The PercuNav system is a stereotaxic accessory for computed tomography (CT), 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 PercuNav system is intended for treatment planning and guidance for clinical, interventional, or diagnostic procedures. The PercuNav system also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.

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.

Example procedures include, but are not limited to, the following:

· Image fusion for diagnostic clinical examinations and procedures
· Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, and so on.)
· Soft tissue ablation (liver, kidney, breast, pancreas, lung, and so on)
Bone ablations
Bone biopsies
· Nerve blocks and pain management
Drainage placements
Tumor resections

Device Description

The proposed PercuNav provides image-guided diagnostic and intervention that enables fusion of diagnostic images and guidance of tracked instruments to physician-defined 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 proposed PercuNav provides real-time, three-dimensional visualization and navigation tools for all stages of diagnosis and intervention, including pre-procedure planning and procedure navigation. 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 PercuNav system performs spatial mapping from one image space to another image space or from image space to physical space (registration), allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive diagnostic and interventional procedures.

Features include the following:

Multiple Applications: The PercuNav system supports multiple applications and can be used for ablations, biopsies, and other diagnostic and guidance procedures.
Multiple Modalities: The PercuNav system works with images from multiple modalities, including but not limited to CT, MR, PET, and ultrasound.

AI/ML Overview

The Philips PercuNav Image Fusion and Interventional Navigation system, as described in the provided 510(k) summary, adds automatic MR/ultrasound registrations as a new technological characteristic compared to its predicate device. The performance data presented focuses on the accuracy of these new auto-registration features.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Accuracy of auto registrations (liver vessel and liver surface)	The accuracy of auto registrations is "as good as that of the manual registration" (qualitative statement, no specific quantitative metric provided in the summary).

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

The document states that "The accuracy test was done for the liver vessel and liver surface auto registrations." However, it does not specify the sample size used for this testing.

Regarding data provenance, the document does not explicitly state the country of origin of the data. Given Philips Ultrasound Inc. is in Bothell, WA, USA, and the FDA is a U.S. regulatory body, it's highly probable the data is primarily from the United States. The study is a non-clinical performance test, and it's implied to be retrospective as it's a test of the developed feature, not a prospective clinical trial.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. The ground truth for the accuracy test is implicitly the "existing manual registration method available on the currently cleared PercuNav (K132087)." This suggests that the accuracy of the manual registration was used as the benchmark against which the auto-registrations were compared, rather than a separate expert-derived ground truth.

4. Adjudication Method for the Test Set

The document does not describe any explicit adjudication method. The comparison is between the automated process and an existing manual process, implying the manual process provided the reference.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The proposed PercuNav did not require clinical study, since substantial equivalence to the currently marketed predicate devices... was demonstrated with the following attributes... Non-clinical performance testing." The testing described is a non-clinical accuracy test of the auto-registration feature itself, not a study of how human readers improve with AI assistance.

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

Yes, a standalone (algorithm only) performance study was done for the auto-registration features. The accuracy test directly assessed the performance of the auto-registration algorithm by comparing it to the manual registration method. This is an algorithm-only test, as there is no human decision-making loop described for the output of the auto-registration.

7. The Type of Ground Truth Used

The ground truth used for the accuracy test was the established accuracy of the "existing manual registration method available on the currently cleared PercuNav (K132087)." This implies that the accuracy of this manual method served as the reference against which the automated method was deemed "as good as." This is not expert consensus from independent readers, pathology, or outcomes data. It is a comparison to a previously validated manual system.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the auto-registration algorithms.

9. How the Ground Truth for the Training Set was Established

The document does not explicitly state how the ground truth for the training set was established. Given the nature of the device (image fusion and navigation), it is highly probable that the training data's "ground truth" for registration would involve:

Careful manual registration performed by trained operators/engineers.
Potentially, phantoms with known geometric properties.
Utilizing the established accuracy of the predicate device's manual registration technology.

However, this is inferred, as the document provides no specific details on the training data or its ground truth establishment.

Summary

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Public Health Service

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

April 21, 2017

Philips Ultrasound Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street. Nw Buffalo, Minnesota 55313

Re: K170716

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 5, 2017 Received: April 12, 2017

Dear Mark Job:

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

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

Sincerely,

Michael D'Hara

For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170716

Device Name

PercuNav Image Fusion and Interventional Navigation

Indications for Use (Describe)

The PercuNav system is a stereotaxic accessory for computed tomography (CT), 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 guidance for clinical, or diagnostic procedures. The PercuNav system also supports an image-free mode in which the interventional device is displayed relative to another device.

