What is the FDA product code for COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE?

510(k) clearance (submission type: Special).

What are the predicate devices for COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE?

SmartWire® (K021219); FloWire® (K905411, K912776, K921563, K972762).

Who can help prepare an FDA 510(k) submission like COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE

Q: Who is the manufacturer of COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE?

Volcano Therapeutics, Inc. filed the 510(k) submission for COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE (K042996).

K042996 · Volcano Therapeutics, Inc. · DQX · Nov 24, 2004 · Cardiovascular

Device Facts

Record ID	K042996
Device Name	COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
Applicant	Volcano Therapeutics, Inc.
Product Code	DQX · Cardiovascular
Decision Date	Nov 24, 2004
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.

Device Story

Steerable guide wire with integrated pressure transducer (proximal to tip) and ultrasound transducer (at tip); used to measure simultaneous pressure and blood flow velocity. Operated by physician in clinical setting (angiography/interventional suite) to navigate vasculature. Proximal end connects to ComboMap™ Pressure/Flow Instrument via connector cable assembly; torque device facilitates navigation. Combines functionality of separate pressure and flow wires into single device. Output displayed on instrument; assists clinicians in hemodynamic assessment during procedures; provides diagnostic/interventional guidance.

Clinical Evidence

Bench testing only. Performance data evaluated via test plans and protocols; results found acceptable.

Technological Characteristics

0.014" diameter steerable guide wire, 185cm length. Features integrated pressure transducer and ultrasound transducer. Compatible with ComboMap™ instrument. Includes torque device and connector cable assembly. Same fundamental scientific technology and materials as predicate wires.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures requiring simultaneous measurement of blood pressure and flow velocity in coronary and peripheral vessels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

SmartWire® (K021219)
FloWire® (K905411, K912776, K921563, K972762)

Reference Devices

ComboMap™ Pressure/Flow Instrument
WaveMap®
FloMap®
WaveWire®

Related Devices

K111395 — PRIMEWIRE PRESTIGE PLUS · Volcano Corporation · Aug 1, 2011
K070487 — SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX · Volcano Corporation · Mar 16, 2007
K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip · Volcano Corporation · Mar 26, 2020
K210235 — Verrata PLUS Pressure Guide Wire · Volcano Corporation · Apr 15, 2021
K131288 — VERRATA PRESSURE GUIDE WIRE · Volcano Corporation · Jun 21, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ K042996 Volcano Corporation October 18, 2004 NOV 2 4 2004 ComboWire™ Pressure/Flow Guide Wire Family Special 510(k) # 510 (K) Summary ComboWire™/ComboTip™ Pressure/Flow Guide Wire Family of Products | Date Prepared: October 21, 2004 | | | |------------------------------------|--|--| |------------------------------------|--|--| Submitted by: Volcano Corporation 2870 Kilgore Rd. Rancho Cordova, CA 95670 Contact person: Lorry W. Huffman Director Regulatory Affairs Phone number: (916) 638-9404 or (800) 228-4728 ext. 404 Facsimile number: (916) 638-8112 Device Name: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of Products | Device classification: | Class | |----------------------------------------------------|-------| | 870.1330 - Catheter Guide Wire | II | | 870.2100 - Cardiovascular blood flow meters | II | | 870.2870 - Catheter tip pressure transducer | II | | 870.2890 - Vessel occlusion transducer | II | | 870.2900 - Patient Transducer and Electrical Cable | II | #### Predicate Device: | Predicate Wires Product Name | Predicate Wires 510(k) Clearance | Current Catalog Numbers | |-----------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------| | SmartWire® BrightWire (name is used in certain European countries due to trademark issues) | K021219 | 6400, 6400J, 6403, 6403J, 6413, 6413J, 7400, 7400J, 7403, 7403J | | FloWire® | K905411, K912776, K921563, K972762 | 1400, 1400J, 1401, 1401J, 1403, 1403J, 1404, 1404J, 1413, 1413J | Volcano Therapeutics Inc. purchased the assets of JOMED Inc. who had previously purchased Cardiometrics, Inc. under which K021219, K905411, K912776, K921563 and K972762 were filed. {1}------------------------------------------------ ## Device Description: The ComboWire™/ComboTip™ Pressure/Flow Guide Wire is a steerable guide wire with a pressure transducer mounted less than 3 cm proximal to the tip and a tip mounted ultrasound transducer. The ComboWire/ComboTip measures pressure and flow when used with the ComboMap™ Pressure/Flow Instrument, a class IIa currently marketed device. The ComboWire/ComboTip is currently available in a diameter of 0.014" with a length of 185cm however, additional sensor configurations and wire length will be produced in the future to accommodate customer needs just as has been done with SmartWire, WaveWire and FloWire where up to 10 models are offered. The proximal end of the ComboWire/ComboTip is compatible with the provided ComboWire/ComboTip Connector Cable Assembly. The ComboWire/ComboTip can be torqued using the included torque device to facilitate navigation through the vasculature. #### Model Numbers and Accessories: | ComboWire™ Pressure/Flow Guide Wire | Model 9403 | |-------------------------------------|------------| | ComboTip™ Pressure/Flow Guide Wire | Model 9410 | ## Table of Accessories Supplied with Device | and of the first and and and of the many of the start of the status of the same of the same of the first and program like for the more a version a comments of the comments of the comments of the comments of the comments of Accessories | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | - Kan K - K - B - - - Torque Device | | ingle consistential or consisted in consisted in consistent of the consistent of the contract and consideration of the former to the Connector Cable Assembly Particle Production Company Company of Canadian Comments of Canadian Company Company of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ## Intended Use: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures. Device Technological Characteristics and Comparison to Predicate Device: Currently pressure and flow velocity are measured with separate quide wires (SmartWire® or FloWire®), connected to separate systems (WaveMap® or FloMap"). The ComboWire and ComboMap combine the functionality of both technologies into one system. Material construction, measurement modalities and instrument connections are the same as the predecessor wires. The intended use and the fundamental scientific technology of the SmartWire and FloWire have not been altered and the same fundamental scientific technology has been incorporated into the ComboWire/ComboTip Family of products. ## Performance Data: Applicable testing was performed to evaluate the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire. The test results were found to be acceptable as required by the respective test plans and protocols. {2}------------------------------------------------ Volcano Corporation October 18. 2004 ### Conclusion: The ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of products have the same intended use and utilize the same fundamental scientific technology as that of the predicate devices. There are no new questions raised regarding safety and efficacy. The information provided in this Special 510(k) submission along with the Declaration of Conformity with Design Controls support a determination of substantial equivalence of the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of products to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 4 2004 Volcano Corporation c/o Ms Lorry W. Huffman Director, Regulatory Affairs 2870 Kilgore Rd. Rancho Cordova, CA 95670 Re: K042996 Trade Name: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: October 18 , 2004 Received: November 01, 2004 Dear Ms. Huffman: We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve and have and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 rate exaction 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 - Ms Lorry W. Huffman Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read of a reveale a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, B. Zimmerman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ | 510(k) Number (if known): | K042996 | |---------------------------|---------| |---------------------------|---------| ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Device Name: #### Indications for Use: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures. #### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | X | |------------------|---| |------------------|---| (Per 21 CFR 801.19) OR Over-the-Counter Use __________________________________________________________________________________________________________________________________________________________________________ Blhmmmmma (Division Sign-Off)