PercuNav Image Fusion and Interventional Navigation

K201053 · Philips Ultrasound, Inc. · JAK · May 14, 2020 · Radiology

Device Facts

• Record ID: K201053
• Device Name: PercuNav Image Fusion and Interventional Navigation
• Applicant: Philips Ultrasound, Inc.
• Product Code: JAK · Radiology
• Decision Date: May 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The PerculVav system is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PerculNav system is intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting. The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another. The PercuNav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following: - Image fusion for diagnostic clinical examinations and procedures - Soft tissue biopsies - Soft tissue ablation - Bone ablation - Bone biopsies - Nerve blocks and pain management - Drainage placements

Device Story

PercuNav is a stereotaxic accessory for image-guided interventions; inputs include CT, CBCT, MR, US, and PET images. System fuses these modalities to create dynamic representations for diagnostic review and instrument navigation. New 'Tumor Contouring' tool allows semi-automated generation of 3D contours around regions of interest based on greyscale differentiation; user reviews, modifies, and accepts contours. System displays tracked insertion tools (biopsy needles, probes) relative to target organs and projected paths on a monitor. Used in clinical settings by physicians to supplement live imaging; aids in planning and targeting lesions. Benefits include improved visualization for procedural guidance and proximity determination between devices. Does not serve as sole guidance for procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, software verification, risk analysis, and design reviews.

Technological Characteristics

Stereotaxic accessory for image fusion and instrument tracking. Components include Field Generator (FG), Tool Connection Unit (TCU), and tracked instrumentation (needles, probes). Software-based semi-automated contouring tool uses greyscale differentiation to generate 3D meshes for volume measurement. Connectivity supports integration with various imaging modalities (CT, MR, US, PET).

Indications for Use

Indicated for use as a stereotaxic accessory for CT, CBCT, MR, US, and PET imaging to assist in treatment planning and guidance for clinical, interventional, or diagnostic procedures, including soft tissue/bone biopsies, soft tissue/bone ablation, nerve blocks, pain management, and drainage placements.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Philips PercuNav Image Fusion and Interventional Navigation System (K170716)

Reference Devices

• Philips QLAB Advanced Quantification Software (GI 3 DQ) (K191647)
• Veran Medical Technologies IG 4 Image Guided Software (K093995)

Submission Summary (Full Text)

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May 14, 2020

Image /page/0/Picture/1 description: The image shows the logo for 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Philips Ultrasound, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K201053

Trade/Device Name: PercuNav Image Fusion and Interventional Navigation Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, IYO, LLZ Dated: April 20, 2020 Received: April 21, 2020

Dear Prithul Bom:

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 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-reporting

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combination-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K201053

### Device Name

PercuNav Image Fusion and Interventional Navigation

## Indications for Use (Describe)

The PerculVav system is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PerculNav system is intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting.

The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.

The PercuNav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:

- · Image fusion for diagnostic clinical examinations and procedures
- · Soft tissue biopsies
- · Soft tissue ablation
- Bone ablation
- · Bone biopsies
- · Nerve blocks and pain management
- · Drainage placements

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Section 8: 510(k) Summary

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## K201053

## Philips PercuNav Image Fusion and Interventional Navigation System

This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92

#### Submitter's name, address, telephone number, contact person 1.

| Sponsor: | Philips Ultrasound, Inc. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | 22100 Bothell Everett Hwy |
| | Bothell, WA 98021-8431 |
| Contact Person: | Travis Catania |
| | Senior Regulatory Affairs Specialist |
| | 22100 Bothell Everett Hwy |
| | Bothell, WA 98021-8431 |
| | Phone: [phone] |
| | Fax: [phone] |
| Secondary Contact: | Hebe Sun |
| | Senior Manager, Regulatory Affairs |
| Date Prepared | January 28, 2020 |
| 2. | Name of the device, including the trade of proprietary name if applicable, the common or usual name, and<br>the classification name, if known: |

| Proprietary Name: | PercuNav Image Fusion and Interventional Navigation System |
|-------------------|------------------------------------------------------------|
| Common Name: | PercuNav Image Fusion and Interventional Navigation System |
| | Computed Tomography X-ray System |

## Regulation Description:

| Classification Description | 21 CFR Section | Product Code |
|----------------------------------------------------|----------------|--------------|
| Computed Tomography X-ray System | 892.1750 | JAK |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Picture Archiving and Communications System (PACS) | 892.2050 | LLZ |

As stated in 21 CFR, parts 892.1750, 892.1560, and 892.2050, each of these generic types of devices have been classified as Class II.

