Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Device Description

The ILLUMISITE™ Platform is an image-guided electromagnetic navigation system used to guide catheters or endoscopic tools to predetermined targets in or adjacent to the bronchial tree on a path identified by CT scan. During a procedure, the physician navigates endoscopic tools to targets in the lungs such as lymph nodes and solitary pulmonary nodules.

The ILLUMISITE™ Platform, is a modification to the previously cleared predicate device, the superDimension™ navigation system. The primary difference is the ability of the ILLUMISITE Platform to provide continuous positional feedback throughout the procedure (i.e. continuous guidance) via a sensor in the extended working channel. The system console hardware, and extended working channel have been modified to incorporate the continuous guidance navigation feature.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a study that rigorously proves the device meets those criteria in a clinical or large-scale performance setting. The document is a 510(k) summary for the ILLUMISITE™ Platform, focusing on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance efficacy data against a set of predefined acceptance criteria for AI or diagnostic performance.

Here's an analysis of the provided text in relation to the requested information:

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

The document mentions "System Accuracy" with a reported performance of "≤3mm root mean square (RMS) based on accuracy bench testing". This is the closest thing to an acceptance criterion and reported performance. However, this is a bench test, likely for mechanical accuracy, and not a demonstration of clinical performance or AI-driven diagnostic accuracy.

Acceptance Criteria	Reported Device Performance
System Accuracy ≤3mm RMS (bench testing)	≤3mm RMS (bench testing)

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 primarily discusses "Design verification and validation test results" and "Design validation was successfully performed under simulated use conditions by representative users." It does not specify a quantitative sample size for any clinical test set or details about data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be functional and safety-focused, rather than a large-scale clinical performance study.

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)

The document mentions "Design validation testing with qualified physicians, clinicians, and service personnel to confirm functionality and user interface." It does not specify the number of experts, their qualifications, or their role in establishing ground truth for a test set, as no diagnostic performance study is described. Their role appears to be evaluating usability and functionality rather than providing ground truth for diagnostic accuracy.

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

No information is provided regarding an adjudication method, as no study involving multiple readers or diagnostic assessments requiring adjudication is described.

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

No MRMC study is mentioned. The device is an image-guided electromagnetic navigation system, not an AI diagnostic tool primarily aimed at improving human reader performance.

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

The document does not describe a standalone AI algorithm performance study. The device provides "image-guided electromagnetic navigation" and "continuous positional feedback." Its function is to assist in guiding tools, not to autonomously provide a diagnosis or interpretation.

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

For the "System Accuracy" measurement, the ground truth would inherently be a precisely measured physical reference (e.g., a known distance or position on a test bench). However, for any clinical ground truth related to navigation or targeting, it's not specified. The device "does not make a diagnosis," so ground truth for diagnostic accuracy is not relevant to its stated function.

8. The sample size for the training set

The document pertains to a medical device's 510(k) submission, confirming substantial equivalence to a predicate device. It does not describe an AI model's training set or its sample size.

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

As there is no mention of an AI model with a training set, there is no information on how its ground truth was established.

Summary of what is present in the document:

The 510(k) summary focuses on demonstrating that the ILLUMISITE™ Platform is substantially equivalent to its predicate device (superDimension™ Navigation System) based on:

Same indications for use, principle of operation, fundamental technology, and inherent design.
Changes made (e.g., continuous guidance, hardware updates) do not affect safety and effectiveness.
Design verification and validation (including software, electrical safety, biocompatibility, sterilization, mechanical, packaging, hardware component testing).
User validation under simulated use conditions by representative users confirms functionality and user interface.
Compliance with various international and FDA-recognized consensus standards.
A "System Accuracy" bench test result of ≤3mm RMS.

The document explicitly states: "Clinical tests were not required to validate the changes to the ILLUMISITE Platform and accessories." This indicates that a study demonstrating clinical performance or meeting specific diagnostic acceptance criteria, as one might expect for an AI diagnostic device, was not conducted or presented as part of this 510(k) submission. The focus is on the safety and performance of the navigation system itself, and its substantial equivalence to an existing cleared device.

Summary

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August 7, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Covidien LLC % Ms. Kristi Fox Principal Regulatory Affairs Specialist 161 Cheshire Lane N, Suite 100 PLYMOUTH MN 55441

Re: K191394

Trade/Device Name: ILLUMISITE™ Platform Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 23, 2019 Received: May 24, 2019

Dear Ms. Fox:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191394

Device Name ILLUMISITE™ Platform

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/2 description: The image shows the Covidien logo. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.

510(k) Summary

ILLUMISITE™ Platform

The contents of the 510(k) Summary have been provided in conformance with 21 CFR 807.92.

