The Verrata™ Pressure Guide Wire device 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™ Pressure Guide Wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata guide wire measures pressure when used with the SmartMap, s5 Family and ComboMap systems. The Verrata guide wire 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 J tips. The Verrata guide wire is packaged pre-connected to the connector with a torque device to facilitate navigation through the vasculature.

AI/ML Overview

The provided text corresponds to a 510(k) summary for the Volcano Verrata™ Pressure Guide Wire. Based on the document, here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding reported device performance values for the Verrata™ Pressure Guide Wire. Instead, it lists the types of non-clinical tests conducted and states that their completion led to the conclusion of substantial equivalence.

However, based on the tests conducted to confirm performance, we can infer generalized acceptance criteria. The performance is reported as meeting these inferred criteria, leading to the conclusion of substantial equivalence.

Acceptance Criteria Category (Inferred)	Reported Device Performance
Visual Inspection	Conforms to specifications
Dimensional Verification	Conforms to specifications
Wire Connection Durability	Conforms to specifications
Tensile Strength	Conforms to specifications
Connector Resistance	Conforms to specifications
Biocompatibility	Identical to predicate device (no new testing needed)

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

The document does not explicitly state the sample sizes for the "test set" for each of the non-clinical tests (Visual Inspection, Dimensional Verification, Wire Connection Durability, Tensile Strength, Connector Resistance). These tests are typically performed on a statistically relevant number of device units.

Regarding data provenance, the testing was non-clinical, meaning it was conducted in a laboratory or benchtop setting, not using human or animal biological data. The data origin is therefore within the scope of Volcano Corporation's internal testing facilities. It is inherently retrospective as these tests precede the 510(k) submission.

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

This information is not applicable to this submission. The tests performed are non-clinical (bench testing), which typically do not involve human experts establishing ground truth in the way clinical studies or image-based AI studies do. The "ground truth" for these tests would be established by engineering specifications, calibration standards, or measurement devices.

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

This information is not applicable to this submission. Adjudication methods are typically used in clinical studies, particularly those involving human interpretation of data (e.g., medical imaging), to resolve discrepancies between readers. Bench testing does not involve such human-in-the-loop decision-making that would require adjudication.

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

An MRMC comparative effectiveness study was not performed. This submission is for a physical medical device (pressure guide wire), not an AI algorithm or a diagnostic imaging device that involves human readers interpreting results. Therefore, there is no mention of human reader improvement with or without AI assistance.

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

This information is not applicable. The Verrata™ Pressure Guide Wire is a physical medical device. It is not an algorithm, and therefore, standalone algorithm performance is not relevant to this submission.

7. The type of ground truth used

For the non-clinical tests mentioned (Visual Inspection, Dimensional Verification, Wire Connection Durability, Tensile Strength, Connector Resistance), the "ground truth" would be established by:

Engineering specifications and design documents: For visual inspection and dimensional verification.
Known standards/reference materials and calibrated measurement equipment: For wire connection durability, tensile strength, and connector resistance.
The predicate device: For substantial equivalence, the performance is compared against the established performance of the legally marketed predicate device (Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire).

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing processes are developed through engineering and materials science, not machine learning training.

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

This information is not applicable for the same reasons as #8.

Summary

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K131288- Page 1 of 2

JUN 2 1 2013

510(k) SUMMARY

ﺮ ﺍﻟ

The 510(k) Summary is submitted as required by section 807.92(a)

SPONSOR:	Volcano Corporation2870 Kilgore RoadRancho Cordova, CA 95670
CONTACT/SUBMITTER:	Jwala JawharkarRegulatory Affairs SpecialistVolcano Corporation2870 Kilgore RoadRancho Cordova, CA 95670Tel: (916) 281-2925Fax: (916) 638-8112
DATE OF SUBMISSION:	May 3, 2013
DEVICE:	Volcano Verrata™ Pressure Guide Wire
Trade Name:	Verrata™ Pressure Guide Wire
Common Name:	Pressure Guide Wire
Classification:	Class II Device21 CFR Part 870.1330 Catheter guide wire (DQX)21 CFR Part 870.2870 Catheter tip pressure transducer(DX0)
PREDICATE DEVICE:	Volcano PrimeWire PRESTIGE® Plus Pressure GuideWire
DEVICE DESCRIPTION:	The Verrata™ Pressure Guide Wire is a steerable guidewire with a pressure transducer mounted 3 cm proximal tothe tip. The Verrata guide wire measures pressure whenused with the SmartMap, s5 Family and ComboMapsystems. The Verrata guide wire has a diameter of 0.014"(0.36 mm) and is available in lengths of 185 cm or 300 cmand also in straight or pre-shaped J tips. The Verrata guidewire is packaged pre-connected to the connector with atorque device to facilitate navigation through thevasculature.
INDICATIONS FOR USE:	The Verrata™ Pressure Guide Wire device 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.

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COMPARISON OF CHARACTERISTICS:

... ...
... ... ... ..........................................................................................................................................................

The modified device is substantially equivalent to the currently marketed PrimeWire PRESTIGE® Plus device. Both devices are Pressure Guide Wires consisting of a wire and connector. The modified Verrata™ Pressure Guide Wire is offered in two lengths and two tip configurations for a total of 4 models, identical to the currently marketed device. The outer diameter and working length are identical for both the predicate and modified devices. The indications for use are identical for both devices. The only difference lies in a modification to the connector.

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

. Visual Inspection
Dimensional Verification .
Wire Connection Durability .
. Tensile Strength
Connector Resistance .

Biocompatibility testing was not conducted on the device as the direct and indirect blood-contacting materials are identical to those used in the predicate device.

Completion of these tests concluded the Verrata™ Pressure Guide Wire is substantially equivalent to the currently marketed PrimeWire PRESTIGE® Plus Pressure Guide Wire.

PERFORMANCE DATA:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and support.

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

June 21, 2013

Volcano Corporation Jwala Jawharkar Regulatory Affairs Specialist 2870 Kilgore Road Rancho Cordova, CA 95670

Re: K131288

Trade/Device Name: Verrata™ Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX. DXO Dated: May 22, 2013 Received: May 23, 2013

Dear Jwala Jawharkar:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Jwala Jawharkar

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number (if known) K131288

Page | of |

Device Name

Verrata™ Pressure Guide Wire

The Verrata™ Pressure Guide Wire is indicated for use to measure Indications for Use 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.

Prescription Use × (Per 21 CFR 801.109)

Over the Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Brar 2013

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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.