(89 days)
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung,
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.
The System Cart contains the Instrument Arm, electronics for the slave portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the master slave relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The Ion™ Endoluminal System enables automatic device logs retrieval via the network and connects to a hospital networked Picture Archiving and Communication System (PACS).
The provided document describes a 510(k) submission for the Ion™ Endoluminal System, Model IF1000, which has undergone modifications from its predicate device (K182188). The key changes relate to networking capabilities for automatic log retrieval and accessing CT scans directly from hospital networked PACS.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or assign a specific "device performance" metric for the modified features in a structured table. Instead, it relies on demonstrating compliance with standards and successful completion of verification and validation activities. The primary acceptance criteria for the modifications (network communication and PACS access) are implied to be functional correctness, reliability, and security, as demonstrated through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Correctness of Network Communication & PACS Access | "Software for the Ion™ Endoluminal System underwent verification and validation testing. results demonstrate the System meets design specifications and user needs." |
| "The System Cart and Planning Laptop were subjected to bench testing and results confirm the design outputs for the System Cart and the Planning Laptop meet the design input requirements." | |
| "The device modifications made to enable the network communication and direct patient CT scan images download via PACS server on the hospital network have been evaluated and do not raise different questions of safety or effectiveness." | |
| "The performance testing data confirmed that the device performs as intended to its specifications and meets its intended use." | |
| Electromagnetic Compatibility (EMC) | "The subject device (Ion Endoluminal System) was tested for compliance with the new 4th edition version of the standard, IEC 60601-1-2: 2014." |
| "The 4th edition EMC testing of the subject device also verified hardware modifications made to the subject device." | |
| Electrical Safety | "The electrical safety testing performed for compliance with IEC 60601-1 and IEC 60601-2-18 on predicate device (K182188) remains valid for the subject device because the scope of changes for this submission do not impact the electrical safety of the Ion Endoluminal System." |
| Cybersecurity | "The Ion™ Endoluminal System was subjected to Cybersecurity verification and validation testing. Cybersecurity was evaluated per FDA's Draft Guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices' (October 18, 2018). ... The cybersecurity verification and validation test results demonstrate the adequacy of the implemented cybersecurity controls." |
| System Performance (under simulated use conditions - Animal) | "For system design validation, animal testing was performed under simulated use conditions to assess the system performance. Test results demonstrated the Ion™ Endoluminal System performs according to its intended use." |
| Usability | "Changes made to the subject device do not affect previously identified critical tasks, and no new critical tasks were identified. Therefore, data collected during the previous summative usability study for the predicate device... remains valid, and no additional testing was required." |
2. Sample Size Used for the Test Set and Data Provenance
- Software Verification and Validation, Bench Testing, Cybersecurity Testing: The document does not specify a numerical sample size for these tests. The nature of these tests (e.g., unit tests, integration tests, system tests, penetration tests for cybersecurity) typically involves comprehensive coverage rather than a statistical sample size of cases in the way that clinical studies do.
- Animal Testing: The document mentions "animal testing was performed," but does not specify the number of animals or the type of animal used. The provenance is implied to be experimental (simulated use conditions).
- The document does not mention the use of retrospective or prospective data sets from human patients for the evaluation of the new features. The evaluation focuses on technical performance and safety of the modified system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of experts to establish "ground truth" for the test sets in the context of diagnostic accuracy, as the modifications are related to system functionality, networking, and safety rather than a diagnostic algorithm. The ground truth for functional tests would be the expected system behavior, and for cybersecurity, it would be adherence to security best practices and robustness against identified threats.
4. Adjudication Method for the Test Set
Not applicable, as no human-expert-based ground truth establishment or adjudication is described for the technical tests performed for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned in this document. The submission focuses on demonstrating substantial equivalence of the modified system, not on comparing reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the PlanPoint™ Software uses CT scans to create 3D plans and navigation pathways, this document primarily discusses the system's ability to access these CT scans via PACS and automatic log retrieval. It does not provide details about a standalone performance study of the PlanPoint™ Software's algorithmic accuracy in path planning or 3D reconstruction. The animal testing assessed "system performance" under simulated use, which would include the integrated functionality, but not an isolated algorithm-only performance metric.
7. Type of Ground Truth Used
- For Software Verification and Validation, Bench Testing: The ground truth is implicit in the design specifications and user needs. The tests verified that the system's outputs matched the expected behavior defined by these specifications.
- For Cybersecurity Testing: Ground truth is defined by established cybersecurity standards, best practices, and the identified vulnerability landscape.
- For Animal Testing: The ground truth is the successful demonstration of the "Ion™ Endoluminal System performs according to its intended use" in a simulated environment.
- No pathology, clinical outcomes data, or expert consensus (in a diagnostic sense) ground truth is described as being used for the evaluation of the modifications in this submission.
8. Sample Size for the Training Set
The document does not describe any machine learning or AI models being "trained" as part of the modifications being evaluated. Therefore, there is no mention of a training set sample size. The PlanPoint™ Software uses patient CT scans for planning, but it's not described as a learning algorithm that requires a "training set" in the conventional AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is described in this document.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.