K Number
K170716
Device Name
PercuNav Image Fusion and Interventional Navigation
Date Cleared
2017-04-21

(43 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Unknown
The summary mentions "auto registrations" for liver vessel and liver surface, which could potentially utilize AI/ML for automated image registration. However, the description does not explicitly state the use of AI/ML, and the performance study focuses on comparing the accuracy to a manual method, not on validating an AI/ML algorithm. Without further information, it's unclear if these "auto registrations" are AI/ML-based or rely on other computational methods.

No.
The device is a stereotaxic accessory intended for "treatment planning and guidance for clinical, interventional, or diagnostic procedures," but it does not directly administer therapy itself.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "The PercuNav system is intended for treatment planning and guidance for clinical, interventional, or diagnostic procedures" and "The PercuNav system is intended to be used in interventional and diagnostic procedures in a clinical setting." The "Device Description" also mentions "image-guided diagnostic and intervention" and "The resulting dynamic representation supports diagnostic review and instrument navigation."

No

The device description explicitly mentions "tracked instruments" and "guidance of tracked instruments," implying the use of hardware components for tracking and navigation, which are not solely software.

Based on the provided text, the PercuNav system is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the living body.
  • PercuNav's Function: The PercuNav system is described as a stereotaxic accessory for various imaging modalities (CT, MR, US, PET). Its primary function is for treatment planning and guidance during clinical, interventional, or diagnostic procedures performed on the patient. It helps visualize and navigate instruments within the body based on medical images.
  • Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The system works with medical images and tracks instruments within the patient's body.

Therefore, the PercuNav system falls under the category of medical devices used for image-guided procedures and navigation, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

JAK, IYO, LLZ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Positron Emission Tomography (PET), PET/CT

Anatomical Site

Soft tissue (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery), Bone

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Interventional and diagnostic procedures in a 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 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.

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

Target Registration Error (TRE) for accuracy.

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.

K132087

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.

K122825, K130739, K152369, K092619

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

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles forming the staff of the symbol.

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

1

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

2

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

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

4

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.

5) Indications for Use

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

6) Technological comparison to predicate device

5

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 1

Comparison of the proposed PercuNav to the currently marketed Philips PercuNav
Comparative
CharacteristicsPercuNav (K132087)
(Predicate Device)PercuNav
(Proposed Device)
Indications for usePercuNav is a stereotaxic accessory
for Computed Tomography (CT),
Magnetic Resonance (MR),
Ultrasound (US), Positron Emission
Tomography (PET), Single Photon
Emission Computed Tomography
(SPECT), Rotational Fluoroscopy,
Endoscopy, and other imaging
systems. CT, Ultrasound, PET, MR,
and Rotational Fluoroscopy may be
fused in various combinations, such
as CT with MR, MR with ultrasound,
etc. It may include instrumentation to
display the simulated image of a
tracked insertion tool such as a
biopsy needle, guidewire 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
taking into account patient
movement. This is intended for
treatment planning and guidance for
clinical, interventional, and/or
diagnostic procedures. The device
also supports an image-free mode in
which the proximity of the
interventional device is displayed
relative to another device.
The device is intended to be used in
interventional and diagnostic
procedures in a clinical setting. The
device 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:
Image fusion for diagnostic
clinical examinations and
procedures Soft tissue biopsies (liver, lung,
kidney, breast, pancreas, bladderThe 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
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 proceduresmanagement Drainage placements Tumor resections Note: The proposed PercuNav no longer supports the bold features of the Predicate PercuNav (K132087).
Patient contact MaterialsNo change since K132087
Registration methodsManual registrationsManual registrations Automatic registration (CT/Ultrasound and MR/Ultrasound )
Tracked
Instrumentation/accessoryPatient tracker Ultrasound tracker Coaxial needle tracker (CNT) Adaptive needle tracker (ANT) Button probes Biopsy and RFA IntroducersSame 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 2
Comparison for PercuNav Registration feature to eSieFusion on Siemens ACUSON S3000

Ultrasound System
Comparative
CharacteristicseSieFusion
on Siemens ACUSON S3000
Ultrasound System
(Reference)PercuNav Registration
(Proposed)
Clearance statusK122825, K130739, and
K152369NO
Intended useTo align live ultrasound images
with previously acquired CT
imagesTo align live ultrasound images
with previously acquired CT or MR
images
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.