COMBOMAP PRESSURE AND FLOW SYSTEM

K041134 · Volcano Therapeutics, Inc. · OBJ · Jun 2, 2004 · Cardiovascular

Device Facts

• Record ID: K041134
• Device Name: COMBOMAP PRESSURE AND FLOW SYSTEM
• Applicant: Volcano Therapeutics, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Jun 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Indications for Use

ComboMap™ Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.

Device Story

ComboMap™ is a PC-based instrument for real-time measurement of intravascular blood pressure and blood flow velocity. It processes signals from SmartWire® pressure guide wires and FloWire® Doppler guide wires. Operates in four modes: Pressure, Flow, and Combo (simultaneous pressure/velocity). In Pressure mode, provides digital/graphical readout of mean aortic pressure, mean SmartWire® pressure, and calculated parameters like fractional flow reserve (FFR). In Flow mode, measures blood flow velocity in coronary or peripheral vessels, calculating average peak velocity (APV) and flow reserve. Used in clinical settings (e.g., cath lab) by physicians during diagnostic or interventional procedures. Output displayed on screen for real-time clinical decision-making regarding vessel status and treatment. Combines functionality of previously separate systems (WaveMap® and FloMap®) into one unit.

Clinical Evidence

Bench testing only. Performance testing was conducted to evaluate the system, and results were found to be acceptable per established test plans and protocols.

Technological Characteristics

PC-based instrument; processes signals from intravascular guide wires (SmartWire®, FloWire®). Provides digital/graphical waveform display and analog output. Includes patient interface module (PIM), remote control, and printer. Combines pressure and flow measurement modalities previously found in separate predicate systems. Software-controlled signal processing.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures requiring measurement of intravascular blood pressure and/or blood flow velocities in coronary and peripheral arteries.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• SmartMap® Pressure System (K021219)
• WaveMap® Pressure System (K965140)
• FloMap® Doppler Flow System (K921563)

Submission Summary (Full Text)

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Volcano Therapeutics, Inc. April 29, 2004

ComboMap™ Pressure and Flow System Special 510(k)

## 510 (K) Summary ComboMap™ Pressure and Flow System

| Date Prepared: | April 29, 2003 |
|-------------------|----------------------------------------------------------------------------|
| Submitted by: | Volcano Therapeutics, Inc.<br>2870 Kilgore Rd.<br>Rancho Cordova, CA 95670 |
| Contact person: | Lorry W. Huffman<br>Regulatory Affairs Manager |
| Phone number: | [phone] or [phone] ext. 404 |
| Facsimile number: | [phone] |

Device Name: ComboMap™ Pressure and Flow System

| Classification name: | Class |
|----------------------------------------------------|-------|
| 870.2100 – Cardiovascular blood flow meters | II |
| 870.1110 - Blood Pressure Computer | II |
| 870.2900 - Patient Transducer and Electrical Cable | II |

### Predicate Device:

| SmartMap® Pressure System | K021219 |
|-----------------------------|---------|
| WaveMap® Pressure System | K965140 |
| FloMap® Doppler Flow System | K921563 |

Volcano Therapeutics Inc. purchased the assets of JOMED Inc. who had previously purchased Cardiometrics, Inc. under which K021219, K965140 and K921563 were filed.

## Device Description:

The ComboMap™ Pressure and Flow System is a computer-controlled (PCbased) instrument, which processes the information it receives from the transducer mounted in a Volcano Therapeutics SmartWire" Pressure Guide Wire, Volcano Therapeutics FloWire® Doppler Guide Wire, and/or external inputs, to produce real-time blood pressure and/or blood flow velocity. There are 4 modes available to operate from and switch between on the ComboMap™; System. Pressure, Flow, and Combo. Depending on the mode and setup selections made, the computer screen displays a combination of waveforms, measured values, and calculated parameters on the display screen. Additional controls also appear on the display screens.

