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. 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 “Verrata PLUS”) is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata® PLUS measures pressure when used with the SmartMap®, ComboMap®, s5 Series™, and CORE™ Series of systems. The Verrata PLUS has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and also in straight or pre-shaped tips. The Verrata PLUS is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.

AI/ML Overview

The provided text describes the Verrata PLUS Pressure Guide Wire and its performance testing to demonstrate substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Visual Inspection (Cable Routing)	Cable must be routed out the right side of the connector.	Sample wires and connectors were visually inspected to confirm proper routing of the cable out of the connector. Implied: Complied with acceptance criteria.
Visual Inspection (Pressure Sensor)	The sensor adhesive is not protruding out of the housing and the sensor is not damaged or misaligned.	Sample wires were visually inspected to confirm that the pressure sensor within the pressure housing is properly aligned, positioned and potted in place. Implied: Complied with acceptance criteria.
Wire Outer Diameter	The sensor housing outer diameter must meet product specifications.	The maximum diameter of the sensor housing is measured with a micrometer. Implied: Complied with acceptance criteria.
Zero Test and Connection Durability	The wire must successfully zero the first time and after 20 disconnect and re-connect cycles.	Wires with connectors were connected to a Volcano Pressure System and "zeroed". The pressure value on the screen of the System should read "0". Disconnect the wire from the connector and re-connect up to 20 times. After 20 disconnect and re-connects, verified that the wire still "zeros". Implied: Complied with acceptance criteria.
Accuracy Test	The pressure measured by the wire must meet product specifications.	The wire is connected to a test fixture and is placed in an air pressure chamber at 37℃. The pressure inside the chamber is varied and the pressure reading from the wire is compared to the pressure to which the chamber is set. Implied: Complied with acceptance criteria.
Drift Test	The drift over 10 minutes must meet product specifications.	The wire is connected to a test fixture and placed in saline at 37℃. The pressure reading is recorded for 10 minutes. Implied: Complied with acceptance criteria.
Connector to Cable Tensile Test	The tensile strength must meet product specifications.	The connector to cable connection was pull tested to assess its tensile strength. Implied: Complied with acceptance criteria.
Biocompatibility (ISO 10993)	Per ISO 10993 and test protocols.	Biocompatibility of the raw materials in the Verrata PLUS wire were assessed per ISO 10993. Implied: Complied with acceptance criteria.
Biocompatibility (Direct Hemolysis)	The difference between the hemolytic indices of the test article and negative control must be <2%.	Direct Contact Hemolysis testing was performed. Implied: Complied with acceptance criteria.
Biocompatibility (Indirect Hemolysis)	The difference between the hemolytic indices of the test article and negative control must be <2%.	Extract In-direct Contact Hemolysis testing was performed. Implied: Complied with acceptance criteria.
Biocompatibility (Latex Elisa test)	Reporting Limit = 0.03ug/ml.	Latex Elisa test for Antigenic Protein was performed. Implied: Complied with acceptance criteria.
Biocompatibility (Cytotoxicity)	A score of <2 indicates that the test article is not cytotoxic.	Cytotoxicity testing was performed. Implied: Complied with acceptance criteria.
Connector Fluid Ingress	Stable signal time of the Verrata PLUS connector in the presence of saline is equal to or better than the stable signal time of the Verrata connector in the presence of saline.	Sample wires and connectors were connected to a Volcano Pressure System. The connector was placed on top of absorbent drapes. The System was turned on and saline was dripped on the connector while the pressure waveform was monitored on the screen of the System. After 5 minutes, the connector was flipped over. After an additional 5 minutes the recording was stopped. Verrata PLUS was compared to the Verrata. The document states the condition was met.
Device Deliverability/Compatibility	Two different heart models in a 37°C water bath were used to assess the ability of the Verrata PLUS to support the delivery and deployment of standard interventional devices. The first model was used to assess device deliverability in simulated Left Circumflex and First Obtuse Marginal vessels. The second model was used to assess the ability of the Verrata PLUS to support the inflation of a standard balloon catheter and the deployment of a stent. Implied: Complied with acceptance criteria.	The document only states the acceptance criteria for this test and implies compliance by stating "Completion of all performance tests concludes that the Verrata PLUS Pressure Guide Wire is substantially equivalent..." It does not provide specific performance results for this test.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of devices/wires) used for each individual bench test. Terms like "Sample wires" (for visual inspection, fluid ingress) are used, suggesting a subset was tested, but no specific number is given.

