(92 days)
No
The device description focuses on standard physiological parameter computation and data display/transfer, with no mention of AI or ML terms or functionalities.
No.
The device is a diagnostic computer that provides hemodynamic information for use in the diagnosis and treatment of cardiovascular diseases, indicating a diagnostic rather than therapeutic purpose.
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 refers to it as a "diagnostic computer."
No
The device description explicitly states it is a "diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire... and other external transducers." This indicates the device includes hardware components (the computer itself) in addition to software.
Based on the provided information, the QUANTIEN Measurement System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (e.g., blood, urine, tissue). The QUANTIEN Measurement System analyzes physiological parameters within the body using sensors (PressureWire™ guidewire and other external transducers) inserted into the coronary or peripheral arteries.
- The intended use and device description clearly state it measures hemodynamic information directly from within the patient's circulatory system. It's a diagnostic tool used in vivo (within a living organism), not in vitro (in glass or outside the body).
Therefore, the QUANTIEN Measurement System is a diagnostic device, but it falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK, DSK
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
RadiAnalyzer® Xpress K092105
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.
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
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:
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.
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
1
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.
2
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.
3
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
4
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.
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.
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)
OR
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Owen P. Faris -S
2013.03.28
11:27:43 -04'00'