The Visions® PV .018 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 cerebral vessels.

The Visions® PV .018 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 Visions® PV .018 Digital IVUS 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 Visions® PV .018 catheter utilizes an internal lumen that allows the catheters to track over a 0.018" (0.46 mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The PV .018 catheters are introduced either percutaneously or via surgical cut down into the vascular system.

The Visions® PV .018 catheter may only be used with Volcano imaging systems, such as the Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheter will not operate if connected to any other imaging system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Volcano Visions PV .018 Digital IVUS Catheter. This is a medical device submission, and the focus of the performance data is on demonstrating substantial equivalence to a predicate device, rather than proving a new diagnostic algorithm meets specific acceptance criteria based on human performance. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not directly applicable or available in this type of document.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document states that "All bench testing was successfully completed and met the pre-determined acceptance criteria." However, the specific quantitative acceptance criteria and detailed reported performance values for each test are not provided in this summary. The document only lists the categories of tests performed.

Test Category	Acceptance Criteria (Not Detailed)	Reported Device Performance
Shelf Life	Met pre-determined specifications	Successfully completed
Floppy Tip Tensile Testing	Met pre-determined specifications	Successfully completed
ESL Tensile Testing	Met pre-determined specifications	Successfully completed
Signal Processing	Met pre-determined specifications	Successfully completed
Biocompatibility:		Successfully completed for all listed tests
- Cytotoxicity	Met pre-determined specifications	Passed
- Sensitization	Met pre-determined specifications	Passed
- Intracutaneous Reactivity	Met pre-determined specifications	Passed
- Systemic Toxicity	Met pre-determined specifications	Passed
- Pyrogenicity	Met pre-determined specifications	Passed
- ASTM Hemolysis	Met pre-determined specifications	Passed
- Partial Thromboplastin Time	Met pre-determined specifications	Passed
- In vivo Thromboresistance	Met pre-determined specifications	Passed
- C3a Complement Activation	Met pre-determined specifications	Passed
- SC5-b Complement Activation	Met pre-determined specifications	Passed
- Bacterial Endotoxins (LAL)	Met pre-determined specifications	Passed
- LEAP Latex Elisa for Antigenic Protein	Met pre-determined specifications	Passed
- Platelet and Leukocyte Counts	Met pre-determined specifications	Passed
- Chemical Characterization	Met pre-determined specifications	Passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-clinical device testing" and "Bench testing" and "Biocompatibility testing." These refer to laboratory tests on the device itself, not clinical data from patients. Therefore, terms like "sample size for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this submission focused on device modifications and substantial equivalence through bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "test set" here refers to the device itself under various laboratory conditions (e.g., tensile strength, signal processing, biocompatibility assays), not a diagnostic algorithm or image analysis requiring expert interpretation or ground truth establishment in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no clinical "test set" requiring human adjudication mentioned in the document. The testing described is non-clinical bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an Intravascular Ultrasound (IVUS) Catheter, not an AI-powered diagnostic system. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable in the clinical sense. For the non-clinical tests, the "ground truth" would be established by validated measurement methods and a comparison to predetermined engineering and biocompatibility specifications. For example, a tensile strength test would have a "ground truth" based on the material's known properties and established engineering standards.

8. The sample size for the training set

This is not applicable. This document describes a physical medical device. There is no mention of a "training set" as it would pertain to an AI algorithm.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set for an AI algorithm mentioned, the establishment of ground truth for such a set is irrelevant to this submission.

Summary of the Device and Submission Context:

The Volcano Visions® PV .018 Digital IVUS Catheter is designed for evaluating vascular morphology. The 510(k) submission (K150442) relates to modifications made to an existing predicate device (Visions F/X Model 82700). The performance data provided is entirely non-clinical, focusing on bench testing to confirm the physical and functional integrity of the modified device and biocompatibility testing to ensure its safety for human contact. The key assertion is that these modifications do not alter the intended use or fundamental scientific technologies, and the device remains substantially equivalent to the predicate. The document does not contain information about algorithmic performance, clinical study results with human readers, or patient-level ground truth data, as these are typically not required for this type of 510(k) clearance based on substantial equivalence to an existing device after minor modifications.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that form the shape of a head and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 4, 2015

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

Re: K150442

Trade/Device Name: Volcano Visions PV .018 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: May 22, 2015 Received: May 26, 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 of medical device

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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.

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) K150442

Device Name

Visions ® PV.018 Digital IVUS Catheter

Indications for Use (Describe)

The Visions® PV .018 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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Volcano Corpora 3721 Valley Centre Drive San Diego, California 92130 www.volcanocorp.com

510(K) SUMMARY

SPONSOR:	Volcano Corporation3721 Valley Centre Drive, Suite 500San Diego, CA 92130
CONTACT/SUBMITTER:	Mary StannersRegulatory Affairs SpecialistVolcano Corporation3721 Valley Centre DriveSan Diego, California 92130Tel: (858) 764-1296
DATE OF SUBMISSION:	August 31, 2015
DEVICE:	Volcano Visions® PV .018 Digital IVUS Catheter
Trade Name:	Volcano Visions® PV .018 Digital IVUS Catheter
Common Name:	Diagnostic Intravascular Catheter

Classification and Product Codes:

CFR Number	Class	Product Code
21 CFR 870.1200 DiagnosticIntravascular Catheter	II	OBJ
21 CFR 892.1570 DiagnosticUltrasound Transducer	II	ITX

PANEL:

Cardiovascular

PREDICATE DEVICE: Visions F/X Model 82700 (K944004)

DEVICE DESCRIPTION:

The Visions® PV .018 Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the

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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.

INDICATIONS FOR USE:

The Visions® PV .018 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 crosssectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The Visions® PV .018 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISICS:

The modifications made to the Visions® PV .018 Digital IVUS Catheter (changes in catheter material, catheter scanner assembly and catheter connector assembly) do not affect the intended use of the device or technologies included as part of the device and they do not alter the fundamental scientific technologies. The indications for use are identical to those of the currently marketed predicate device (Visions F/X Model 82700; cleared under K944004). The modified catheter is substantially equivalently to currently marketed predicate device.

PERFORMANCE DATA:

Non-clinical device testing was conducted to confirm the performance of the modified device. Bench testing was conducted against product specification and evaluated the following:

Shelf Life
Floppy Tip Tensile Testing ●
. ESL Tensile Testing
. Signal Processing

All bench testing was successfully completed and met the pre-determined acceptance criteria. The successful completion of performance testing concluded that the modified Visions® PV .018 catheter is substantially equivalent to the currently marketed Visions F/X (Model 82700) catheter.

Biocompatibility testing was conducted on the device and the following tests were successfully completed:

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Cytotoxicity
Sensitization
Intracutaneous Reactivity
. Systemic Toxicity
Pyrogenicity
ASTM Hemolysis
Partial Thromboplastin Time
In vivo Thromboresistance
. C3a Complement Activation
SC5-b Complement Activation
Bacterial Endotoxins (LAL)
LEAP Latex Elisa for Antigenic Protein
Platelet and Leukocyte Counts •
Chemical Characterization .

The successful completion of performance testing and biocompatibility testing concluded that the modified Visions® PV .018 catheter is substantially equivalent to the currently marketed Visions F/X (Model 82700) catheter.

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).