(82 days)
FloWire Doppler Guide Wire, FloWire XT Doppler Guide Wire
Not Found
No
The description focuses on the physical construction and function of a Doppler guide wire for measuring blood flow velocity, with no mention of AI or ML for data analysis or interpretation.
No.
The device is used for diagnostic purposes to measure blood flow velocities and provide hemodynamic information for diagnosis and treatment. While it may guide other interventional devices, its primary function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the device is used "to measure blood flow velocities during diagnostic angiography and/or interventional procedures" and that "Blood flow velocity measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary or peripheral artery disease." This directly indicates its role in diagnosis.
No
The device description clearly details a physical guide wire with an ultrasound transducer, core wire, hypotube, coils, and a transducer housing. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Cardiometrics FloWire 300/FloWire XT 300 Doppler Guide Wire is an invasive medical device used inside the body (in blood vessels) to measure blood flow velocity using ultrasound. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for measuring blood flow velocities during diagnostic angiography and/or interventional procedures within blood vessels.
Therefore, this device falls under the category of an in vivo (within the living body) diagnostic and interventional device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all blood vessels, including both coronary and peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: 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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
FloWire Doppler Guide Wire, FloWire XT Doppler Guide Wire
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Avenue
Mountain View, California 94043
(415) 961-6993 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Claire Andrews
Vice President, Regulatory, Quality and Clinical Affairs |
| Date Prepared: | July 22, 1997 |
| vice Information | |
| Classification: | Class II |
| Trade Name: | FloWire® 300 Doppler Guide Wire
FloWire® 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 Wire
FloWire XT Doppler Guide Wire |
Intended Use
Dev
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.
1
Product 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.
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:
2
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
3
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)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)