Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound catheter and system with manual controls and does not mention any AI/ML capabilities for image processing, analysis, or guidance.

Therapeutic

No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures." This indicates it's a diagnostic imaging tool, not a therapeutic device.

Diagnostic

Yes

The device description explicitly states, "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 Pro ICE Catheter is a component of a larger "Diagnostic Ultrasound System," indicating its role in providing diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including catheters with transducers, a handle, steering wheels, and a patient interface module (PIM). Performance testing also includes hardware-specific evaluations like dimensional, tensile, and actuation tests.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside the body (in vitro).
Device Function: The VeriSight VeriSight Pro ICE Catheter is used for intracardiac and intra-luminal visualization inside the body (in vivo). It uses ultrasound technology to create images of the heart and blood vessels.
Intended Use: The intended use clearly states it's for "imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures." This is a diagnostic imaging tool used during a medical procedure, not a test performed on a sample outside the body.

The device description and performance testing also support this conclusion, focusing on the physical and imaging performance of the catheter within the body, rather than the analysis of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

OBJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound Imaging

Anatomical Site

cardiac and great vessel

Indicated Patient Age Range

Not Found. The predicate device mentions "adult and pediatric patients", but the subject device's indications for use do not specify patient age.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

EN IEC 60601-1
EN IEC 60601-1-2
EN IEC 60601-2-37, Diagnostic Ultrasound Safety Standards
IEC 62359, Ultrasonics - Field characterization

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170263

Reference Device(s)

K173618

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

1

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)

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.

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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K200812 - 510(k) Summary

Submitter Information:

Date Prepared	August 13, 2020
Manufacturer Name
and Address	Philips Image Guided Therapy Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670
Establishment Registration
Number	2939520
Primary Contact/Submitter
Information	Rand Daoud
Regulatory Affairs Specialist, 4
TEL: 1-858-720-4049
EMAIL: rand.daoud@philips.com
Philips Image Guided Therapy Corporation
3721 Valley Center Dr.
Suite 500
San 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).

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.

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.

| Standard
Feature | VeriSight/VeriSight
Pro ICE Catheters
K200812
(Proposed Device) | AcuNav Diagnostic
Ultrasound Catheter
K170263
(Predicate Device) | ACUSON AcuNav
Volume ICE Catheter
K173618
(Reference Device) |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The VeriSight/VeriSight
Pro ICE catheter is
intended for intra-
cardiac 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. | The catheter is intended
for intra-cardiac and
intra-luminal
visualization of cardiac
and great vessel
anatomy and physiology
as well as visualization
of other devices in the
heart of adult and
pediatric patients. The
catheter is intended for
imaging guidance only,
not treatment delivery,
during cardiac
interventional
percutaneous
procedures. | The catheter is intended
for intra-cardiac and
intra-luminal
visualization of cardiac
and great vessel
anatomy and physiology
as well as visualization
of other devices in the
heart of adult and
pediatric patients. The
catheter is intended for
imaging guidance only,
not treatment delivery,
during cardiac
interventional
percutaneous
procedures. |
| Catheter | Intracardiac | Intracardiac | Intracardiac |
| Type
Single-Use | Echocardiography
Yes | Echocardiography
Yes | Echocardiography
Yes |
| Duration of
Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Limited (≤ 24 hours) |
| Scientific | Ultrasound Imaging | Ultrasound Imaging | Ultrasound Imaging |
| Technology | Frequency | Frequency | Frequency |
| Compatible
with
Previously-
cleared
Ultrasound
Systems? | Yes | Yes | Yes |
| Number of | 840 | 64 | Unknown |
| Standard
Feature | VeriSight/VeriSight
Pro ICE Catheters
K200812
(Proposed Device) | AcuNav Diagnostic
Ultrasound Catheter
K170263
(Predicate Device) | ACUSON AcuNav
Volume ICE Catheter
K173618
(Reference Device) |
| Ultrasound
Transducer
Elements | | | |
| Nominal
Center
Frequency
[MHz] | 7 MHz | 6.5 MHz | Unknown |
| Operating
principles | Catheter with
ultrasound sensors
that is used with an
imaging system to
display to provide high-
resolution real-time
visualization of cardiac
structures, continuous
monitoring of catheter
location within the
heart | Catheter with
ultrasound sensors that
is used with an imaging
system to display to
provide high-resolution
real-time visualization of
cardiac structures,
continuous monitoring
of catheter location
within the heart | Catheter with
ultrasound sensors that
is used with an imaging
system to display to
provide high-resolution
real-time visualization of
cardiac structures,
continuous monitoring
of catheter location
within the heart |
| Image
Technique to
Visualize
Device | Fluoroscopy | Fluoroscopy | Fluoroscopy |
| Catheter
Diameter | 9F | 8F, 10F | 12.5F |
| Sheath
Compatibility | 10F | 9F, 11F | >12.5F |
| Catheter
Working
Length | 90cm | 90cm | 90 cm |
| Imaging
Modes | VeriSight:
• 2D (B-Mode)
• M-Mode
• Pulse wave Doppler
• Continuous wave
Doppler
• Color Doppler

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.