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The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

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.

Volcano s5/s5i Series Intravascular Imaging and Pressure System: This system is available in 3 configurations; 1) a tower or portable model, 2) an integrated model, and 3) an integrated model with communication capabilities with 3rd party angiography equipment. When operating in IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5/s5i system is an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® (not available with Revolution catheter), a two-dimensional color map of relative blood velocities is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital feature displays a two-dimensional, longitudinal view of the vessel. The angle of the longitudinal cut can be varied around the full 360 degrees. When operating in pressure mode, the system acquires intraluminal data from the pressure guidewire (SmartWire II and ComboWire II) while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment.

ComboMap Pressure and Flow System: The ComboMap™ Pressure and Flow System is a computer-controlled (PC-based) instrument, which processes the information it receives from the transducer mounted in a Volcano Corporation SmartWireR Pressure Guide Wire (K021219), Volcano Corporation FloWireR Doppler Guide Wire (K905411, K912776, K921563, K972762), 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 SmartWireR pressure, and a calculated parameter, such as gradient or fractional flow reserve (FFR), and one of six (6) selected waveforms. The ComboMap™ also supplies an analog output of the SmartWireR pressure for display on a conventional physiologic monitoring system. 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Volcano s5/s5i Series Intravascular Imaging and Pressure Systems and ComboMap Pressure and Flow System:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics. Instead, it relies on a general statement about compliance with internal procedures and a conclusion of substantial equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Study Details

The provided 510(k) summary is a premarket notification for substantial equivalence, which primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. It does not contain details of a clinical study or a performance study with specific quantitative results as would be typically found for novel devices or those requiring a PMA.

Here's what can be inferred or explicitly stated based on the text provided:

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

• Not specified. The document refers to "applicable testing" and "test plans and protocols" but does not provide details on the sample size of any test sets (e.g., patient data, phantom studies, etc.) or the provenance of any data used for performance validation.

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)

• Not specified. Given the nature of a 510(k) summary for substantial equivalence, it's unlikely that external experts were used to establish ground truth in the way one might for a novel diagnostic algorithm. The "ground truth" for showing substantial equivalence likely refers to the established performance of the predicate devices and internal validation processes against engineering specifications.

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

• Not specified.

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

• No evidence of an MRMC study. This submission predates the widespread regulatory focus on AI-driven clinical decision support and MRMC studies for such tools. The devices are described as imaging and pressure/flow systems, not AI-assisted diagnostic tools in the modern sense. The "VH IVUS" feature includes semi-automatic visualization and spectral analysis, which hints at some automated processing, but an MRMC study exploring human improvement with this feature is not mentioned.

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

• Implied for some components, but not explicitly detailed. The devices are systems that acquire and display data (IVUS images, pressure/flow readings). The "semi-automatic visualization" and "spectral analysis" features of VH IVUS likely involve algorithms operating in a standalone capacity within the system to process data before presentation to the user. However, no specific standalone performance metrics for these algorithmic components are provided.

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

• Not specified directly. For an imaging system, ground truth would typically come from a combination of:
  • Predicate device comparison: The performance is benchmarked against the cleared predicate devices.
  • Physical phantoms/simulators: For sensor accuracy (pressure, flow) and imaging resolution.
  • Clinical observation: The ability to visualize structures and measure physiological parameters in patients, likely compared with established clinical methods.
    The document only broadly states "applicable testing was performed as required by the Quality System to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols."

8. The sample size for the training set

• Not applicable / Not specified. This submission is for hardware systems and their associated software for data acquisition and display. It does not describe a machine learning model that would require a "training set" in the modern AI sense. While some algorithms (like those for semi-automatic visualization or spectral analysis) might have been developed using data, the concept of a "training set" for regulatory submission in this context is not explicitly mentioned.

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

• Not applicable / Not specified. See point 8.

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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.

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.

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.

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The Cardiometrics WaveWire/WaveMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The WaveWire may be used to guide the positioning of balloon dilatation catheters, as well as other interventional devices such as atherectomy devices, lasers and stents. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary and/or peripheral artery disease.

The Cardiometrics WaveWire Pressure Wire is a steerable guide wire designed to perform real-time invasive pressure measurements in the vasculature. The WaveWire has a nominal outer diameter of either .014" or .018" and is 175 cm in length. It has a 3 cm . shapeable radiopaque tip coil that is available in three different stiffnesses: floppy. flex and firm. The WaveWire XT Pressure Wire design provides increased column strength in the distal segment of the wire just proximal to the guide wire while retaining the floppy characteristics of the tip itself: the increased column strength supports certain interventional devices (Note: All other characteristics of the WaveWire XT Pressure Wire are the same as the non-XT WaveWire). A miniature pressure transducer is mounted at the junction of the radiopaque tip coil and the radiolucent proximal coil. The WaveWire Pressure Wire is connected to the WaveMap Pressure Instrument via a rotary connector cable and patient cable. Each rotary connector cable includes an identification memory chip containing the calibration constants for the pressure transducer. In addition, the WaveWire Pressure Guide Wire is designed to be compatible with the Cordis CINCH® extension system.

