(84 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on hardware components and standard physiological measurements (FFR, iFR).
No
The device is intended to measure blood pressure and provide FFR and iFR measurements for diagnostic purposes, not to treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states the system measures blood pressure "during diagnostic and/or interventional procedures." Additionally, the "Device Description" mentions its capability to make "Fractional Flow Reserve (FFR) and Instant Wave-Free Ratio™ (iFR®) measurements," which are diagnostic tools used to assess the severity of coronary artery disease.
No
The device description explicitly states that the system consists of hardware components including a PC Console, a patient interface module (OPIM), and Hemo Converter Box (HCB) modules, in addition to software.
Based on the provided information, the CORE® FM System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "measure blood pressure in all blood vessels... during diagnostic and/or interventional procedures." This involves direct measurement within the body, not testing samples (like blood, urine, or tissue) outside the body.
- Device Description: The system components (PC Console, patient interface module, Hemo Converter Box) are designed to connect to a pressure measurement guide wire and hemodynamic monitoring system, indicating in-vivo measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CORE® FM System's function is to measure physiological parameters directly within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The CORE® FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures.
The CORE FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.
Product codes (comma separated list FDA assigned to the subject device)
DSK, DSA
Device Description
The CORE FM System provides the capability to make Fractional Flow Reserve (FFR) and Instant Wave-Free Ratio™ (iFR®) measurements. The system consists of a bedrail or cart mounted PC Console, a patient interface module (OPIM) for connecting the pressure measurement guide wire to the PC Console, and one or more Hemo Converter Box (HCB) modules for transmitting the aortic pressure and ECG signals form the hemodynamic monitoring system to the PC Console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all blood vessels, including the coronary and peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.
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)
Performance testing completed for a determination of substantial equivalence included the following:
EMC, Reliability and Electrical Safety
Design Verification
Software Verification
Packaging Validation
Simulated Use / Usability Validation
The results of the performance data demonstrate equivalence to the predicate device.
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.
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
§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).
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Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2015
Volcano Corporation Nathan Da Silva Regulatory Engineer 3721 Valley Centre Dr. Ste 500 San Diego, California 92130
Re: K152582
Trade/Device Name: CORE FM Physiological Measurement System Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II Product Code: DSK, DSA Dated: November 5, 2015 Received: November 6, 2015
Dear Mr. Da Silva:
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 devicerelated 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.
1
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 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 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 vours.
Mitchell Stein
forBram 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) K152582
Device Name
CORE® FM Physiological Measurement System
Indications for Use (Describe)
The CORE® FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures.
The CORE FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.
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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510 (k) SUMMARY
| SPONSOR: | Volcano Corporation
3721 Valley Center Drive
San Diego, CA 92130 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Nathan da Silva
Regulatory Engineer
Volcano Corporation
3721 Valley Center Drive
San Diego, CA 92130
Tel: (858) 764-1232
Fax: (858) 481-1027 |
| DATE PREPARED: | December 1, 2015 |
| DEVICE: | Volcano CORE® FM Physiological Measurement System |
| TRADE NAME: | Volcano CORE® FM Physiological Measurement System |
| COMMON NAME: | Blood Pressure Computer |
| CLASSIFICATION: | 21 CFR Part 870.1110
DSK: Blood Pressure Computer
Class II Device |
| | 21 CFR Part 870.2900
DSA: Patient Transducer and Electrical Cable
Class II Device |
| PREDICATE DEVICE: | CORE Control Pad, CORE Series SW v3.4 Installation Kit,
CORE, CORE Mobile (K133641) |
| DEVICE DESCRIPTION: | The CORE FM System provides the capability to make
Fractional Flow Reserve (FFR) and Instant Wave-Free
Ratio™ (iFR®) measurements. The system consists of a
bedrail or cart mounted PC Console, a patient interface
module (OPIM) for connecting the pressure measurement
guide wire to the PC Console, and one or more Hemo
Converter Box (HCB) modules for transmitting the aortic
pressure and ECG signals form the hemodynamic
monitoring system to the PC Console. |
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INTENDED USE: The CORE FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures. The CORE® FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures. COMPARISON OF CHARACTERISTICS: The CORE FM System is a modification to the currently marketed CORE Mobile system. The CORE FM system is designed to measure blood pressure in the coronary and peripheral vasculature only. The CORE FM takes the software code base for blood pressure measurement (FFR and iFR) from the software currently implemented on the CORE Mobile system. PERFORMANCE DATA: Performance testing completed for a determination of substantial equivalence included the following: ● EMC, Reliability and Electrical Safety ● Design Verification ● Software Verification
- Packaging Validation ●
- Simulated Use / Usability Validation ●
The results of the performance data demonstrate equivalence to the predicate device.