ENSITE VERISMO SOFTWARE

K051840 · St Jude Medical · LLZ · Aug 15, 2005 · Radiology

Device Facts

• Record ID: K051840
• Device Name: ENSITE VERISMO SOFTWARE
• Applicant: St Jude Medical
• Product Code: LLZ · Radiology
• Decision Date: Aug 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The EnSite Verismo™ Segmentation Tool (EV 1000) is indicated for use in generating 3D models from slice-based DICOM3 image data. Generated models are intended to be displayed on the EnSite® System.

Device Story

EnSite Verismo™ Segmentation Tool (EV1000) is software operating on EnSite System display workstation; imports DICOM slice data from CT/MRI scanners; segments data into 3D surface models; displays models during electrophysiology (EP) studies. Used by clinicians in clinical settings to visualize cardiac anatomy; aids in navigation and procedural planning during EP procedures; provides anatomical context to improve procedural outcomes.

Clinical Evidence

Bench testing only. Device validation conducted via bench and user tests in accordance with in-house procedures.

Technological Characteristics

Software-based segmentation tool; operates on EnSite System workstation; processes DICOM3 image data; generates 3D surface models for display.

Indications for Use

Indicated for generating 3D models from slice-based DICOM3 image data for display on the EnSite® System. No specific patient population, age, or disease state contraindications provided.

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

• Vitrea®2 (Vital Images, Inc)

Submission Summary (Full Text)

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K651840.

## AUG 1 5 2005

## 510(k) Summary for Public Disclosure

St. Jude Medical, Inc Submitter: Endocardial Solutions 1350 Energy Lane, Suite 110 St. Paul. MN 55108 USA Phone: [phone] Fax:

Karen J. McKelvey Contact: Regulatory Compliance Engineer

May 23, 2005 Date Prepared:

EnSite Verismo Trade Name:

Electrophysiology cardiac mapping system Common name:

(21 CFR Processing, Radiological lmage Classification Name: System, 892.2050)

Predicate Device: Vital Images, Inc - Vitrea®2

- Device Description: The EnSite Verismo™ Segmentation Tool is designed to function on the EnSite System's display workstation. This software tool allows importation of DICOM slice data from a variety of CT and MRI manufacturers. Once imported into the EnSite System, this slice data can be segmented into a 3D surface model. This model can be displayed during EP studies conducted on the EnSite System.
- The EnSite Verismo™ Segmentation Tool (EV 1000) is Intended use: indicated for use in generating 3D models from slice-bases

St. Jude Medical, Inc. Endocardial Solutions EnSite Verismo

Appendix 11, page 2

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| | DICOM3 image data. Generated models are intended to be<br>displayed on the EnSite® System. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The new device has the same technological characteristics as the<br>legally marketed predicate device. |
| Non-clinical<br>Performance Data: | The EnSite Verismo Software underwent a battery of bench and<br>user tests. Device validation testing was conducted in accordance<br>with in-house procedures. |
| Conclusion: | An evaluation of new software EnSite Verismo indicates that the<br>device is as safe and effective as the previously marketed device to<br>which it is being compared and does not raise any new issues of<br>safety and effectiveness. |

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical, Inc. Endocardial Solutions % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K051840

AUG 1 5 2005

Trade/Device Name: EnSite Verismo™ Segmentation Tool (EV1000) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: LLZ Dated: August 2, 2005 Received: August 3, 2005

Dear Mr. Job:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your decise (10(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The I DA miding or bassification 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 Part 801), please If you desire specific advice for your deriver mumbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| | | 240-276-0100 |
| Other | | |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entition, "Allsonation on your responsibilities under the Act from the 807.97). You may obtain other general mismation on John of 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,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Kos 8 4 O

لقت تبت ترت ترتف

Device Name: EnSite Verismo™ Segmentation Tool (EV1000)

Indications For Use:

The EnSite Verismo™ Segmentation Tool (EV 1000) is indicated for use in generating 3D models from slice-based DICOM3 image data. Generated models are intended to be displayed on the EnSite® System.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Ryerson
(Division Sign-Off)

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Division of Reproductive, Abdom and Radiological Devices 510(k) Number _