The Revolution® 45 MHz Rotational IVUS Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidate for transluminal coronary interventional procedures.

The Revolution catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Device Description

The Revolution® 45 MHz Rotational IVUS Imaging Catheter is substantially equivalent to the Revolution® 45 MHz Rotational Imaging Catheter cleared under K050995 on 06/20/2005. Modifications include implementation of a double seal on the pouch packaging.

The Revolution® 45 MHz Rotational Imaging Catheter uses the same fundamental scientific technologies and has the same intended use as that of the predicate device, Revolution® 45 MHz Rotational Imaging Catheter.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Revolution™ 45 MHz Rotational IVUS Imaging Catheter:

Summary of Device and Context:

The Revolution™ 45 MHz Rotational IVUS Imaging Catheter is an intravascular ultrasound device for examining coronary arteries, indicated for patients undergoing transluminal coronary interventional procedures. This 510(k) submission (K080891) is for a modification to an already cleared device (K050995), specifically involving a double seal on the pouch packaging.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission focuses on demonstrating substantial equivalence for a packaging modification, not on establishing new performance claims for the imaging capabilities of the device itself. Therefore, the "acceptance criteria" and "reported device performance" are primarily related to the packaging change and its impact on the device's functional integrity.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance/Conclusion
Substantial Equivalence (Overall)	The device, with modifications, must be substantially equivalent to the predicate device, raising no new questions of safety or efficacy.	The Revolution® 45 MHz Rotational Imaging Catheter is substantially equivalent to the predicate device (K050995). The double seal implementation does not raise any new questions regarding safety and efficacy. Test results and conformity with design controls support this determination.
Packaging Integrity/Sterility Barrier	The modified double seal pouch must maintain its integrity and ensure the safety and efficacy of the device.	Applicable testing was performed in accordance with Design Controls, including a risk analysis addressing the impact of modifications. (Implicitly, these tests demonstrated that the packaging change did not negatively impact the device).
Fundamental Scientific Technologies	The device must utilize the same fundamental scientific technologies as the predicate device.	The device uses the same fundamental scientific technologies as the predicate device.
Intended Use	The device must have the same intended use as the predicate device.	The device has the same intended use as the predicate device: for ultrasound examination of coronary intravascular pathology in patients who are candidates for transluminal coronary interventional procedures.

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

The document does not explicitly state a specific sample size for a "test set" in the context of device performance, as the submission primarily concerns a packaging change. It broadly mentions "Applicable testing was performed in accordance with Design Controls," which would include verification and validation activities for the packaging.

Test Set Sample Size: Not explicitly stated as this submission primarily addresses a packaging change, not a clinical performance study. The "testing" referred to would be V&V for the packaging.
Data Provenance: Not applicable in the context of a clinical study. The relevant data would be internal engineering and quality testing data related to the packaging.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided and is not relevant to this specific 510(k) submission. The submission is for a packaging change, not a new imaging algorithm or clinical diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant to this specific 510(k) submission as it does not involve expert interpretation or subjective assessment of clinical images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or at least not mentioned in this submission. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is involved and needs to be compared with or augmented by AI. This submission is for a packaging modification.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done or mentioned. The device is purely an imaging catheter, not an algorithm. Its "performance" refers to its ability to acquire images, which is not evaluated as a standalone algorithm in this context.

7. The Type of Ground Truth Used

The concept of "ground truth" (e.g., pathology, outcomes data) as typically understood in AI or diagnostic imaging performance studies is not applicable to this submission. The "ground truth" here would relate to the successful performance of the packaging (e.g., sterility maintenance, seal integrity) as determined by validated engineering and quality control tests, which are not detailed in this summary.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission. This device is a physical medical device (an IVUS catheter), not an AI algorithm that requires a training set.

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

As indicated above, the concept of a "training set" and its "ground truth" is not applicable to this submission.

Summary

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Volcano Corporation

Kos0891 Pg 1 of 2

510 (K) Summary Revolution™ 45 MHz Rotational IVUS Imaging Catheter

Date Prepared:	March 28, 2008
Submitted by:	Volcano Corporation2870 Kilgore Rd.Rancho Cordova, CA 95670	MAY 12 2008
Contact person:	Jennifer MottoSpecialist, Regulatory Affairs
Phone number:	(916) 231-4509
Facsimile number:	(916) 638-2647
Device Name:	Revolution TM 45 MHz Rotational IVUS Imaging Catheter

Classification name:

Class . 870.1200 Diagnostic Intravascular catheter 11 . 892.1560 Ultrasonic pulsed echo imaging system 11 892.1570 Diagnostic ultrasonic transducer . -

Predicate Device:

The Revolution® 45 MHz Rotational Imaging Catheter is substantially equivalent to the Revolution® 45 MHz Rotational Imaging Catheter cleared under K050995 on 06/20/2005.

Intended Use:

Device Technological Characteristics and Comparison to Predicate Device:

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Image /page/1/Picture/0 description: The image shows the text "Volcano Corporation" at the top. Below that is the text "K080891 Pg 2 of 2". The text appears to be handwritten. There is a horizontal line below the handwritten text.

Performance Data:

Applicable testing was performed in accordance with Design Controls including a risk analysis addressing the impact of modifications to the device and components. The test results indicate the subject device is comparable to the predicate device.

Conclusion:

Revolution® 45 MHz Rotational Imaging Catheter has the same Intended Use and utilizes the same fundamental scientific technology as that of the predicate device. Revolution® 45 MHz Rotational Imaging Catheter cleared under K050995 on 06/20/2005.

Implementation of the double seal to the pouch package does not raise any new questions regarding safety and efficacy. The test results and a declaration of conformity with design controls support a determination of substantial equivalence of the subject device to the predicate device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 12 2008

Volcano Corporation c/o Ms. Jennifer Motto Specialist, Regulatory Affairs 2870 Kilgore Road Rancho Cordova, CA 95670

Re: K080891

Trade/Device Name: Revolution 45 MHz Rotational IVUS Imaging Catheter Regulation Number: 21 CFR 870, 1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: OBJ Dated: March 5, 2008 Received: March 6. 2008

Dear Ms. Motto:

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. Jennifer Motto

proceed to the market.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Bettmann/Cor

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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Volcano Corporation

Indications for Use

510(k) Number (if known): Ko8089 |

Device Name: Revolution® 45MHz Rotational Catheter

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummenauer

(Division Sign-Off) Division of Cardlovaso 510(k) Number

Page 1 of

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).