(125 days)
Not Found
No
The summary explicitly states that the changes have no impact on the fundamental scientific technology, software core algorithms, or principle of operation. There is no mention of AI, ML, or related concepts like training or test sets. The new feature, local registration, is described as incorporating additional fluoroscopic imaging data, not using AI/ML for analysis or guidance.
No
The device aids in guiding endoscopic tools and marker placement, but the provided text explicitly states, "It does not make a diagnosis and is not an endoscopic tool." This indicates it is a navigation/guidance system rather than one that directly treats or prevents a disease/condition.
No
The 'Intended Use / Indications for Use' section explicitly states, "It does not make a diagnosis."
No
The device description explicitly states it is a "system" that guides endoscopic tools and allows placement of catheters and markers. While the submission focuses on a software modification (V7.2), the overall device is a navigation system that likely includes hardware components beyond just software to perform its intended function (e.g., electromagnetic tracking hardware, display, etc.). The performance studies also mention "Fiducial marker board design verification and shipping validation," further suggesting hardware components are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "displaying images... to aid the physician in guiding endoscopic tools or catheters... and to enable marker placement." It explicitly states, "It does not make a diagnosis." IVDs are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on guiding tools and visualizing the bronchial tree based on imaging data. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
This device is a medical imaging and navigation system used during procedures, not a diagnostic test performed on in vitro samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan, fluoroscopic imaging data
Anatomical Site
tracheobronchial tree, pulmonary tract, lung tissue
Indicated Patient Age Range
Not for pediatric use.
Intended User / Care Setting
Physician, bronchoscopists, clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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February 8, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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)
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)
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Image /page/3/Picture/1 description: The image contains the word "COVIDIEN" in a sans-serif font. To the left of the word is a blue square with a white cross in the center. The cross is made up of two intersecting bars, one horizontal and one vertical. The square is a dark blue color, and the cross is a lighter blue color.
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
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.
5. Indications for Use
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.
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.