The WaveMap Pressure Instrument is intended for use only with the WaveWire Pressure Wire. The WaveMap is a microcomputer controlled instrument which processes the information from the transducer mounted in the WaveWire to produce real-time blood pressure measurements. The WaveMap provides digital readouts of mean aortic pressure from a guide catheter, mean WaveWire pressure, and a calculated parameter, such as gradient or fractional flow reserve (FFR). The WaveMap also supplies an analog output of the WaveWire pressure for display on a conventional physiologic monitoring system or strip chart recorder.

The Cardiometrics WaveWire/WaveMap Pressure System's 510(k) submission (K9605140) does not contain a study section that directly addresses user performance or the specific performance metrics (like sensitivity, specificity, accuracy, etc.) related to an AI/algorithm's diagnostic output.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

• Bench Testing: Verifying the device's physical and electrical integrity and functionality.
• Biocompatibility Evaluations: Ensuring the materials used are safe for internal use.
• Substantial Equivalence Claims: Comparing the new system's design, intended use, and materials to existing approved devices.

Therefore, many of the requested categories for AI/algorithm-based criteria cannot be fulfilled directly from this document.

Here's an analysis based on the provided text, highlighting what is available and what is not:

Acceptance Criteria and Device Performance (Not Applicable for AI/Algorithm metrics)

• Screw Tip to Core Wire Joint Test
• Screw Tip to Tip Coil Tensile Strength
• Tip Coil to (Housing) Proximal Coil Tensile Strength
• Proximal Coil to Hypotube Tensile Strength
• Turns-to-Failure
• Torque Response
• Functional (Accuracy) Testing (Details of accuracy metrics not provided in the summary)

Results: The submission implies successful completion of these tests, stating: "Based upon the information described in this submission, the functional/mechanical evaluations... the Cardiometrics WaveMap Pressure System has been shown to be substantially equivalent..." (Specific numerical results or thresholds are not disclosed in this summary).

Evaluations not performed (due to similarity with predicate devices): Inadvertent disengagement (Cordis CINCH® Extension System), Coating and Particulate Testing, Radiopacity, Dome Integrity, Core Wire-to-Hypotube Joint Test, and Bending/Stiffness. The results from predicate device tests "equally apply" to the WaveWire. |
| Biocompatibility | Materials: Similar to FloWire Doppler Guide Wire and AccuTrac Intravascular Guide Wire, with two new materials also tested.
Testing: New and existing materials tested according to FDA BlueBook Memorandum #G95-1 ("Use of International Standard ISO-10993").
Results: "meet the requirements for "Externally Communicating Devices, Circulating Blood, Limited Contact"." |
| Electrical Safety | Testing: IEC-601-1, UL2601, CSA 22.2, CSA601-1 (Safety of Medical Electrical Equipment).
Results: "conducted to assure the WaveMap Pressure Instrument complies with the requirements". |
| Electromagnetic Compatibility (EMC) | Testing: IEC 601-1-2.
Results: "conducted to assure the WaveMap Pressure Instrument complies with the requirements". |
| Substantial Equivalence | Claim: The device is substantially equivalent in design and intended use to the FloWire®/FloMap® Doppler Ultrasound Instrument, AccuTrac™ Intravascular Guide Wire, Medtronic Floscan® Doppler Diagnostic Catheter, and Millar Mikro-Tip® Catheter Pressure Transducer.
Results: FDA granted 510(k) clearance, indicating agreement with the substantial equivalence claim. |

Detailed Study Information (Focus on AI/Algorithm-specific questions)

1. Sample size used for the test set and the data provenance:

   • Not Applicable. The submission describes physical and electrical bench testing, not a clinical study with a test set of patient data for an algorithm. The "Functional (Accuracy) Testing" described in the bench testing section would have involved a test set of physical scenarios or calibration measurements, but details are not provided in this summary.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This is not a study involving expert-derived ground truth for diagnostic interpretation. Ground truth for the bench tests would be known physical or electrical parameters.

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

   • Not Applicable. No human adjudication of results is described.

4. 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:

   • No. This device is a pressure measurement system and guide wire, it does not involve AI or algorithms assisting human readers in diagnostic interpretation.

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

   • No. The device is a physical instrument for measuring pressure, not a standalone diagnostic algorithm. The "WaveMap Pressure Instrument is a microcomputer controlled instrument which processes the information from the transducer mounted in the WaveWire to produce real-time blood pressure measurements." This "processing" is standard signal processing, not an AI or machine learning algorithm in the modern sense.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

   • Physical/Electrical Standards. For bench testing validation, the ground truth would be established by reference standards for pressure, tensile strength, electrical safety, etc. This is not related to clinical outcome or expert consensus on medical images.

7. The sample size for the training set:

   • Not Applicable. There is no mention of a training set as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to this device submission.

Conclusion:

The K9605140 submission for the Cardiometrics WaveWire/WaveMap Pressure System demonstrates substantial equivalence through extensive bench testing, biocompatibility evaluation, and electrical/EMC safety testing, comparing it to other legally marketed predicate devices. It establishes the device's physical and functional integrity for its intended purpose of accurately measuring blood pressure and serving as a guide wire.

However, this submission predates the widespread use of AI/ML in medical devices and does not include any studies or criteria related to AI or algorithmic diagnostic performance, human reader studies, or training/test sets for machine learning models. The device's "microcomputer controlled instrument" performs signal processing to produce real-time measurements, which is distinct from AI-driven diagnostic interpretation.

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