1. Submitter

510(k) Submitter:

Covidien Ilc 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 USA

Contact Person:

Kristi Fox Principal Regulatory Affairs Specialist Phone: 763-647-5553 Fax: 763-210-4098 Email: kristin.fox@medtronic.com

Date Prepared: May 23, 2019

2. Subject Device

Trade Name :	ILLUMISITE Platform
Common Name:	Electromagnetic Navigation Bronchoscopy System
Classification Name:	Computed tomography x-ray system21 CFR 829.1750
Product code:	JAK
Regulatory Class:	II
Manufacturer:	Covidien llc

3. Predicate Device

Device Name :	superDimension™ Navigation System
Common Name:	Electromagnetic Navigation Bronchoscopy System
510(k):	K173244
Classification Name:	Computed tomography x-ray system21 CFR 829.1750
Product code:	JAK
Regulatory Class:	II
Manufacturer:	Covidien llc

4. Device Description

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5. Indications for Use

Summary of Characteristics Compared to Predicate Device 6.

The subject and predicate devices have the same indications for use, principle of operation, fundamental technology, and inherent design. The primary difference between the proposed ILLUMISITE™ Platform and the predicate is to expand upon the existing sensing capability by enabling continuous guidance through the integration of a sensor in the extended working channel and updates to the system console hardware and software. Other changes have been made to update hardware components to current technology and to integrate a fiducial marker board, used for the existing optional local registration feature, into the location board.

Design verification and validation test results demonstrate that the changes do not affect the safety and effectiveness of the device as the subject device conforms to the requirements and specifications of the device. The table below summarizes the differences between the predicate device and the proposed device.

Characteristic	superDimension™ Navigation System(Predicate Device – K173244)	ILLUMISITE™ Platform(Proposed Device)
Intended Use Comparison
Indications for Use	Indicated for displaying images of thetracheobronchial tree to aid the physicianin guiding endoscopic tools or cathetersin the pulmonary tract and to enablemarker placement within soft lung tissue.It does not make a diagnosis and is not anendoscopic tool. Not for pediatric use.	Same
Anatomical Site	Lung, airways and tracheobronchial tree	Same
Technology Comparison
Basic principle	Guide endoscopic tools, catheters, andmarkers to a target on path indicated byCT scan and provide visualization ofpulmonary tract and target.	Same, except guidance andvisualization is additionally providedafter locatable guide removal via asensor in the distal tip of the extendedworking channel.
VisualizationPrinciple	Position predicted based on measuredposition and orientation of tip andlocalizing device as determined byelectromagnetic sensors.	Same, with an additional sensor addedto the extended working channel
Characteristic	superDimension™ Navigation System(Predicate Device – K173244)	ILLUMISITE™ Platform(Proposed Device)
Method for trackinglocation of instrument	Electromagnetic sensors on tip oflocatable guide	Electromagnetic sensors on the tip ofthe locatable guide and on the tip ofthe extended working channel
Registration Modes	Automatic and manual process ofmatching of registration points selectedduring Planning to the patient's anatomy(CT-to-Body Registration)Optional local registration feature updatesthe catheter position in the ENB systembased on the 3D position of the catheterrelative to the target during the localregistration process.	Same, automatic registrationalgorithm has been modified toenhance the registration.
Navigation	Navigates to targets to perform biopsy orother procedure using single usecomponents, console system andsoftware.	Same
Accuracy Check	System accuracy test completed as part ofinstallation and maintenanceFluoroscopic accuracy tested completedas part of installation	Same with the addition of a systemaccuracy test for the extended workingchannel sensor
System Accuracy	$≤3mm$ root mean square (RMS) based onaccuracy bench testing	Same
Software Comparison
Procedure Application	Version 7.2	ILLUMISITE Version 1.0Fundamental technology and primaryworkflow remains the same.
Planning Application	Version 7.1	ILLUMISITE Version 1.0Fundamental technology and primaryworkflow remains the same.
Hardware Comparison
Hardware	Console: IPC, LSS, UPS, monitor,•keyboard, mouse•Planning laptop computer•Cables (LG, PST)•Location board•Fiducial marker board•Video cable	Console: IPC, CGS, UPS,•monitor, keyboard, trackball•Cables (LG, EWC (sensor), PST)•Location board with integratedfiducial markers•Video cables
Use of computer andcomputer type	Industrial PCLaptop provided by Covidien as part ofthe system	Equivalent Industrial PCPredicate Laptop compatible (laptopsold separately)
Location Board	Board that generates signals used for•localization by the LSS•Fiducial marker overlay	Board that generates signals usedfor localization by the CGS•Integrated fiducial markers withinthe location board
LocalizationElectronics	Location Subsystem (LSS)	Continuous Guidance System (CGS)
Patient Sensor	Sensors placed on the patient	Same
User Input Devices(Peripherals)	MonitorKeyboard	MonitorKeyboard
Characteristic	superDimension™ Navigation System(Predicate Device – K173244)	ILLUMISITE™ Platform(Proposed Device)
	Mouse	Trackball
	Infrared remote control	Dual footswitch
	Footswitch
Single Use Disposable Accessories Comparison
Extended Working Channel
Minimum InnerDiameter (ID)	2.0 mm	Same
Outer Diameter (OD)	2.7 mm	Same
Working Length	1070 mm	Same
Sensors	Not applicable	Continuous wind coil sensor
Tip Shape Offering	45°, 90°, 180°, 190°, Medial, Straight	45°, 90° and 180°
Sterility	Sterilized by EtOSAL 10-6	Same
Telescope - No change between predicate and proposed device
Measuring Tube – No change between predicate and proposed device
Locatable Guide – No change between predicate and proposed device
Bronchoscope Adapter – No change between predicate and proposed device
Single Use Non-Sterile Disposable Accessories Comparison
Patient Sensor Patch – No change between predicate and proposed device

