(23 days)
No
The document describes a "semi-automated visualization tool" for contouring, which is typically based on traditional image processing techniques, not AI/ML. There are no mentions of AI, ML, or related terms like deep learning or neural networks. The performance studies section also does not mention metrics commonly associated with AI/ML model evaluation.
No.
Explanation: The device is intended for treatment planning and guidance for clinical, interventional, or diagnostic procedures, but it does not directly provide therapy. It is described as an "Image Fusion and Interventional Navigation System" and acts as an accessory to imaging modalities, displaying simulated images and assisting in instrument guidance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the PercuNav system is "intended for treatment planning and to assist guidance for clinical, interventional, or diagnostic procedures in a clinical setting." Furthermore, the "Device Description" mentions that it "provides image-guided diagnostic and intervention."
No
The device description explicitly states it is a "System" and mentions "instrumentation to display the simulated image of a tracked insertion tool". This implies hardware components beyond just software are part of the device. The 510(k) is for a software modification to an existing system, not the system itself being purely software.
Based on the provided text, the Philips PercuNav system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- PercuNav's Function: The PercuNav system is described as a stereotaxic accessory and image guidance system. Its primary function is to assist in treatment planning and guide interventional or diagnostic procedures on the patient's body using imaging modalities. It helps visualize and navigate instruments within the body based on medical images.
- No Specimen Analysis: There is no mention of the PercuNav system analyzing any biological specimens from the patient. Its inputs are medical images, and its output is guidance information for procedures performed directly on the patient.
Therefore, the PercuNav system falls under the category of medical devices used for image guidance and navigation during procedures, not for in vitro analysis of specimens.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
JAK, IYO, LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT), cone beam CT (CBCT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET).
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting.
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)
Non-Clinical Testing: The proposed software modifications (the introduction of the Tumor Contouring visualization tool) to the subject Philips PercuNav System were tested in accordance with Philips internal processes. Successful completion of the prescribed verification testing support the proposed modification to the PercuNav System software relative to the currently marketed unmodified PercuNav System.
Design Control activities to assure the safe and effective performance of the modified PercuNav System software / Tumor Contouring visualization tool include but are not limited to the following:
- Software Verification – Standard verification testing in order to ensure the proposed PercuNav meets the specifications and user needs
- Quality Assurance measure applied to the system design and development, include, but were not limited to:
- Risk Analysis
- Product Specifications
- Design Reviews O
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 8: 510(k) Summary
4
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: (908) 227-9423 | |
| Fax: 425-402-3481 | |
| 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 |
| 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
5
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
6
| Philips Ultrasound, Inc. | Traditional 510(k)
PercuNav Image Fusion and Interventional
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:
7
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 | |||||
| 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 | |||||
| system | Computed tomography x-ray system | System, Image processing, | ||||
| Radiological - Picture | ||||||
| Archiving and | ||||||
| Communications System | ||||||
| (PACS) | Computed tomography x-ray | |||||
| system | Regulation Number, | |||||
| Regulation Name, | ||||||
| Classification, and Product | ||||||
| Code are identical between | ||||||
| subject device and primary | ||||||
| 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 | |||||
| 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 | ||||||
| PercuNav system is intended for | 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 | QLAB Quantification | |||||
| software is a software | ||||||
| application package. It is | ||||||
| designed to view and | ||||||
| quantify image data | ||||||
