The VeriSight VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Device Description

The Intracardiac Echocardiography (ICE) System comprises of the VeriSight Pro ICE Catheters, the ICE PIM, and the EPIQ Diagnostic Ultrasound System (cleared under K202216).

The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm.

The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide.

The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216.

AI/ML Overview

The provided document, a 510(k) Summary for the Philips VeriSight Intracardiac Echocardiography (ICE) Catheter, indicates that clinical data was not required to establish substantial equivalence for this device. Therefore, there is no study detailing acceptance criteria or device performance in a clinical setting for this submission.

The manufacturer states: "The VeriSight/VeriSight Pro ICE catheters use the same scientific technology, operating principles and shares similar indications for use as the predicate device. Therefore, clinical data is not required to establish substantial equivalence." (Page 8).

Instead, the submission relies on the substantial equivalence to a predicate device (Siemens AcuNav Diagnostic Ultrasound Catheter 8F, 10F, cleared under K170263) and extensive non-clinical performance testing to demonstrate safety and effectiveness.

Here's a breakdown of the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

Since a clinical study was not conducted to establish performance metrics like sensitivity, specificity, or accuracy against an established ground truth, there is no direct table of acceptance criteria and reported device performance in the context of clinical outcomes. The "performance" in this context refers to the successful completion of engineering design verification and validation tests.

Test Category	Specific Test	Acceptance Criteria Implicit (e.g., meeting design specs, established safety limits)	Reported Device Performance (Successful completion)
Mechanical/Physical	Visual inspection	Device meets visual quality standards	Performed satisfactorily
	Dimensional	Device dimensions meet specifications	Performed satisfactorily
	Actuation characteristics	Catheter steering and control meet specifications	Performed satisfactorily
	Tip deflection	Tip deflection within design limits	Performed satisfactorily
	Torsional shaft	Shaft torque resistance meets specifications	Performed satisfactorily
	Tensile tests	Device structural integrity under tension meets specifications	Performed satisfactorily
	Deliverability	Catheter navigability and deployment meet specifications	Performed satisfactorily
Imaging	Saline imaging	Demonstrates clear imaging in a simulated environment	Performed satisfactorily
Safety	Particulate	Particulate matter within acceptable limits	Performed satisfactorily
	Biocompatibility	Meets biocompatibility standards for patient contact	Performed satisfactorily
	Sterilization	Achieves and maintains sterility	Performed satisfactorily
	Packaging and Shelf Life	Maintains integrity and sterility over shelf life	Performed satisfactorily
System Integration	Usability	Device is user-friendly and functions as intended	Performed satisfactorily
	Preclinical Animal testing	Demonstrates safe and effective function in an animal model	Performed satisfactorily
	System testing with EPIQ System	Fully functional and compatible with the EPIQ System	Performed satisfactorily
	Electrical Safety, EMC and acoustic output testing with EPIQ System	Complies with relevant electrical safety, EMC, and acoustic output standards (e.g., EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-37, IEC 62359)	Performed satisfactorily

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

Not applicable, as no clinical test set was used for the purpose of demonstrating device performance against clinical acceptance criteria. The testing listed above refers to engineering and bench testing, for which specific sample sizes are not detailed in this summary but are generally conducted on a representative number of devices.

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

Not applicable, as no ground truth was established by experts in a clinical context for this submission. The "ground truth" for the non-clinical tests would have been the established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical data was not required.

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

Not applicable. The device is a physical intracardiac echocardiography catheter, not an AI algorithm. Its function is to provide imaging capabilities for human interpretation.

7. The Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" was defined by:

Engineering design specifications and performance requirements for the device.
Established national and international voluntary standards for medical devices, electrical safety, electromagnetic compatibility (EMC), and diagnostic ultrasound safety (e.g., EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-37, IEC 62359).
Results from preclinical animal testing for safety and function.

8. The Sample Size for the Training Set:

Not applicable, as this device does not involve a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the 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 symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.

