The Visions PV .035 catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels.

The Visions PV .035 ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

Device Description

The Visions PV .035 Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The Visions PV .035 Catheter is introduced percutaneously or via surgical cutdown into the vascular system, and is designed to track over 0.035"-0.038" (0.89-0.97mm) guide wires.

The catheter body has markers 1 cm apart along the working length. There are 25 radiopaque (RO) markers on the distal end of the catheter, starting 1 cm from the imaging plane, with the 25th RO marker overlapping the distal-most wide inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle, with wider marks indicating 5 cm intervals.

A lubricious GlyDx® hydrophilic coating is applied externally to a distal portion of the catheter. The Visions® PV .035 Catheter, catalog number 88901, catheters may only be used with the In-Vision Imaging System, Volcano s5™ or Volcano s5i™ imaging systems, or later systems. This catheter will not operate if connected to any other imaging system.

AI/ML Overview

The provided text describes a 510(k) submission for the Volcano Visions® PV .035 Digital IVUS Catheter. This is a premarket notification for a medical device redesign, aiming to demonstrate substantial equivalence to a legally marketed predicate device. As such, the document does not contain a study designed to prove the device meets acceptance criteria in the way a clinical trial or performance study would.

Instead, the submission focuses on demonstrating that the redesigned device is as safe and effective as the predicate device by comparing their intended use, principles of operation, and design elements, and ensuring that design changes do not negatively impact performance. The "acceptance criteria" here are implicitly related to maintaining the performance and safety standards established by the predicate device and relevant regulations.

Here's an analysis based on the provided text, highlighting what is included and what is not typically part of a 510(k) submission for a device modification of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of "acceptance criteria" for clinical performance with corresponding "reported device performance" in the context of a new efficacy study. The device is a diagnostic imaging catheter, and its performance is judged against its ability to display vascular morphology and provide dimensional measurements, similar to its predicate.

The main "performance" data presented is the Acoustic Output Reporting Table for Track 3 (Page 4). This table details physical acoustic parameters of the transducer, which are critical safety and performance characteristics for ultrasound devices.

Index Label	Acceptance Criteria (Implied by Regulatory Standards)	Reported Device Performance
Maximum index value (MI)	Within regulatory limits for diagnostic ultrasound.	0.0162 (Very low, well within typical safety limits for MI < 1.3)
pr.3 (MPa)	Not explicitly stated, but within safe operating range.	0.0482
W0 (mW)	Not explicitly stated, but within safe operating range.	2.89E-3
fc (MHz)	Consistent with diagnostic imaging requirements.	9.00 MHz
PD (µsec)	Consistent with diagnostic imaging requirements.	0.333 µsec
PRF (Hz)	Consistent with diagnostic imaging requirements.	2.09E+4 Hz
IPA.3 @ MImax (W/cm²)	Not explicitly stated, but within safe operating range.	0.0680 W/cm²

The implied acceptance criteria for these acoustic outputs are that they fall within the established safety guidelines for diagnostic ultrasound devices (e.g., MI < 1.3, TI < 1.0 for non-ophthalmic use as per FDA guidance). The reported values (e.g., MI of 0.0162) are extremely low, indicating a very safe acoustic profile.

Other "acceptance criteria" would relate to mechanical properties, biocompatibility, sterilization, and shelf life, which are mentioned as having been "performed/will be performed" to prove the materials and manufacturing processes are safe. Specific numerical acceptance criteria for these tests are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical "test set" with a specific sample size. As a 510(k) for a device redesign primarily focused on changes to the catheter body and materials, the submission relies on non-clinical testing (e.g., biocompatibility, mechanical durability, acoustic output measurements, sterilization validation).

Therefore, there is no human patient data test set or provenance described in this submission summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Since there is no clinical "test set" or ground truth based on patient data, there are no medical experts (e.g., radiologists) involved in establishing ground truth for such a study in this document. The "experts" involved would be engineers and scientists performing the non-clinical tests and regulatory specialists ensuring compliance.

4. Adjudication Method for the Test Set

Not applicable, as there is no clinical "test set" or human review of images that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study would compare human reader performance with and without AI assistance for tasks like image interpretation. The Visions® PV .035 Digital IVUS Catheter is a diagnostic imaging device (hardware), not an AI-based image analysis software.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is an imaging catheter that provides raw image data. It does not contain a standalone algorithm for automated analysis without human input.