| acquired on Philips | ||||||
| ultrasound systems. | The ig4™ Image Guided | |||||
| System is a stereotactic | ||||||
| accessory for Computed | ||||||
| Tomography (CT) or 3D | ||||||
| fluoroscopic x-ray systems. | ||||||
| The ig4 System is indicated | ||||||
| for displaying an | ||||||
| interventional instrument | ||||||
| such as a biopsy needle, an | ||||||
| aspiration needle, or ablation | ||||||
| needle on a computer | ||||||
| monitor that also displays | ||||||
| CT-based or 3D fluoroscopic | ||||||
| x-ray based model of the | ||||||
| target organ(s). The ig4™ | ||||||
| System is additionally | ||||||
| indicated for overlaying | ||||||
| Ultrasound images onto the | ||||||
| model of the target organ(s). | ||||||
| The ig4™ System | ||||||
| compensates for the patient's | ||||||
| respiratory phases. | The Indications for Use of the | |||||
| subject PercuNav System and | ||||||
| the primary predicate | ||||||
| PercuNav System are the | ||||||
| same and have not | ||||||
| fundamentally changed from | ||||||
| the previous clearance of this | ||||||
| system. The PercuNav and | ||||||
| QLAB System are similar in | ||||||
| regards to image display and | ||||||
| quantification purposes to | ||||||
| the end user. Additionally, | ||||||
| the subject PercuNav System | ||||||
| and the Veran ig4 System | ||||||
| also share similar indications | ||||||
| for use in regards to | ||||||
| visualization technologies | ||||||
| being used for procedural | ||||||
| planning and instrument | ||||||
| focused interventions. | ||||||
| Moreover, the Veran ig4 | ||||||
| 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 | |||||
| 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 | PercuNav Software
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 | QAPP - GI 3DQ | IG 4 Software
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
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 | |
| | 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 | PercuNav Software | QAPP - GI 3DQ | IG 4 Software | None | |
| | Tool Connection Unit
(TCU) PercuNav Software Instrumentation | Tool Connection Unit (TCU) PercuNav Software Instrumentation | QLAB System is a software
platform with individually
designated QAPPs (i.e. GI 3
DQ, etc.). | accessory for needles and ultrasound probes Patient referencing system EM Field Generator and Tracking System Ig4 software | the subject PercuNav System
and the primary predicate
PercuNav System are
identical and have not been
changed from the previous
clearance of this system. As
mentioned, the scope of this
submission is to introduce
modifications to the
PercuNav Software in
releasing the Tumor
Contouring visualization tool.
The subject PercuNav and
the predicate IG4 Systems
are similar in regards to the
system components
including technologies to
facilitate instrumentation
tracking. | |
| Tracked Instrumentation /
Accessories | Patient Tracker Ultrasound Tracker Coaxial Needle Tracker (CNT) Adaptive Needle Tracker (ANT) Button Probes Biopsy and RFA Introducers | Patient Tracker Ultrasound Tracker Coaxial Needle Tracker (CNT) Adaptive Needle Tracker (ANT) Button Probes Biopsy and RFA Introducers | The sole component of the
QLAB System is a software
platform with individually
designated QAPPs (i.e. GI 3
DQ, etc.). | EM Tracking accessory for needles and ultrasound probes Patient Referencing System | The Instrumentation /
Accessories of the subject
PercuNav System and the
primary predicate PercuNav
System are identical and have
not been changed from the
previous clearance of this
system. As mentioned, the
scope of this submission is to
introduce modifications to the
PercuNav Software in
releasing the Tumor
Contouring visualization tool.
The subject PercuNav and the | |
| | | 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 | PercuNav Software | QAPP - GI 3DQ | IG 4 Software | None |
| | | | | | | predicate IG4 System include
similar tracked instrumentation
and accessories in order to
track needles and/or US probes
in the tracking environment.
The Tumor Contouring tool |
| Software
Design | Tool /
Application
Description | Visualization tool generates
semi-automated anatomic
border detection based on
greyscale differentiation. The
tool generates a preliminary
border that the user must
modify and review. This tool
computes and presents the
volume of the contour to the end
user. | Transforms two-dimensional patient
images (Ultrasound, CT, PET,
PER/CT, and MRI) into dynamic
representation that can be fused with
live ultrasound or other previously
acquired images. The resulting
dynamic representation supports
diagnostic review and instrument
navigation within tracking volume
produced by the Field Generator. | Manual anatomic border
tracing then generates
automated 3D volume
measurement. Diameter
measurements are manually.
