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The Cardiometrics FloWire 300 Doppler Guide Wire and the Cardiometrics FloWire XT 300 Doppler Guide Wires are intended for use in all blood vessels, including both coronary and peripheral arteries, to measure blood flow velocities during diagnostic angiography and/or interventional procedures. The FloWire may be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood flow velocity measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary or peripheral artery disease.

The FloWire 300/ FloWire XT 300 Doppler Guide Wire is a steerable guide wire with a ultrasound transducer mounted in a housing at the tip of the radiopaque tip coil. The FloWire 300/ FloWire XT 300 utilizes a coaxial design, has a nominal outer diameter of .014" throughout the entire length of the guide wire, and is approximately 300 cm in length. The FloWire 300/ FloWire XT 300 is constructed from a core wire, tapered at the distal end. Two different taper configurations are available, one is for the standard FloWire 300 Doppler Guide Wire, while the second configuration is for the FloWire XT 300 Doppler Guide Wire. The FloWire XT 300 Doppler Guide Wire has increased column strength in the distal segment of the wire just proximal to the tip of the wire, while retaining the floppy characteristics of the tip itself; the increased column strength provides additional support for tracking interventional devices, such as atherectorny devices, lasers and stents. External to the core wire is a hypotube, proximal and tip coils, and the transducer housing. The hypotube extends from the conductive bands at the proximal end of the FloWire 300/FloWire XT 300 Doppler Guide Wire to the proximal coil. The distal tip is available in three different stiffnesses: floppy or flex. In addition, the FloWire 300/FloWire XT 300 Doppler Guide Wire is coated to provide lubricity for tracking interventional devices, such as balloon dilatation catheters. The FloWire 300/FloWire XT 300 Doppler Guide Wire connects to the FloMap/FloMap II Instrument via the Rotary Connector Cable and Patient Cable.

The provided text describes a 510(k) premarket notification for a medical device, the FloWire 300/FloWire XT 300 Doppler Guide Wire. This submission is for a modification to an existing device (lengthening the guide wire), rather than a completely new device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not presented in the traditional sense of a clinical trial proving a new device's efficacy against a set of performance metrics.

Instead, the submission focuses on substantial equivalence to a previously cleared predicate device. This means the primary "acceptance criterion" is demonstrating that the modified device performs equivalently and safety to the original, shorter FloWire/FloWire XT Doppler Guide Wire, and that the changes do not raise new questions of safety or effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in terms of a "test set" of patients or cases. The testing was primarily bench testing (mechanical and acoustic). For bench testing, sample sizes are typically determined by engineering and statistical methods to ensure representativeness and confidence in the results, but these details are not provided in this summary.
• Data Provenance: The data provenance is from bench testing performed by the manufacturer, Cardiometrics, Inc., in the United States (Mountain View, California). This is retrospective in the sense that it's performed on manufactured devices for the purpose of the 510(k) submission, not on patient data from a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable as the provided text describes bench testing (mechanical and acoustic performance) and biocompatibility, not a study requiring expert-established ground truth for patient outcomes or diagnoses. The "ground truth" here is the physical and functional properties of the device as measured against engineering specifications and regulatory guidelines.

4. Adjudication Method for the Test Set

• This information is not applicable as the provided text describes bench testing, not a study requiring adjudication of clinical outcomes or diagnoses.

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 information is not applicable. The device is a Doppler guide wire, not a diagnostic imaging AI system. The submission does not involve human readers or AI assistance in the context of diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This information is not applicable. The device is a physical medical instrument (guide wire), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering specifications, performance standards (e.g., FDA guidance documents), and comparison to the established performance of the predicate device. For biocompatibility, the ground truth is established by the ISO-10993 standard.

8. The Sample Size for the Training Set

• This information is not applicable. The device is a physical medical instrument, not a learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable for the reasons stated in point 8.

