GUIDED MEASUREMENT CATHETER (GMC)

K091780 · Mediguide, Ltd. · DQO · Oct 16, 2009 · Cardiovascular

Device Facts

• Record ID: K091780
• Device Name: GUIDED MEASUREMENT CATHETER (GMC)
• Applicant: Mediguide, Ltd.
• Product Code: DQO · Cardiovascular
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Guided Measurement Catheter GMC™ device is a gMPS™ enabled intravascular catheter intended for the diagnostic evaluation of the coronary vasculature in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI). The GMC™ is used with compatible gMPS™ system to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication, and landmarking. The System is indicated for use as an adjunct to fluoroscopy.

Device Story

GMC is an intravascular catheter with an embedded gMPS sensor for use with the MediGuide gMPS system. During coronary procedures, the catheter is inserted into a target artery and manually pulled back. The gMPS system tracks the catheter's 3D trajectory, reconstructing a 3D trace displayed separately and superimposed on 2D X-ray images (Smart Trace). The system provides real-time tip positioning, navigation, quantitative length measurement, landmarking, and qualitative 3D foreshortening indication. A 3D lumen model is automatically generated from a single X-ray projection. Used in clinical settings by physicians as an adjunct to fluoroscopy to assist in diagnostic assessment and procedural planning.

Clinical Evidence

Safety and performance were demonstrated through a combination of bench, animal, and clinical testing. The testing verified that the device performs its intended diagnostic functions and does not introduce new safety or effectiveness risks compared to predicate devices.

Technological Characteristics

Intravascular catheter with embedded gMPS electromagnetic tracking sensor. Operates in conjunction with the MediGuide gMPS system for 3D spatial tracking and reconstruction. Connectivity is via the gMPS system interface. Sterilization method not specified. Software-based processing for 3D trace reconstruction and lumen modeling from single-projection X-ray data.

Indications for Use

Indicated for diagnostic evaluation of coronary vasculature in patients undergoing coronary angiography or Percutaneous Coronary Intervention (PCI).

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Eagle Eye™ Gold IVUS Catheter and Volcano VH IVUS System (K051337)
• Metricath System (K042685)
• CS RefStar Catheter (K080425)

Submission Summary (Full Text)

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ell's

### 510(K) SUMMARY

OCT 1 6 2009

## 510(K) Number K091780

Applicant's Name: 5.1 MediGuide Ltd. Advanced Technology Center, POB 15003, Haifa, Israel · Tel: [phone] Fax: [phone]

- 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]
5.2

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

#### 5.4 Trade Name:

Guided Measurement Catheter (GMCTM)

- ર્સ્ડ Classification Name:
Diagnostic intravascular catheter

5-3

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#### 5.6 Product Code:

DOO

- 5.7 Device Class:
II

- Regulation Number: 5.8
870.1200

- 5.9 -Panel:
Cardiovascular

#### Predicate Devices: 5.10

- Eagle Eye™ Gold IVUS Catheter and Volcano VH IVUS System . [Volcano Corp.] cleared under K051337; hereinafter: Eagle Eye Catheter.
- Metricath System [Angiometrx Inc.] cleared under K042685. .
- CS RefStar Catheter [Biosense Webster Inc.] cleared under K080425; . hereinafter: RefStar Catheter.

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

The Guided Measurement Catheter GMC™ device is a gMPS™ enabled intravascular catheter intended for the diagnostic evaluation of the coronary vasculature in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI).

The GMC™ is used with compatible gMPS™ system to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication, and landmarking.

The System is indicated for use as an adjunct to fluoroscopy.

#### Device Description: 5.12

The Guided Measurement Catheter (GMC™) is a Medical Positioning System (gMPS™) enabled coronary diagnostic catheter designed to allow catheter tracking during a routine diagnostic catheterization of the coronary arteries using the MediGuide's gMPS™ system. The catheter includes an embedded gMPS™ sensor in order to allow its tracking by the gMPSTM system.

The GMC™ gMPS™ enabled catheter is intended to be used during a percutancous coronary procedure, and similarly to an IVUS assessment, inserted to a target coronary artery, usually past a stenotic region, and then pulled back manually, to screen the

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selected arterial segment. As the pullback is completed, the 3D trace of the catheter's trajectory is reconstructed and displayed separately in a 3D display, and also superimposed on the 2D X-ray image by the gMPS™ system. The superimposed trace, the Smart Trace, is color coded to show an indication of the angular percent of foreshortening of the artery as it exists in the respective X-ray image. A model of the artery's lumen is automatically generated by the gMPS™ system from only one X-ray image, taken from a single angle (projection).

#### 5.13 Substantial Equivalence:

The intended use and indications for use of the GMC™ catheter are similar to predicate devices. In addition, the GMCTM catheter has substantially similar technological characteristics as well as principles of operation to the predicate devices. Specifically, the GMC™ and its predicates working in conjunction with a computerized system, such as a tracking system, thus providing the user with diagnostic information, including information on its position, enabled by the computerized system.

A set of bench, animal and clinical testing was performed in order to demonstrate the safety and performance of the GMC™ 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 GMC™ 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.

ર-ર

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

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

OCT 1 6 2009

Re: K091780

Trade/Device Name: GMCTM Guided Measurement Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO 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/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/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): K091780

Device Name: Guided Measurement Catheter (GMCTM)

Indications for Use:

The GMC™ device is a gMPS™ enabled intravascular catheter intended for the diagnostic evaluation of the coronary vasculature in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI).

The GMC™ is used with compatible gMPS™ system to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication, and landmarking.

The System is indicated for use as an adjunct to fluoroscopy.

| Prescription Use | AND/OR | Over-The-Counter Use |
|-----------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | (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) | |
| | 0/16/09 |
| Division of Cardiovascular Devices | |
| GMC 510(k) submission page 00510(k) Number | K091780 |