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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence: Maintain intended use, function, materials, performance, and sterilization method as predicate device.	The FloWire 300/FloWire XT 300 is demonstrated to be substantially equivalent to the currently marketed FloWire/FloWire XT Doppler Guide Wire with regard to intended use, function, materials, performance, and sterilization method. The only modification is the length (175 cm to 300 cm), which is addressed through testing.
Biocompatibility: Meet requirements for "Externally Communicating Devices, Circulating Blood, Limited Contact" (ISO-10993).	Materials used were tested for biocompatibility and meet the requirements of FDA BlueBook Memorandum #G95-1 ("Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"). These results support the safety of the device.
Mechanical Performance: Maintain structural integrity and mechanical properties as per FDA guidance for guide wires.	Bench testing of the FloWire 300/FloWire XT 300 Doppler Guide Wire was conducted according to the FDA guidance document "Coronary and Cerebrovascular Guide Wire Guidance" (January 1995). Evaluations included: `Turns-to-Failure Torque Response`. Other tests (joint tensile strength, coating/particulate, radiopacity) were not re-performed as materials/dimensions/processes are identical to the predicate device, and prior results apply.
Acoustic Performance: Equivalent to predicate device.	Acoustic performance testing was performed to assure the performance of the FloWire 300/FloWire XT 300 Doppler Guide Wire was equivalent to the performance of the FloWire/FloWire XT Doppler Guide Wire. (Specific metrics not provided in this summary).
Manufacturing Quality: Compliance with Good Manufacturing Practices.	A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820). The FDA verifies this through periodic QS inspections.

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.

Summary

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510(k) Premarket Notification Submission Cardiometrics .014" FloWire 300/FloWire XT 300 Doppler Guide Wire

510(k) Summary of Safety and Effectiveness FloWire® 300 and FloWire® XT 300 Doppler Guide Wires

This 510(k) safety and effectiveness summary is being submitted in accordance with the requirements of Safe Medical Devices Act 1990 and 21 CFR 8807.92.

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:	July 22, 1997
vice Information
Classification:	Class II
Trade Name:	FloWire® 300 Doppler Guide WireFloWire® XT 300 Doppler Guide Wire
Common Name:	Catheter Guide Wire
Classification Name:	Catheter guide wire (§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 Device(s):	FloWire Doppler Guide WireFloWire XT Doppler Guide Wire

Intended Use

Dev

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Product Description

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.

Substantial Equivalence

This 510(k) premarket notification is being submitted for a modification to the FloWire/FloWire XT Doppler Guide Wire. The guide wire length is being modified from 175 cm to 300 cm. The FloWire 300 Doppler Guide Wire and the FloWire XT 300 Doppler Guide Wire are substantially equivalent to the currently marketed Cardiometrics FloWire Doppler Guide Wire with CINCH® extension and the FloWire XT Doppler Guide Wire with CINCH® extension, respectively, with regard to intended use, function, materials, performance and sterilization method.

Biocompatibility Evaluations

The materials used in the FloWire XT 300 Doppler Guide Wire 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, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". These biocompatibility test results support the safety of the device.

Functional and Mechanical Testing

Bench testing of the FloWire 300/FloWire XT 300 Doppler Guide Wire was conducted according to the FDA guidance document entitled, "Coronary and Cerebrovascular Guide Wire Guidance", dated January 1995. Evaluations completed were:

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Turns-to-Failure Torque Response

The joint tensile strength tests, along with coating/particulate testing and radiopacity evaluations were not performed again due to the FloWire 300/FloWire XT 300 Doppler Guide Wires being manufactured using the same materials with identical dimensions following the same procedures and processes as the FloWire/FloWire XT Doppler Guide Wire. The results from the tests performed on the FloWire/FloWire XT Doppler Guide Wire apply equally to the FloWire 300/FloWire XT 300 Doppler Guide Wire.

In addition to mechanical testing, acoustic performance testing was also performed to assure the performance of the FloWire 300/FloWire XT 300 Doppler Guide Wire was equivalent to the performance of the FloWire/FloWire XT Doppler Guide Wire.

Summary

Based upon the modifications described in this submission, the test data supports the substantial equivalence of the FloWire 300/FloWire XT 300 Doppler Guide Wire to the FloWire/FloWire XT Doppler Guide Wire.

Clarie Kindred

aire Andrews Vice President, Regulatory, Quality and Clinical Affairs Cardiometrics. Inc. July 22, 1997

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Image /page/3/Picture/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human figure with outstretched arms, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 1 4 1997

Mr. Claire Andrews Cardiometrics, Inc. 645 Clyde Avenue Mountain View, California 94043

Re: K972762 Cardiometrics FloWire® 300 and FloWire® XT 300 Doppler Guide Wire Requlatory Class: II (two) Product Code: 74 DQX Dated: July 22, 1997 Received: July 24, 1997

Dear Mr. 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, Drug, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.

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Page 2 - Mr. Claire Andrews

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) 594-4639. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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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Page 1 of 1

510(k) Number (if known):_

Device Name: Cardiometrics FloWire 300/FloWire XT 300 Doppler GuideWire

...dications For Use: The Cardiometrics FloWire 300 Doppler Guide Hire and the Cardiometrics manodonis Por Ose: The Cardionetrics rionite for use in all blood vessels, including both Flowire XT 300 Doptier Guide Mres are meence blood flow velocities during diagnostic angiograph coronary and peripheral arteries, to measure brood from the one of absolvenents and/or interventional procedres . Interventional devices . Blood flow velocity measurements
dilatation catheter, as well as other for the diamost . and treatment of cornary dilatation catheter, as Well as other interventioner devices. "Store of coronary or peripheral artery disease.

Tant.l

(Division Sign-Off) (Division of Cardinvascular, Respiratory,
and Neurological Devese and Neurological Devices 510(k) Number K972762

¨¹LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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.