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 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.

AI/ML Overview

The provided text describes the Volcano Corporation ComboWire™ Pressure/Flow Guide Wire Family Special 510(k) submission (K042996). However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, nor does it include information typically associated with AI/ML device studies.

The document is a traditional 510(k) summary focused on demonstrating substantial equivalence to predicate devices (SmartWire® and FloWire®) for an updated medical device. The "Performance Data" section merely states: "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." It does not elaborate on what these tests were, their acceptance criteria, or their results.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria and performance studies in the context of an AI/ML device.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document states "test results were found to be acceptable as required by the respective test plans and protocols," but the specific criteria and results are not detailed.	Not specified in the document. The document states "test results were found to be acceptable as required by the respective test plans and protocols," but the specific performance metrics are not detailed.

Missing Information (and why it's missing from this type of 510(k) submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. This type of detail is typically not included in a 510(k) summary for a non-AI device unless significant clinical trials with human subjects are involved. The testing mentioned would likely be bench testing (e.g., pressure accuracy, flow velocity accuracy, mechanical properties, biocompatibility).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth establishment by experts is usually for diagnostic imaging or similar AI/ML applications, which is not the nature of this device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided.
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: Not applicable. This is a non-AI medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would likely refer to calibrated measurements from reference instruments during bench testing, not clinical expert assessments.
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Device and Performance Information Provided:

Device Name: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of Products
Intended Use: To measure simultaneous pressure and blood flow velocities in blood vessels (coronary and peripheral) during diagnostic angiography and/or interventional procedures.
Technological Characteristics Comparison to Predicate: Combines functionality of two separate predicate wires (SmartWire® for pressure, FloWire® for flow) into one system. Material construction, measurement modalities, and instrument connections are stated to be the same as predecessor wires.
Performance Data Statement: "Applicable testing was performed... The test results were found to be acceptable as required by the respective test plans and protocols." This is a general statement asserting compliance with internal testing protocols, but specific results are not disclosed in this summary.
Conclusion: The device has 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."

In essence, this 510(k) relies on the argument of "substantial equivalence" to previously cleared predicate devices, rather than presenting novel performance data for acceptance criteria as one would expect for an AI/ML system.

Summary

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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
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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:

PredicateWiresProductName	PredicateWires 510(k)Clearance	CurrentCatalogNumbers
SmartWire®BrightWire(name is usedin certainEuropeancountries dueto trademarkissues)	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.

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Device Description:

Model Numbers and Accessories:

ComboWire™ Pressure/Flow Guide Wire	Model 9403
ComboTip™ Pressure/Flow Guide Wire	Model 9410

Table of Accessories Supplied with Device

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ingle consistential or consisted in consisted in consistent of the consistent of the contract and consideration of the former to theConnector Cable AssemblyParticle Production Company Company of Canadian Comments of Canadian Company Company of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 andprogram like for the more a version a comments of the comments of the comments of the comments of the comments ofAccessories

- 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 theConnector Cable AssemblyParticle Production Company Company of Canadian Comments of Canadian Company Company of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Intended Use:

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.

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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.

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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.

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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

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510(k) Number (if known):	K042996
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ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Device Name:

Indications for Use:

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
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(Per 21 CFR 801.19)

Over-the-Counter Use __________________________________________________________________________________________________________________________________________________________________________

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(Division Sign-Off)

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.