(113 days)
Not Found
No
The description focuses on computing and displaying physiological parameters from transducers and does not mention AI/ML capabilities. The performance study compares RFR and iFR, which are established physiological indices, not AI/ML algorithms.
No.
The device is indicated for diagnosis and does not provide direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease." Additionally, the "Device Description" calls it a "diagnostic computer." The performance data also includes "Diagnostic Accuracy."
No
The device description explicitly states it is a "diagnostic computer designed to record, compute, display and store data from PressureWireTM guidewire and other external transducers." This indicates the device includes hardware components (the computer itself, and the ability to interface with external transducers and guidewires), not just software.
Based on the provided information, the QUANTIEN™ Measurement System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- QUANTIEN™ Function: The QUANTIEN™ Measurement System directly measures physiological parameters in vivo (within the living body) using sensors (PressureWire™ guidewire and other external transducers) placed within the coronary or peripheral arteries. It processes and displays this real-time physiological data.
- Lack of Specimen Handling: The description does not mention the collection, preparation, or analysis of any biological specimens.
Therefore, the QUANTIEN™ Measurement System falls under the category of a physiological monitoring and diagnostic device used in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DOK, DSK
Device Description
The QUANTIENTM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
catheterization and related cardiovascular specialty laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k). However, a prospective study was performed to determine the diagnostic utility of RFR for the physiological assessment of coronary artery disease in real world patients. 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:
RFR 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 between the RFR-FFR and iFR-FFR hybrid approaches (reference Table 3).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
RFR-FFR:
Diagnostic Accuracy: 93.6% [91.1%, 95.6%]
Percent Positive Agreement: 91.3% [86.9%, 94.5%]
Percent Negative Agreement: 95.8% [92.6%, 97.9%]
PPV: 95.2% [91.6%, 97.6%]
NPV: 92.3% [88.4%, 95.1%]
Diagnostic Accuracy Outside the Grey Zone: 88.5% [84.1%, 92.0%]
Lesions free from Hyperemic Agents: 55.5% [51.0%, 59.9%]
Patients free from Hyperemic Agents: 50.8% [46.0%, 55.6%]
iFR-FFR:
Diagnostic Accuracy: 92.2% [89.5%, 94.4%]
Percent Positive Agreement: 88.8% [84.1%, 92.5%]
Percent Negative Agreement: 95.4% [92.1%, 97.6%]
PPV: 94.7% [90.9%, 97.2%]
NPV: 90.2% [86.1%, 93.5%]
Diagnostic Accuracy Outside the Grey Zone: 86.8% [82.4%, 90.4%]
Lesions free from Hyperemic Agents: 58.9% [54.4%, 63.2%]
Patients free from Hyperemic Agents: 54.3% [49.5%, 59.1%]
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 & | |
| Address | St. Jude Medical |
| One St. Jude Medical Drive | |
| St. Paul, MN 55117 | |
| Contact Person | Ka Zoua Xiong |
| Senior Specialist, Regulatory Affairs | |
| Phone: (651) 756-3903 | |
| Fax: (877) 497-0309 | |
| Email: kazoua.xiong@abbott.com | |
| Alternative Contact | |
| Person | Marlene Peterson |
| Manager, Regulatory Affairs | |
| Phone: (651) 756-3268 | |
| Fax: (651) 756-3301 | |
| Email: marlene.peterson@abbott.com | |
| Proprietary/Trade | |
| Name | QUANTIENTTM Measurement System with Software Version 1.12.1 |
| Common/Usual Name | QUANTIEN |
| Product Classification | |
| Code | Product Code: DQK |
| Subsequent Product Code: DSK | |
| Product Regulation | |
| Number and Name | 21 CFR 870.1425, Programmable diagnostic computer |
| 21 CFR 810.1110, Blood pressure computer | |
| Device Class | II |
| Predicate Device | Primary: QUANTIENTTM Measurement System (K172182), cleared 18 August 2017 |
| Secondary: 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 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. |
| Indications for Use/
Intended Use | The QUANTIENTTM Measurement System is indicated to provide hemodynamic
information for use in the diagnosis and treatment of coronary or peripheral artery
disease.
