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.

Device Description

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 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).

AI/ML Overview

Here's an analysis of the provided text regarding the Guided Measurement Catheter (GMC™) and its acceptance criteria and supporting study information.

It's important to note that the provided text is a 510(k) summary and FDA clearance letter, which focuses more on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data in a tabular format. Therefore, some information may need to be inferred or is explicitly stated as being performed without detailed results.

Acceptance Criteria and Device Performance Study for the Guided Measurement Catheter (GMC™)

The provided document, a 510(k) summary for the MediGuide Ltd. Guided Measurement Catheter (GMC™), details the device's intended use and claims substantial equivalence to predicate devices based on safety and performance testing. While specific numerical acceptance criteria for each function are not explicitly laid out, the overall acceptance criterion is demonstrating 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."

The summary indicates that "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."

Unfortunately, the document does not contain a specific table of acceptance criteria paired with reported device performance for each feature. It broadly states that tests were performed and indicated substantial equivalence.

Based on the information available, here are the details regarding the study:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a specific table with numerical acceptance criteria and performance metrics (e.g., accuracy for length measurement, real-time performance for tracking) is not provided in this 510(k) summary. The summary concludes that "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." This implies that the device met internal design specifications and performed comparably to the predicate devices in the conducted studies, thereby meeting the overarching acceptance criterion of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "bench, animal and clinical testing" were performed. However, it does not provide any specific sample sizes for these test sets (e.g., number of animals, number of clinical cases/patients). The provenance of data is also not specified (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in the provided 510(k) summary. The device's primary function described is to provide diagnostic information and guidance, not to assist human readers in interpreting images in a comparative effectiveness setting.

6. Standalone (Algorithm Only) Performance Study

The device is an "intravascular catheter intended for the diagnostic evaluation" that "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 also "indicated for use as an adjunct to fluoroscopy."

Given this description, the "device" (GMC™ catheter) works in conjunction with the gMPS™ system to perform its intended functions. Therefore, its performance is inherently tied to the system. The phrase "A model of the artery's lumen is automatically generated by the gMPS™ system from only one X-ray image" suggests an algorithmic component. However, the document does not explicitly detail a standalone (algorithm only) performance study decoupled from the overall system's operation or human interaction/supervision. The tests performed ("bench, animal and clinical testing") would likely encompass the integrated system's performance.

7. Type of Ground Truth Used

The document does not explicitly specify the type of ground truth used for the testing (e.g., expert consensus, pathology, outcomes data). In the context of a diagnostic intravascular catheter, ground truth for measurements (like length, 3D reconstruction accuracy) would typically involve comparison to a gold standard measurement method (e.g., precise physical measurements in bench models, highly accurate imaging modalities or direct measurements in animal/clinical settings).

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is likely because the device, as described, performs real-time measurement and reconstruction based on physical principles and sensor data, rather than being a machine learning algorithm trained on a large dataset in the conventional sense. While it has a "computerized system," the text suggests it's more about processing sensor data and known anatomical models than a deep learning approach requiring a distinct training phase.

9. How Ground Truth for the Training Set Was Established

Since information regarding a training set is not provided, the method for establishing its ground truth is also not specified.

Summary of Missing Information:

It's crucial to understand that 510(k) summaries are designed to establish substantial equivalence for market clearance, not to be comprehensive scientific study reports. They often lack the granular detail on study design, sample sizes, specific performance metrics, and ground truth methodologies that would be found in a peer-reviewed publication or full study report. The intent here is to demonstrate that the device is not new or significantly different from existing devices and is safe and effective.

Summary

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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: +972-4-8137000 Fax: +972-4-8550412

Contact Person: Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910 Mail: JSKahan@hhlaw.com
5.2

And/Or

Merav Yarmus, Ph.D. BioMedical Strategy (2004) Ltd. 7 Jabotinsky Street. · Ramat Gan 52520, Israel Tel: +972-3-6123281 Fax: +972-3-6123282 Mail: merav@ebms.co.il

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 System is indicated for use as an adjunct to fluoroscopy.

Device Description: 5.12

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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 (800) 638-2041 or (240) 276-3150 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 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

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).