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7. Performance Data

The ILLUMISITE Platform was subjected to the Covidien design control process. Risk Management was performed to analyze the potential hazards associated with the changes. Appropriate design verification and validations were performed to assure the ILLUMISITE Platform continues to meet its intended use.

Design testing performed on the ILLUMISITE Platform included the following:

. Software and firmware verification testing
Electrical safety and electromagnetic compatibility of the ILLUMISITE console hardware, ● locatable guide, and extended working channel
Biocompatibility, sterilization, and shelf life testing of the extended working channel ●
Design verification including mechanical, packaging, and hardware component testing .
Design validation testing with qualified physicians, clinicians, and service personnel to . confirm functionality and user interface

The combined verification and validation testing confirmed that the ILLUMISITE Platform met its product specification and system requirements.

Design validation was successfully performed under simulated use conditions by representative users including physicians, clinicians, and service personnel. Each user group performed typical use scenarios defined in the design validation protocol. In conclusion, the design validation study ensured that the ILLUMISITE Platform conformed to defined user needs and intended uses.

The ILLUMISITE is in compliance with the applicable parts of the following International and FDArecognized consensus standards:

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Image /page/7/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a grid-like pattern inside, followed by the word "COVIDIEN" in a bold, dark blue font. The square is composed of smaller squares in varying shades of blue, creating a subtle gradient effect. The overall design is clean and corporate, suggesting a professional and established brand.

ISO 14971: 2007 Medical Devices - Application of Risk Management to Medical Devices
IEC 62366-1: 2015 Medical devices Part 1: application of usability engineering to medical . devices
ANSI/AAMI/IEC 62304: 2006 + A1: 2015 Medical device software - software life cycle processes
IEC 60601-1: 2005 + A1: 2012 Medical electrical equipment part 1: general requirements . for basic safety and essential performance
IEC 60601-1-2: 2014 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances requirements and tests
IEC 60601-1-6: 2013 Medical electrical equipment- part 1-6: general requirements for basic safety and essential performance - collateral standard: usability
IEC 60601-2-18:2009 - Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
. ISO 11737-1:2006 (Corr 1:2007) Sterilization of Medical Devices- Microbiological methods -Part 1: Determination of a population of microorganisms on products
ISO 11737-2:2009 Sterilization of Medical Devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: ● Classification of air cleanliness - Parts applicable to a Class 7 clean room only
ISO 11607-1: 2006 + A1: 2014 Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006+A1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ASTM D4169:2016 Standard Practice for Performance Testing of Shipping Containers and ● Systems
. ASTM F88:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
. ASTM F2096:2011 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO 15223-1: 2016 Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements.
ISO 10993-1: 2009 (Corr 1:2010) Biological evaluation of medical devices Part 1: ● Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: tests for in vitro cytotoxicity
. ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

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Image /page/8/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square made up of smaller squares in different shades of blue. To the right of the square is the word "COVIDIEN" in a bold, sans-serif font, also in blue.

ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic ● toxicity
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials

8. Clinical Data

Clinical tests were not required to validate the changes to the ILLUMISITE Platform and accessories.

9. Conclusion

The ILLUMISITE Platform has the same indications for use, principle of operation, fundamental scientific technology, and performance characteristics as the predicate device as demonstrated through performance data. Any new risks identified in comparison to the predicate device have been assessed in the device risk assessment per the ISO 14971 Risk Management standard. The modifications within the ILLUMISITE Platform and its accessories that allow continuous navigation guidance, do not significantly change the overall device risks. Therefore, Covidien Ilc considers the ILLUMISITE Platform to be substantially equivalent to the legally marketed predicate device; superDimension navigation system, cleared under 510(k) K173244.

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.