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 superDimension™ navigation system is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension™ navigation system also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.

AI/ML Overview

This document is a 510(k) premarket notification for the superDimension Navigation System, specifically for software release version 7.1. It details the substantial equivalence to a predicate device and the testing performed.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics in the format typically seen for algorithms with quantitative outputs (e.g., sensitivity, specificity, accuracy against a numerical threshold). Instead, the "acceptance criteria" are implied through the design verification and validation processes.

The reported performance is qualitative and focused on the successful execution of tasks and compliance with specifications:

Acceptance Criteria (Implied)	Reported Performance
Conformance to product specification and system requirements	"Design verification performed on the superDimension system V7.1 Planning and Procedure application and confirmed that the superDimension navigation system met its product specification and system requirements.""A full regression testing was executed to verify the modifications and ensure that the superDimension navigation system meets its product specification and requirements."
Conformance to defined user needs and intended uses (under simulated use)	"100 % of users across the three categories (bronchoscopists, clinicians, and service personnel.) successfully completed validation tasks.""In conclusion, the design validation study ensured that the Version 7.1 superDimension™ Navigation System with planning and procedure software version 7.1, conform to defined user needs and intended uses."
Safety and Effectiveness of the Device (following changes)	"Design verification and validation test results demonstrate that the changes don't affect the safety and effectiveness of the device as the subject device conforms to the requirements and specifications of the device."
Compliance with ISO 14971:2007 (Risk Management)	"The superDimension navigation system is in compliance with the following International and FDA-recognized consensus standard: ISO 14971: 2007 Medical Devices - Application of Risk Management to Medical Devices"

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

Test set sample size: The document does not specify a numerical sample size for the "test set" in terms of patient data or CT scans. The testing described focuses on the software's functionality and user interaction rather than its performance on a dataset of clinical cases. The "test set" for design validation involved representative users (bronchoscopists, clinicians, and service technicians) performing "typical use scenario defined in the design validation protocol." However, the exact number of users is not stated, nor is the number of scenarios or cases they performed.
Data provenance: Not applicable in the traditional sense of a clinical dataset for an AI algorithm (e.g., retrospective/prospective patient data from specific countries). The validation was conducted under simulated use conditions at Covidien LLC facilities in Plymouth, MN (USA) and Herzliya, Israel.

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

This information is not directly applicable in the context of this device's validation as described. The validation was a functional and user-experience validation, not an assessment of an AI algorithm's diagnostic accuracy against a "ground truth" derived from expert consensus. The "experts" involved were the "representative users" who participated in the design validation:

Qualifications: "qualified bronchoscopists, clinician, and service technicians."
Number of experts: The specific number is not provided, only stating "representative users from each targeted user group."

4. Adjudication method for the test set

Not applicable. The validation involved users successfully completing tasks, rather than an adjudication process for a diagnostic outcome. The success was evidently unanimous ("100 % of users... successfully completed validation tasks"), suggesting no need for adjudication for disagreement.

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, an MRMC comparative effectiveness study was not conducted or described. The device is a navigation system that aids in guiding tools, not an AI intended to improve human reader diagnostic accuracy (e.g., in reading images). The changes described are software enhancements for planning and procedure, not a new AI diagnostic component.

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

This concept is not directly applicable to the device as described. The superDimension Navigation System is an interactive system designed to be used by a human (physician) to guide tools. It is not a standalone algorithm that provides a diagnosis or output without human interaction. The validation focused on the system's functionality and its successful use by humans.

7. The type of ground truth used

The "ground truth" was the pre-defined successful completion of "typical use scenarios" and conformance to product specifications and user needs. This is essentially a functional and user-acceptance "ground truth" for a medical device software modification, rather than a clinical ground truth like pathology, expert consensus on imaging, or outcomes data, which would be typical for a diagnostic AI.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning or AI models. The software modifications are described as "software features" and "minor software enhancements," suggesting traditional software development and testing, not a machine learning model that requires a training set.