This app computes linear
measurements, area
measurements, stacked
contour volume
measurements, and ellipsoid
volume measurements. | The ig4TM Image Guided
System utilizes electromagnetic
tracking technology to locate
and navigate instruments
relative to a CT-based or 3D
fluoroscopic x-ray based model
of the patient anatomy. The
system software allows
additional data overlay of real-
time Ultrasound images onto
the model of the patient
anatomy. | provides the end user with
similar functionality as the GI
3DQ application as both
allow the user to generate a
border or contour around
the region of interest. The
Tumor Contouring tool is an
extension of the PercuNav
Software in that it relies on
the PercuNav software to
generate a 3D volume for the
user. Unlike the GI 3DQ
application, the Tumor
Contouring Tool provides a
preliminary contour based
on grey scale differentiation
to the end user and is
considered to be semi-
automated. However, both
the Tumor Contouring tool
and GI 3 DQ, require the user
to modify and confirm the
contour before it is accepted.
The predicate IG4 System
provides similar
visualization functionality to
the subject PercuNav 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
Tool | PercuNav Software | QAPP – GI 3DQ | IG 4 Software | None | |
| Contour
Generation | Preliminary borders and 3D
contour are created semi-
automatically based on grey
scale differentiation and then
the user is required to edit,
accept, or reject contours. As the
contour is being generated,
software displays volume
measurements for the selected
contour. | The ability to generate a contour
does not exist in the predicate device
and is the subject of the present
submission. | Preliminary borders are
created manually by end
user to create a 3D model
and the user is then
required to edit, accept or
reject contours. | The ability to generate a
contour is not clearly
mentioned as part of this
technology and is unknown if
this functionality exists | The Tumor Contouring tool
and the GI 3DQ application
both allow the user to create
a contour around a specified
region of interest. The
difference is that the Tumor
Contouring tool is
considered to be semi-
automated in that the tool
utilizes grey scale
differentiation to generate an
initial contour whereas the
GI 3DQ requires the user to
manually create the contour.
However, both the Tumor
Contouring tool and the GI
3DQ application require that
the end user review and
modify the contour, either at
individual points or the
overall area of the contour
itself, prior to accepting the
generated contour. | |
| Quantificati
on
Technology | Semi-automated contour
generation, by which the
software produces a preliminary
contour trace and then the user
must edit and accept contour,
within the tracking volume.
Creates 3D mesh to derive
volume measurement of the
contour generated. | The predicate PercuNav Software
does not produce or derive any
quantifiable measurements related
to the images. | Manual border tracing
over multiple slices;
Creates 3D mesh to derive
volume measurement;
diameter measurement
done via manual distance
measurement tool | The quantification
technology is not clearly
mentioned as part of this
technology and is unknown if
this technology exists. | The Tumor Contouring
visualization tool is a semi-
automated tool that
produces a contour around a
region based on grey scale
differentiation whereas the
GI 3DQ application utilizes a
manual contour to be
generated by the end user.
However, both the Tumor | |
| | 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 | PercuNav Software | QAPP - GI 3DQ | IG 4 Software | Contouring tool and the GI
3DQ application create and
utilize the 3D mesh to derive
measurements for the region
of interest. The Tumor
Contouring tool only
produces the volume of the
contour for the end user. | |
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7. Non-Clinical Testing
The proposed software modifications (the introduction of the Tumor Contouring visualization tool) to the subject Philips PercuNav System were tested in accordance with Philips internal processes. Successful completion of the prescribed verification testing support the proposed modification to the PerculVav System software relative to the currently marketed unmodified PercuNav System.
Design Control activities to assure the safe and effective performance of the modified PercuNav System software / Tumor Contouring visualization tool include but are not limited to the following:
- Software Verification – Standard verification testing in order to ensure the proposed PercuNav meets the specifications and user needs
- . Quality Assurance measure applied to the system design and development, include, but were not limited to:
- o Risk Analysis
- O Product Specifications
- Design Reviews O
8. Clinical Testing
The subject Philips PercuNav System did not require clinical data in order to make a determination for substantial equivalence when compared to the predicate device(s).
9. Conclusion
Based on the conformance to standards, development under Philips Ultrasound's Quality Management System, the successful verification and validation testing, Philips Ultrasound believes that the proposed Philips PercuNav System is substantially equivalent to the predicate devices. Testing performed demonstrated that the proposed PercuNav System with the Tumor Contouring visualization tool meets the defined requirements and performance claims.