The QUANTIENTTM 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. |
4
K183099
pg. 2 of 4
| The QUANTIENTM Measurement System is equivalent to the QUANTIENTM
Measurement 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 Resting
| Full-Cycle Ratio index (reference Table 2). | |||
|---|---|---|---|
| Comparison of | |||
| Subject to Predicate | |||
| Device | Features | QUANTIENTM Measurement System | |
| (Subject Device) | QUANTIENTM Measurement System - K172182 (Predicate Device) | ||
| Intended Use | The QUANTIEN™ 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 QUANTIEN™ 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. | |||
| Indications | |||
| for Use/ | |||
| Intended Use | The 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. | The 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. | |||
| Display | Backlit LCD display | Backlit LCD display | |
| Display | |||
| Features | PressureWire™ distal (Pd) and | ||
| proximal/aortic (Pa) pressure, Mean | |||
| Pd and Pa, Pd/Pa, RFR and ECG | PressureWire™ distal (Pd) and | ||
| proximal/aortic (Pa) pressure, Mean | |||
| Pd and Pa, Pd/Pa and ECG | |||
| Graphic User | |||
| Interface | Display data includes systolic, | ||
| diastolic and mean blood pressure, | |||
| heart rate, FFR, RFR, Pd/Pa, and | |||
| ECG | Display data includes systolic, | ||
| diastolic and mean blood pressure, | |||
| heart rate, FFR, Pd/Pa, and ECG. | |||
| Measurement | |||
| Modes | FFR and RFR | FFR | |
| Table 2: QUANTIEN compared to Predicate (K133323) | |||
| Features | QUANTIEN™ Measurement System | ||
| (Subject Device) | Volcano iFR® Modality - K133323 | ||
| (Predicate Device) | |||
| Intended | |||
| Use | The QUANTIEN™ 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 Volcano | ||
| s5TM/s5i/CORE/CORETM Mobile | |||
| Precision Guided Therapy System is | |||
| used for the qualitative and | |||
| quantitative evaluation of vascular | |||
| morphology in the coronary arteries | |||
| and vessels of the peripheral | |||
| vasculature. It is also indicated as an | |||
| adjunct to conventional angiographic | |||
| procedures to provide an image of | |||
| vessel lumen and wall structures. |
The pressure feature is intended for
use in all blood vessels, including
coronary and peripheral arteries, to
measure intravascular blood pressure
during diagnostic angiography and/or
interventional procedures |
| | Indications
for Use | The 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. | The iFR® Modality of the
s5/sSiCORE/CORE Mobile Precision
Guided Therapy System is indicated in
all blood vessels, including coronary
and peripheral arteries, to measure
intravascular blood pressure during
diagnostic angiography and/or
interventional procedures.
The iFR® Modality is intended to be
used in conjunction with currently
marketed Volcano pressure wires. |
| | Relevant
Display
Features | RFR resting full cycle ratio | iFR instant wave free ratio |
| Summary on Non-
Clinical Testing | Verification and Validation testing were completed to demonstrate safety and
effectiveness and ensure that the subject device performs as intended. Design
verification and validation included the following:
Software Verification and Validation – performed to ensure that the subject
device meets requirements and functions as intended Usability Study - performed to evaluate the usability and possible use errors
that may lead to patient safety issues with the introduction of the new features
on the graphical user interface | | |
5
K183099
pg. 3 of 4
6
K183099 pg. 4 of 4
| Summary of Clinical
Testing | No new clinical testing was completed, nor relied upon, in support of this Traditional
510(k). However, a prospective study was performed to determine the diagnostic utility
of RFR for the physiological assessment of coronary artery disease in real world
patients. 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) and
negative (non-ischemia causing) were used for RFR result interpretation: | |
| | RFR 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 between
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%
[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 of
Equivalence | The QUANTIENT™ Measurement System with Software v1.12.1 is equivalent to the
QUANTIENT™ 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 the
Philips' Volcano iFR® Modality (K133323) in terms of the pressure measurement
modality for the Resting Full-Cycle Ratio index. | |