Data provenance: The testing described is non-clinical bench testing. The data is generated from laboratory experiments and simulations, not from human or animal subjects. Therefore, there is no country of origin of data in the human/clinical sense, nor is it retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests described are bench tests with clearly defined physical and chemical parameters and product specifications. There is no expert review or human interpretation involved in establishing the "ground truth" for these tests, as the ground truth is based on objective measurements and established physical/chemical standards.

4. Adjudication method for the test set

Not applicable. As described above, these are objective bench tests, not clinical studies requiring adjudication of expert opinions.

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

Not applicable. This document describes a medical device (pressure guide wire), not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study or AI-related comparative effectiveness was conducted.

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

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

7. The type of ground truth used

The ground truth for these tests is based on:

Product Specifications: For wire outer diameter, accuracy, drift, and tensile strength.
Established Industry Standards: ISO 10993 for biocompatibility, ASTM F756, ASTM D6499.
Objective Visual Assessment: For cable routing and sensor alignment.
Functional Performance Requirements: For zeroing, connection durability, and fluid ingress comparison to the predicate.
Simulated Use Performance: For deliverability/compatibility in heart models.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set.

Summary

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Public Health Service

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

September 20, 2016

Volcano Corporation Brian Park Regulatory Affairs Manager 3721 Valley Centre Drive, Suite 500 San Diego, California 92130

Re: K161887

Trade/Device Name: Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip; Verrata PLUS Pressure Guide Wire, 185 cm J-tip; Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip; Verrata PLUS Pressure Guide Wire, 300 cm J-tip Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: August 19, 2016 Received: August 22, 2016

Dear Brian Park:

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

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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 devicerelated 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 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.

Sincerelv

Muda Yellman
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) K161887

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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510(K) SUMMARY

SPONSOR:	Volcano Corporation3721 Valley Center Drive Suite 500San Diego, CA 92130
CONTACT/SUBMITTER:	Brian ParkRegulatory Affairs SpecialistVolcano Corporation3721 Valley Center Drive Suite 500San Diego, CA 92130Tel: (858) 720-4176Fax: (858) 481-1027
DATE PREPARED:	July 8, 2016
DEVICE:	Volcano Verrata® PLUS Pressure Guide Wire
TRADE NAME:	Verrata® PLUS Pressure Guide Wire
COMMON NAME:	Pressure Guide Wire
CLASSIFICATION:	21 CFR 870.1330DQX: Catheter Guide WireClass II Device21 CFR 870.2870DXO: Catheter Tip Pressure TransducerClass II Device
PREDICATE DEVICE:	Verrata® Pressure Guide Wire, K131288Model numbers:10185, Straight Tip, 185 cm long, 0.014" (0.036 mm) dia.10185J, J-Tip, 185 cm long, 0.014" (0.036mm) dia.10300, Straight Tip, 300 cm long, 0.014" (0.036 mm) dia.10300J, J-Tip, 300 cm long, 0.014" (0.036mm) dia.

Image /page/3/Picture/5 description: The image contains the word "VOLCANO" in large, bold, blue letters. To the left of the word is a gray square with a blue triangle inside, resembling a stylized volcano. The overall design is simple and modern, likely representing a company or brand named Volcano.