Device Class:

Class II

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#### 3. Indications for Use

The PerculNav system is a stereotaxic accessory for computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET), CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with ultrasound, and so on. It may include instrumentation to display the simulated imsertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PercuNav system is intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting.

The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.

The PerculVav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:

- Image fusion for diagnostic clinical examinations and procedures
- · Soft tissue biopsies
- Soft tissue ablation
- Bone ablation
- · Bone biopsies
- Nerve blocks and pain management
- Drainage placements

#### Device Description 4.

The Philips PercuNav Image Fusion and Interventional Navigation System provides image-guided diagnostic and intervention that enables fusion of diagnostic images and guidance of tracked instruments to physiciandefined targets. The target can be indicated either pre-procedurally or intra-procedurally, either using images or relative to an indicated position on the patient. The system transforms two-dimensional patient images into dynamic representations that can be fused with live ultrasound or other previously acquired images. Those two-dimensional patient images, or scan sets, are derived from Ultrasound, CT, PET, PET/CT, and MRI. The resulting dynamic representation supports diagnostic review and instrument navigation.

The purpose of this Traditional 510(K) Pre-market Notification is to introduce a new semi-automated visualization tool entitled "Tumor Contouring" to the current PercuNav software system. The Tumor Contouring visualization tool is designed to aid the end user in the planning and targeting of lesions, structures, and other regions of interests prior to an interventional procedure, soft tissue ablation, etc. The Tumor Contouring tool allows the end user to generate and modify a 3D contour around a region or soft tissue structure of interest and then this contour, once accepted by the user, can be visualized and dynamically reformatted and fused in various imaging combinations for later procedures.

#### 5. Substantially Equivalent Devices

### Primary Predicate Device

Philips PercuNav Image Fusion an Interventional Navigation System K170716 April 21, 2017

### Reference Predicate Device

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| Philips Ultrasound, Inc. | Traditional 510(k)<br>PercuNav Image Fusion and Interventional<br>Navigation System | | Page 4 of 11 |
|--------------------------|-------------------------------------------------------------------------------------|---------|-------------------|
| | Philips QLAB Advanced Quantification Software (GI 3 DQ) | K191647 | December 20, 2019 |
| | Veran Medical Technologies IG 4 Image Guided Software | K093995 | January 27, 2010 |

## 6. Technological Comparison to Predicate Devices

The PercuNav Image Fusion and Interventional Navigation System with the addition of the Tumor Contouring visualization tool has the same intended use and similar technological characteristics as the legally marketed primary PercuNav predicate device. A comparison of the proposed PercuNav System (including the Tumor Contouring visualization tool) to the currently marketed predicate PercuNav device and the reference predicates Philips QLAB System (GI 3 DQ application) and Veran Medical Technologies IG 4 Image Guided Software are provided in the table below:

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Table 8.1: Comparison of Subject Philips PerculVar and Interventional Navigation to the predicate Philips Percultay Image Fusion and Interventional Navigation, QLAB Advanced Quantification Software (GI 3DQ Application) and Veran Medical Technologies IG 4 Image Guided System.

