Search Results

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.

Ask a specific question about this device