7. The Type of Ground Truth Used

For the safety and performance aspects reported, the "ground truth" is derived from:

Physical measurements: Acoustic output parameters (MI, pr.3, W0, fc, etc.) are measured using standardized test methods and equipment.
Material specifications: Biocompatibility testing assesses material safety against established standards.
Mechanical and electrical engineering tests: To ensure the catheter's structural integrity, tracking capability, and electrical safety.
Sterilization and packaging validation: To confirm the device remains sterile and functional over its shelf life.

There is no pathology, expert consensus on patient images, or outcomes data used as ground truth in this particular 510(k) summary for a redesign. The primary "ground truth" for the device's overall safety and effectiveness is its substantial equivalence to the predicate device, which has already demonstrated safety and effectiveness in the market.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm.

Summary

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Volcano Corporation April 26, 2012

Visions® PV .035 Digital IVUS Catheter Abbreviated 510(k)

Section 2: 510(k) Summary

Submitter Name:	Volcano Corporation
Address:	3661 Valley Centre Dr.San Diego, CA 92130
Contact:	Marilyn PourazarSenior Director of Regulatory Affairs
Phone:	(858) 720-4116
Fax:E-mail:	(858) 720-0612mpourazar@volcanocorp.com
Date Prepared:	April 26, 2012
Device Trade Name:	Vision® PV .035 Digital IVUS Catheter
Device Common Name:	Ultrasonic Imaging Catheter
Classification Name:	Diagnostic Intravascular Catheter, 870.1200 - Class IIDiagnostic Ultrasound Transducer, 892.1570 - Class II
Classification Code:	IYN: Ultrasonic Imaging Catheter, Intravascular UltrasonicImaging SystemITX: Transducer, Ultrasonic, Diagnostic, Intravascular UltrasonicImaging System
Predicate Devices:	Volcano Visions PV 8.2 PV IVUS Imaging Catheter,510(k) Number K071660 Classification Code: OBI, ITX

Device Description :

The Visions PV .035 Catheter is introduced percutaneously or via surgical cutdown into the vascular system, and is designed to track over 0.035"-0.038" (0.89-0.97mm) guide wires.

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Volcano Corporation April 26, 2012

continue along the shaft, spaced 1 cm apart, middle, with wider marks indicating 5 cm intervals.

Intended Use:

The Visions PV .035 catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels.

Device Design Requirements:

Biocompatibility, shelf life, sterilization, packaging integrity, safety, and design verification testing have been/will be performed to prove that the materials and manufacturing processes selected for the catheter shaft and body of the Visions® PV .035 Catheter do not pose a significant safety risk to the patient.

Substantial Equivalence Discussion:

The Visions® PV .035 Digital IVUS Catheter is substantially equivalent to the predicate device in intended use and principles of operation. Predicate device information is below:

Predicate DeviceName	Model Number(s)	510(k) Number	Clearance Date
Volcano Visions PV8.2 PV IVUS ImagingCatheter	88900	K07166	8/31/2007

The Visions® PV .035 Catheter uses the same fundamental scientific technologies and has the same intended use as that of the predicate device, the Volcano Visions PV 8.2 PV IVUS Imaging Catheter. It is an Over-the-Wire catheter design as is the Volcano Visions PV 8.2 PV IVUS Imaging Catheter Model 88900.

The Visions® PV .035 Digital IVUS Catheter is a redesign of the catheter body elements of the Volcano Visions PV 8.2 PV IVUS Imaging Catheter. The significant design changes are:

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Volcano Corporation April 26, 2012

