(127 days)
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.
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).
The provided text describes EP navigator Rel. 5.0, a software medical device that offers navigation support for cardiovascular devices by superimposing 3D anatomical image data (CT, MRI, 3D rotational scan) over intra-procedural X-ray images. However, the document does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes, ground truth establishment for test or training sets, expert qualifications, adjudication methods, or MRMC studies.
The document states:
- "Verification and validation tests have been performed to address intended use, the technical claims, requirement specifications and the risk management results."
- "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."
- "EP navigator Rel. 5.0 did not require clinical studies to demonstrate substantial equivalence to the currently marketed and secondary predicate devices..."
Based on the provided text, the following information can be extracted or explicitly stated as not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (as per document) | Reported Device Performance (as per document) |
|---|---|
| Intended Use | Met |
| Technical Claims | Met |
| Requirement Specifications | Met |
| Risk Management Results | Met (risks sufficiently mitigated, no new risks, overall residual risk acceptable) |
| IEC 62304 | Compliance demonstrated |
| IEC 62366 | Compliance demonstrated |
| ISO 14971 | Compliance demonstrated |
| NEMA PS 3.1-3.20 (DICOM) | Compliance demonstrated |
| FDA Guidance Document (May 11, 2005) | Compliance demonstrated |
| Proper introduction of individual modifications (listed as enhancements) | Ensured through verification and validation testing |
Note: The document states that the device "meets the acceptance criteria," but it does not detail what those specific quantitative or qualitative criteria were for each function or claim, nor does it provide specific performance metrics beyond a statement of compliance.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. The text mentions "sample clinical images" were used, but no details on size, country of origin, or whether they were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed, or at least not described. The document explicitly states: "EP navigator Rel. 5.0 did not require clinical studies to demonstrate substantial equivalence..." This suggests that human-in-the-loop performance studies were not a requirement for this 510(k) submission.
6. Standalone (Algorithm Only) Performance Study:
The document primarily focuses on non-clinical performance testing for verification and validation of features and compliance with standards. It performed "system verification test" and "verification and validation testing" of individual modifications using "sample clinical images." However, it does not explicitly provide a separate, detailed "standalone performance study" with specific metrics (e.g., accuracy, precision) for its algorithms in isolation. The testing appears to be focused on ensuring functional correctness and compliance with design controls and standards.
7. Type of Ground Truth Used:
This information is not provided in the document. It mentions "sample clinical images," but how ground truth was established for these images is not detailed. Given the device's function (overlaying 3D data on X-ray), ground truth might involve accurate registration and anatomical landmark identification, but the method for validating this ground truth is not described.
8. Sample Size for the Training Set:
This information is not provided in the document. The device uses "image processing algorithms" and is capable of "automatic segmentation of MR datasets" and "automatic segmentation of a 3D EP rotational scan," which implies machine learning or complex image processing that might involve training. However, no details on training data are given.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document.
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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.
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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
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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 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277 | |
| Contact Person: | Ms. Liselotte Kornmann, PhDRegulatory Affairs ManagerPhone: +31 611621238E-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. 5.0EP navigatorClass IIImage-intensified fluoroscopic x-ray system21CFR §892.1650RadiologyOWB (Interventional x-ray system)LLZ (system, image processing, radiological) |
| Primary1 PredicateDevice: | Trade Name:Manufacturer:510(k) Clearance:Classification Regulation:Classification Name:Classification Panel:Device Class:Product Code: | Allura Xper FD seriesAllura Xper OR Table seriesPhilips Medical Systems Nederland B.V.K133292 (March 05, 2014)21 CFR, Part 892.1650Image-intensified fluoroscopic x-ray systemRadiologyClass IIOWB (primary), JAA (secondary) |
| Secondary PredicateDevices #1: | Trade Name:Manufacturer:510(k) Clearance:Classification Regulation:Classification Name:Classification Panel:Device Class:Product Code: | EP navigator Rel. 3.0Philips Medical Systems Nederland B.V.K101311 (Sep 30, 2010)21 CFR, Part 892.2050Picture Archiving and Communications SystemRadiologyClass IILLZ |
| Secondary PredicateDevices #2: | Trade Name:Manufacturer:510(k) Clearance:Classification Regulation:Classification Name:Classification Panel:Device Class:Product Code: | HeartNavigator Rel. 2.0Philips Medical Systems Nederland B.V.K140138 (June 10, 2014)21 CFR, Part 892.1650Image-intensified fluoroscopic x-ray systemRadiologyClass IIOWB, LLZ |
| Device Description: | EP navigator Rel. 5.0 is a software medical device that contains imageprocessing 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 devicesfor heart rhythm disorders, such as catheters and guidewires, by superimposing3D cardiac anatomical image data, such as CT, MRI, or 3D rotational scan overintra-procedural X-ray images of the same anatomy. | |
| FundamentalScientificTechnology: | EP navigator Rel. 5.0 is intended to be used in combination with the primarypredicate device Allura X-ray system (K133292). While the secondary predicatedevice EP navigator Rel. 3.0 (K101311) and EP navigator Rel. 5.0 share thesame technological characteristics, EP navigator Rel. 5.0 offers the followingenhancements to existing functions: (1) Support of the import and automaticsegmentation of MR datasets, (2) Reduced angular range of 3D EP rotationalscan and support of the automatic segmentation of a 3D EP rotational scan withreduced angular angle, (3) Manual 2D measurements, (4) Anatomical-basedviewing planes, and (5) Communication with Philips X-ray system, includingAutomatic Position Control (APC). The modifications represented byEP 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.
§ 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.