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 version 7.2 (V7.2) is a device that guides endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by a previous CT scan. The superDimension™ navigation system V7.2 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.

Covidien Ilc is introducing the superDimension™ navigation system software release V7.2, which is a software modification to the predicate device superDimension navigation system cleared under 510(k) K151376. The V7.2 software includes an optional local registration feature intended to compensate for CT-to-body divergence though incorporation of additional fluoroscopic imaging data taken during the electromagnetic navigation procedure. Local registration is an optional feature and can be used at the physician's discretion.

AI/ML Overview

This document describes a 510(k) premarket notification for the superDimension™ Navigation System V7.2. The device is a software modification to a previously cleared predicate device (K151376). The core of the information provided focuses on the substantial equivalence argument, particularly how the safety and effectiveness are maintained despite the modifications.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Key Takeaway: This submission (K173244) is for a software modification (V7.2) to an existing device. Crucially, no clinical studies were required for this submission. The "studies" proving acceptance are primarily design verification and validation tests, and a demonstration of substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a software update to an already cleared device, the "acceptance criteria" are predominantly about ensuring the updated device continues to meet the safety and effectiveness standards of the predicate, and that the new feature (local registration) functions as intended without introducing new risks or compromising existing functions.

Acceptance Criterion (Based on Design V&V)	Reported Device Performance
Software Verification Testing
Target visualization accuracy	Met specifications
Target marking accuracy	Met specifications
Local registration accuracy	Met specifications
Software application testing	Met specifications
Regression testing (no impact on unmodified software)	Confirmed no impact
Usability Validation Testing
Functionality	Confirmed by users
User interface	Confirmed by users
User needs and intended uses	Conformed to user needs and intended uses
Fiducial Marker Board Design Verification	Met specifications
Shipping Validation	Met specifications
Risk Management	Performed to analyze potential hazards; demonstrated the addition of the local registration feature does not significantly change device risks.
Compliance with Standards	Met listed International and FDA-recognized consensus standards (ISO 14971, IEC 62366-1, ISO 15223-1, ASTM D4169, ANSI/AAMI/IEC 62304)
No change in intended use/Indications for Use	Confirmed identical indications for use as the predicate device.

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

Sample Size: The document does not specify a numerical "sample size" in terms of patient data or clinical cases for testing. The testing described is primarily engineering and usability validation.
- For software verification, this would typically involve a comprehensive set of test cases designed to exercise all functionalities, including the new local registration feature. The document indicates "target visualization and marking accuracy, local registration accuracy, software application testing and regression testing." These are likely performed on simulated data, phantom studies, and possibly existing de-identified CT scans.
- For usability validation, the text mentions "representative users from targeted user groups." No specific number of users is provided.
- For fiducial marker board testing, no specific sample size is mentioned.
Data Provenance: Not applicable in the context of clinical studies for this submission. The tests are primarily in-house design verification and validation. If any imaging data were used for software testing, its origin (e.g., country) is not specified, but it's implied to be de-identified or synthetic data suitable for testing.
Retrospective or Prospective: Not applicable as this was not a clinical study involving patients. The design verification and validation were prospective in nature (performed specifically for this submission).

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

Number of Experts: For usability validation, the document mentions "qualified bronchoscopists and clinicians." A specific number is not provided.
Qualifications of Experts: They are described as "qualified bronchoscopists and clinicians." This implies medical professionals with relevant experience in the use of such navigation systems in pulmonary procedures. No specific years of experience are listed.
Ground Truth Establishment: For the technical software verification tests (accuracy, regression), the "ground truth" would be established by engineering specifications and expected outputs generated by the development team. For usability validation, "ground truth" is established by user feedback and observation against defined usability metrics.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This was not a multi-reader assessment of subjective image interpretations. For usability testing, observed behaviors and subjective feedback from users would be collected and analyzed, likely against predefined criteria, but not through a formal adjudication process akin to clinical diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not required to validate the changes to the superDimension™ navigation system V7.2."
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: The software verification testing (e.g., target visualization accuracy, target marking accuracy, local registration accuracy) could be considered a form of "standalone" evaluation of the algorithm's performance against predefined metrics, though the device is inherently intended for human-in-the-loop use. It assesses the software's computational correctness and accuracy independent of real-time human interaction during a procedure for these specific metrics. However, it's not a standalone diagnostic AI system.