Predicate Device (PV 8.2)	Subject Device (PV.035)	Comparison
Proximal Shaft (0.092" to0.108" OD)	Proximal Shaft (0.092" to 0.108"OD)	PV.035 is a 72D Pebaxbased single lumen designwith the same OD. PV 8.2is a multi-lumen HDPEdesign that incorporatesthe inner lumen.
Inner Lumen (0.043" ID)	Inner Lumen (0.043" x 0.048")	PV.035 and PV8.2 havethe same ID and HDPEinterface. PV.035 utilizesan independent innerlumen with a pebax outerlayer, where PV8.2 is amulti-lumen shaft design.
Connector Assembly	Connector Assembly	PV.035 is identical indesign except that it addsan extra 20cm to theconnector length utilizingexcess microcablecurrently in the design.
Tip	Tip	PV.035 tip is slightlysmaller OD and changesmaterials to a flexible 63Dand 55D Pebax. PV 8.2uses an HDPE blend. Theinner lumen is unchanged.
ESL tubing over proximalscanner seal	Adhesive over proximal scannerseal	PV035 uses the samematerial for the proximalseal as used on the distalseal, PV8.2 uses anexpanded and shrunk PEmaterial instead ofadhesive.
RO Marker	Inked and RO markers	PV 8.2 uses a PT/IRmarker on the tip but hasno other marks on thecatheter. PV.035 adds 25RO markers on the distalinner member and theninked markers along theremaining inner lumen upto the y-arm. Theproximal shaft is clear sothe inked markers can bevisualized.

Packaging materials and methods for the Visions® PV .035 Catheter will remain unchanged from that of the predicate device at the time of release pending 510(k) approval. Sterility, EO residuals, Bioburden, LAL, and package integrity testing will be completed to ensure that the

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Volcano Corporation April 26, 2012

Visions® PV .035 Digital IVUS Catheter Abbreviated 510(k)

changes to the catheter body shape and materials do not have a negative impact on the packaged device. The shelf life of the Visions® PV 8.2 PV IVUS Imaging Catheter will be based upon the data available at the time of product release. The shelf life test plan has been written to include time points up to two years.

The Predicate Device Comparison Tables are contained in the Substantial Equivalence Discussion in Section 9 of this filing. The predicate comparison table and the supporting information provided in this 510(k) are sufficient to demonstrate that the Visions® PV .035 Digital IVUS Catheter is as safe and effective as the legally marked predicate device.

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Report No. 744 18 of 50

Acoustic Output Reporting Table for Track 3

Transducer Model:

PV .035 IVUS catheter

Operating Mode:

B-Mode

Index Label	MI	Scan	TIS		TIB	TIC
			Non-scanAaprt≤1 cm2	Non-scanAaprt>1 cm2	Non-scan
Maximum index value	0.0162	6.18E-5	-	-	-	#
pr.3 (MPa)	0.0482		-	-	-	#
W0 (mW)		2.89E-3	-	-	-	#
min of [W.3(z1), ITA,3(z1)] (mW)			-	-	-
Associatedacousticparameter	z1 (cm)			-	-	-
	zbp (cm)			-	-	-
	zsp (cm)	0.0850		-	-	-
	deq(zsp) (cm)			-	-	-
	fc (MHz)	9.00	9.00	-	-	-	#
	Dim of Aaprt X (cm)		0.0160	-	-	-	#
	Y (cm)		0.150	-	-	-	#
	PD (µsec)	0.333		-	-	-
OtherInformation	PRF (Hz)		2.09E+4	-	-	-
	pr@ PIImax (MPa)	0.0495		-	-	-
	deq @ PIImax (cm)			-	-	-
	FocalLength FLx (cm)		N/A*	-	-	-
	FLy (cm)		N/A*	-	-	-
	IPA.3 @ MImax (W/cm²)	0.0680		-	-	-
	Image Rate: 11.673 HzTransmits/sector: 1792Angle: 360 degreesSector offset: 1.27 mmW01 Factor: 0.5
Note 1: Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode.
Note 2: Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses.
Note 3: Information on MI and TI need not be provided if the equipment meets both the exemption clauses given in 51.2 aa) and 51.2 dd).
(a) Intended use does not include cephalic so TIC is not computed
# No data reported.
* Device is not focused

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

SEP 10 2012

Volcano Corporation c/o Ms. Marilyn Pourazar Sr. Director, Regulatory Affairs 3661 Valley Centre Drive Suite 200 San Diego, CA 92130

Re: K121273

Trade Name: Visions PV .035 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Codes: OBJ Dated: August 28, 2012 Received: August 29, 2012

Dear Ms. Pourazar:

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.

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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

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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510(k) Number (if known):

Visions® PV .035 Digital IVUS Catheter Device Name:

Indications for Use:

The Visions PV .035 catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K121273 Page 1 of 1

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).