(32 days)
The PreView® Forward-Looking IVUS System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.0 14" guidewire lumens. The Preview® Forward-Looking IVUS System is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures.
The PreView Forward-Looking IVUS System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.
The PreView® Forward-Looking IVUS System consists of the PreView® catheter, PIMf, FL.IVUS Software and Volcano s5TM System. The PreView® Catheter is a single use disposable device with a disposable single use motor for rotation of the catheter. The catheter is 135cm in length and connects to a PIM (Patient Interface Module; PIMf) which contains the electronics. The PIMf translates the echo data and sends it to the Volcano s5TM System for display on the system monitor.
The Volcano PreView® Forward-Looking IVUS System is largely a hardware-based device. No specific acceptance criteria or a dedicated study proving performance against such criteria are explicitly detailed in the provided documentation. The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through various technical verification and validation activities.
However, based on the information provided, we can infer how acceptance criteria are addressed:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no explicit quantitative acceptance criteria are given, the "reported device performance" section focuses on the completion of required tests to ensure the device functions as intended and is compatible with the existing Volcano s5TM System.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Software Verification and Validation | Tests concluded that the PreView® Forward-Looking IVUS System is substantially equivalent to the currently marketed predicate devices. |
| Packaging Validation FL.IVUS Modality Option | Tests concluded that the PreView® Forward-Looking IVUS System is substantially equivalent to the currently marketed predicate devices. |
| Verification of support for FL.IVUS modality operation on the s5™ System | Tests concluded that the PreView® Forward-Looking IVUS System is substantially equivalent to the currently marketed predicate devices. |
| Electrical Safety Test | Tests concluded that the PreView® Forward-Looking IVUS System is substantially equivalent to the currently marketed predicate devices. |
| Electromagnetic Compatibility test | Tests concluded that the PreView® Forward-Looking IVUS System is substantially equivalent to the currently marketed predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify sample sizes for any test sets in the context of clinical or image-based performance evaluation. The listed tests (Software V&V, Packaging, Electrical Safety, EMC) are typically engineering validation tests that don't involve clinical "test sets" in the same way an AI algorithm would. Data provenance (country of origin, retrospective/prospective) is also not applicable or provided for these types of engineering tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided as the submission focuses on engineering and system compatibility, not on a clinical performance study requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable given the nature of the validation tests mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The device's validation focuses on its technical functionality and compatibility with the existing system, not on a comparative study of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is not an AI algorithm. It is a medical imaging system. Therefore, a "standalone algorithm performance" study is not applicable. The device's primary function is to provide images for human interpretation.
7. The Type of Ground Truth Used:
For the engineering validation tests conducted (Software V&V, Packaging, Electrical Safety, EMC), ground truth is established through:
- Engineering specifications and standards: Compliance with established industry standards for electrical safety, EMC, and software quality.
- Functional requirements: Verification that the hardware and software components perform their designed functions correctly.
There is no mention of expert consensus, pathology, or outcomes data used as ground truth in this context, as these are not relevant to the types of tests reported.
8. The Sample Size for the Training Set:
This information is not applicable as the device is not an AI/machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not an AI/machine learning system.
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| SPONSOR: | Volcano Corporation2870 Kilgore Road.Rancho Cordova, CA 95670 |
|---|---|
| CONTACT/SUBMITTER: | Marcus GarciaRegulatory Affairs SpecialistVolcano Corporation1 Fortune DriveBillerica, MA 01821Tel: (978) 439-3312Fax: (978) 262-0035 |
| SEP 27 2013 | |
| DATE OF SUBMISSION: | August 23, 2013 |
| DEVICE: | Volcano PreView® Forward-Looking IVUS System |
| Trade Name: | Volcano PreView® Forward-Looking IVUS System |
| Common Name: | Ultrasound Catheter/Catheter, Ultrasound, Intravascular;Percutaneous Catheter |
| Classification: | 870.1250 Percutaneous Catheter, II, DQY870.1200 Diagnostic Intravascular Catheter, II, OBJ |
| PREDICATE DEVICE: | PreView® Forward-Looking IVUS Catheter and LaptopSystem (K122826)Volcano s5TM/s5i Intravascular Ultrasound Imaging andPressure System (K123898) |
| DEVICE DESCRIPTION: | The PreView® Forward-Looking IVUS System consists ofthe PreView® catheter, PIMf, FL.IVUS Software andVolcano s5TM System. The PreView® Catheter is a singleuse disposable device with a disposable single use motorfor rotation of the catheter. The catheter is 135cm in lengtand connects to a PIM (Patient Interface Module; PIMf)which contains the electronics. The PIMf translates theecho data and sends it to the Volcano s5TM System fordisplay on the system monitor. |
| INTENDED USE: | The PreView® Forward-Looking IVUS System isindicated for use to facilitate the intraluminal placement of |
510(k) SUMMARY
The 510(k) Summary is submitted as required by section 807.92(a)
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guidewires in the peripheral vasculature prior to further percutaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices. The PreView® Forward- Looking IVUS System is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures.
The PreView® Forward-Looking IVUS System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.
The proposed device is substantially equivalent to currently marketed devices. The devices are ultrasonic pulsed echo imaging systems that consist of catheters. patient interface modules, software and system computers that allow the user to generate images of coronary arteries or peripheral vasculature. They share the same intended use, same design characteristics, and the same fundamental scientific technology.
Applicable testing was performed as required by the Ouality System to evaluate the modifications necessary for the FL.IVUS imaging modality to be compatible with Volcano s5TM System. The following tests were conducted:
- Software Verification and Validation ●
- o Packaging Validation FL.IVUS Modality Option
- . Verification of support for FL.IVUS modality operation on the s5™ System
- Electrical Safety Test .
- Electromagnetic Compatibility test o
Completion of these tests concluded that the PreView® Forward-Looking IVUS System is substantially equivalent to the currently marketed predicate devices.
COMPARISON OF CHARACTERISTICS:
PERFORMANCE DATA:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Image /page/2/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with three flowing lines representing the body and head. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.
September 27, 2013
Volcano Corporation Marcus Garcia 1 Fortune Drive Billerica, MA 01821 US
Re: K132659 Trade/Device Name: Volcano Preview Forward-Looking IVUS System Regulation Number: 21 CFR 870.1250 Regulation Name: Ultrasound Catheter, Ultrasound, Intravascular, Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, OBJ Dated: August 29, 2013 Received: August 30, 2013
Dear Marcus Garcia:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2 - Marcus Garcia
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen-P.Faris -S
for 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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K132659
Indications for Use Statement
510(k) Number (if known)
Page I of I
Device Name: Volcano PreView® FL.IVUS System
Indications for Use: The PreView® Forward-Looking IVUS System is indicated for use to facilitate the intraluminal placement of guidewires in the peripheral vasculature prior to further perculaneous intervention and to support guidewires in accessing discrete regions of the peripheral vasculature, to assess vessel morphology, assess the position of the catheter tip within the vessel lumen, and to facilitate placement and exchanges of guidewires and other interventional devices compatible with 0.0 14" guidewire lumens. The Preview® Forward-Looking IVUS System is designed as an adjunct to conventional angiographic procedures to provide a forward-looking image of the vessel lumen and wall structures.
The PreView Forward-Looking IVUS System is not indicated for use for imaging with the exposed rotating tip inside a stent. This device is not indicated for use in coronary or cerebral vessels.
Prescription Use OR Over the Counter Use × (Per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Digitally signed by
Owen P. Faris -S
Date: 2013.09.27
15:28:02-04'00'
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).