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 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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Guided Medical Positioning System (gMPS™), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria or specific performance metrics with target values. Instead, it makes a general statement about performance testing.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was conducted."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided text does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

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

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

The provided text does not mention if a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document.

6. Standalone (Algorithm Only) Performance Study

The provided text describes the device's function as "real time tip positioning and navigation" and states "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." This implies that the algorithm's performance in guiding the device was evaluated, which aligns with a standalone performance study. However, specific details of this study are not provided.

7. Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the device's function for "real time tip positioning and navigation" and "3D reconstructed model" of anatomical structures, it's highly likely that ground truth would involve either:
* Direct measurement/imaging: Comparing the system's reported position/reconstruction to a known physical measurement or a high-accuracy imaging modality.
* Expert validation: Clinical experts confirming the accuracy of the system's output against their anatomical knowledge or other reference images.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set.

9. How Ground Truth for the Training Set Was Established

The provided text does not specify how ground truth for the training set was established.

Summary

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

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: (202) 637-5794 Fax: (202) 637-5910 Mail: JSKahan@hhlaw.com

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

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

5.12 Device Description:

The gMPS™ system is intended to provide the following:

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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 (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): K09178 I

Device Name: Guided Medical Positioning System (gMPS™)

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	√	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

-Concurrence of CDRH, Office of Device Evaluation (ODE

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

gMPS 510(k) submission page 000025 of 001112

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

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