The Verrata PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to guide the positioning of a balloon dilatation cather interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Device Description

The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.

AI/ML Overview

The provided document does not contain all the requested information for acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary for the Verrata PLUS Pressure Guide Wire and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a clinical study with specific acceptance criteria and detailed performance statistics.

Here is the information that can be extracted or inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All device acceptance criteria were met" and that the device "meets its intended use." However, it does not provide a specific table of quantitative acceptance criteria values or the corresponding reported device performance values. It lists types of performance testing completed.

Acceptance Criteria Category	Reported Device Performance
EMC and Electrical Safety	Met (implied)
Design Verification	Met (implied)
Shelf Life	Met (implied)
Drift Performance	Met (implied)
System Verification	Met (implied)
Sensor Accuracy	SAME as predicate (K161887)
Sensor Drift	SAME as predicate (K161887)
Sensor Operating Range	SAME as predicate (K161887)

The comparison table on page 4-5 explicitly states that for "Sensor" attributes, the "Accuracy," "Drift," and "Operating Range" are "SAME" as the predicate device (Verrata PLUS Pressure Guide Wire, K161887). This implies that the acceptance criteria for these sensor-related performance metrics are identical to those established for the predicate device, and the subject device achieved performance equivalent to the predicate.

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench and laboratory-based design verification and system verification, not human clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document describes performance testing, likely against established engineering and technical standards, rather than expert-established ground truth from clinical data.

4. Adjudication Method for Test Set:

Not applicable. There is no indication of an adjudication method for a test set, as no clinical study or expert review for ground truth establishment is described.

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

No, an MRMC comparative effectiveness study is not mentioned or implied. The device is a pressure guide wire, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical medical instrument (pressure guide wire) meant for use in conjunction with other systems and interventional procedures, not a standalone algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing cited would be based on established engineering specifications, calibration standards, and industry-recognized testing methodologies for medical devices, particularly pressure sensors and guide wires. This is not explicitly stated but is inferred from the types of tests listed (EMC, Electrical Safety, Design Verification, Shelf Life, Drift, System Verification).

8. Sample Size for Training Set:

Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

April 15, 2020

Volcano Corporation Leilani Taylor Sr. Regulatory Affairs Specialist 3721 Valley Centre Drive, Ste 500 San Diego, California 92130

Re: K210235

Trade/Device Name: Verrata PLUS Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: March 15, 2021 Received: March 16, 2021

Dear Leilani Taylor:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210235

Device Name Verrata PLUS Pressure Guide Wire

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a blue triangle inside, followed by the word "VOLCANO" in large, blue, sans-serif letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, black, sans-serif letters.

K210235

This 510(k) Summary was prepared in accordance with 21 CFR 807.92 (c)

510(k) SUMMARY

SUBMITTER:	Volcano Corporation3721 Valley Centre Drive, Ste 500San Diego, CA 92130
CONTACT PERSON:	Leilani TaylorRegulatory Affairs SpecialistVolcano Corporation3721 Valley Centre Drive, Suite500 San Diego, CA 92130Tel: (858) 720-4121
DATE PREPARED:	April 02, 2021
DEVICE NAME:	Verrata PLUS Pressure Guide Wire
COMMON NAME:	Wire, guide, catheterCatheter Tip Pressure Transducer
CLASSIFICATION:	870.1330 Catheter guide wire / DQX870.2870 Catheter Tip Pressure Transducer /DXOCLASS II
PREDICATE DEVICE:	Verrata PLUS Pressure Guide Wire, K161887

DEVICE DESCRIPTION:

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Image /page/4/Picture/0 description: The image contains the logo for Volcano Corporation. The logo features a stylized mountain graphic to the left of the word "VOLCANO" in large, bold, blue letters. Below the word "VOLCANO" is the text "PRECISION GUIDED THERAPY" in a smaller font.

INDICATION FOR USE:

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The Verrata® PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

