GUIDED MEDICAL POSITIONING SYSTEM (GMPS)

K091781 · Mediguide, Ltd. · DQK · Oct 16, 2009 · Cardiovascular

Device Facts

• Record ID: K091781
• Device Name: GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
• Applicant: Mediguide, Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Guided Medical Positioning System (gMPS™) is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a gMPS™ enabled (equipped with a gMPS™ 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

gMPS uses magnetic positioning technology to track sensors embedded in invasive diagnostic or therapeutic devices; inputs include magnetic field data and X-ray images (live fluoroscopy or recorded cine-loops). System transforms magnetic sensor data into 3D coordinates, projecting device trajectory onto 2D X-ray images to provide real-time tip positioning and navigation. Features include 'Smart trace' for foreshortening indication, 3D anatomical reconstruction, quantitative longitudinal measurements, 3D Quantitative Coronary Angiography (QCA), and virtual landmarking. Used in Cath Lab by physicians to guide invasive procedures; output displayed on system monitor to assist navigation and anatomical evaluation. Benefits include improved visualization of device position relative to anatomy, reduction of foreshortening-induced measurement errors, and enhanced guidance during cardiac/vascular interventions.

Clinical Evidence

Bench testing only. Performance testing conducted to verify accuracy of 3D positioning, navigation, and quantitative measurements compared to predicate systems.

Technological Characteristics

Magnetic positioning system; integrates with X-ray imaging systems. Provides 3D tracking of sensors embedded in invasive devices. Features include 3D reconstruction, QCA, and virtual landmarking. Software-based processing for image overlay and measurement. Class II device.

Indications for Use

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

• IC-PRO System, model version 3.2 (K083745)
• CARTO XP EP Navigation System, Version 9 (K070240)
• Niobe Magnetic Navigation System w/Navigant Navigation Workstation (K060967)

Submission Summary (Full Text)

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### 510(K) SUMMARY

### 510(K) Number KO9178 |

OCT 1 6 2009

Applicant's Name: MediGuidc Ltd. Advanced Technology Center, POB 15003, Haifa, Israel Tel: [phone] Fax: [phone]

- 5.2
5.1

Contact Person: Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 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]

- 5.3 Date Prepared:
June, 2009

#### Trade Name: 5.4

Guided Medical Positioning System (gMPSTM)

#### Classification Name: ર્સ્ડ

Programmable diagnostic computer

5-3

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## 5.6 Product Code: DOK 5.7 Device Class: II Regulation Number: 5.8 870.1425 Panel: ર્ તે

Cardiovascular

#### Predicate Devices: 5.10

- The IC-PRO System, model version 3.2 [Paieon, Inc.] cleared under ● K083745.
- CARTO XP EP Navigation System, Version 9 [Biosense Webster, Inc.] . cleared under K070240; hereinafter: CARTO System.
- Niobe Magnetic Navigation System w/Navigant Navigation Workstation . [Stereotaxis Inc.] cleared under K060967; hereinafter: Niobe System.

#### Intended Use / Indication for Use: 5.11

The Guided Medical Positioning System (gMPS™) is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a gMPS™ enabled (equipped with a gMPS™ 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.

#### 5.12 Device Description:

The gMPS™, used in conjunction with an X-ray System, employs magnetic positioning technology to track a gMPS™ 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 gMPS™ system is intended to provide the following:

Catheter tip positioning and navigation - The real time position of the gMPSTM sensor (and thus of the gMPS™ enabled device) is displayed in real time ("Live") fluoroscopy mode or in a recorded mode.

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Smart trace (foreshortening indication) - A 3D trace of the gMPS™ enabled device trajectory is projected and superimposed on the 2D X-ray images (either on live fluoroscopy, recorded cine-loop or recorded still image).

3D reconstructed model - The system reconstructs a 3D model of the inspected anatomical structure.

Quantitative longitudinal measurements - The measurements are based on the 3D trace, thus overcoming length measurement errors induced by the foreshortening effect.

Quantitative Coronary Angiography (OCA) - While working in conjunction with gMPSTM enabled coronary device, the gMPS™ provides 3D QCA.

Virtual landmarking - A manually marked point or region of interest superimposed on X-ray images (real-time angiography and cine-loop) and on the 3D reconstruction.

#### Substantial Equivalence: 5.13

The intended use and indications for use of the gMPS™ are similar to or encompassed within the intended use and indications for use of its predicate devices. In addition, the gMPS™ has substantially similar technological characteristics, as well as principles of operation, as its predicate devices. Specifically, the gMPS™ and its predicates use magnetic technology for navigating invasive devices through tissue.

Performance testing was conducted in order to demonstrate the performance and accuracy of the gMPS™ and to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate devices.

Tests results indicated that the gMPSTM is as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues

5-5

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

OCT 1 6 2009

MediGuide, Ltd. c/o Mr. Jonathan S. Kahan Partner Hogan & Hartson LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Re: K091781

Trade/Device Name: gMPS™ Guided Medical Positioning System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 8, 2009 Received: October 8, 2009

Dear Mr. Kahan:

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 (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.

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Page 2 - Mr. Jonathan S. Kahan

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.

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/ReportalProblem/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/ResourcesforYou/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

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# INDICATIONS FOR USE

510(k) Number (if known): K09178 I

Device Name: Guided Medical Positioning System (gMPS™)

Indications for Use:

The Guided Medical Positioning System (gMPS™) is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a gMPS™ enabled (equipped with a gMPS™ 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<br>(Part 21 CFR 801 Subpart D) | √ | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|-------------------------------------------------|---|--------|------------------------------------------------|--|
|-------------------------------------------------|---|--------|------------------------------------------------|--|

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

-Concurrence of CDRH, Office of Device Evaluation (ODE

(Division Sign-Off) /
Division of Cardiovascular Devices
510(k) Number
10/16/09
K091781

gMPS 510(k) submission page 000025 of 001112