The Visions® PV.014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in the cerebral vessels.

The Visions® PV.014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Device Description

The PV . 014P RX Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the Catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.

The term RX has been added to the PV.014P Catheter to identify it as a rapid exchange catheter. The rapid exchange feature has not changed from the currently marketed PV.014P Catheter. Volcano is adding the term RX to the name to clearly identify the catheter as rapid exchange.

The PV . 014P RX Catheter utilizes an internal lumen that allows the catheter to track over a 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the Catheter tip. The device is introduced either percutaneously or via surgical cut down into the vascular system.

The PV . 014P RX Catheter may be used with the Volcano s5™. Volcano CORE Mobile, and Volcano CORE imaging systems. The device is designed to work with Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.

The modified PV.014P Catheter (PV.014P RX) has a stiffer core to help improve device deliverability. The stiffer core wire provides increased "pushability" while maintaining the same trackability as the currently marketed PV.014P Catheter. In order to increase "pushability", the size of the core within the proximal shaft of the catheter was made with a larger OD. The proximal end was increased while keeping the distal end diameter the same. The modified PV.014P Catheter (PV.014P RX) with stiffer core utilizes the same current manufacturing processes, equipment and materials as the currently marketed device.

AI/ML Overview

The provided document is a 510(k) summary for the Volcano Visions® PV.014P RX Digital IVUS Catheter. This device is an intravascular ultrasound (IVUS) catheter, which is a diagnostic tool used to visualize the internal structure of blood vessels.

The 510(k) in question is for a modification to an existing device (Visions® PV.014P Catheter) specifically, "The modified PV.014P Catheter (PV.014P RX) has a stiffer core to help improve device deliverability." Therefore, the "study" described is primarily focused on demonstrating that this modification does not negatively impact the safety or effectiveness of the device compared to the predicate device, rather than proving the device meets novel acceptance criteria for a new type of device.

Given this context, some of the requested information (like expert consensus for ground truth on images, MRMC studies, or training set details for an AI algorithm) are not applicable to this type of device modification submission. The "acceptance criteria" here are largely related to bench testing performance to ensure functional equivalence and safety.

Here's the breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing to ensure the modified device is substantially equivalent to the predicate. The "acceptance criteria" are implied by the successful completion of these tests and demonstrating no statistically significant difference or acceptable performance compared to known standards or product specifications.

Acceptance Criterion (Implied)	Reported Device Performance
Cross and Re-Cross Force (No statistically significant difference from predicate)	"The results demonstrated that there is no statistically significant difference between the subject device and control device for Cross/Re-Cross..."
Insertion and Recovery (Trackability) Force (No statistically significant difference from predicate)	"... and Insertion/Recovery (Trackability)."
Buckling (Acceptable rigidity)	"The results demonstrated acceptable rigidity of the catheter." (Conducted in accordance with FDA's Guidance Document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers")
Signal Processing / Image Quality (No change in imaging)	"The results demonstrated that the change did not affect imaging." (Quantitative and qualitative image assessment performed).

2. Sample Size and Data Provenance

Sample size used for the test set: Not explicitly stated for each test (Cross/Re-Cross, Insertion/Recovery, Buckling, Signal Processing). The language "The results demonstrated..." suggests sufficient testing was performed, but specific numbers are not provided in this summary.
Data Provenance: The tests are non-clinical bench tests. The data is generated internally by the manufacturer (Volcano Corporation) in a controlled laboratory environment. The country of origin of the data is implied to be the US, where Volcano Corporation is based. The data is prospective, generated specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

Number of experts: Not applicable. For this type of device modification, the ground truth is established through physical measurements and comparisons against engineering specifications and the predicate device's performance, not human expert consensus on images.
Qualifications of experts: Not applicable in the context of image interpretation. The "experts" would be the engineers and quality control personnel performing the bench tests.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable. This is not a study involving subjective human interpretation that would require an adjudication process. It's a series of objective physical and performance measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

MRMC study: No, an MRMC comparative effectiveness study was not conducted. This is not an AI-assisted diagnostic device where human reader performance is being evaluated. The device is purely a diagnostic imaging catheter whose modification impacts physical properties (stiffness, deliverability), not directly human diagnostic accuracy.

6. Standalone (Algorithm Only) Performance

Standalone performance: Not applicable. This is not a software algorithm, but a physical medical device. The "performance data" refers to its mechanical and imaging capabilities.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this submission is based on:
- Engineering specifications and standards: e.g., acceptable rigidity for buckling according to FDA guidance.
- Bench test measurements: Direct quantitative measurements of forces, dimensions, and image characteristics.
- Comparison to predicate device: The key "ground truth" is that the modified device's performance metrics are either statistically equivalent to the predicate or meet established safety thresholds.

