(90 days)
Not Found
No
The description details image processing and spectral analysis but does not mention AI or ML algorithms. The "semi-automatically visualize boundary features" and "manually adjusted until they appear in the proper location" suggest rule-based or traditional image processing techniques rather than AI/ML.
No.
The device is strictly for diagnostic purposes, used in conjunction with imaging catheters for diagnostic ultrasound imaging and analysis of vascular features. It does not provide any treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is used for "diagnostic ultrasound imaging" and to "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." This clearly indicates its diagnostic purpose.
No
The device description explicitly states that the Volcano IVUS System is a "combination of proprietary hardware and software and a phantom normalization device." It details specific hardware components like a high-speed computer, analog-to-digital conversion circuitry, and gating circuitry.
Based on the provided information, the Volcano Therapeutics, Inc. Volcano IVUS System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections. The tests are performed outside of the body (in vitro).
- Volcano IVUS System Function: The Volcano IVUS System is used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. It processes ultrasound signals received from within the body to visualize and analyze vascular features. This is an in vivo imaging process, not an in vitro test on a sample.
- Intended Use: The intended use clearly states it's for "diagnostic ultrasound imaging" and "visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features". This aligns with imaging, not laboratory testing of samples.
- Device Description: The description details hardware and software that process ultrasound signals and ECG data, not equipment for handling or analyzing biological samples.
- No Mention of Sample Analysis: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample.
In summary, the Volcano IVUS System is an imaging device that processes ultrasound signals acquired from within the patient's body. This falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Volcano Therapeutics. Inc. Volcano IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano 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.
Product codes
IYO
Device Description
The Volcano Therapeutics. Inc. Volcano IVUS System is a combination of proprietary hardware and software and a phantom normalization device.
The hardware portion consists of a high-speed computer, with monitor, specifically built for use in medical institutions; high-speed analog-to-digital conversion circuitry and proprietary gating circuitry. The system is connected to the output connectors of conventional IVUS systems and the ECG system using typical cabling. The IVUS radiofrequency output is used directly by the Volcano IVUS System and the ECG output is used to gate or time the collection / recording of the IVUS signal.
The software that provides the user interface is Windows 2000 Professional. The Volcano IVUS System applications presently exist in two pieces. The first is the data acquisition package, IVUSLabRF. This application contains the drivers that control the Gage A/D converter card which digitizes the RF data from the IVUS console. It also manages the joining of the data from individual scans that constitute a "slice".
The second software program is called IVUSLabVH. This program analyzes each of the slices. These images are visually reviewed and the control points are manually adjusted until they appear in the proper location on the vessel inner and outer borders. Once all the control points have been properly located the software produces a set of data files called "snaxel" files which define the coordinates of the control points. The black and white IVUS files and the snaxel files are loaded into the IVUSLabVH software which processes the data to produce the five color bit mapped Volcano IVUS image files.
The system requires the use of a "phantom" to "normalize" the conventional IVUS output. The phantom is a small piece of acrylic material machined to allow placement over the IVUS catheter distal tip.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
peripheral and coronary vasculature
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
The Volcano IVUS System complies with IEC 60601-1 and IEC 60601-1-2 as verified by independent test facilities. The Volcano IVUS System also displays the UL mark. The Volcano IVUS System software was verified and validated per FDA guidance documents and the System passed internal tests per internal company procedures.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K042188 510(k) Notification Volcano VIJS
SECTION 8 - 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c)
K042188 The assigned 510(k) number is:
Name and Address of Applicant
Volcano Therapeutics, Inc. 2870 Kilgore Road Rancho Cordova, CA 95670 916-638-9404 phone 916-638-8112 facsimile
Primary Contact: Lorry Huffman lhuffman@volcanotherapeutics.com
| Preparation Date: | August 4, 2004/October 8, 2004 |
|---|---|
| Trade name: | Volcano IVUS System |
| Common names: | Ultrasound Pulsed Echo Imaging System |
| Picture Archiving and Communications Systems |
Predicate devices:
- K022824, TomTec Imaging Systems, GmbH, Cardio-View device .
