Who is the manufacturer of EP NAVIGATOR REL. 5.0?

Philips Medical Systems Nederland B.V. filed the 510(k) submission for EP NAVIGATOR REL. 5.0 (K142126).

What is the FDA product code for EP NAVIGATOR REL. 5.0?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for EP NAVIGATOR REL. 5.0?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for EP NAVIGATOR REL. 5.0?

EP navigator Rel. 3.0 (K101311); HeartNavigator Rel. 2.0 (K140138).

Who can help prepare an FDA 510(k) submission like EP NAVIGATOR REL. 5.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EP NAVIGATOR REL. 5.0

K142126 · Philips Medical Systems Nederland B.V. · OWB · Dec 9, 2014 · Radiology

Device Facts

Record ID	K142126
Device Name	EP NAVIGATOR REL. 5.0
Applicant	Philips Medical Systems Nederland B.V.
Product Code	OWB · Radiology
Decision Date	Dec 9, 2014
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

EP navigator is intended to provide navigation support for cardiovascular devices for heart rhythm disorders, such as catheters and guidewires, by superimposing 3D cardiac anatomical image data, such as CT, MRI, or 3D rotational scan over intra-procedural X-ray images of the same anatomy.

Device Story

EP navigator Rel. 5.0 is a software medical device operating on a PC-based platform; used in clinical settings to assist physicians during cardiovascular procedures. Input data includes previously acquired 3D anatomical images (CT, MRI, or 3D rotational scans) and real-time intra-procedural X-ray images. The software segments 3D datasets, registers them with X-ray images, and superimposes the 3D anatomy and landmarks onto the live X-ray view. Features include visual marker placement (tag points), EndoView for internal volume visualization, manual 2D measurements, and anatomical-based viewing planes. It communicates with Philips X-ray systems to enable Automatic Position Control (APC). By providing a 3D roadmap of the patient's cardiac anatomy overlaid on live fluoroscopy, the device aids navigation of catheters and guidewires, potentially improving procedural accuracy and efficiency for heart rhythm disorder treatments.

Clinical Evidence

No clinical data; bench testing only. Verification and validation testing, including system verification and assessment of individual modifications, demonstrated compliance with IEC 62304, IEC 62366, ISO 14971, and NEMA PS 3.1-3.20 standards.

Technological Characteristics

PC-based software medical device. Integrates with Philips X-ray systems. Features: 3D image segmentation (CT, MRI, rotational scan), registration, and superimposition. Connectivity: DICOM compliant. Standards: IEC 62304 (software lifecycle), IEC 62366 (usability), ISO 14971 (risk management), NEMA PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for patients with heart rhythm disorders requiring cardiovascular device navigation (e.g., catheters, guidewires) during interventional procedures.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

EP navigator Rel. 3.0 (K101311)
HeartNavigator Rel. 2.0 (K140138)

Reference Devices

Allura Xper FD series (K133292)
Allura Xper OR Table series (K133292)