The PerculVav 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.

Example procedures include, but are not limited to, the following:

· Image fusion for diagnostic clinical examinations and procedures
· Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, and so on.)
· Soft tissue ablation (liver, kidney, breast, pancreas, lung, and so on)
· Bone ablations
· Bone biopsies
· Nerve blocks and pain management
· Drainage placements
· Tumor resections

Type of Use (Select one or both, as applicable)

☑ Research Use (Part 21 CFR 801.4 exempt)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

1. Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431
  Contact person: Peng Cui. Regulatory Affairs Specialist Email: peng.cui@philips.com Tel: (978) 659-7966 Fax: (978) 487-4450

Date prepared: April 18, 2017

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/usual name: Computer assisted, image-guided surgery system Proprietary name: PercuNav Image Fusion and Interventional Navigation

Classification Name: Computed Tomography X-ray System Class II as described in 21 CFR 892.1750 Primary Product Code: JAK Secondary Product Codes:

3) Substantially Equivalent Device

Philips Ultrasound believes the proposed PercuNav Image Fusion and Interventional Navigation (referred to as PercuNav in this summary) is substantially equivalent to the currently marketed Philips PercuNav (K132087).

4) Device Description

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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.

Features include the following:

Multiple Applications: The PercuNav system supports multiple applications and can be used for ablations, biopsies, and other diagnostic and guidance procedures.
Multiple Modalities: The PercuNav system works with images from multiple modalities, including but not limited to CT, MR, PET, and ultrasound.

5) Indications for Use

Example procedures include, but are not limited to, the following:

· Image fusion for diagnostic clinical examinations and procedures
· Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, and so on.)
· Soft tissue ablation (liver, kidney, breast, pancreas, lung, and so on)
Bone ablations
Bone biopsies
· Nerve blocks and pain management
Drainage placements
Tumor resections

6) Technological comparison to predicate device

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The technological characteristics of the proposed PercuNav are essentially the same as those included in the currently cleared and marketed PercuNav (K132087), except the addition of the auto MR/ultrasound registrations.

Table 1Comparison of the proposed PercuNav to the currently marketed Philips PercuNav
ComparativeCharacteristics	PercuNav (K132087)(Predicate Device)	PercuNav(Proposed Device)
Indications for use	PercuNav is a stereotaxic accessoryfor Computed Tomography (CT),Magnetic Resonance (MR),Ultrasound (US), Positron EmissionTomography (PET), Single PhotonEmission Computed Tomography(SPECT), Rotational Fluoroscopy,Endoscopy, and other imagingsystems. CT, Ultrasound, PET, MR,and Rotational Fluoroscopy may befused in various combinations, suchas CT with MR, MR with ultrasound,etc. It may include instrumentation todisplay the simulated image of atracked insertion tool such as abiopsy needle, guidewire or probe ona computer monitor screen that showsimages of the target organs and thecurrent and the projected future pathof the interventional instrumenttaking into account patientmovement. This is intended fortreatment planning and guidance forclinical, interventional, and/ordiagnostic procedures. The devicealso supports an image-free mode inwhich the proximity of theinterventional device is displayedrelative to another device.The device is intended to be used ininterventional and diagnosticprocedures in a clinical setting. Thedevice is also intended for use inclinical interventions to determine theproximity of one device relative toanother.Example procedures include, but arenot limited to:Image fusion for diagnosticclinical examinations andprocedures Soft tissue biopsies (liver, lung,kidney, breast, pancreas, bladder	The PercuNav system is a stereotaxicaccessory for computed tomography(CT), magnetic resonance (MR),ultrasound (US), and positron emissiontomography (PET). CT, Ultrasound,PET, and MR may be fused in variouscombinations, such as CT with MR,MR with ultrasound, and so on. It mayinclude instrumentation to display thesimulated image of a tracked insertiontool such as a biopsy needle or probeon a computer monitor screen thatshows images of the target organs andthe current and the projected futurepath of the interventional instrument.The PercuNav system is intended fortreatment planning and guidance forclinical, interventional, or diagnosticprocedures. The PercuNav system alsosupports an image-free mode in whichthe proximity of the interventionaldevice is displayed relative to anotherdevice.The PercuNav system is intended to beused in interventional and diagnosticprocedures in a clinical setting. ThePercuNav system is also intended foruse in clinical interventions todetermine the proximity of one devicerelative to another.Example procedures include, but arenot limited to, the following:Image fusion for diagnostic clinicalexaminations and procedures Soft tissue biopsies (liver, lung,kidney, breast, pancreas, bladder,adrenal glands, lymph node,mesentery, and so on.) Soft tissue ablation (liver, kidney,breast, pancreas, lung, and so on) Bone ablations Bone biopsies Nerve blocks and pain
	adrenal glands, lymph node, mesentery, etc. Soft tissue ablation (liver, kidney, breast, pancreas, lung, etc.) Bone ablations Bone biopsies Nerve Blocks & Pain Management Drainage placements Hydrodissections Bladder Stimulation Fiducial placements Tumor resections Sinus procedures Intranasal procedures Transphenoidal procedures	management Drainage placements Tumor resections Note: The proposed PercuNav no longer supports the bold features of the Predicate PercuNav (K132087).
Patient contact Materials	No change since K132087
Registration methods	Manual registrations	Manual registrations Automatic registration (CT/Ultrasound and MR/Ultrasound )
TrackedInstrumentation/accessory	Patient tracker Ultrasound tracker Coaxial needle tracker (CNT) Adaptive needle tracker (ANT) Button probes Biopsy and RFA Introducers	Same with addition of eTrax**eTrax has been cleared and marketed by CIVCO Medical (K092619).