September 2, 2020

Philips Image Guided Therapy Corporation % Rand Daoud Regulatory Affairs Specialist, 4 Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, Washington 98021

Re: K200812

Trade/Device Name: VeriSight Intracardiac Echocardiography (ICE) Catheter, and VeriSight Pro ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: August 13, 2020 Received: August 17, 2020

Dear Rand Daoud:

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

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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-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 medical devices and radiation-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,

Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200812

Device Name

VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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K200812 - 510(k) Summary

Submitter Information:

Date Prepared	August 13, 2020
Manufacturer Nameand Address	Philips Image Guided Therapy Corporation2870 Kilgore RoadRancho Cordova, CA 95670
Establishment RegistrationNumber	2939520
Primary Contact/SubmitterInformation	Rand DaoudRegulatory Affairs Specialist, 4TEL: 1-858-720-4049EMAIL: rand.daoud@philips.comPhilips Image Guided Therapy Corporation3721 Valley Center Dr.Suite 500San Diego, CA 92130

Subject Device Information:

Trade Name	VeriSight Intracardiac Echocardiography Catheter,VeriSight Pro Intracardiac Echocardiography Catheter
Common Name	Intravascular Ultrasound Catheter
Regulation Description	Diagnostic intravascular catheter
Regulation Number	870.1200
Product Code	OBJ
Device Class	Class II
Classification Panel	Cardiovascular

K170263 - Siemens AcuNav Diagnostic Ultrasound Predicate Device: Catheter 8F, 10F Reference Devices:

K173618 - ACUSON AcuNav Volume ICE Catheter

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Subject Device Description:

The Intracardiac Echocardiography (ICE) System comprises of the VeriSight Pro ICE Catheters, the ICE PIM, and the EPIQ Diagnostic Ultrasound System (cleared under K202216).

Indications for Use:

VeriSight/ VeriSight Pro ICE catheter:

The VeriSight/ VeriSight Pro ICE catheter is intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

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Predicate Device Comparison:

Technological Comparison Table:

Comparison of the proposed VeriSight/VeriSight Pro ICE Catheters to the currently marketed predicate device, the AcuNav Diagnostic Ultrasound Catheter 8F, 10F.

StandardFeature	VeriSight/VeriSightPro ICE CathetersK200812(Proposed Device)	AcuNav DiagnosticUltrasound CatheterK170263(Predicate Device)	ACUSON AcuNavVolume ICE CatheterK173618(Reference Device)
Indicationsfor Use	The VeriSight/VeriSightPro ICE catheter isintended for intra-cardiac and intra-luminal visualization ofcardiac and greatvessel anatomy andphysiology as well asvisualization of otherdevices in the heart.The catheter isintended for imagingguidance only, nottreatment delivery,during cardiacinterventionalpercutaneousprocedures.	The catheter is intendedfor intra-cardiac andintra-luminalvisualization of cardiacand great vesselanatomy and physiologyas well as visualizationof other devices in theheart of adult andpediatric patients. Thecatheter is intended forimaging guidance only,not treatment delivery,during cardiacinterventionalpercutaneousprocedures.	The catheter is intendedfor intra-cardiac andintra-luminalvisualization of cardiacand great vesselanatomy and physiologyas well as visualizationof other devices in theheart of adult andpediatric patients. Thecatheter is intended forimaging guidance only,not treatment delivery,during cardiacinterventionalpercutaneousprocedures.
Catheter	Intracardiac	Intracardiac	Intracardiac
TypeSingle-Use	EchocardiographyYes	EchocardiographyYes	EchocardiographyYes
Duration ofUse	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Limited (≤ 24 hours)
Scientific	Ultrasound Imaging	Ultrasound Imaging	Ultrasound Imaging
Technology	Frequency	Frequency	Frequency
CompatiblewithPreviously-clearedUltrasoundSystems?	Yes	Yes	Yes
Number of	840	64	Unknown
StandardFeature	VeriSight/VeriSightPro ICE CathetersK200812(Proposed Device)	AcuNav DiagnosticUltrasound CatheterK170263(Predicate Device)	ACUSON AcuNavVolume ICE CatheterK173618(Reference Device)
UltrasoundTransducerElements
NominalCenterFrequency[MHz]	7 MHz	6.5 MHz	Unknown
Operatingprinciples	Catheter withultrasound sensorsthat is used with animaging system todisplay to provide high-resolution real-timevisualization of cardiacstructures, continuousmonitoring of catheterlocation within theheart	Catheter withultrasound sensors thatis used with an imagingsystem to display toprovide high-resolutionreal-time visualization ofcardiac structures,continuous monitoringof catheter locationwithin the heart	Catheter withultrasound sensors thatis used with an imagingsystem to display toprovide high-resolutionreal-time visualization ofcardiac structures,continuous monitoringof catheter locationwithin the heart
ImageTechnique toVisualizeDevice	Fluoroscopy	Fluoroscopy	Fluoroscopy
CatheterDiameter	9F	8F, 10F	12.5F
SheathCompatibility	10F	9F, 11F	>12.5F
CatheterWorkingLength	90cm	90cm	90 cm
ImagingModes	VeriSight:• 2D (B-Mode)• M-Mode• Pulse wave Doppler• Continuous waveDoppler• Color DopplerVeriSight Pro:	• 2D (B-Mode)• M-Mode• Pulse wave Doppler• Continuous waveDoppler• Color Doppler	• 2D (B-Mode)• M-Mode• Pulse wave Doppler• Continuous waveDoppler• Color Doppler Volume• 3D
StandardFeature	VeriSight/VeriSightPro ICE CathetersK200812(Proposed Device)	AcuNav DiagnosticUltrasound CatheterK170263(Predicate Device)	ACUSON AcuNavVolume ICE CatheterK173618(Reference Device)
	• 2D (B-Mode)
	• M-Mode
	• Pulse wave Doppler
	• Continuous waveDoppler
	• Color Doppler
	• Live 3D
	• Live 3D color
AcousticOutput Track	Track 3	Track 3	Track 3
Safety andEMCCompliance	EN/IEC 60601-1IEC 60601-2-37EN/IEC 60601-1-2	IEC 60601-1IEC 60601-2-37IEC 60601-1-2	IEC 60601-1IEC 60601-2-37IEC 60601-1-2
Accessories	Philips ICE PIM	Sterile Cover, SwiftlinkCatheter Connector	Sterile Cover, SwiftlinkCatheter Connector

