(269 days)
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
This EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The BF-XT190 is indicated for use within the airways and tracheobronchial tree. The BF-XT190 is a video scope used for the endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-MP190F which was previously cleared under K172726.
The provided text describes a 510(k) premarket notification for the EVIS EXERA III Bronchovideoscope Olympus BF-XT190. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or analytical performance.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, and detailed study information are not present in the provided text, as this type of submission relies on comparisons to an already cleared device and bench testing for new features.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding performance metrics for clinical or analytical performance. Instead, it lists the types of performance testing conducted to support substantial equivalence.
| Acceptance Criteria (Implied by type of testing) | Reported Device Performance (Summary from text) |
|---|---|
| Reprocessing validation | Performed in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling" (March 2015). |
| Biocompatibility | Performed in accordance with FDA Guidance "Use of International Standard ISO 10993-1" (June 2013). Included Cytotoxicity, Intracutaneous, Guinea Pig Maximization Sensitization, and Acute Systemic Toxicity tests. |
| Software verification and validation | Performed in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005) and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2014). |
| Electrical safety and EMC | Complies with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-2-18:2009 for safety, and IEC 60601-1-2:2014 for EMC. |
| Bench Performance Testing | Carried out to demonstrate safety and effectiveness. Included Thermal Safety, Mechanical Durability, Photobiological Safety, and Optical Performance tests. |
| Risk Analysis | Carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and their acceptance criteria were identified and performed as a result of this analysis. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any of the performance tests. The nature of these tests (e.g., biocompatibility, electrical safety) typically involves a specific number of units/samples for testing, but these numbers are not detailed in this summary.
- Data Provenance: Not explicitly stated. The company, Olympus Medical Systems Corp., is based in Tokyo, Japan, and the contact person is in the USA. However, the location where the tests were physically performed is not provided. The document implies these are internal validation tests, not clinical studies with patient data.
- Retrospective or Prospective: Not applicable as no clinical or patient data study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth concept, typically involving expert consensus on patient cases for diagnostic devices, is not relevant here as no clinical or patient data study was conducted. The performance testing described relates to the device's physical, electrical, and functional characteristics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process is described as there is no clinical or image-based test set requiring expert interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This device is a bronchoscope, not an AI-assisted diagnostic tool. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bronchoscope, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it applies to diagnostic or prognostic data is not relevant to the performance tests described. For bench tests, the "ground truth" would be the established engineering specifications, international standards (e.g., ISO, IEC), and regulatory guidelines (e.g., FDA guidance documents) against which the device's performance is measured. For example:
- For biocompatibility: Adherence to ISO 10993-1.
- For electrical safety: Compliance with ANSI/AAMI ES 60601-1 and IEC 60601-2-18.
- For software: Compliance with FDA software guidance.
8. The sample size for the training set
Not applicable. This device is a bronchoscope, not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned as it is not an AI/ML device.
§ 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.