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DEVICE DESCRIPTION:	The Verrata® PLUS Pressure Guide Wire (hereafterreferred to as the “Verrata PLUS”) is a steerable guide wirewith a pressure transducer mounted 3 cm proximal to thetip. The Verrata® PLUS measures pressure when used withthe SmartMap®, ComboMap®, s5 Series™, and CORE™Series of systems. The Verrata PLUS has a diameter of0.014" (0.36 mm) and is available in lengths of 185 cm or300 cm and also in straight or pre-shaped tips. The VerrataPLUS is packaged attached to the connector with a torquedevice to facilitate navigation through the vasculature.
INDICATIONS FOR USE:	The Verrata® PLUS pressure guide wire is indicated foruse to measure pressure in blood vessels, including bothcoronary and peripheral vessels, during diagnosticangiography and/or any interventional procedures. Bloodpressure measurements provide hemodynamic informationfor the diagnosis and treatment of blood vessel disease.
COMPARISON OFCHARACTERISTICS:	Volcano Corporation made minor revisions to the currentlymarketed Verrata Pressure Guide Wire. The pressuresensor and its encapsulating adhesive was changed, therouting of the connector cable was changed from exiting theconnector body from the bottom to exiting from the side inline with the wire, paraffin wax was added to a non-patientcontacting surface inside of the connector drawer and thenon-patient contacting torsion spring inside the connector isnow coated with a soap solution. There are no changes toany final product or performance specifications as a resultof these changes.
PERFORMANCE DATA:	Non-clinical device testing was conducted to confirm theperformance of the device. Bench testing was conductedagainst the product specification and evaluated thefollowing:Visual Inspection: Sample wires and connectors werevisually inspected to confirm proper routing of thecable out of the connector. Acceptance Criteria: Cablemust be routed out the right side of the connector. Visual Inspection: Sample wires were visuallyinspected to confirm that the pressure sensor within thepressure housing is properly aligned, positioned andpotted in place. Acceptance Criteria: The sensoradhesive is not protruding out of the housing and the

sensor is not damaged or misaligned.

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· Wire Outer Diameter: The maximum diameter of the sensor housing is measured with a micrometer. Acceptance Criteria: The sensor housing outer diameter must meet product specifications.
· Zero Test and Connection Durability Test: Wires with connectors were connected to a Volcano Pressure System and "zeroed". The pressure value on the screen of the System should read "0". Disconnect the wire from the connector and re-connect up to 20 times. After 20 disconnect and re-connects, verify that the wire still "zeros". Acceptance Criteria: The wire must successfully zero the first time and after 20 disconnect and re-connect cycles.
· Accuracy Test: The wire is connected to a test fixture and is placed in an air pressure chamber at 37℃. The pressure inside the chamber is varied and the pressure reading from the wire is compared to the pressure to which the chamber is set. Acceptance Criteria: The pressure measured by the wire must meet product specifications.
· Drift Test: The wire is connected to a test fixture and placed in saline at 37℃. The pressure reading is recorded for 10 minutes. Acceptance Criteria: The drift over 10 minutes must meet product specifications.
· Connector to Cable Tensile Test: The connector to cable connection was pull tested to assess its tensile strength. Acceptance Criteria: The tensile strength must meet product specifications.
Biocompatibility: Biocompatibility of the raw materials in the Verrata PLUS wire were assessed per ISO 10993. Acceptance Criteria: Per ISO 10993 and test protocols. Direct Contact Hemolysis Acceptance Criteria: The difference between the hemolytic indices of the test article and negative control must be <2%. Extract In-direct Contact Hemolysis Acceptance Criteria: The difference between the hemolytic indices of the test article and negative control must be <2%. Latex Elisa test for Antigenic Protein Acceptance Criteria: Reporting Limit = 0.03ug/ml. Cytotoxicity Acceptance Criteria: A score of <2 indicates that the test article is not cytotoxic.

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· Connector Fluid Ingress: Sample wires and connectors were connected to a Volcano Pressure System. The connector was placed on top of absorbent drapes. The System was turned on and saline was dripped on the connector while the pressure waveform was monitored on the screen of the System. After 5 minutes, the connector was flipped over. After an additional 5 minutes the recording was stopped. Verrata PLUS was compared to the Verrata. Acceptance Criteria: Stable signal time of the Verrata PLUS connector in the presence of saline is equal to or better than the stable signal time of the Verrata connector in the presence of saline.
· Device Deliverability/Compatibility: Two different heart models in a 37°C water bath were used to assess the ability of the Verrata PLUS to support the delivery and deployment of standard interventional devices. The first model was used to assess device deliverability in simulated Left Circumflex and First Obtuse Marginal vessels. The second model was used to assess the ability of the Verrata PLUS to support the inflation of a standard balloon catheter and the deployment of a stent. Acceptance Criteria:

CONSENSUS STANDARDS

The Verrata PLUS Pressure Guide Wire complies with the following consensus standards:

The ISO 10993 series of biocompatibility standards including

ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ASTM F756 -13, Standard Practice for Assessment of Hemolytic Properties of Materials

ASTM D6499-12, Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

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ISO 14971:2007 Medical devices - Application of risk management to medical devices

CONCLUSION

Completion of all performance tests concludes that the Verrata PLUS Pressure Guide Wire is substantially equivalent to the currently marketed Verrata 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.