Page 3 of 6

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The Technological Comparison Table above provides a detailed comparison demonstrating that both the VeriSight/VeriSight Pro ICE Catheters and the predicate AcuNav Diagnostic Ultrasound Catheter share the same intended use and similar indications for use, same principle of operation for primary function (ultrasonic imaging), the same mechanism of action for achieving actuation, similar physical form of the catheter, and the same clinical operation and the device life cycle (sterile, single use disposable). Hence, the VeriSight Pro ICE Catheters are substantially equivalent to the predicate device, the Siemens AcuNav Diagnostic Ultrasound Catheter 8F, 10F cleared under K170263.

Any differences between the subject and predicate devices were evaluated through design verification and validation testing, which did not raise new questions of safety and/or effectiveness and support a determination of substantial equivalence.

Reference Device Comparison:

The ACUSON AcuNav Volume ICE Catheter (K173618), is identified as a reference device and shares the same operating principles and technological characteristics, specifically when related to Philips VeriSight Pro ICE catheter's 3D imaging modalities.

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Summary of Non-Clinical Performance Testing:

The VeriSight/VeriSight Pro ICE Catheters have been evaluated for performance and technological characteristics by completion of the following design verification and validation tests:

Visual inspection
Dimensional
Actuation characteristics
Tip deflection ●
Torsional shaft
Tensile tests
Deliverability
Saline imaging ●
Particulate
Usability
Preclinical Animal testing
Biocompatibility
Sterilization
Packaging and Shelf Life Validation
System testing with EPIQ System
Electrical Safety, EMC and acoustic output testing with EPIQ System

The VeriSight and VeriSight Pro Catheters comply with the following voluntary standards for Electrical Safety, EMC and Acoustic Outputs:

. Electrical Safety and EMC Requirements for Medical Equipment
- EN IEC 60601-1
- A EN IEC 60601-1-2
EN IEC 60601-2-37, Diagnostic Ultrasound Safety Standards ●
IEC 62359, Ultrasonics - Field characterization

Summary of Clinical Performance Testing:

The VeriSight/VeriSight Pro ICE catheters use the same scientific technology, operating principles and shares similar indications for use as the predicate device. Therefore, clinical data is not required to establish substantial equivalence.

Conclusion:

The VeriSight/VeriSight Pro ICE catheters, when connected to the EPIQ Diagnostic Ultrasound System, use the same scientific technology, operating principles and indications for use as the predicate device. Based on results of non-clinical testing, and the information submitted in this 510(k) Premarket Notification, the subject VeriSight/VeriSight Pro ICE Catheters are substantially equivalent to currently marketed devices.

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).