HEARTNAVIGATOR RELEASE 2.0

K140138 · Philips Medical Systems Nederland B.V. · OWB · Jun 10, 2014 · Radiology

Device Facts

• Record ID: K140138
• Device Name: HEARTNAVIGATOR RELEASE 2.0
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: OWB · Radiology
• Decision Date: Jun 10, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

HeartNavigator is a tool to assist the user with the treatment of structural heart diseases using minimal invasive interventional techniques. In addition to the conventional live fluoroscopy it provides the user with tools to plan and guide the procedure using 3D image data.

Device Story

HeartNavigator Release 2.0 is a software tool used as an accessory to the AlluraClarity Xper FD series X-ray system. It integrates previously acquired patient DICOM cardiac CT data with live X-ray fluoroscopy to assist cardiac surgeons and interventional radiologists during structural heart procedures. The software provides 3D image-based planning and guidance tools. Key features include automatic anatomical distance measurements and real-time tracking of the X-ray system's table and L-arm movements during live guidance. By overlaying 3D anatomical data onto live fluoroscopic images, the device aids clinicians in procedure planning and navigation, potentially improving precision in minimally invasive interventions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical verification and validation testing, including software verification, against international consensus standards (IEC 62366, IEC 62304, ISO 14971, NEMA PS 3.1-3.2).

Technological Characteristics

Software-based medical device accessory to X-ray systems. Utilizes DICOM cardiac CT data and live X-ray inputs. Features include automatic anatomical distance measurement algorithms and real-time tracking of mechanical table/L-arm positions. Complies with IEC 62304 (software life cycle) and NEMA PS 3.1-3.2 (DICOM).

Indications for Use

Indicated for use by cardiac surgeons and interventional radiologists to assist in the planning and treatment of structural heart diseases via minimally invasive interventional techniques.

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

• AlluraClarity Xper FD series X-ray system (K130638)
• HeartNavigator Release 1.0 (K111245)

Submission Summary (Full Text)

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# JUN 1 0 2014

K140138
Page 1 of 2

## 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness has been prepared in accordance with Code of Federal Regulations, Title 21 CFR, Part 807.92.

| Date Prepared: | May 23, 2014 |
|--------------------------------|--------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands |
| Contact Person: | Hans Venings<br>Telephone: [phone] |
| Device Name: | HeartNavigator Release 2.0 |
| Classification: | |
| Classification regulation: | 21 CFR, Part 892.1650 |
| Classification name: | Image-intensified fluoroscopic x-ray system |
| Classification panel: | Radiology |
| Device classification: | Class II |
| Primary Product Code: | OWB |
| Secondary Product Code: | LLZ |
| Primary' Predicate<br>Device: | |
| Trade name: | AlluraClarity Xper FD series X-ray system |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| FDA clearance: | K130638 (June 28, 2013) |
| Classification regulation: | 21 CFR, Parts 892.1650 |
| Classification name: | Image-intensified fluoroscopic x-ray system |
| Classification panel: | Radiology |
| Device classification: | Class II |
| Product Code: | OWB |
| Secondary Predicate<br>Device: | |
| Trade name: | HeartNavigator Release 1.0 |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| FDA clearance: | K111245 (July 29, 2011) |
| Classification regulation: | 21 CFR, Parts 892.2050 |
| Classification name: | Picture archiving and communications system |
| Classification panel: | Radiology |
| Device classification: | Class II |
| Product Code: | LLZ |

1 The HeartNavigator software medical device is an accessory to the AlluraClarity Xper FD series X-ray system. The AlluraClarity Xper FD Series X-ray system will be abbreviated as Allura X-ray system in this 510(k) Summary of Safety and Effectiveness. -

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K140138
Page 2 of 2

HeartNavigator is a tool to assist the user with the treatment of structural heart Indications for Use: diseases using minimal invasive interventional techniques. In addition to the conventional live fluoroscopy it provides the user with tools to plan and guide the procedure using 3D image data.

Device Description: The HeartNavigator software tool is intended to be used in combination with the primary predicate device Allura X-ray system (K130638) to assist cardiac surgeons and interventional radiologists with the planning and treatment of structural heart diseases using minimal invasive interventional techniques. In addition to conventional live fluoroscopy HeartNavigator provides the user with tools to plan and guide the procedure using 3D image data; by enabling the use of previously acquired DICOM cardiac CT data of the patient in conjunction with the X-ray image data from the Allura X-ray system. While HeartNavigator Release 1.0 (K111245) and Release 2.0 share the same technological characteristics, HeartNavigator Release 2.0 offers enhancements to existing functions, i.e., (1) automatic anatomical distance measurements, and (2) tracking movements of the table and L-arm of the connected Allura X-ray system during live guidance. The modifications represented by HeartNavigator Release 2.0 do not affect the safety and effectiveness of the device.

#### Performance Data:

The HeartNavigator conforms to the following international standards:

- IEC 62366 Application of usability engineering to medical devices (2007); .
- IEC 62304 Medical device software Software life cycle processes (2006); .
- ISO 14971 Application of risk management to medical devices (2007); .
- . NEMA PS 3.1-3.2 Digital Imaging and Communications in Medicine (DICOM) Set (2011).

Non-clinical verification and validation tests were performed with respect to the requirement specifications, including software verification and validation. The test results demonstrate that HeartNavigator Release 2.0 meets the acceptance criteria, and is adequate for its intended use.

Substantial Equivalence Conclusion:

Substantial equivalence was demonstrated with non-clinical performance (verification and validation) testing, which complied with the requirements specified in the international, FDA-recognized consensus standards. The results of these tests demonstrate that the HeartNavigator Release 2.0 software medical device is safe, effective and performs as well or better than the secondary predicate device HeartNavigator Release 1.0 (K111245).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MI) 20993-0002

June 10, 2014

Philips Medical Systems Nederland B.V. % Michael Davion, MA, RAC Senior Consultant Biomed Research, Inc. 3959 Van Dyke Road, Suite 245 LUTZ FL 33558

Re: K140138 Trade/Device Name: HeartNavigator Release 2.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: March 8, 2014 Received: March 13, 2014

Dear Mr. Dayton:

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 for and starsing 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 cither 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 r rease of a 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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse cvents) (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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### Page 2 - Mr. Michael Dayton

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 [phone] or [phone] 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" (2) 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 Biometries/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours,

Sm.7)

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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K140138

Device Name HeartNavigator Release 2.0

Indications for Use (Describe)

HeartNavigator is a tool to assist the user with the treatment of structural heart diseases using minimal invasive interventional techniques. In addition to the conventional live fluoroscopy it provides the user with tools to plan and guide using 3D image data.

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)

## 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)

Sm.h.7)

FORM FDA 3881 (9/13)

nor Servers (10) | 443 PSC Pub

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