HEARTNAVIGATOR RELEASE 1

K111245 · Philips Medical Systems Nederland B.V. · LLZ · Jul 29, 2011 · Radiology

Device Facts

• Record ID: K111245
• Device Name: HEARTNAVIGATOR RELEASE 1
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LLZ · Radiology
• Decision Date: Jul 29, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

HeartNavigator Release 1 is a tool which assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance for structural heart disease procedures.

Device Story

HeartNavigator Release 1 utilizes patient cardiac 3D image data for interventional procedure planning and guidance. During planning, tool identifies/visualizes anatomical structures, determines/stores X-ray viewing angles, and evaluates device placement. During procedures, tool registers 3D data to X-ray system, recalls stored angles, and provides overlay of 3D data onto live fluoroscopy on a separate monitor. Operated by trained clinical specialists or assisting nurses in interventional settings. Output assists clinicians in navigating structural heart procedures; enhances visualization of anatomy relative to live X-ray; potentially improves procedural accuracy and patient outcomes.

Clinical Evidence

Clinical evaluation performed to demonstrate safety and effectiveness in the intended clinical environment. Non-clinical verification and validation testing included software verification, validation, and DICOM conformance testing.

Technological Characteristics

PC-based hardware platform; software-based image processing algorithms; DICOM compliant; integrates with Allura Xper systems for 3D image registration and fluoroscopic overlay.

Indications for Use

Indicated for patients of all ages with structural heart diseases undergoing interventional procedures. Used in combination with Allura Xper systems. Contraindications not specified.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Philips EP navigator (K101311)
• Philips Xper CT (K060749)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the text "K111245" and "Page 1 of 3". The text is centered above the word "PHILIPS".

# 510(k) summary

JUL 2 9 2011

The following information is submitted in accordance with the requirements of 21CFR 807.92.

# ldentification of manufacturer

| Company: | Philips Medical Systems Nederland B.V. |
|----------------------|----------------------------------------|
| Address: | Veenpluis 4-6, |
| | 5684-PC, Best, The Netherlands |
| Registration number: | 3003768277 |

# ldentification of U.S. designated agent

| Company: | Philips Medical Systems |
|----------------------|-----------------------------------------------------------------|
| Address: | 22100 Bothell Everett Highway<br>Bothell, WA 98021-8431, U.S.A. |
| Registration number: | 1217116 |

# ldentification of official correspondent

| Name: | Lynn Harmer |
|----------------|------------------------------------|
| Position: | Senior Manager, Regulatory Affairs |
| Telephone: | [phone] |
| Date prepared: | April 27, 2011 |

### Device identification

| Trade name: | Philips |
|-------------------------|---------------------------------------------|
| Device name: | HeartNavigator |
| Regulation description: | Picture archiving and communications system |
| Regulation number: | 21CFR 892.2050 |
| Class: | II |
| Product code: | 90L--LZ |

#### Legally marketed devices

| Trade names: | Philips EP navigator, Philips Xper CT |
|-----------------|---------------------------------------|
| Manufacturer: | Philips |
| 510(k) numbers: | K101311, K060749 |

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Image /page/1/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word, there is some smaller text that reads "KT11245" and "Page 2 of 3". A horizontal line is located underneath the word "PHILIPS".

### Device description

HeartNavigator Release 1 uses cardiac 3D image data of the patient as a source for procedure planning.

In the procedure planning phase, the tool supports the user to:

- Identify and Visualize relevant anatomical structures in the 3D image data. ।
- Determine and store the X-ray system viewing angles to be used during the l procedure.
- Evaluate device placement for the current treatment. -

During the procedure the tool allows the user to:

- Visualize the relevant anatomical structures in the 3D image data. -
- Recall stored viewing angles and assists the user to move to these angles. -
- Register the 3D image data to the X-ray system. -
- See an overlay image of the 3D image data and the live fluoroscopy on a sep-। arate monitor in addition to the normal monitor showing the conventional live X-ray without alteration.

#### Intended use

HeartNavigator Release 1 is a tool which assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance for structural heart disease procedures.

#### Indications for Use:

#### Medical purpose:

HeartNavigator Release 1 is a tool which assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance for structural heart disease procedures.

#### Patient population:

HeartNavigator Release 1 is intended to be used in combination with Allura Xper systems for treating the entire population of patients with structural heart diseases via interventional technologies.

#### Operator profile:

The user is a clinical specialist who is fully skilled and qualified to perform the structural heart disease procedure and is responsible for sound clinical judgment and for applying the best clinical procedure. The user may also be a nurse assisting the clinical specialist. The user must have received adequate training in its safe intended and effective use before operating the HeartNavigator.

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Image /page/2/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word, there is the text "K111245" and "Page 3 of 3". The text is smaller than the word "PHILIPS" and is located at the top center of the image.

# Technological characteristics

HeartNavigator Release 1 image software processing algorithms are executed on a PC based hardware platform

### Summary of testing

HeartNavigator Release 1 complies with standards as detailed in this premarket submission. Clinical evaluation was performed to show safety and effectiveness of HeartNavigator Release 1 in the intended clinical environment. Non-clinical verification and validation tests were performed relative to the requirement specifications and risk management results, specifically including software verification, validation and DICOM conformance testing. Corresponding clinical evaluation report and test results are included in this submission.

Conclusion:................................................................................................................................................................... currently legally marketed devices.

This opinion is based on the following:

- HeartNavigator Release 1 does not introduce new . technology
- HeartNavigator Release 1 does not raise new issues . of safety and effectiveness.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Philips Medical Systems Nederland B.V. % Lynn Harmer Sr. Manager, IS Regulatory Affairs Philips Healthcare 22100 Bothell Everett Highway BOTHELL WA 98021-8431

2 9 2011

Re: K111245

Trade/Device Name: HeartNavigator Release 1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 2, 2011 Received: May 3, 2011

Dear Ms. Harmer:

:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Device Name

HeartNavigator

# Indications for Use

#### Medical purpose:

HeartNavigator Release 1 is a tool which assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance for structural heart disease procedures.

#### Patient population:

HeartNavigator Release 1 is intended to be used in combination with Allura Xper systems for treating the entire population of patients with structural heart diseases via interventional technologies.

#### Operator profile:

The user is a clinical specialist who is fully skilled and qualified to perform the structural heart disease procedure and is responsible for sound clinical judgment and for applying the best clinical procedure. The user may also be a nurse assisting the clinical specialist. The user must have received adequate training in its safe intended and effective use before operating the HeartNavigator.

# Intended use

HeartNavigator Release 1 is a tool which assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance for structural heart disease procedures.

#### Device description:

HeartNavigator Release 1 uses cardiac 3D image data of the patient as a source for procedure planning.

In the procedure planning phase, the tool supports the user to:

- Identify and Visualize relevant anatomical structures in the 3D image data. l
- -Determine and store the X-ray system viewing angles to be used during the procedure.
- Evaluate device placement for the current treatment. ・

.

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During the procedure the tool allows the user to:

- Visualize the relevant anatomical structures in the 3D image data. -
- Recall stored viewing angles and assists the user to move to these angles. -
- Register the 3D image data to the X-ray system. -
- See an overlay image of the 3D image data and the live fluoroscopy on a -
- separate monitor in addition to the normal monitor showing the conventional . live X-ray without alteration.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __No__ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S Patil
(Division Sign-On

Office of In

510K K///245