(34 days)
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.
The superDimension/Bronchus Premium 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 nearnet aod the interior of the tree. It has been modified to permit external video monitoring and recording devices. Other minor improvements have been made also.
The provided text describes the superDimension/Bronchus Premium device but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document is a 510(k) summary for a Special 510(k), which implies that the device is substantially equivalent to a previously cleared device (superDimension/Bronchus 4.1, K052260) and incorporates minor modifications.
Here's a breakdown of why the requested information is absent based on the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present. The document states, "Since no new technology is used, clinical tests are not required." This indicates that the device's performance was not evaluated through a new clinical study with pre-defined acceptance criteria, but rather by demonstrating substantial equivalence to a predicate device.
- Sample size for the test set and data provenance: No test set is mentioned because no new clinical testing was deemed necessary.
- Number of experts and their qualifications: Not applicable as no new ground truth establishment process is described.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
- Standalone (algorithm only) performance: Not applicable, as this is a device for guiding a bronchoscope, not a diagnostic algorithm.
- Type of ground truth used: Not applicable as no new clinical study to establish ground truth was performed.
- Sample size for the training set: Not applicable as "no new technology is used."
- How the ground truth for the training set was established: Not applicable.
Summary from the provided text:
| Information Requested | суперDimension/Bronchus Premium |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not provided a new study. The device satisfied EN60601-1 and EN 60601-1-2 and underwent extensive bench testing. Its substantial equivalence to superDimension/Bronchus 4.1 (K052260) was used for clearance. |
| 2. Sample size for test set & data provenance | Not applicable; no new clinical tests were required. |
| 3. Number and qualifications of experts for ground truth | Not applicable; no new clinical tests were required. |
| 4. Adjudication method | Not applicable; no new clinical tests were required. |
| 5. MRMC comparative effectiveness study | No. |
| 6. Standalone performance study | No. |
| 7. Type of ground truth used | Not applicable; no new clinical tests were required. |
| 8. Sample size for training set | Not applicable; no new technology was used, and no new clinical tests were required. |
| 9. How ground truth for training set was established | Not applicable; no new technology was used, and no new clinical tests were required. |
Reasoning for "Not applicable":
The document explicitly states: "Since no new technology is used, clinical tests are not required." This means that the device's clearance was based on its substantial equivalence to a predicate device, rather than new clinical data demonstrating its performance against specific acceptance criteria. The modifications were minor, primarily allowing external video monitoring/recording and other minor improvements. Therefore, the detailed information about clinical studies, test sets, ground truth establishment, and expert involvement is not present in this 510(k) summary.
§ 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.