(90 days)
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.
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.
The provided 510(k) summary for the Volcano IVUS System (K042188) does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the way typically expected for an AI/ML device.
Instead, this submission primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with general quality and safety standards.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will explain why each section cannot be populated directly and provide what information is available.
1. Table of Acceptance Criteria and Reported Device Performance
Information within the document: The document states, "Additionally, testing and validation exercises have produced results consistent with design input requirements." However, the design input requirements themselves, which would define the acceptance criteria and specific performance metrics, are not disclosed in this summary. No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, dice coefficient, etc.) are reported for features like semi-automatic boundary visualization or spectral analysis.
| Acceptance Criteria (e.g., minimum sensitivity, detection rate, image quality metrics) | Reported Device Performance (with specific numerical values) |
|---|---|
| Not specified in the document. | Not specified in the document. |
2. Sample Size Used for the Test Set and Data Provenance
Information within the document: The document mentions "testing and validation exercises," but it does not specify any sample size for a test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature).
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Information within the document: The summary does not mention any expert-led ground truth establishment process for the performance testing. The "semi-automatic border detection" description implies user interaction ("control points are manually adjusted"), but this is part of the device's operational workflow, not necessarily a ground truth adjudication process for performance evaluation.
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
Information within the document: As no specific test set and ground truth establishment is described, an adjudication method is also not mentioned.
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Information within the document: There is no indication that an MRMC comparative effectiveness study was conducted or reported in this 510(k) summary. The focus is on demonstrating substantial equivalence to predicate devices, not on quantifying human performance improvement with or without AI assistance.
- MRMC Study Conducted: No.
- Effect Size (human readers with/without AI): Not applicable, as no such study was reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Information within the document: The device description clearly states, "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." This indicates it is a "semi-automatic" system, meaning it requires human-in-the-loop interaction for its primary function of boundary detection. Therefore, a standalone (algorithm only) performance would not be representative of its intended use and is not reported.
- Standalone Performance Study: Not reported, and the device's nature suggests it's designed for human-in-the-loop operation.
7. The Type of Ground Truth Used
Information within the document: The summary does not specify the type of ground truth used for performance evaluation. Given the context of IVUS imaging, potential ground truth types could include expert consensus on images, comparison to other imaging modalities or histology (though less common for real-time IVUS validation in this context). However, none are explicitly stated. The "manual adjustment of control points" refers to the user interaction with the device, not the ground truth for an independent test.
- Type of Ground Truth: Not specified.
8. The Sample Size for the Training Set
Information within the document: The document does not mention any training set or its sample size. This 510(k) submission predates the common requirements for detailed AI/ML model training data specifics.
- Sample Size for Training Set: Not specified.
9. How the Ground Truth for the Training Set Was Established
Information within the document: As no training set is mentioned (see point 8), the method for establishing its ground truth is also not described.
- How Ground Truth for Training Set Was Established: Not specified.
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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 SystemPicture 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.
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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.
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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.
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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
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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)
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Prescription Use __________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.19) OR
Over-the-Counter Use
Blummenthal
(Division Sign-Off Division of Cardiova 510(k) Numl
§ 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.