- K001592, TomTec Imaging Systems, GmbH, EchoCom device t
Description of the new device:
The Volcano Therapeutics. Inc. Volcano IVUS System is a combination of proprietary hardware and software and a phantom normalization device.
The hardware portion consists of a high-speed computer, with monitor, specifically built for use in medical institutions; high-speed analog-to-digital conversion circuitry and proprietary gating circuitry. The system is connected to the output connectors of conventional IVUS systems and the ECG system using typical cabling. The IVUS radiofrequency output is used directly by the Volcano IVUS System and the ECG output is used to gate or time the collection / recording of the IVUS signal.
The software that provides the user interface is Windows 2000 Professional. The Volcano IVUS System applications presently exist in two pieces. The first is the data acquisition package, IVUSLabRF. This application contains the drivers that control the Gage A/D converter card which digitizes the RF data from the IVUS console. It also manages the joining of the data from individual scans that constitute a "slice".
The second software program is called IVUSLabVH. This program analyzes each of the slices. These images are visually reviewed and the control points are manually adjusted until they appear in the proper location on the vessel inner and outer borders. Once all the control points have been properly located the software produces a set of data files called "snaxel" files which define the coordinates of the control points. The black and white IVUS files and the snaxel files are loaded into the IVUSLabVH software which processes the data to produce the five color bit mapped Volcano IVUS image files.
The system requires the use of a "phantom" to "normalize" the conventional IVUS output. The phantom is a small piece of acrylic material machined to allow placement over the IVUS catheter distal tip.
1
Intended use / Indications for Use:
The Volcano Therapeutics. Inc. Volcano IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano 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.
Technological Characteristics and comparison to predicate devices:
The Volcano IVUS System has the same technological features and characteristics as the two listed predicate devices. Both of these devices are intended to be used as an adjunct to conventional angiographic and IVUS procedures. Both of these devices are used to evaluate features of the human heart and/or vasculature and visualize internal boundary features.
Semi-automatic border detection and color coding information are features that are found on predicate devices and the Volcano IVUS System.
Each of the technological characteristics found in the Volcano IVUS System is similar or identical to the specified predicate devices. As a result, Volcano Therapeutics, Inc. believes that the combination of the two commercially-available predicate devices supports the claim of substantial equivalence to the Volcano IVUS System consistent with the 510(k) requlatory paradigm.
Performance / test data:
The Volcano IVUS System complies with IEC 60601-1 and IEC 60601-1-2 as verified by independent test facilities. The Volcano IVUS System also displays the UL mark. The Volcano IVUS System software was verified and validated per FDA guidance documents and the System passed internal tests per internal company procedures.
Conclusions:
The Volcano IVUS System has the same intended use as the predicate devices. The Volcano IVUS system also includes similar or identical features and characteristics as the predicate devices. Additionally, testing and validation exercises have produced results consistent with design input requirements. Therefore, the Volcano IVUS system does not raise new questions of safety and effectiveness.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. In the center of the seal is a stylized symbol that resembles three curved lines stacked on top of each other. The symbol is black and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2004
Volcano Therapeutics, Inc. Ms Lorry Huffman Director, Regulatory Affairs and Quality Assurance 2870 Kilgore Road Rancho Cordova, CA 95671
Re: K042188 Trade Name: Volcano IVUS System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: II (two) Product Code: IYO Dated: August 10, 2004 Received: August 12, 2004
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.
3
Page 2 -- Ms Lorry Huffman
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 (301) 594-4646. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimmarfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Volcano Therapeutics, Inc.
SECTION 9 - INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K042188
Device Name: Volcano IVUS System
Indications for Use:
The Volcano Therapeutics, Inc. Volcano IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
==============================================================================================================================================================================
Prescription Use __________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.19) OR
Over-the-Counter Use
Blummenthal
(Division Sign-Off Division of Cardiova 510(k) Numl