CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

K152582 · Volcano Corporation · DSK · Dec 3, 2015 · Cardiovascular

Device Facts

• Record ID: K152582
• Device Name: CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
• Applicant: Volcano Corporation
• Product Code: DSK · Cardiovascular
• Decision Date: Dec 3, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1110
• Device Class: Class 2

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.

Device Story

CORE FM Physiological Measurement System measures blood pressure in coronary and peripheral arteries; calculates Fractional Flow Reserve (FFR) and Instant Wave-Free Ratio (iFR). System components: bedrail/cart-mounted PC console, patient interface module (OPIM) for pressure guide wire connection, and Hemo Converter Box (HCB) for aortic pressure and ECG signal acquisition from hemodynamic monitoring systems. Used in clinical settings (cath lab) by trained physicians. Device processes pressure and ECG signals to provide real-time physiological measurements. Output assists physicians in assessing vessel stenosis severity during interventional procedures, facilitating clinical decision-making regarding treatment.

Clinical Evidence

Bench testing only. Performance data included EMC, reliability, electrical safety, design verification, software verification, packaging validation, and simulated use/usability validation. Results demonstrate equivalence to the predicate device.

Technological Characteristics

System consists of a PC console, patient interface module (OPIM), and Hemo Converter Box (HCB). Measures blood pressure via pressure guide wires and ECG signals. Software-based processing for FFR and iFR calculations. Connectivity via HCB to existing hemodynamic monitoring systems. Class II device.

Indications for Use

Indicated for patients undergoing diagnostic or interventional cardiac or peripheral vessel catheterization procedures requiring blood pressure measurement in coronary or peripheral arteries.

Regulatory Classification

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.

Predicate Devices

• CORE Control Pad, CORE Series SW v3.4 Installation Kit, CORE, CORE Mobile (K133641)

Submission Summary (Full Text)

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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.

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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 [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 at its toll-free number [phone] or [phone] 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<br>3721 Valley Center Drive<br>San Diego, CA 92130 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Nathan da Silva<br>Regulatory Engineer<br>Volcano Corporation<br>3721 Valley Center Drive<br>San Diego, CA 92130<br>Tel: [phone]<br>Fax: [phone] |
| 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<br>DSK: Blood Pressure Computer<br>Class II Device |
| | 21 CFR Part 870.2900<br>DSA: Patient Transducer and Electrical Cable<br>Class II Device |
| PREDICATE DEVICE: | CORE Control Pad, CORE Series SW v3.4 Installation Kit,<br>CORE, CORE Mobile (K133641) |
| DEVICE DESCRIPTION: | The CORE FM System provides the capability to make<br>Fractional Flow Reserve (FFR) and Instant Wave-Free<br>Ratio™ (iFR®) measurements. The system consists of a<br>bedrail or cart mounted PC Console, a patient interface<br>module (OPIM) for connecting the pressure measurement<br>guide wire to the PC Console, and one or more Hemo<br>Converter Box (HCB) modules for transmitting the aortic<br>pressure and ECG signals form the hemodynamic<br>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.