measurement System

Indications for Use:

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

Prescription Use ------X

(Per 21 CFR 801.109)

—

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Owen P. Faris -S
2013.03.28
11:27:43 -04'00'

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).