(211 days)
No
The document describes standard intravascular imaging and pressure measurement technologies with features like ChromaFlo and VH IVUS, but there is no mention of AI or ML in the intended use, device description, or performance studies. The VH IVUS mentions "semi-automatically visualize boundary features and perform spectral analysis," which is more indicative of traditional image processing algorithms rather than AI/ML.
No.
The device is used for diagnostic purposes (evaluation of vascular morphology, blood flow information, pressure measurement) and as an adjunct to interventional therapies, but it does not directly treat a disease or condition.
Yes
The Intended Use/Indications for Use section explicitly states that the device is used for “qualitative and quantitative evaluation of vascular morphology,” “adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures,” "qualitative blood flow information," and "diagnostic ultrasound imaging examinations." It also mentions "to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures," all of which point to a diagnostic purpose.
No
The device description explicitly mentions a "system console" and acquiring data from a "pressure guidewire," indicating the presence of hardware components beyond just 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 s5/s5i Series Intravascular Imaging and Pressure System operates in vivo (within the living body). It uses intravascular ultrasound and pressure measurements taken directly from within blood vessels.
- Intended Use: The intended use clearly describes the evaluation of vascular morphology and pressure within the coronary arteries and peripheral vasculature. It is an adjunct to angiographic procedures, which are also performed in vivo.
- Device Description: The description details the system's operation in IVUS and pressure modes, both of which involve direct interaction with the patient's internal anatomy.
Therefore, because the device operates and collects data directly from within the patient's body rather than on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Volcano s5/s5i Series Intravascular Imaging and Pressure System 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.
VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
Product codes
IYO, DSK, DSA, OBJ
Device Description
When operating in IVUS mode, 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 s5/s5i system is an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® (not available with Revolution catheter), a two-dimensional color map of relative blood velocities is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital feature displays a two-dimensional, longitudinal view of the vessel. The angle of the longitudinal cut can be varied around the full 360 degrees.
When operating in pressure mode, the system acquires intraluminal data from the pressure guidewire (SmartWire II/ComboWire) while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. In conjunction with the procedure, the system measures pressure and calculates pressure differences between the aoritic pressure and the SmartWire/ComboWire pressure transducer typically located distal to the vascular lesion and calculates the fractional flow reserve (FFR).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Coronary arteries, peripheral vasculature, all blood vessels
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)
A risk analysis was conducted according to 803475-001 Risk Management which was written to comply with ISO 14971 and IEC 60601-1-4 as specific risk management standards. Also taken into consideration in this procedure are 21 CFR 820.30 and the Medical Device Directive of the European Union (93/46/EEC). Applicable testing was performed as required by the Quality System to evaluate the modifications to the Volcano s5/s5i Intravascular Imaging and Pressure System. 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)
K061215, K051920, K041134, K051337, K052348
Reference Device(s)
K051337, K000820, K944004, K902329, K021219, K070487, K042996, K050995, K965140, K021219, K963290, K965223, K031148
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Submitter: Volcano Corporation
510(k) SUMMARY
The 510(k) Summary is submitted as required by Section 807.92(a)
| Submitter Name: | Volcano Corporation |
|---|---|
| Contact Person: | Lorry W. Huffman, RAC, MT(ASCP), CLS(NCA) |
| Sr. Director Regulatory Affairs | |
| Address: | 2870 Kilgore Road |
| Rancho Cordova, CA 95670 | |
| Phone Number: | 916-281-4503 |
| Fax Number: | 916-638-2647 |
| Date Prepared: | June 4, 2007 |
| Device Trade Name: | Volcano s5/s5i Series Intravascular Imaging and Pressure |
| Systems | |
| Device Common Name: | Ultrasonic imaging system |
| Classification Name, | |
| Number, Product Code: | 892.1560 Ultrasonic pulsed echo imaging system, II, IYO |
| 870.1110 Blood Pressure Computer, II, DSK | |
| 870.2900 Patient Transducer and Electrical Cable, II, DSA |
KOJ1554
1
Special 510(k) Premarket Notification
Predicate Device Table
| Predicate
System
Name | Predicate
System 510(k)
Clearance | Current Catalog
Numbers | Predicate
Catheters/Wires
510(k)
Clearance | Current Catalog
Numbers |
|------------------------------------------------|-----------------------------------------|------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Volcano s5i
Family of
Imaging
Systems | K061215 | s5/806300-001
s5/806300-003 | K051337
K000820
K944004
K902329 | 85900 Eagle Eye Gold
85700 Avanar FX 2.9F
86700 PV 0.018
88900 PV8.2 |
| Volcano s5
Imaging
System | K051920 | s5/804200-001 | K051337
K000820
K944004
K902329 | 85900 Eagle Eye Gold
85700 Avanar FX 2.9F
86700 PV 0.018
88900 PV8.2 |
| ComboMap®
Pressure
and Flow
System | K041134 | 6800 | K021219
K070487
K042996 | SmartWire II/BrightWire II
6600, 6600J, 6603,
6603J, 6613, 6613J
(7600, 7600J, 7603,
7603J)
FloWire
1400, 1400J, 1401,
1401J, 1403, 1403J,
1404, 1404J, 1413,
1413J
ComboWire II
9603, 9610 |
| VH IVUS®
System | K051337 | 804906-001
804907-001
804908-001
804911-001 | K051337 | 85900 Eagle Eye Gold |
| In-Vision
Gold with
SpinVision | K052348 | 804906-001
804907-001
804908-001
804911-001 | K050995
K051337
K000820
K944004
K902329 | 89000 Revolution
85900 Eagle Eye Gold
85700 Avanar FX 2.9F
86700 PV 0.018
88900 PV8.2 |
Other prior predicates:
WaveMap cleared under K965140; SmartMap cleared under K021219; ColorFloo Option for the Oracle In Vision Intravascular Ultrasound Imaging System cleared under K963290 on August 6, 1997; the Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223 on June 29, 1998, the InVision Imaging System cleared under K031148 on May 28, 2003.