Table 1: System Comparison to the Predicate device

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Table 2: Registration Feature Comparison

Table 2Comparison for PercuNav Registration feature to eSieFusion on Siemens ACUSON S3000Ultrasound System
ComparativeCharacteristics	eSieFusionon Siemens ACUSON S3000Ultrasound System(Reference)	PercuNav Registration(Proposed)
Clearance status	K122825, K130739, andK152369	NO
Intended use	To align live ultrasound imageswith previously acquired CTimages	To align live ultrasound imageswith previously acquired CT or MRimages
Registration methods	• Manual	• Manual

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7) Nonclinical Performance Data

Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the proposed PercuNav:

Software verification and validation To ensure the proposed PercuNav meets . the specifications and user needs.
. Non-Clinical Performance Data -- The accuracy test was done for the liver vessel and liver surface auto registrations. The accuracy was determined using the Target Registration Error (TRE) and was compared to an existing manual registration method available on the currently cleared PercuNav (K132087). The test results show the auto registrations' accuracy is as good as that of the manual registration.
. Non-Clinical Tests
- o AAMI / ANSI /ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (consolidated text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
- IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1 o 2: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- AAMI / ANSI / IEC 62304:2006, Medical Device Software Software о Life Cycle Processes
- AAMI / ANSI / ISO 10993-1:2009/(R) 2013. Biological Evaluation of o Medical devices - part 1: Evaluation and Testing Within A Risk Management Process
- ISO 11135 Second Edition 2014. Sterilization of Health-care Products о Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices
- AAMI ANSI ISO 11607-1:2006/(R)2010, Packaging For Terminally o Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]
- AAMI ANSI ISO 11607-2:2006/(R)2010, Packaging For Terminally o Sterilized Medical Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly Processes [Including: Amendment 1 (2014)]
. Quality assurance measures applied to the system design and development include, but were not limited to:
- . Risk Analysis
- Product Specifications ●
- Design Reviews ●
- Verification and Validation ●

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8) Clinical Data

The proposed PercuNay did not require clinical study, since substantial equivalence to the currently marketed predicate devices; Philips PercuNav (K132087) was demonstrated with the following attributes:

Design features; ●
Indication for use;
Fundamental scientific technology: .
Non-clinical performance testing; and ●
Safety and effectiveness. ●

9) Conclusion

Based on the conformance to standards, development under Philips Ultrasound's quality system, and the successful verification and the performance testing. Philips Ultrasound believes that the proposed PercuNav is substantially equivalent to the predicate device Philips PercuNav (K132087). The proposed PercuNav has different technological characteristics such as auto liver vessel and surface registrations but these differences do not raise new questions of safety and effectiveness. The performance test data demonstrates the auto registrations' accuracy is as good as that of the existing manual registration available on the currently cleared PercuNav (K132087). Therefore, the proposed PerculNav is as safe and effective as the currently marketed and predicate device, Philips PercuNav (K132087), without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.