The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying:

. An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
. Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract.
The ig4™ System compensates for the patient's respiratory phases.
The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

Device Description

The ig4™ EndoBronchial is an accessory for a CT System that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CTbased model of the tracheobronchial tree. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary planning workstation. The EM tracking accessory consists of a navigation guidewire and may include additional navigated endoscopic tools.

AI/ML Overview

The provided text describes the Veran Medical Technologies ig4™ EndoBronchial device, an accessory for CT and endoscopic bronchoscope systems. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of reported device performance metrics.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not explicitly provided in the document.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics (e.g., accuracy, sensitivity, specificity, etc.) for the ig4™ EndoBronchial in a clinical or benchmarked sense.

Instead, the performance evaluation is described qualitatively as:

"Bench testing on a static phantom and animal testing were completed to demonstrate navigation accuracy."
"Additionally, biological testing was completed on the EM navigation accessory to demonstrate that there are no biocompatibility issues."
"As required by Veran Medical Technologies design control processes and risk analysis, all verification and validation activities have been completed by designated individuals and have demonstrated the safety and effectiveness of the device."

The focus of the 510(k) submission is on demonstrating "safety and effectiveness" through substantial equivalence to predicate devices rather than meeting predefined quantitative performance targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench testing on a static phantom and animal testing," but it does not specify the sample sizes for these tests. It also does not provide information on the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The tests performed ("bench testing" and "animal testing") would not typically involve human experts establishing ground truth in the way described for diagnostics devices. For navigation accuracy, ground truth is usually established through precise measurement systems.

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

This information is not provided. Given the nature of the bench and animal tests, an adjudication method for a test set as typically understood for diagnostic imaging or AI performance is not applicable.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed. The device is an "image-guided system" and "stereotactic accessory," implying a tool for assisting procedures, not an AI diagnostic system directly improving human reader performance.

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

The device is an "image-guided system" and "stereotactic accessory" for "guiding endoscopic tools, catheters or guidewires." This implies it's fundamentally designed for human-in-the-loop use. Therefore, a standalone performance evaluation in the context of an AI algorithm is not applicable and was not performed, nor would it be relevant for this type of device.

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

For "navigation accuracy" in "bench testing on a static phantom and animal testing," the ground truth would likely be established through physical measurements against known spatial coordinates or anatomical landmarks. Expert consensus, pathology, or outcomes data would not be the primary ground truth for demonstrating navigation accuracy.

8. The sample size for the training set

The document does not mention a training set for an AI/machine learning model. The ig4™ EndoBronchial is described as utilizing "electromagnetic tracking technology" and software for navigation, not as a device employing machine learning that would require a distinct training set.

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

Since a training set for an AI model is not mentioned or implied, this question is not applicable.

Summary

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510(k) Summarv Veran Medical Technologies Traditional 510(k) ig4™ EndoBronchial

Date Prepared:

6/25/09

DEC - 2 2009

510(k) Applicant:

Veran Medical Technologies, Inc. 5743 West Park Avenue St. Louis, MO 63110 Telephone: (314) 659-8500 Fax: (314) 659-8560

Scott Wrightstone Contact:

Device Information:

ig4™ EndoBronchial Trade Name: Common Name: CT stereotactic accessory . Classification Name: Computed Tomography X-ray System Classification Code: JAK

Equivalent Legally-Marketed Devices:

ig4TM Image Guided System (K060903) superDimension inReach System (K081379)

Device Description:

Intended Use:

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope Systems. The ig4 System is indicated for displaying:

An interventional instrument such as a biopsy needle, an aspiration needle, or ablation . needle on a computer monitor that also displays a CT-based model of the target organ(s).
. A CT-based model of the lungs and images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires in the pulmonary tract.

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The ig4TM System compensates for the patient's respiratory phases.

The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

Substantial Equivalence:

The primary difference between the ig4™ EndoBronchial and the ig4™ Image Guided System is that the bronchoscopic application is indicated for endobronchial navigation of endoscopic tools, catheters and guidewires rather than percutaneous navigation of interventional instruments.

The main differences between the ig4TM EndoBronchial and the inReach System is that the ig4™ EndoBronchial automatically registers the patient location to the CT-based model via the use of reference points, and compensates for the effects of respiration on soft tissue locations by gating the navigation displays to the point in the respiratory cycle where the CT-scans were acquired.

Dissimilarities between the ig4™ EndoBronchial and the predicate devices do not affect the safety or effectiveness of this device.

Performance Data:

Bench testing on a static phantom and animal testing were completed to demonstrate navigation accuracy. Additionally, biological testing was completed on the EM navigation accessory to demonstrate that there are no biocompatibility issues. As required by Veran Medical Technologies design control processes and risk analysis, all verification and validation activities have been completed by designated individuals and have demonstrated the safety and effectiveness of the device.

Clinical Data:

Clinical tests were not required to demonstrate the safety and effectiveness of the device.

Conclusion:

The information provided in this 510(k) notification supports that the ig4™ EndoBronchial was shown to be substantially equivalent to the inReach System (K081379) for its intended use of navigating endoscopic tools, catheters and guidewires in the pulmonary tract and to the ig4TM Image Guided System (K060903) in automatic 3D registration to a CT-based model of the lungs and navigation of instruments.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

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

DEC - 2 2009

Mr. Scott Wrightstone QA/RA Manager Veran Medical Technologies, Inc. 5743 West Park Avenue ST LOUIS MO 63110

Re: K091934

Trade/Device Name: ig4TM EndoBronchial Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, KTI, and LLZ Dated: November 14, 2009 Received: November 17, 2009

Dear Mr. Wrightstone:

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.

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

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Page 2 -

Enclosure

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,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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SECTION 4 - Indications for Use

510(k) Number: K091934

Device Name: ig4™ EndoBronchial ·

Indications for Use:

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying:

. An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
. Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract.

The ig4™ System compensates for the patient's respiratory phases.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aonni mrz
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Page of

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.