| | Subject Device | Predicate Device | Reference Predicate Device | Reference Predicate Device | Explanation of Differences | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Philips Ultrasound, Inc. | Philips Ultrasound, Inc. | Philips Ultrasound, Inc. | Veran Medical Technologies | None | |
| Trade Name | PercuNav System | PercuNav System | QLAB System | IG 4 Image Guided System | None | |
| Feature | Tumor Contouring Visualization<br>Tool | PercuNav Software | QAPP - GI 3DQ | IG 4 Software | None | |
| 510(k) Number | Pending | K170716 | K191647 | K093995 | None | |
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.2050 | 21 CFR 892.1750 | | |
| Regulation Name | Computed tomography x-ray<br>system | Computed tomography x-ray system | System, Image processing,<br>Radiological - Picture<br>Archiving and<br>Communications System<br>(PACS) | Computed tomography x-ray<br>system | Regulation Number,<br>Regulation Name,<br>Classification, and Product<br>Code are identical between<br>subject device and primary<br>predicate device. | |
| Classification | Class II | Class II | Class II | Class II | | |
| Product Code(s) | JAK, IYO, LLZ | JAK, IYO, LLZ | LLZ | JAK | | |
| Indications for Use | The PercuNav system is a<br>stereotaxic accessory for<br>computed tomography (CT),<br>cone beam CT (CBCT), magnetic<br>resonance (MR), ultrasound<br>(US), and positron emission<br>tomography (PET). CT,<br>Ultrasound, PET, and MR may be<br>fused in various combinations,<br>such as CT with MR, MR with<br>ultrasound, and so on. It may<br>include instrumentation to<br>display the simulated image of a<br>tracked insertion tool such as a<br>biopsy needle or probe on a<br>computer monitor screen that<br>shows images of the target<br>organs and the current and the<br>projected future path of the<br>interventional instrument. The<br>PercuNav system is intended for | The PercuNav system is a stereotaxic<br>accessory for computed tomography<br>(CT), magnetic resonance (MR),<br>ultrasound (US), and positron<br>emission tomography (PET). CT,<br>Ultrasound, PET, and MR may be<br>fused in various combinations, such<br>as CT with MR, MR with ultrasound,<br>and so on. It may include<br>instrumentation to display the<br>simulated image of a tracked<br>insertion tool such as a biopsy needle<br>or probe on a computer monitor<br>screen that shows images of the<br>target organs and the current and the<br>projected future path of the<br>interventional instrument. The<br>PercuNav system is intended for<br>treatment planning and guidance for<br>clinical, interventional, or diagnostic<br>procedures. The PercuNav system<br>also supports an image-free mode in | QLAB Quantification<br>software is a software<br>application package. It is<br>designed to view and<br>quantify image data<br>acquired on Philips<br>ultrasound systems. | The ig4™ Image Guided<br>System is a stereotactic<br>accessory for Computed<br>Tomography (CT) or 3D<br>fluoroscopic x-ray systems.<br>The ig4 System is indicated<br>for displaying an<br>interventional instrument<br>such as a biopsy needle, an<br>aspiration needle, or ablation<br>needle on a computer<br>monitor that also displays<br>CT-based or 3D fluoroscopic<br>x-ray based model of the<br>target organ(s). The ig4™<br>System is additionally<br>indicated for overlaying<br>Ultrasound images onto the<br>model of the target organ(s).<br>The ig4™ System<br>compensates for the patient's<br>respiratory phases. | The Indications for Use of the<br>subject PercuNav System and<br>the primary predicate<br>PercuNav System are the<br>same and have not<br>fundamentally changed from<br>the previous clearance of this<br>system. The PercuNav and<br>QLAB System are similar in<br>regards to image display and<br>quantification purposes to<br>the end user. Additionally,<br>the subject PercuNav System<br>and the Veran ig4 System<br>also share similar indications<br>for use in regards to<br>visualization technologies<br>being used for procedural<br>planning and instrument<br>focused interventions.<br>Moreover, the Veran ig4<br>System is indicated for use | |
| | Subject Device | Predicate Device | Reference Predicate Device | Reference Predicate Device | Explanation of Differences | |
| Manufacturer | Philips Ultrasound, Inc. | Philips Ultrasound, Inc. | Philips Ultrasound, Inc. | Veran Medical Technologies | None | |
| Trade Name | PercuNav System | PercuNav System | QLAB System | IG 4 Image Guided System | None | |
| Feature | Tumor Contouring Visualization Tool<br>guidance for clinical, interventional, or diagnostic procedures in a clinical setting.<br><br>The PercuNav system is also intended to supplement live imaging in clinical interventions to determine the proximity of one device relative to another.<br><br>The PercuNav system is not intended to be the sole guidance for any procedure. Procedures that can be guided by the PercuNav system adjunctively include, but are not limited to, the following:<br>• Image fusion for diagnostic clinical examinations and procedures<br>• Soft tissue biopsies<br>• Soft tissue ablation<br>• Bone ablation<br>• Bone biopsies<br>• Nerve blocks and pain management<br>• Drainage placements | PercuNav Software<br>which the proximity of the interventional device is displayed relative to another device.<br><br>The PercuNav system is intended to be used in interventional and diagnostic procedures in a clinical setting. The PercuNav system is also intended for use in clinical interventions to determine the proximity of one device relative to another.<br><br>Example procedures include, but are not limited to, the following:<br>• Image fusion for diagnostic clinical examinations and procedures<br>• Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, and so on.)<br>• Soft tissue ablation (liver, kidney, breast, pancreas, lung, and so on)<br>• Bone ablations<br>• Bone biopsies<br>• Nerve blocks and pain management<br>• Drainage placements<br>• Tumor resections | QAPP - GI 3DQ | IG 4 Software<br>The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography, 3D fluoroscopic x-ray, or ultrasound are currently used for visualizing such procedures. | None<br>with 3D fluoroscopic x-ray systems, which is a term that is synonymous with Cone Beam CT imaging acquisition | |
| System Components | • Field Generator (FG) | • Field Generator (FG) | The sole component of the | • EM tracking | The System Components of…