(94 days)
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy 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.
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy 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.
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy 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.
The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 are used for endoscopic diagnosis and treatment within the respiratory organs. These endoscopes consist of three parts: the control section, the insertion section, and the connector section.
The provided FDA 510(k) clearance documentation for the Olympus Bronchovideoscopes (K250862) primarily demonstrates substantial equivalence based on technological characteristics and bench testing. It does not contain information about comparative effectiveness studies (like MRMC studies for AI devices), expert ground truth establishment, or typical performance metrics associated with AI/software-as-a-medical-device (SaMD) clearances.
This submission focuses on:
- Technological Equivalence: Showing that the devices (BF-XP190, BF-P190, BF-XT190, BF-H1100, and BF-1TH1100) are fundamentally the same as their predicates, with the primary change being compatibility with a new video system center (CV-1500) and updated labeling related to laser/high-frequency/APC systems.
- Bench Testing: Verification of physical and imaging performance parameters (e.g., thermal safety, color performance, resolution, noise, video latency) to ensure they meet specifications, particularly when combined with the new video system.
- Animal Testing: To assess the imaging modes (WLI, NBI, TXI, BAI-MAC) with the new video processor.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) is not present in this document. The document explicitly states that "Software Testing and Cybersecurity" was "not performed" due to "no design, material, sterilization, reprocessing, packaging, shelf life, or software changes" (Page 29). This implies that the device itself is a hardware endoscope, and any software associated with it is considered an intrinsic part of its established functionality, not a new or significantly changed software component requiring a separate performance study with clinical endpoints or AI evaluation.
The "acceptance criteria" here relate to the successful completion of the listed bench (and limited animal) tests, demonstrating that the new combination (endoscope + CV-1500) functions as intended and safely, similar to the predicate combinations.
Below is a table summarizing the "acceptance criteria" and "reported device performance" as derived from the document's comparison tables and performance data section, which are primarily about technical specifications and functional verification, not software/AI performance metrics.
Acceptance Criteria and Reported Device Performance (Summary based on provided text)
Since this 510(k) is for existing endoscopes with a new video system and updated labeling, the "acceptance criteria" are implied by the extensive comparison tables (Tables 1-5) which show the subject devices having nearly identical technical specifications to their predicate devices, and the successful completion of specified bench and animal testing. The performance data section doesn't list specific quantitative acceptance criteria for each test but rather states that tests were conducted to "ensure that the subject device performs as intended and meet design specifications."
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Defined by Predicate Equivalence) | Reported Device Performance (as stated or implied by equivalence) |
|---|---|---|
| Indications for Use | Identical to predicate devices. | The Indications for Use for the Subject Device is exactly the same as the Indications for Use for the equivalent Predicate Device (Page 9). |
| Material Composition | Identical materials used for key components (e.g., Insertion Tube, Bending Section Rubber). | Materials are identical to predicates (e.g., Fluoro Resin, Fluoro Rubber, Epoxy Glue, Polytetrafluoro-ethylene, Polysulfone, Glass/Sapphire) (Pages 12-13, 16-17, 20-21). |
| Physical Dimensions | Maintain specific dimensions (e.g., Outer Diameter, Working Length, Instrument Channel inner diameter). | Dimensions are identical to predicates across all models (e.g., BF-P190 Outer Diameter of Distal End Φ4.2mm, Working Length 600mm, Instrument Channel inner diameter φ2.0; BF-XP190 Outer Diameter of Distal End Φ3.1mm; BF-XT190 Outer Diameter of Distal End Φ6.1mm; BF-H1100 Distal end outer diameter ø 4.9 mm; BF-1TH1100 Distal end outer diameter ø 5.8 mm) (Pages 12, 16, 19-20, 23, 26). |
| Optical/Imaging Performance | Maintain specific optical characteristics (e.g., Depth of Field, Field of View, Pixels, CCD type). | Identical optical characteristics to predicates (e.g., Depth of Field 2-50mm/3-100mm, Field of View 110°/120°, Total Number of Pixels 50,621 / 465,588, Color CCD) (Pages 11-12, 15, 19, 22, 25). |
