MEDIGUIDE TECHNOLOGY

K120301 · St. Jude Medical, Mediguide Navigation Systems · DQK · Feb 24, 2012 · Cardiovascular

Device Facts

• Record ID: K120301
• Device Name: MEDIGUIDE TECHNOLOGY
• Applicant: St. Jude Medical, Mediguide Navigation Systems
• Product Code: DQK · Cardiovascular
• Decision Date: Feb 24, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The MediGuide Technology System is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide enabled (equipped with a MediGuide sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

Device Story

MediGuide Technology uses magnetic positioning to track MediGuide-enabled invasive devices; system integrates with X-ray equipment. Input: magnetic sensor data from invasive devices; X-ray images (live or recorded cine-loops). Processing: system superimposes real-time 3D device position onto X-ray images; supports simultaneous tracking of up to three devices. Features include landmarking, 3D reconstruction, trace rendering, 2D fusion, 3D measurements, and Quantitative Coronary Angiography. Used in Cath Lab by physicians to navigate devices during vascular/cardiac procedures. Output: visual overlay on X-ray display. Benefit: provides real-time anatomical navigation and positioning guidance, potentially reducing radiation exposure and improving procedural accuracy.

Clinical Evidence

Bench testing only. Performance and accuracy testing conducted to verify device functionality and safety compared to the predicate device.

Technological Characteristics

Magnetic positioning system; integrates with X-ray imaging. Supports up to three tracked sensors. Software packages include Coronary and Cardiac modules. Features include 3D reconstruction, 2D fusion, and quantitative measurement tools. Operates as an adjunct to fluoroscopy in a Cath Lab environment.

Indications for Use

Indicated for patients undergoing vascular or cardiac interventions in a Cath Lab environment requiring real-time tip positioning and navigation of diagnostic or therapeutic invasive devices as an adjunct to fluoroscopy.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Guided Medical Positioning System II (gMPS™ II) (K102905)

Submission Summary (Full Text)

{0}------------------------------------------------

# FEB 2 4 2012

### 510(K) SUMMARY

## 510(K) Number K 12030 |

### Applicant's Name:

St. Jude Medical MediGuide Navigation Systems Advanced Technology Center, POB 15003, Haifa, Israel Tel: [phone] Fax: [phone]

### Contact Person:

Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: [phone] Fax: [phone] Mail: [e-mail]

## And/Or

Merav Yarmus, Ph.D. Biomedical Strategy (2004) Ltd. 7 Jabotinsky Street. Ramat Gan 52520, Israel Tel: [phone] Fax: [phone] Mail: [e-mail]

### Date Prepared:

January, 2012

### Trade Name:

MediGuide Technology

#### Classification Name:

Programmable diagnostic computer

{1}------------------------------------------------

Product Code: DOK

Device Class: II

Regulation Number: 870.1425

Panel: Cardiovascular

#### Predicate Devices:

Guided Medical Positioning System II (gMPS™ II) [MediGuide Ltd.] cleared under K 102905.

#### Intended Use / Indications for Use:

The MediGuide Technology System is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide enabled (equipped with a MediGuide sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

### Device Description:

The MediGuide Technology System, used in conjunction with an X-ray System, employs magnetic positioning technology to track a MediGuide enabled diagnostic or therapeutic invasive device for the 3D position relative to any X-Ray image, in real-time or previously recorded cine-loop.

The MediGuide Technology System includes two optional software packages. The Coronary package includes the Coronary application, and it supports coronary procedures. The Cardiac package includes the Cardiac Navigation and the Cardiac Navigation with Angio Survey™ application, both support cardiac procedures.

The most fundamental capability of the MediGuide Technology is the positioning and navigation of MediGuide enabled devices. This feature enables projection of the real time position of a MediGuide sensor (and thus of the MediGuide enabled device) on real time 2D X-Ray images (live mode) or in a recorded mode (the MediGuide enabled device tip real time position is superimposed on a previously recorded cine loop or still image). The MediGuide Technology enables simultaneous tracking of up to three MediGuide enabled devices.

{2}------------------------------------------------

In addition, the MediGuide Technology provides the following features:

- Landmarking (for both coronary and cardiac procedures) .
- 3D reconstruction model (for both coronary and cardiac procedures) .
- Trace rendering (Smart trace for coronary procedures, and shaft rendering for cardiac . procedures)
- 2D fusion (for cardiac procedures) .
- . 3D measurements (for coronary procedures)
- Quantitative Coronary Angiography (for coronary procedures) .

## Substantial Equivalence:

The intended use and indications for use of the MediGuide Technology are identical to the intended use and indications for use of its predicate device, the gMPS™ II system. In addition, the same technological characteristics and principles of operation apply for both the MediGuide Technology system and its predicate device.

Performance testing was conducted in order to demonstrate the performance and accuracy of the MediGuide Technology and to verify that all the modifications introduced in the device as compared to its predicate device did not raise any new safety and effectiveness issues.

Test results indicated that the MediGuide Technology is as safe and effective as its predicate device for its intended use and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.

{3}------------------------------------------------

## 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

FEB 2 4 2012

St. Jude Medical, Inc. c/o Mr. Jonathan S. Kahan, Esq. Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

K120301 Re:

Trade/Device Name: MediGuide Technology Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Codes: DQK Dated: January 31, 2012 Received: January 31, 2012

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your 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 use stated in the enactment date of the enactment date of the Medical Device Amendments, or to econments that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelere, mains 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 (PMA), it your device is classified (600 a00 -0) . 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 I least oc advised that I Dri 3 ibsumited that your device complies with other requirements of the Act

{4}------------------------------------------------

Page 2 - St. Jude Medical, Inc. c/o Mr. Jonathan S. Kahan, Esq.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known):_KIZO30 |

Device Name: MediGuide Technology

Indications For Use:

The MediGuide Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide enabled (equipped with a MediGuide sensor) diagnostic or therapeutic invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

√ Prescription Use __ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K120301 |