8. Sample Size for the Training Set

Training set size: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How Ground Truth for the Training Set was Established

Ground truth for training set: Not applicable (as above).

Summary

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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

November 19, 2015

Volcano Corporation Mary Stanners Regulatory Affairs Specialist 3721 Valley Centre Drive, Suite 500 San Diego, California 92130

Re: K152829

Trade/Device Name: Visions PV.014P RX Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: November 3, 2015 Received: November 4, 2015

Dear Mary Stanners:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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 Industry and Consumer Education 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.

Sincerely yours,

Mitchell Stein

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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Indications for Use

510(k) Number (if known) K152829

Device Name Visions® PV.014P RX Digital IVUS Catheter

Indications for Use (Describe)

The Visions® PV.014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY

SPONSOR:	Volcano Corporation3721 Valley Centre Drive, Suite 500San Diego, CA 92130
CONTACT/SUBMITTER:	Mary StannersRegulatory Affairs SpecialistVolcano Corporation3721 Valley Centre Drive, Suite 500San Diego, CA 92130Tel: (858) 764-1296mstanners@volcanocorp.com
DATE OF SUBMISSION:	November 16, 2015
DEVICE:
Trade Name:	Visions® PV.014P RX Digital IVUS Catheter
Common Name:	Diagnostic Intravascular CatheterDiagnostic Ultrasound Transducer

Classification and Product Codes:

CFR Number	Class	Product Code
21 CFR 870.1200 Diagnostic Intravascular Catheter	II	OBJ
21 CFR 892.1570 Diagnostic Ultrasound Transducer	II	ITX

PREDICATE DEVICE:

Trade Name:	K143701-Eagle Eye Platinum Catheter (EEP), Eagle EyePlatinum Short Tip (EEP-ST), Visions® PV.014 Platinum(PV.014P)
Common Name:	Diagnostic Intravascular Catheter

Diagnostic Intravascular Catheler
Diagnostic Ultrasound Transducer

Classification and Product Codes:

CFR Number	Class	Product Code
21 CFR 870.1200 Diagnostic Intravascular Catheter	II	OBJ
21 CFR 892.1570 Diagnostic Ultrasound Transducer	II	ITX

Special 510(k): Modification of the Volcano PV.014P RX Catheter

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DEVICE DESCRIPTION:

The modified PV.014P Catheter (PV.014P RX) has the same intended use, same fundamental scientific technologies and the indications for use are identical to the currently marketed PV.014P . The modified PV.014P Catheter (PV.014P RX) was tested and verified. The modified PV.014P Catheter (PV.014P RX) does not raise any new questions of safety or effectiveness and the modified device is substantially equivalent to the currently marketed PV.014P Catheter. Therefore, Volcano concludes that the modification is substantially equivalent to the currently marketed PV.014P Catheter.

INDICATIONS FOR USE:

The Indications For Use remain the same and is as follows:

The Visions® PV.014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

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COMPARISON OF TECHNOLOGICAL CHARACTERISICS:

The modification made to the PV.014P Catheter does not affect the intended use of the device or technologies and it does not alter the fundamental scientific technologies. The indications for use are identical to those of the currently marketed device. The modified catheter is substantially equivalent to currently marketed device.

PERFORMANCE DATA:

Non-clinical device testing was conducted to confirm the performance of the modified device. Bench testing was conducted against known standards or product specification and evaluated the follow ing:

Cross and Re-Cross ●
. Insertion and Recovery (Trackability)
Buckling. ●
Signal Processing

Cross/Re-Cross and Insertion/Recovery tests measured the force required to advance and retract the catheter. Cross/Re-Cross utilizes a simulated lesion through a tortuous block. Insertion/Recovery testing was completed without a simulated lesion to demonstrate the ability of the catheter to move through the vasculature. The results demonstrated that there is no statistically significant difference between the subject device and control device for Cross/Re-Cross and Insertion/Recovery (Trackability).

Buckling was conducted in accordance with FDA's Guidance Document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" which recommends mechanical testing to include buckling is a measure of the rigidity of the catheter. The results demonstrated acceptable rigidity of the catheter.

Signal processing provided a quantitative and qualitative image assessment. The results demonstrated that the change did not affect imaging.

All bench testing was successfully completed. The successful completion of performance testing concluded that the modified PV.014P Catheter (PV.014P RX) is substantially equivalent to the currently marketed PV.014P Catheter.

For this change (core wire diameter change from 0.016"), the Standards as described in Attachment F FDA 3654 forms of submission) used were the following:

BS EN ISO 13485:2012	Medical Devices Quality Management System Requirements forRegulatory Purposes
ISO 14971:2012	Medical Devices - Application of Risk Management to MedicalDevices

Regulation Number and Section

§ 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).