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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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The FloWire Doppler Guide Wires and the FloMap Ultrasound Instrument measure blood velocities in peripheral and coronary arteries. The FloWire/FloMap System are intended for use in conjunction with diagnostic procedures such as peripheral and coronary angiography and for interventional procedures such as balloon angioplasty, as well as other interventional procedures which utilize a guide wire in the peripheral and coronary vasculature. The SmartWire Doppler Guide Wire and SmartMap Ultrasound Instrument are intended for use in the cerebral vasculature to measure blood flow velocities during diagnostic angiography and/or any interventional procedures.

This 510(k) Notification is being submitted for modifications to the tip mounted transducer of Cardiometrics Doppler Guide Wires (both FloWire and SmartWire Doppler Guide Wires). The transducer modifications allow the beam width to increase from 28° to 35° and allow the Doppler Guide Wires to all function at 12 MHz. Previously, the .014" Doppler Guide Wire functioned at 15 MHz and the .018" Doppler Guide Wire functioned at 12 MHz. This modified transducer will be more efficient with a higher signal to noise ratio with the wider beam width will allow for easier signal acquisition by the user when positioning the Doppler Guide Wire in the vessel.

The currently marketed FloWire and SmartWire Doppler Guide Wires have the mechanical properties of other floppy steerable guide wires with the addition of a tip mounted ultrasound Doppler transducer. FloWire and SmartWire Doppler Guide Wires connect to a Rotary Connector Cable which is supplied with each guide wire. The Rotary Connector Cable in turn connects to the Patient Cable which connects to the Cardiometrics FloMap Ultrasound Instrument. The FloMap Instrument incorporates the electronics and software required to process the Doppler ultrasound signals in real time, displaying blood flow velocity measurements and spectral patterns on the instrument monitor. Blood flow velocity measurements are obtained using the FloWire and SmartWire Doppler Guide Wires to provide hemodynamic information in diagnostic and/or interventional procedures.

The provided text describes a 510(k) modification K951567 for Cardiometrics Doppler Guide Wires. This submission is for modifications to the tip-mounted transducer to increase beam width and standardize the operating frequency.

Here's an analysis of the provided information against your requested criteria:

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

Unfortunately, the provided text does not contain any explicit acceptance criteria or reported device performance metrics in the way you might expect for a typical diagnostic device study (e.g., sensitivity, specificity, or quantitative accuracy targets).

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices after a modification. The "performance" described is largely qualitative, centering on the improvements due to the modification:

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

The document does not describe a specific clinical "test set" or study involving patient data for the modified device's performance. The rationale for substantial equivalence is based on the technical modifications and their expected impact, rather than a new clinical trial comparing the old and new transducers head-to-head on a patient cohort.

Therefore, information regarding:

• Sample size for the test set: Not applicable / Not provided.
• Data provenance (country of origin, retrospective/prospective): Not applicable / Not provided.

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)

Since there is no described clinical "test set" requiring ground truth establishment, this information is not applicable and not provided.

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

Since there is no described clinical "test set," this information is not applicable and not provided.

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 section is not applicable. This device is a medical instrument (Doppler Guide Wire) not an AI-powered diagnostic tool for image interpretation by "human readers." Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This section is not applicable. The device is a physical medical instrument, not a standalone algorithm. Its function relies on being used by a clinician to acquire data which is then processed and displayed by the FloMap/SmartMap instrument for the clinician's interpretation.

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

Since there is no described clinical "test set" and a focus on substantial equivalence based on technical specifications and existing device performance, specific "ground truth" data of this nature (expert consensus, pathology, outcomes) is not applicable and not provided for this modification submission. The "ground truth" here is more akin to engineering specifications and equivalence to previously cleared devices.

8. The sample size for the training set

This section is not applicable. The device is a physical instrument, not a machine learning model, so there is no concept of a "training set" in the context of AI/ML development.

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

This section is not applicable for the same reason as point 8.

Summary of the K951567 Submission Type:

This 510(k) submission is for a device modification, not an original device clearance or a de novo submission. The primary goal is to demonstrate substantial equivalence of the modified device to its own previously cleared version (predicate device). The evidence presented focuses on the technical changes (transducer design) and asserts that these changes improve efficiency and user experience without altering the fundamental intended use, safety, or core performance when a signal is acquired. It relies heavily on comparative analysis of specifications and existing biocompatibility data rather than new clinical outcome studies.

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