(100 days)
No
The document describes standard image processing and connectivity features, with no mention of AI or ML terms or concepts.
No
The device is described as an "Imaging System" used for diagnostic evaluation of vascular morphology and as an adjunct to angiographic procedures. It provides "diagnostic information" and can be an "adjunct to interventional therapies," but it does not directly treat or provide therapy itself.
Yes
The device is used for "qualitative and quantitative evaluation of vascular morphology" and provides "diagnostic information," indicating its role in identifying and assessing medical conditions.
No
The device description explicitly states that the system consists of an imaging catheter, a patient interface module, and a system console, which are hardware components. While software is mentioned as part of the system's functionality, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Volcano s5i Family of Imaging Systems is an imaging system that uses ultrasound to visualize the internal structure of blood vessels (coronary arteries and peripheral vasculature). It provides qualitative and quantitative evaluation of vascular morphology and blood flow.
- Method of Use: The system involves inserting an imaging catheter directly into the blood vessels to acquire images. This is an in vivo procedure (performed within the living body), not an in vitro procedure (performed outside the living body).
The device is a medical imaging system used for diagnostic purposes, but it does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Volcano s5i Family of Imaging Systems is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
Product codes
IYO
Device Description
The Volcano s5i Family of Imaging Systems consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5i Imaging Systems can be an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® a twodimensional color map of relative blood flow is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital option displays a twodimensional, 360 rotations and longitudinal view of the Volcano s5i Imaging System software provides an option for connectivity with third party fluoroscopic imaging systems. The software option simplifies the Cardiac Catherization Lab workflow with the fluoroscopic imaging systems by, 1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes, etc.) from the fluoroscopic imaging system with the Volcano s5i Imaging System, 2) providing a remote access to commonly used IVUS functions from the fluoroscopic imaging system user interface.
The imaging catheters are all marketed under separate premarket notifications; Visions catheter K982329, Avanar catheter K000820 and Eagle Eye Gold K031346.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed echo imaging
Anatomical Site
coronary arteries and vessels of the peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiac Catherization Lab
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 to evaluate the modifications to the Volcano s5i Family of Imaging Systems. The test results were found to be acceptable as required by the respective test plans and protocols.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K944004, K963290, K965223, K031148, K051920
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
149
(06/21 2
Volcano s5i Family of Imaging System Special 510(k) Premarket Notification
510(k) SUMMARY
The 510(k) Summary is submitted as required by Section 807.92(a)
| Submitter Name: | Volcano Corp. | AUG 10 2006 |
|---|---|---|
| Contact Person: | Michelle J. Badal, RAC | |
| Manager, Regulatory Affairs | ||
| Address: | 2870 Kilgore Road | |
| Rancho Cordova, CA 95670 | ||
| Phone Number: | 916-231-4497 | |
| Fax Number: | 916-638-2647 | |
| Date Prepared: | May 1, 2006 | |
| Device Trade Name: | Volcano s5i Family of Imaging Systems | |
| Device Common Name: | Ultrasonic imaging system | |
| Classification Name, | ||
| Number, Product Code: | Ultrasonic pulsed echo imaging system | |
| 21 CFR 892.1560, Product Code: IYO |
Predicate Device:
Submitter:
Volcano Corp.
Cathscanner III Imaging System cleared under K944004; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K963290; Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223; In Vision Imaging System cleared under K031148, and Volcano s5 Imaging System cleared under K051920.
Device Description:
The Volcano s5i Family of Imaging Systems consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays highresolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5i Imaging Systems can be an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® a twodimensional color map of relative blood flow is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital option displays a twodimensional, 360 rotations and longitudinal view of the Volcano s5i Imaging System software provides an option for connectivity with third party fluoroscopic imaging systems. The software option simplifies the Cardiac Catherization Lab workflow with the
1/2
1
| Submitter: | Volcano s5i Family of Imaging System |
|---|---|
| Volcano Corp. | Special 510(k) Premarket Notification |
fluoroscopic imaging systems by, 1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes, etc.) from the fluoroscopic imaging system with the Volcano s5i Imaging System, 2) providing a remote access to commonly used IVUS functions from the fluoroscopic imaging system user interface.
The imaging catheters are all marketed under separate premarket notifications; Visions catheter K982329, Avanar catheter K000820 and Eagle Eye Gold K031346.
Intended Use:
Volcano s5i Family of Imaging Systems is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
Performance Data:
Applicable testing was performed to evaluate the modifications to the Volcano s5i Family of Imaging Systems. The test results were found to be acceptable as required by the respective test plans and protocols.
Conclusion:
The testing reported in this 510(k) establishes the device is safe and effective for its intended use and substantially equivalent to the predicate devices.
4061215
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2006
Ms. Michelle J. Badal, RAC Manager, Regulatory Affairs Volcano Corp. 2870 Kilgore Road Rancho Cordova, CA 95670
Re: K061215
Trade/Device Name: Volcano s5i Family of Imaging Systems Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO Dated: July 7, 2006 Received: July 10, 2006
Dear Ms. Badal:
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). and coometer fore, market the device, subject to the general controls provisions of the Act. The I ou may, increrers, misions 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 rr your de rice to such additional controls. Existing major regulations affecting your device can may be subject to back address and egulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Michelle J. Badel, RAC
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 yours,
Bhimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K 061215
Device Name: Volcano s5i Family of Imaging Systems
Indications for Use:
The Volcano s5i Family of Imaging Systems is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.A. Montana
(Posted November 13, 2003)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K06/215