| Software Functionality | Identical software functions (e.g., pixel defect correction, scope info, NBI, Pre-freeze). | All listed software functions are "Available" and match the predicate devices (Pages 13, 17, 21, 24, 27-28). The RDI, TXI, and BAI-MAC modes are explicitly stated as "Available" for the subject devices when previously "Not Available" for some predicates, implying this is the new feature enabled by the CV-1500 system, and their performance was assessed. |
| Safety | Meet safety standards for thermal, photobiological, and ignition factors (especially with laser/HF/APC compatibility). | Bench testing conducted for: Thermal Safety, Photobiological Safety, Ignition Factors Safety Study (Laser, High-Frequency, APC, Scope Comparison) to ensure performance and safety (Page 28). |
| Functional Verification | Performance as intended with the new CV-1500 video system center. | Bench testing (Color Performance, Resolution, Noise and Dynamic Range, Image Intensity Uniformity, Video Latency, RDI, TXI, BAI-MAC, Automatic Brightness Adjustment, Pre-Freeze) was conducted to ensure intended performance (Page 28). Animal testing performed to assess imaging modes (WLI, NBI, TXI, BAI-MAC) with CV-1500 (Page 29). |
| Risk Management | Risks identified and mitigated in accordance with ISO 14971:2019. | Risk management performed, and design verification tests and acceptance criteria identified as a result (Page 29). |
Study Details (based on provided text)
The document describes performance testing rather than a comparative clinical study for AI/software-as-a-medical-device.
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A table of acceptance criteria and the reported device performance:
- See table above. The acceptance criteria are largely implied by the equivalence to the predicate devices in terms of physical, optical, and functional characteristics, and the successful completion of specified bench and animal tests. Quantitative metrics for these tests are not provided in this summary but would have been part of the full submission.
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Sample sizes used for the test set and the data provenance:
- Test set sample size: Not specified. The document mentions "bench testing" and "animal testing." For bench tests, it typically refers to a small number of devices or engineered test setups. For animal testing, the number of animals or studies is not provided.
- Data provenance: Not specified. It can be inferred that the testing was conducted by or on behalf of Olympus Medical Systems Corp. in Japan, given the manufacturing site and submitter location. It does not state if the data is retrospective or prospective, or from which country/region the "animal" data would originate.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. This type of information is typically provided for studies evaluating AI algorithms or diagnostic accuracy, where human experts establish a ground truth for imaging interpretation. The present submission is for a hardware endoscope system, and its performance evaluation relies on engineering specifications and functional testing, not expert interpretation of diagnostic images.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Adjudication methods are relevant for human reader studies or expert ground truth establishment, which are not detailed here.
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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, not performed / Not applicable. This submission is not for an AI companion diagnostic or an AI-software-as-a-medical-device. It's for an endoscope system. The document explicitly lists "Software Testing and Cybersecurity" and "Clinical" as "not performed" because there were no fundamental software changes beyond integration with a new video system, which itself does not constitute an AI component in the context of this 510(k) summary. The NBI, RDI, TXI, and BAI-MAC modes are imaging enhancements, not AI algorithms.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to AI/software performance, which is not the focus of this 510(k).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this device (endoscope), ground truth typically relates to engineering specifications (e.g., accurate measurements, clear image quality as determined by reproducible test patterns, proper functionality of mechanical parts). For the animal testing of imaging modes, the "ground truth" would be the direct observation of the animal's internal anatomy via the endoscope itself and comparison to expected/known characteristics, not an independent "pathology" or "outcomes" ground truth in a diagnostic sense.
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The sample size for the training set:
- Not applicable. This submission is not for an AI system that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. As above, no AI training set is described.
§ 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.