The SmartWire Pressure Guide Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Device Description

The SmartWire II is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The SmartWire measures pressure when used with the SmartMap®, WaveMap®, and ComboMap® Instruments. The SmartWire II is available in a diameter of 0.014" (0.36 mm), lengths of 185 cm and 300 cm, and different tip flexibilities. The SmartWire II is packaged preconnected to the connector with a torque device to facilitate navigation through vasculature.

AI/ML Overview

The provided text is a 510(k) summary for the Volcano Corporation's SmartWire Pressure Guide Wire. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and a study proving those criteria are met for the device in question.

Here's an analysis based on the limited information provided, addressing your requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific pressure measurement accuracy ranges) or report detailed numerical performance results for the SmartWire Pressure Guide Wire itself. Instead, it relies on a qualitative comparison to the predicate device.

Acceptance Criteria (Explicit)	Reported Device Performance
Same fundamental scientific technology	The modified SmartWire® Pressure Guide Wire uses the same fundamental scientific technology.
Same intended use	Has the same intended use as that of the predicate device.
Biocompatibility according to ISO 10993-1	The new material was tested for biocompatibility according to ISO 10993-1, and the results met the predetermined acceptance criteria.
Comparable performance to predicate device	The test results indicate the revised product is comparable to the predicate device.
No new questions regarding safety or efficacy	Modifications to the device do not raise any new questions regarding safety or efficacy.
Continuing substantial equivalence	The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a separate "test set" in the context of a clinical performance study. The "applicable testing" mentioned is part of design verification. The sample sizes for this testing are not provided, nor is the provenance of any data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth for a test set. This type of evaluation is typically associated with AI/software-based devices and not with a physical medical device like a guide wire, for which performance is assessed through engineering and biocompatibility testing.

4. Adjudication Method for the Test Set:

Not applicable, as no external expert-adjudicated test set is described.

5. MRMC Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study would be relevant for devices that assist human readers in interpreting medical images or data, which is not the primary function of a pressure guide wire.

6. Standalone (Algorithm Only) Performance:

Not applicable. The SmartWire Pressure Guide Wire is a physical medical device, not an algorithm. Its performance is intrinsically tied to its physical characteristics and interaction with the human body and other medical instruments (SmartMap®, WaveMap®, and ComboMap® Instruments).

7. Type of Ground Truth Used:

For the biocompatibility testing, the "ground truth" was established by the predetermined acceptance criteria for ISO 10993-1. For the overall device performance, the "ground truth" for comparison appears to be the performance of the predicate device, as the goal was to show comparability. This is an engineering and regulatory "ground truth" rather than a clinical outcome or expert consensus.

8. Sample Size for the Training Set:

Not applicable. The SmartWire Pressure Guide Wire is a physical medical device; there is no "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established:

Not applicable, for the same reason as point 8.

Summary of the Study (Based on the document):

The "study" or "performance data" referred to in the document is a Design Verification Plan that included a Risk Analysis. This testing aimed to demonstrate that the revised product (SmartWire Pressure Guide Wire with new material) is comparable to its predicate device (Volcano SmartWire® Pressure Guide Wire cleared under K021219) and that modifications did not introduce new safety or efficacy concerns.

Specifically, the document highlights:

Testing for biocompatibility according to ISO 10993-1, with results meeting predetermined acceptance criteria.
General statement that "test results indicate the revised product is comparable to the predicate device."

The nature of the modifications (changes to material) suggests that the focus of the performance data would have been on demonstrating that the new material did not negatively impact the established performance characteristics (e.g., pressure measurement accuracy, steerability, durability) already validated for the predicate device. However, the exact tests and their detailed results are not provided in this public summary.

Conclusion:

This 510(k) submission relies on a demonstration of substantial equivalence through rigorous design verification and compliance testing (e.g., biocompatibility) rather than a clinical trial with human-in-the-loop performance evaluation or AI algorithm validation. The acceptance criteria and "study" are framed around ensuring the modified device maintains the safety and efficacy profile of its predicate.

Summary

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Volcano Corporation February 8, 2007

510 (K) Summary SmartWire Pressure Guide Wire

Dave Prepared:	February 8, 2007
Submitted by:	Volcano Corporation2870 Kilgore Rd.Rancho Cordova, CA 95670
Contact person:	Cynthia Van DukerRegulatory Affairs Manager	MAR 16 2007
Phone number:	(916) 231-4510
Facsimile number:	(916) 638-2647
Device Name:	SmartWire® Pressure Guide Wire
Classification name:	➤ 870.1330 Catheter guide wire	Class
	➤ 870.2870 Catheter tip pressure transducer	II
		II

Predicate Device:

The Volcano Corporation SmartWire® Pressure Guide Wire is substantially equivalent to the predicate device, Volcano SmartWire® Pressure Guide Wire cleared under K021219 on May 17, 2002.

Device Description:

Intended Use:

The SmartWire® Pressure Guide Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography

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and/or any interventional procedures. Blood pressure measurements provide homodynamic information for the diagnosis and treatment of blood vessel disease.

Device Technological Characteristics and Comparison to Predicate Device: The Volcano Corporation SmartWire® Pressure Guide Wire is substantially equivalent to the predicate device, Volcano SmartWire® Pressure Guide Wire cleared under K021219 on May 17, 2002. Modifications include changes to the material used in the Guide Wire.

The modified SmartWire® Pressure Guide Wire uses the same fundamental scientific technology and has the same intended use as that of the predicate device.

Performance Data:

Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of modifications to the device and components. The test results indicate the revised product is comparable to the predicate device. The new material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria.

Conclusion:

The Volcano SmartWire Pressure Guide Wire has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, Volcano SmartWire Pressure Guide Wire cleared under K021219 on May 17, 2002. Modifications to the device do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the modified device to the predicate device.

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Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2007

Volcano Corporation c/o Ms. Cynthia Van Duker Regulatory Affairs Manager 2870 Kilgore Road Ranch Cordova, CA 95670

Re: K070487

Trade Name: SmartWire™ Pressure Guide Wire Regulation Number: 21 CFR 870.1330 and 870.2870 Regulation Name: Catheter Guide Wire and Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXQ and DXO Dated: February 8, 2007 Received: February 20, 2007

Dear Ms. Van Duker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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. Cynthia Van Duker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Bremima for

Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Volcano Corporation February 8, 2007

510(k) Number (if known):

K070487

Device Name: SmartWire Pressure Guide Wire

Indications for Use:

The intended use and indications for use of the modified device as described in its labeling have not changed. The fundamental scientific technology of the modified device has not changed.

(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)

Division of Cardiovascular Devices 510ik) Number

Regulation Number and Section

§ 870.2870 Catheter tip pressure transducer.

(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).