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.

Device Description

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.

AI/ML Overview

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)

Acceptance Criteria Category	Reported Device Performance (as per the 510(k) submission)
Functional/Mechanical Performance	Bench Testing performed according to FDA guidance "Coronary and Cerebrovascular Guide Wire Guidance" (January 1995).- 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)

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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication of results is described.
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.
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.
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.
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.
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.

Summary

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K9605140

510(k) Premarket Notification Submission Cardiometrics WaveWire/WaveMap Pressure System

AUG 1 8 1997

SECTION 2.0

SUMMARY OF SAFETY AND EFFECTIVENESS

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510(k) Summary of Safety and Effectiveness WaveWire™/WaveMap™ Pressure System

This 510(k) safety and effectiveness summary is being submitted in accordance with the requirements of Safe Medical Devices Act 1990 and 21 CFR §807.92.

General Information

Manufacturer:	Cardiometrics, Inc.645 Clyde AvenueMountain View, California 94043(415) 961-6993
Contact Person:	Claire AndrewsVice President, Regulatory, Quality and Clinical Affairs
Date Prepared:	May 31, 1997

Device Information

Classification:	Class II
Trade Names:	WaveWire/WaveMap Pressure SystemWaveWire Pressure WireWaveWire XT Pressure WireWaveMap Pressure Instrument

Common/Classification Names:

Common/Classification Names:	Guide, Wire, Catheter (870.1330)Cardiovascular Blood Flow Meter (870.2100)Catheter Tip Pressure Transducer (870.2870)Vessel Occlusion Transducer (870.2890)Patient Transducer and Electrical Cable (870.2900)
Predicate Devices:	FloWire®/FloMap® Doppler Ultrasound InstrumentAccuTrac™ Intravascular Guide WireMedtronic Floscan® Doppler Diagnostic CatheterMillar Mikro-Tip® Catheter Pressure Transducer

Intended Use

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Product Description

Substantial Equivalence

The WaveWire/WaveMap Pressure System is substantially equivalent in design to two currently marketed Cardiometrics products, the FloWire®/FloMap® Doppler Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K961777. In addition, the WaveWire/WaveMap Pressure System's intended use, to measure and monitor intravascular blood pressure, is substantially equivalent to the Medtronic Floscan® Doppler Diagnostic Catheter, accession number K862673, and the Millar Mikro-Tip® Catheter Pressure Transducer, accession number K823434.

Biocompatibility Evaluations

The materials used in the WaveWire Pressure Wire are the same as those used in the FloWire Doppler Guide Wire and the AccuTrac Intravascular Guide Wire with the exception of two materials. The materials used in the FloWire and AccuTrac, along with the new materials, have been tested for biocompatibility and meet the requirements for "Externally Communicating Devices, Circulating Blood, Limited Contact" as described in the FDA BlueBook Memorandum #G95-1 entitled, "Use of International Standard ISO-10993".

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Bench Testing

Bench testing for the WaveWire Pressure Wire was conducted according to the FDA guidance document entitled, "Coronary and Cerebrovascular Guide Wire Guidance", dated January 1995. Evaluations completed were:

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

Inadvertent disengagement (for the Cordis CINCH® Extension System), Coating and Particulate Testing, Radiopacity, Dome Integrity, Core Wire-to-Hypotube Joint Test, and Bending/Stiffness evaluations were not performed due to the similarity in design between the WaveWire Pressure Wire, the FloWire Doppler Guide Wire and AccuTrac Intravascular Guide Wire. The results from these tests equally apply to the WaveWire Pressure Wire.

Electrical safety testing was conducted to assure the WaveMap Pressure Instrument complies with the requirements of IEC-601-1, UL2601, CSA 22.2 and CSA601-1, Safety of Medical Electrical Equipment. Electromagnetic compatibility testing was conducted to assure the WaveMap Pressure Instrument complies with the requirements of IEC 601-1-2.

Summary

Based upon the information described in this submission, the functional/mechanical evaluations, biocompatibility testing, electrical safety testing, and electromagnetic compatibility testing the Cardiometrics WaveMap Pressure System has been shown to be substantially equivalent to the FloWire/FloMap Doppler Ultrasound Instrument, the AccuTrac Intravascular Guide Wire, the Medtronic FloScan Doppler Diagnostic Catheter and the Millar Mikro-Tip Catheter Pressure Transducer.

Clavie Hindecuz

Claire Andrews Vice President, Regulatory, Quality and Clinical Affairs Cardiometrics, Inc. May 31, 1997

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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

AUG 1 8 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Ms. Claire L. Andrews Vice President, Requlatory, Quality and Clinical Affairs Cardiometrics, Inc. 645 Clyde Avenue Mountain View, California 94043

AUG 1 8 1997

Re: K965140 Cardiometrics WaveWire™/WaveMap™ Pressure System Requlatory Class: II (two) Product Code: DQX Dated: June 9, 1997 Received: June 9, 1997

Dear Ms. Andrews:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will vecify such assumptions. Failure to comply with the GMP requlation may result in

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requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):__ K965140

Device Name: Cardiometrics WaveWire/WaveMap Pressure System

Indications For Use:

The Cardiometrics WaveWire/WaveMap Pressure System is intended for use in coronary and peripheral blood vessels 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.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.