In the Pressure Mode, the ComboMap™ provides digital and graphical readout of mean aortic pressure from a guide catheter, mean SmartWire® pressure, and a calculated parameter, such as gradient or fractional flow reserve (FR), and one of

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six (6) selected waveforms. The ComboMap™ also supplies an analog output of the SmartWire® pressure for display on a conventional physiologic monitoring svstem.

In the Flow Mode, there are two (2) operating modes to measure blood flow velocity in either coronary or peripheral vessels. This is because in coronary arteries, maximum blood flow velocity occurs predominantly during diastole and in peripheral arteries, maximum flow occurs during systole. The ComboMap™ displays the waveforms selected and provides digital readout of calculated parameters such as average peak velocity (APV) and flow reserve.

The ComboMap™ System offers the unique ability to simultaneously display pressure and velocity waveforms using the Combo Mode. Layout of the Pressure and Doppler display as well as selected waveforms is customized by the user allowing a combination of any of those described above in Pressure Mode and Flow Mode.

Depending on the clinicians' preference, the physician has the option of using a pressure guide wire (SmartWire®), a flow guide wire (FloWire®) or both. By using these guide wires from Volcano Therapeutics, the physician can measure pressure and/or flow velocity.

The pressure and flow guide wires are marketed under separate 510(k)'s; SmartWires K021219 K905411, K912776, K921563, K972762 FloWire"

Wires that can currently be used with the ComboMap are as follows: 6400, 6400J, 6403, 6403J, 6413, 6413J (BrightWire name is used in certain European SmartWire countries due to trademark issues 7400, 7400J, 7403, 7403J) 1400, 1400J, 1401, 1401J, 1403, 1403J, 1404, 1404J, 1413, 1413J FloWire

#### Model Numbers and Accessories:

| ComboMap™ Unit | 6800 |
|-------------------------------|------------|
| ComboMap™ Patient Cable (PIM) | 6805 |
| ComboMap™ Remote Control | 6810 |
| ComboMap™ Printer | 6815 |
| ComboMap™ Cart | 6820 |
| Printer Paper | 803545-001 |
| Printer Power Supply | 803933-001 |

#### Intended Use:

ComboMap™ Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.

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Volcano Therapeutics, Inc. April 29, 2004

Device Technological Characteristics and Comparison to Predicate Device: Currently pressure and flow velocity are measured with separate guide wires (SmartWire® or FloWires), connected to separate systems (WaveMap® or FloMap"). The ComboMap™ combines the functionality of both technologies in one system. Signal processing, measurement modalities and instrument connections are the same as the predecessor instruments. The intended use and the fundamental scientific technology of the SmartMap® WaveMap® and FloMap have not been altered but are combined together in the ComboMap™.

### Performance Data:

Applicable testing was performed to evaluate the ComboMap™ Pressure and Flow System. The test results were found to be acceptable as required by the respective test plans and protocols.

### Conclusion:

The ComboMap™ Pressure and Flow System has the same intended use and utilizes the same fundamental scientific technology as that of the predicate devices. There are no new questions raised regarding safety and efficacy. The information provided in this Special 510(k) submission along with the Declaration of Conformity with Design Controls support a determination of substantial equivalence of the ComboMap™ Pressure and Flow System to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

MAY 2 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Volcano Therapeutics, Inc. c/o Ms. Lorry W. Huffman Manager, Regulatory Affairs 2870 Kilgore Rd. Rancho Cordova, CA 95670

Re: K041134

Trade/Device Name: ComboMap Pressure and Flow System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II Product Code: OBJ Dated: April 29, 2004 Received: April 30, 2004

Dear Ms. Huffman:

This letter corrects our substantially equivalent letter of June 2, 2004.

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 (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.

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. Huffman

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

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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| 510(k) Number (if known): | k041134 |
|---------------------------|---------|
|---------------------------|---------|

ComboMap™ Pressure and Flow System Device Name:

## Indications for Use:

ComboMap™ Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K041134
for

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4*************************************************************************************************************************************************************************** Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.19) OR

Over-the-Counter Use

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