(42 days)
Not Found
No
The summary describes a rotational IVUS catheter and its intended use for imaging. It mentions modifications to packaging and states substantial equivalence to a predicate device from 2005. There is no mention of AI, ML, image processing beyond basic imaging, or any performance metrics typically associated with AI/ML algorithms. The focus is on the physical device and its imaging capability.
No
The device is an imaging catheter used for ultrasound examination to visualize coronary intravascular pathology, which aids in diagnostic assessment rather than providing direct therapy.
Yes
The device is intended for "ultrasound examination of coronary intravascular pathology" and "intravascular ultrasound examination of coronary arteries," which directly indicates its use for diagnosing pathologies within the coronary arteries. It is used to provide information for decisions regarding "transluminal coronary interventional procedures."
No
The device description explicitly states it is a "Rotational IVUS Imaging Catheter," which is a physical hardware device used for intravascular ultrasound imaging. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "ultrasound examination of coronary intravascular pathology only" and "intravascular ultrasound imaging." This describes a device used within the body to visualize structures, not a device used to test samples outside the body (which is the definition of an in vitro diagnostic).
- Device Description: The description focuses on the catheter itself and its function in imaging within the coronary arteries.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is an imaging catheter used for intravascular ultrasound, which is a type of medical imaging performed in vivo (within a living organism).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OBJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
coronary intravascular pathology; coronary 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)
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.
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.
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
§ 870.1200 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).
0
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 Corporation | |
| 2870 Kilgore Rd. | ||
| Rancho Cordova, CA 95670 | MAY 12 2008 | |
| Contact person: | Jennifer Motto | |
| Specialist, 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:
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.
Device Technological Characteristics and Comparison to Predicate Device:
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.
1
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.
2
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.
3
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
4
Volcano Corporation
Indications for Use
510(k) Number (if known): Ko8089 |
Device Name: Revolution® 45MHz Rotational Catheter
Indications for Use:
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.
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
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