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.

AI/ML Overview

The provided text describes the MediGuide Technology system, its intended use, and substantial equivalence to a predicate device. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study proving the device meets them.

Here's a breakdown of what is and is not available in the provided text:

Information Present:

Device Name: MediGuide Technology
Intended Use/Indications for Use: Evaluation of vascular and cardiac anatomy; real-time tip positioning and navigation of MediGuide enabled devices in vascular or cardiac interventions in the Cath Lab, as an adjunct to fluoroscopy.
Device Description: Uses magnetic positioning technology to track MediGuide enabled diagnostic or therapeutic invasive devices for 3D position relative to X-Ray image (real-time or recorded). Supports up to three devices simultaneously.
Features: Landmarking, 3D reconstruction, trace rendering, 2D fusion, 3D measurements, Quantitative Coronary Angiography.
Substantial Equivalence: Claimed based on identical intended use/indications for use, similar technological characteristics, and principles of operation to the gMPS™ II system (K 102905).
General Performance Statement: "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."

Information NOT Present (and therefore cannot be included in the table or detailed answers):

Specific Acceptance Criteria: The document mentions "performance and accuracy" but does not define what those quantitative or qualitative criteria were (e.g., specific error margins for positioning, success rates for navigation, etc.).
Reported Device Performance: While it states "Test results indicated that the MediGuide Technology is as safe and effective," no specific performance metrics are reported.
Sample Size for Test Set: Not mentioned.
Data Provenance (country, retrospective/prospective): Not mentioned.
Number of Experts for Ground Truth: Not mentioned.
Qualifications of Experts: Not mentioned.
Adjudication Method: Not mentioned.
MRMC Comparative Effectiveness Study: No mention of a study comparing human readers with and without AI assistance, nor any effect sizes.
Standalone Performance Study: The document focuses on the system as an adjunct to fluoroscopy and comparing it to a predicate; it doesn't describe a standalone algorithm-only performance assessment clearly.
Type of Ground Truth: Not specified (e.g., reference standard from pathology, clinical outcomes, expert consensus with defined criteria).
Sample Size for Training Set: Not mentioned.
How Ground Truth for Training Set was Established: Not mentioned.

Based on the provided text, here is what can be inferred and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from general statements)	Reported Device Performance (General Statement in document)
Demonstrate performance and accuracy	Test results indicated the device is "as safe and effective as its predicate device" and "substantially equivalent"
Verify modifications did not raise new safety/effectiveness issues	Modifications did not raise new safety and/or effectiveness issues

Note: Specific, quantifiable acceptance criteria (e.g., positioning accuracy within X mm, navigation success rate > Y%) and corresponding measured performance values are not provided in the document.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified in the provided text.
Qualifications of Experts: Not specified in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The document focuses on the device's performance relative to a predicate, not enhancement of human reader performance.
Effect Size: Not applicable, as no such study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies the system is an "adjunct to fluoroscopy" and provides "real time tip positioning and navigation." While the core technology tracks the device, the description does not explicitly detail a "standalone algorithm-only" performance study in isolation from the clinical environment or human interaction. The focus is on the integrated system's function alongside existing procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Not specified in the provided text. The "performance testing" is mentioned, but the reference standard against which performance was measured is not detailed.

8. The sample size for the training set:

Sample Size for Training Set: Not specified in the provided text. The document refers to "performance testing" but does not distinguish between training and test sets or provide sizes for either.

9. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not specified in the provided text.

Summary

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

Contact Person:

Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910 Mail: jonathan.kahan@hoganlovells.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

Date Prepared:

January, 2012

Trade Name:

MediGuide Technology

Classification Name:

Programmable diagnostic computer

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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:

Device Description:

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.

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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.

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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

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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 (800) 638-2041 or (301) 796-7100 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

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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

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).