NOTE: Volcano Therapeutics, Inc. (now Volcano Corporation) purchased the assets of JOMED Inc. on July 21, 2003. JOMED Inc. purchased Endosonics Corporation.
2
Special 510(k) Premarket Notification
Device Description:
General Operation Overview
When operating in IVUS mode, 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 s5/s5i system is an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® (not available with Revolution catheter), a two-dimensional color map of relative blood velocities is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital feature displays a two-dimensional, longitudinal view of the vessel. The angle of the longitudinal cut can be varied around the full 360 degrees.
When operating in pressure mode, the system acquires intraluminal data from the pressure guidewire (SmartWire II/ComboWire) while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. In conjunction with the procedure, the system measures pressure and calculates pressure differences between the aoritic pressure and the SmartWire/ComboWire pressure transducer typically located distal to the vascular lesion and calculates the fractional flow reserve (FFR).
Volcano s5/s5i Series Intravascular System (Subject Device)
| s5 tower or portable configuration | Model 807300-xxx |
|---|---|
| s5i integrated configuration | Model 807400-xxx |
| s5i integrated configuration with 3rd party connectivity | Model Multiple, TBD |
| Accessories and Option kits | |
| s5-rev Option Kit | part number 806071-008 |
| s5i-rev Option Kit | part number 806071-009 |
| s5-ffr Option Kit | part number 807342-001 |
| s5i-ffr Option Kit | part number 807343-001 |
| S5i PIMr rail Hanger Option Kit | part number 807334-001 |
| s5 PC Chassis Upgrade Kit | part number 807301-004 |
| Multiple peripheral components | part number(s) Multiple, refer to Marketing brochure in Attachment 4 for a current listing |
| Catheters | 85900 Eagle Eye Gold |
| 85700 Avanar FX 2.9F | |
| 86700 PV 0.018 | |
| 88900 PV8.2 | |
| 89000 Revolution 45 MHz Rotational | |
| Wires | SmartWire II 6600 6600J |
| 6603 6603J | |
| 6613 6613J | |
| BrightWire II 7600 7600J | |
| 7606 7603J | |
| ComboWire II 9603 9610 | |
| (operates the pressure transducer only) |
3
: 14
Intended Use:
The Volcano s5/s5i Series Intravascular Imaging and Pressure System 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.
VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
Performance Data:
A risk analysis was conducted according to 803475-001 Risk Management which was written to comply with ISO 14971 and IEC 60601-1-4 as specific risk management standards. Also taken into consideration in this procedure are 21 CFR 820.30 and the Medical Device Directive of the European Union (93/46/EEC). Applicable testing was performed as required by the Quality System to evaluate the modifications to the Volcano s5/s5i Intravascular Imaging and Pressure System. The test results were found to be acceptable as required by the respective test plans and protocols.
Conclusion:
The discussion and data presented in this 510(k) and conformance with Design Controls and the Quality System Regulations establishes the Volcano s5/s5i Series Intravascular Imaging and Pressure System to be substantially equivalent for its intended use to the predicate devices listed in this submission.
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines that suggest the head, body, and tail feathers.
JAN - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Volcano Corporation c/o Lorry Huffman, RAC Sr. Director, Regulatory Affairs 2870 Kilgore Road Rancho Cordova, CA 95670
Re: K071554
Trade Name: Volcano s5/s5i Intravascular Imaging and Pressure System Regulation Number: 21 CFR 870.1200 Regulation Name: Intravascular Ultrasound Catheter Regulatory Class: Class II (two) Product Code: OBJ, IYO Dated: December 3, 2007 Received: December 5, 2007
Dear Ms. Huffman:
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.
5
Page 2 – Ms. Lorry Huffman, 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,
Blummore fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Statement of Indications for Use
510(k) Number (if known):
Device Name: Volcano s5/s5i Series Intravascular Imaging and Pressure System
Indications for Use:
The Volcano s5/s5i Series Intravascular Imaging and Pressure System 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.
VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumma
(Posted November 13, 2003)
Slan-Off ision of Cardlovascular Devices STÜRK Number Ka