Related Devices

K101311 — EP NAVIGATOR R3 · Philips Medical Systems North America Co. · Sep 30, 2010
K092639 — INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP · GE Medical Systems SCS · Dec 2, 2009
K130069 — INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 · GE Healthcare · Apr 5, 2013
K062650 — EP NAVIGATOR SOFTWARE · Philips Medical Systems · Sep 21, 2006
K140138 — HEARTNAVIGATOR RELEASE 2.0 · Philips Medical Systems Nederland B.V. · Jun 10, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 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 a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Philips Medical Systems Nederland B.V. % Ms. Liselotte Kornmann Regulatory Affairs Manager Veenpluis 4-6 Best, 5684 PC Netherlands December 9, 2014 Re: K142126 Trade/Device Name: EP Navigator rel. 5.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: November 14, 2014 Received: November 17, 2014 Dear Ms. Kornmann: 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-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. {1}------------------------------------------------ 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/Resourcesfor You/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 yours, Robert A Ochs for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K142126 Device Name EP navigator Indications for Use (Describe) EP navigator is intended to provide navigation support for cardiovascular devices for heart rhythm disorders, such as catheters and guidewires, by superimposing 3D cardiac anatomical image data, such as CT, MRI, or 3D rotational scan over intra-procedural X-ray images of the same anatomy. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. # 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | July 31, 2014 | | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands Establishment Registration Number: 3003768277 | | | Contact Person: | Ms. Liselotte Kornmann, PhD Regulatory Affairs Manager Phone: +31 611621238 E-mail: Liselotte.Kornmann@philips.com | | | Device: | Trade Name: Common Name: Device Class: Classification Name: Classification Regulation: Classification Panel: Primary Product Code: Secondary Product Code: | EP navigator Rel. 5.0 EP navigator Class II Image-intensified fluoroscopic x-ray system 21CFR §892.1650 Radiology OWB (Interventional x-ray system) LLZ (system, image processing, radiological) | | Primary1 Predicate Device: | Trade Name: Manufacturer: 510(k) Clearance: Classification Regulation: Classification Name: Classification Panel: Device Class: Product Code: | Allura Xper FD series Allura Xper OR Table series Philips Medical Systems Nederland B.V. K133292 (March 05, 2014) 21 CFR, Part 892.1650 Image-intensified fluoroscopic x-ray system Radiology Class II OWB (primary), JAA (secondary) | | Secondary Predicate Devices #1: | Trade Name: Manufacturer: 510(k) Clearance: Classification Regulation: Classification Name: Classification Panel: Device Class: Product Code: | EP navigator Rel. 3.0 Philips Medical Systems Nederland B.V. K101311 (Sep 30, 2010) 21 CFR, Part 892.2050 Picture Archiving and Communications System Radiology Class II LLZ | | Secondary Predicate Devices #2: | Trade Name: Manufacturer: 510(k) Clearance: Classification Regulation: Classification Name: Classification Panel: Device Class: Product Code: | HeartNavigator Rel. 2.0 Philips Medical Systems Nederland B.V. K140138 (June 10, 2014) 21 CFR, Part 892.1650 Image-intensified fluoroscopic x-ray system Radiology Class II OWB, LLZ | | Device Description: | EP navigator Rel. 5.0 is a software medical device that contains image processing algorithms that are executed on a PC-based hardware platform. EP navigator Rel. 5.0 can perform the following functions: view previously acquired 3D anatomical image data in a slice viewer, such ● as CT, MRI, or 3D rotational scan, segment previously acquired 3D anatomical image data, ● register the segmented 3D dataset and landmarks with intra-procedural X-ray ● images, superimpose the segmented 3D dataset and landmarks on intra-procedural X- ● ray images of the same anatomy, position visual markers such as tag points, and ● visualize the inside of the 3D volume (EndoView). ● | | | Indications for Use: | EP navigator is intended to provide navigation support for cardiovascular devices for heart rhythm disorders, such as catheters and guidewires, by superimposing 3D cardiac anatomical image data, such as CT, MRI, or 3D rotational scan over intra-procedural X-ray images of the same anatomy. | | | Fundamental Scientific Technology: | EP navigator Rel. 5.0 is intended to be used in combination with the primary predicate device Allura X-ray system (K133292). While the secondary predicate device EP navigator Rel. 3.0 (K101311) and EP navigator Rel. 5.0 share the same technological characteristics, EP navigator Rel. 5.0 offers the following enhancements to existing functions: (1) Support of the import and automatic segmentation of MR datasets, (2) Reduced angular range of 3D EP rotational scan and support of the automatic segmentation of a 3D EP rotational scan with reduced angular angle, (3) Manual 2D measurements, (4) Anatomical-based viewing planes, and (5) Communication with Philips X-ray system, including Automatic Position Control (APC). The modifications represented by EP navigator Rel. 5.0 do not affect the safety and effectiveness of the device. | | 1 Note: the EP navigator Rel. 5.0 software medical device is an accessory to the currently marketed and primary predicate Allura Xper FD series and Allura Xper OR Table series K133292. The Allura Xper FD series and Allura Xper OR Table series will be abbreviated as Allura X-ray system in this 510(k) Premarket notification. Substantial equivalence demonstration to the primary predicate is not warranted as they are devices with which EP navigator Rel. 5.0 is to be used. Therefore, substantial equivalence is demonstrated to the secondary predicate devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and centered in the image. Therefore, EP navigator Rel. 5.0 is substantially equivalent to the currently marketed and secondary predicate EP navigator Rel. 3.0 (K101311) and HeartNavigator Rel. 2.0 (K140138) in terms of fundamental scientific technology. Summary of Nonclinical Performance Data: Non-clinical performance testing has been performed on EP navigator Rel. 5.0 and demonstrates compliance with the following International and FDArecognized consensus standards and FDA guidance document: - IEC 62304 Medical device software Software life cycle processes (Ed. 1.0, . 2006). - IEC 62366 Medical devices - Application of usability engineering to medical devices (Ed. 1.0, 2007), - ISO 14971 Medical devices Application of risk management to medical ● devices (Ed. 2.0, corrected version, 2007), - NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2011), and - . Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005, document number 337). Verification and validation tests have been performed to address intended use, the technical claims, requirement specifications and the risk management results. The modifications of the EP navigator Rel. 5.0 that are required to implement the enhancements are within the design controls and specifications; a system verification test was performed to ensure that the modifications are properly introduced; verification and validation testing was conducted to ensure the proper introduction of the individual modifications listed; sample clinical images as well as conformance to IEC standards and guidance documents were provided. All of these components and tests were used to support substantial equivalence of the subject device. The test results in this 510(k) premarket notification demonstrate that EP navigator Rel. 5.0 complies with the aforementioned international and FDArecognized consensus standards and FDA guidance document, meets the acceptance criteria, and is adequate for its intended use. Additionally, all risks are sufficiently mitigated, no new risks are introduced and the overall residual risk is acceptable. Therefore, EP navigator Rel. 5.0 is substantially equivalent to the currently marketed and secondary predicate devices EP navigator Rel. 3.0 (K101311) and HeartNavigator Rel. 2.0 (K140138) in terms of safety and effectiveness. Summary of Clinical EP navigator Rel. 5.0 did not require clinical studies to demonstrate substantial Data: equivalence to the currently marketed and secondary predicate devices EP navigator Rel. 3.0 (K101311) and HeartNavigator Rel. 2.0 (K140138). The EP navigator Rel. 5.0 software medical device is substantially equivalent to Substantial Equivalence the currently marketed and secondary predicate devices EP navigator Rel. 3.0 Conclusion: (K101311) and HeartNavigator Rel. 2.0 (K140138) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with nonclinical performance testing, which complied with the requirements specified in {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and the background is white. the international and FDA-recognized consensus standards. The non-clinical performance tests provided in this 510(k) premarket notification demonstrates that the proposed EP navigator Rel. 5.0 is as safe and effective as its predicate devices without raising any new safety and/or effectiveness concerns.