Attribute/Feature	Comparison of the Predicate Volcano Verrata PLUS PressureGuide Wire (K161887) and Subject Devices Volcano VerrataPLUS Pressure Guide Wire Alternate Sensor
Indications for Use	SAME
Materials (Guide Wire)
Tip Coil	SAME
Tip Coil Solder	SAME
Proximal Coil	SAME
Distal Coating	SAME
Sensor Housing	SAMESAMESAME
Pressure Transducer	SAMESAME, except for Silicon Nitride, which is identified in the subjectdevice, but not specified in the predicate device. See table below.
Conductor Wire	SAMESAME
Contact Pad	Different, see table below.
Hypotube	SAME
Hypotube Coating	SAME
Core Wire	SAME
Retaining Sleeve	SAME
Conductive Bands	SAME
Insulator Sleeve	SAME
Locking Core	SAME
Insulator Sleeve,conductive band	SAME
Adhesive, UV Cured	SAMESAME
Attribute/Feature	Comparison of the Predicate Volcano Verrata PLUS Pressure Guide Wire (K161887) and Subject Devices Volcano Verrata PLUS Pressure Guide Wire Alternate Sensor
Adhesive, UV Cured	SAME
Materials (Connector)
Connector Shell	SAME
Contact	SAME
Locking Clip	SAME
Torsional Spring	SAME
Cable	SAME
Cable 10 pin connector assembly	SAME
Materials (Torque Device)
Body	SAME
Cap	SAME
Collet	SAME
Design
Core Design	SAME
Tip Design	SAME
Tip Joint Design	SAME
Transducer Location	SAME
Tip Coil to Core Wire	SAME
Core Wire to Housing	SAME
Proximal Locking	SAME
Core tensile strength	SAME
Turns to Failure	SAME
Connector Cable Routing	SAME
Sensor
Sensor	Different sensor but same performance specifications
Accuracy	SAME
Drift	SAME
Operating Range	SAME
Dimensions
Overall Outer Diameter	SAME
Working Length (Distal tip of the wire to the distal end of the connector)	SAME
Attribute/Feature	Comparison of the Predicate Volcano Verrata PLUS Pressure Guide Wire (K161887) and Subject Devices Volcano Verrata PLUS Pressure Guide Wire Alternate Sensor
Length
Sensor Housing Length	SAME
Core Wire Diameter	SAME
Flexible Distal Section	SAME
Packaging Materials
Carton	SAME
Spiral Dispenser with Clips	SAME
Wire Tray	SAME
Pouch	SAME

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1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

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Image /page/5/Picture/0 description: The image contains the logo for "VOLCANO". To the left of the word, there is a gray square with a white triangle inside. The triangle has a blue triangle inside of it. The word "VOLCANO" is in blue.

PRECISION GUIL

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Image /page/6/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a white triangle inside, followed by the word "VOLCANO" in large, blue, bold letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, gray letters.

PRECISION GUIDE

Wire Tray	SAME
Pouch	SAME
RJ50 Cap	SAME
Sterilization and Shelf Life
Sterilization Method	SAME
Sterilization	SAME
Sterilization Assurance Level (SAL)
Shelf Life	SAME

The following table describes the differences between the two sensors:

Sensor Part	Predicate VolcanoVerrata PLUSPressure GuideWire (K161887)Sensor Material	Subject VolcanoVerrata PLUSPressure GuideWire AlternateSensor	Rationale
Bond Pads(Metallization)(Not bloodContacting)	Base: TantalumTop Layer: Platinum	Base: Niobium -Titanium-TungstenTop Layer: Gold	Sensor Manufacturerdriven. AlternateSupplier does not havecapability to metalizeplatinum. Gold Padsare beneficial for theTrifilar to Sensor Bond(Compatible with goldplated trifilar)
Base (HandleLayer)(BloodContacting)	Silicon	Silicon	No Change
Device Layer and	Silicon	Silicon	No Change
Diaphragm(BloodContacting)	Silicon Oxide(silicon naturallyoxidizes when	Silicon Oxide	Passivation layer 1(adherence, 2ndprotection)
	exposed to air)	Silicon Nitride	Passivation Layer 2(Protective). SiliconNitride is widely usedin semi conductorindustry for itsinsulation properties.Biocompatibilitystudies were executedto verify materialimpact. Allbiocompatibilityrequirements wereeffectively met perISO10993. There wereno new biologicalhazards or risksidentified compared topredicate device.
Adhesive Marker(Distal Markeraka Dielectricmarker)(BloodContacting)	NA	Silicon Dioxide	Dielectric materialadded Formanufacturing Purposes(Indicator for maximumamount of adhesive andpositioning of die inprotective housing,yield improvement,cosmetic feature)
Trifilar Insulator(BloodContacting)	NA	Silicon Dioxide	Dielectric materialadded formanufacturing purposes(to avoid the Trifilar toshort with the HandleLayer, yieldimprovement).
Electrical Circuit(inside) (Notblood Contacting)	Unknown	Traces of Boronand Phosphorous(< 0.1%)	Not Blood Contacting.

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Image /page/7/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a blue triangle inside, followed by the word "VOLCANO" in large, blue, bold letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, gray letters.

K210235

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Image /page/8/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a blue triangle inside, followed by the word "VOLCANO" in large, bold, blue letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, black letters.

PERFORMANCE DATA:

Performance testing completed for a determination of substantial equivalence included the following:

EMC and Electrical Safety Testing
. Design Verification
. Self Life Studies
Drift Performance Testing ●
System Verification ●

CONCLUSION:

All device acceptance criteria were met. Results of testing show that the proposed Verrata PLUS Pressure Guide Wire with alternate sensor meets its intended use. The differences between the subject device and predicate device do not raise new questions of safety and/or effectiveness. Therefore, the proposed Verrata PLUS Pressure Guide Wire with alternate sensor is substantially equivalent to the predicate Verrata PLUS Pressure Guide Wire.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.