7. The Type of Ground Truth Used

Type of Ground Truth:
- For software verification (accuracy): Engineering specifications, mathematically derived correct outputs, or measurements from controlled phantom studies.
- For usability validation: User feedback, observed user interactions, and conformance to predefined user needs and task completion criteria.
- Clinical ground truth (e.g., pathology, outcomes data) was not used, as no clinical studies were performed.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This submission is for a software update for a medical device that guides instruments, not for a machine learning/AI algorithm that requires a "training set" in the conventional sense (e.g., for image classification or prediction). The "software modification" refers to changes in the core application logic and potentially new computational features (like local registration), which are developed through traditional software engineering processes, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there was no machine learning training set in the context of this device update. The "ground truth" for the software's functionality and accuracy would be established through its design specifications and algorithms, which are based on established physics, geometry, and engineering principles relevant to navigation and imaging.

Summary

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February 8, 2018

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Covidien LLC % Ms. Kristen Swanson Regulatory Affairs Consultant Kompass Regulatory Consulting, LLC 1583 Northrop Street FALCON HEIGHTS MN 55108

Re: K173244

Trade/Device Name: superDimension™ Navigation System V7.2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 11, 2018 Received: January 16, 2018

Dear Ms. Swanson:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'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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Indications for Use

510(k) Number (if known)

K173244

Device Name superDimension™ Navigation System V7.2

Indications for Use (Describe)

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)

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510(k) Summary

Covidien llc Traditional 510(k) K173244 superDimension™ Navigation System v7.2

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

1. Submitter

510(k) Submitter: Covidien llc 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 U.S.A.

Contact Person:

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

Date Prepared: 10/05/2017

2. Subject Device

Trade Name :	superDimension™ Navigation System V7.2
Common Name:	Electromagnetic Navigation Bronchoscopy System
	Classification Name: Computed tomography x-ray system
	21 CFR 829.1750
Product code:	JAK
Manufacturer:	Covidien llc

3. Predicate Device

superDimension™ Navigation System
Electromagnetic Navigation Bronchoscopy System
K151376
Classification Name: Computed tomography x-ray system
21 CFR 829.1750
JAK
Covidien Ilc

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4. Device Description

5. Indications for Use

6. Summary of Characteristics Compared to Predicate Device

The subject and predicate devices have identical indications for use. Both the subject and predicate devices include the same system hardware. Planning software, disposable sterile devices, and disposable non-sterile components. The proposed superDimension™ navigation system version 7.2 includes a Procedure application software modification and one additional standalone hardware component, called a fiducial marker board. The software change implements an optional local registration feature. The local registration feature uses a fluoroscopic video taken during the procedure and a fiducial marker board to allow 3D reconstruction of a small region of interest in the lung to compensate for possible CT-to-body divergence.

The only difference between the subject and predicate devices is one additional software feature, an additional fiducial board, and an updated user manual. The changes in the subject device provide an additional software function to end users. However, the changes do not 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 do not 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, fiducial marker board, and Instructions for Use were subjected to the Covidien design control process. Risk Management was performed to

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analyze the potential hazards associated with the changes. Appropriate design verification and validations were performed to assure the superDimension™ navigation system V7.2 continues to meet its intended use.

Design testing performed on the superDimension navigation system V7.2 included the following:

. Software verification testing including target visualization and marking accuracy, local registration accuracy, software application testing and regression testing
. Usability validation testing with qualified bronchoscopists and clinicians to confirm functionality and user interface
. Fiducial marker board design verification and shipping validation.

The combined verification and validation testing confirmed that the superDimension navigation system V7.2 met its product specification and system requirements. Regression testing was executed to verify the modifications did not impact unmodified software elements.

Design validation was successfully performed under simulated use conditions by representative users from targeted user groups including qualified bronchoscopists and clinicians. Each user group performed typical use scenarios defined in the design validation protocol. In conclusion, the design validation study ensured that the superDimension™ navigation system V7.2 conformed 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
IEC 62366-1: 2015 Medical devices Part 1: application of usability engineering ● to 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.
. ASTM D4169: 2016 Standard Practice for Performance Testing of Shipping Containers and Systems
. ANSI/AAMI/IEC 62304: 2006 Medical device software - software life cycle processes

8. Clinical Data

Clinical tests were not required to validate the changes to the superDimension™ navigation system V7.2.

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9. Conclusion

The superDimension™ navigation system V7.2 has the same indications for use, principle of operation, fundamental scientific technology, and performance characteristics as the predicate device K151376. 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. A thorough risk assessment has shown that the addition of the local registration feature does not significantly change the device risks. Covidien llc considers the superDimension™ navigation system V7.2 to be substantially equivalent to the legally marketed predicate device superDimension navigation system cleared under 510(k) K151376.

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.