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

Not applicable, as no training set for a machine learning model is mentioned.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 5, 2015

Covidien LLC % Ms. Jenny Jiang Manager, Regulatory Affairs 161 Cheshire Lane, Suite 100 PLYMOUTH MN 55441

Re: K151376

Trade/Device Name: superDimension Navigation System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 2, 2015 Received: October 5, 2015

Dear Ms. Jiang:

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. 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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

510(k) Number (if known)	K151376
Device Name	superDimension TM Navigation System
Indications for Use (Describe)	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.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
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PSC Publishing Services (301) 443-6710 EF

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510(k) Summary

Covidien Ilc

Traditional 510(k): superDimension™ Navigation System 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 U.S.A.

Contact Person:

Jenny Jiang Regulatory Affairs Manager Phone: 763-647-5531 Fax: 763-210-4098 Email: jenny.jiang@covidien.com

Date Prepared: October/2/2015

2. Subject Device

Trade Name :	superDimension™ Navigation System
Common Name:	Bronchoscope
Classification Name:	Computed tomography x-ray system21 CFR 829.1750
Product code:	JAK
Manufacturer:	Covidien llc

3. Predicate Device

Device Name :	superDimension iLogic™ inReach System
Common Name:	Bronchoscope
510(k):	K102604
Classification Name:	Computed tomography x-ray system21 CFR 829.1750
Product code:	JAK
Manufacturer:	Covidien llc

4. Device Description

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Covidien llc is introducing the superDimension™ navigation system software release version 7.1, which is a software modification to the predicate device superDimension iLogic™ inReach System cleared under 510(k) K102604.

5. Indications for Use

6. Summary of Characteristics Compared to Predicate Device

Both the subject device and predicate devices have indications for use, principle of operation, technological and performance characteristics. The proposed superDimension™M navigation system version 7.1 implements several software features including Pathway Planning on 3D Map. Fiducial Placement, and some minor software enhancements. No changes are being made to the disposable products, system hardware components, or fundamental scientific technology of the superDimension™ navigation system. The Instructions for Use is being updated to address the changes to the software. There has been no modification to intended use or indications for use.

The primary differences between the subject and predicate devices are additional software features and minor software enhancements. The software changes in the subject device provide additional software functionalities to end users. However, these software changes don't alter the intended use of the device since these changes have no impact on the fundamental scientific technology, software core algorithms, principle of operation, or performance characteristics of the superDimension™ navigation system.

Design verification and validation test results demonstrate that the changes don't affect the safety and effectiveness of the device as the subject device conforms to the requirements and specifications of the device.

7. Performance Data

The changes to the software and Instructions for Use were 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 superDimension™ navigation system version 7.1 continues to meet its intended use.

Design verification performed on the superDimension system V7.1 Planning and Procedure application and confirmed that the superDimension navigation system met its product specification and system requirements. A full regression testing was executed to verify the modifications and ensure that the superDimension navigation system meets its product specification and requirements.

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Design validation was performed under simulated use conditions at the Covidien Ilc facility in Plymouth, MN and the facility in Herzliya, Israel by representative users from each targeted user group that include qualified bronchoscopists, clinician, and service technicians. Each user group performed typical use scenario defined in the design validation protocol. 100 % of users across the three categories (bronchoscopists, clinicians, and service personnel.) successfully completed validation tasks. In conclusion, the design validation study ensured that the Version 7.1 superDimension™ Navigation System with planning and procedure software version 7.1, conform to defined user needs and intended uses.

The superDimension™ navigation system is in compliance with the following International and FDA-recognized consensus standard:

. ISO 14971: 2007 Medical Devices - Application of Risk Management to Medical Devices

8. Clinical Data

Clinical tests were not required to validate the changes to the superDimension™ navigation system.

9. Conclusion

The superDimension™ navigation system V7.1 has the same indications for use, principle of operation, technological and performance characteristics as the predicate device K102604. Design verification and validation test results provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use and intended use. Covidien llc considers the superDimension™ navigation system V7.1 to be substantially equivalent to legally marketed predicate device superDimension iLogic™ inReach System (K102604).

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.