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 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 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.

AI/ML Overview

The provided document does not contain enough information to fully describe the acceptance criteria and the study that proves the device meets those criteria in the requested format.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document states: "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."

This indicates that acceptance criteria and performance data exist, but they are not provided in this summary. The summary only confirms that the device passed its internal testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The device appears to be a measurement system, not one that requires human expert interpretation for ground truth, but the details of its validation are missing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The ComboMap™ Pressure and Flow System is a device for measuring physiological parameters (blood pressure and flow velocity), not an AI-powered diagnostic tool that assists human readers.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

This is not applicable in the context of "algorithm only." The ComboMap™ is a standalone system that performs measurements. Its performance would be evaluated on the accuracy and precision of its measurements against a reference standard, not against a "human-in-the-loop" scenario in the way an AI diagnostic tool would be. The document implies standalone performance testing was done, but no details are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the "type of ground truth." For a measurement device like this, the ground truth would typically be established by highly accurate reference measurement methods (e.g., calibrated pressure transducers, flow meters) in a controlled environment. However, the details of these reference methods are not provided.

8. The sample size for the training set

This is not applicable. This device is a measurement system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

Summary of Available Information:

The document describes the ComboMap™ Pressure and Flow System as a multi-mode system combining the functionality of previous separate pressure and flow measurement devices (SmartMap®, WaveMap®, and FloMap®). It's intended to measure intravascular blood pressure and/or blood flow velocities.

The "Performance Data" section briefly states that "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." This indicates that internal testing was conducted against pre-defined acceptance criteria, and the device passed. However, the specifics of those criteria and the detailed performance results are not included in this 510(k) summary.

The 510(k) process in this case relies on demonstrating substantial equivalence to predicate devices (SmartMap® Pressure System, WaveMap® Pressure System, FloMap® Doppler Flow System). The key argument is that "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™." This implies that the performance characteristics were expected to be similar due to the use of established technologies.

Summary

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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.2870 Kilgore Rd.Rancho Cordova, CA 95670
Contact person:	Lorry W. HuffmanRegulatory Affairs Manager
Phone number:	(916) 638-9404 or (800) 228-4728 ext. 404
Facsimile number:	(916) 638-8112

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:

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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.

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:

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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 (240) 276-4080. 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 (800) 638-2041 or (240) 276-3150 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
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ComboMap™ Pressure and Flow System Device Name:

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Prescription Use X (Per 21 CFR 801.19) OR

Over-the-Counter Use

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).