(127 days)
No
The description focuses on standard image processing algorithms and registration techniques, without mentioning AI, ML, or related concepts like training data or performance metrics typically associated with AI/ML models.
No.
The device provides navigation support for cardiovascular devices, it does not directly treat heart rhythm disorders.
No
Explanation: The device provides navigation support by superimposing image data and does not independently diagnose or detect a disease or condition. Its purpose is to aid in procedures rather than to make a diagnosis.
Yes
The device description explicitly states "EP navigator Rel. 5.0 is a software medical device". While it runs on a PC-based hardware platform, the device itself is defined as the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide navigation support for cardiovascular devices during procedures by superimposing anatomical images over X-ray images. This is a diagnostic imaging and procedural guidance function, not a test performed on biological samples outside the body to diagnose a condition.
- Device Description: The device is software that processes and displays medical images. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The focus is entirely on image processing and visualization for procedural guidance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function falls outside of that definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, 3D rotational scan, intra-procedural X-ray images
Anatomical Site
Cardiac/heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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. 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. EP navigator Rel. 5.0 did not require clinical studies to demonstrate substantial equivalence to the currently marketed and secondary predicate devices EP navigator Rel. 3.0 (K101311) and HeartNavigator Rel. 2.0 (K140138).
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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.
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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.
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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
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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.