(59 days)
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.
The superDimension/Bronchus System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The superDimension/Bronchus also enables the placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.
The provided 510(k) summary (K080271) for the superDimension/Bronchus inReach™ System does not contain a study that proves the device meets specific acceptance criteria with reported performance metrics. Instead, it is an indication expansion for an already cleared device, where the key change is an update to the Instructions for Use (IFU) to include guidance for deploying radiosurgical and dye markers into soft lung tissue.
Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this particular 510(k) submission as it focuses on software or algorithm performance. The submission explicitly states:
- "Clinical tests were not required to validate the changes to the superDimension/Bronchus System."
- "No changes are being made to the hardware or software design, or technological characteristics of the current marketed device."
The basis for the expanded indication is:
- "Multiple published studies have demonstrated the Bronchus is safe and effective when used to place radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery." (However, these studies are not detailed or provided within this K080271 submission.)
- A hazard analysis and appropriate design validations were performed to assure the device continues to meet expanded user needs.
Because this 510(k) is an indication expansion based on existing evidence and no new performance data or clinical studies were submitted, most of the requested fields cannot be filled.
Here's a breakdown of the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The submission does not detail specific acceptance criteria for device performance or report new performance data as part of this K080271 submission. The changes pertain to expanded indications for use based on the existing device's established safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No new test set data was generated or submitted for this indication expansion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. No new test set requiring ground truth establishment was conducted for this submission. The claim refers to "Multiple published studies" but does not detail their methodology or expert involvement within this document.
4. Adjudication Method for the Test Set:
Not applicable. No new test set requiring adjudication was conducted for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC comparative effectiveness study was not done as part of this submission. The submission states, "Clinical tests were not required to validate the changes to the superDimension/Bronchus System."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The superDimension/Bronchus System is a guidance system for human-operated bronchoscopes and tools; it is not a standalone diagnostic or completely autonomous device in the context of this submission. No new algorithm-only performance studies were conducted.
7. The Type of Ground Truth Used:
Not applicable for this submission. The reliance is on "Multiple published studies" which would have established their own ground truth based on clinical outcomes, pathology, or direct observation, but these are not detailed here.
8. The Sample Size for the Training Set:
Not applicable. This submission is not about developing or training a new algorithm or AI model; it's an indication expansion for an existing device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This submission is not about developing or training a new algorithm or AI model.
§ 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.