(125 days)
WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree.
WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree. This system includes a single-use digital bronchoscope and an image system.
- The image system OTU-A is the currently marketed in the United States by OTU Medical Inc. under 510(k) # K181977.
- The single-use bronchoscope is comprised of a control body with an articulation lever, a suction connector, a suction button, and a working channel port, and a flexible insertion tube with an on-tip camera module and LED lighting source.
The provided document is a 510(k) summary for the WiScope® Digital Bronchoscope System. It details the device's characteristics, comparison to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence. Crucially, it explicitly states "No clinical study is included in this submission" in section 10, "Performance Data-Clinical".
Therefore, based on the provided text, there is no information available regarding acceptance criteria based on clinical performance, nor any study that proves the device meets such criteria through clinical data. The submission relies entirely on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence.
However, I can extract the acceptance criteria for the non-clinical performance tests that were conducted and the reported non-clinical device performance.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance (Non-Clinical)
Given that "No clinical study is included in this submission," the acceptance criteria and performance data relate entirely to non-clinical testing and established industry standards for medical devices. The device is deemed to meet acceptance criteria if it passes these tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category / Characteristic | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 and IEC 60601-2-18 compliance. | "All evaluation acceptance criteria were met." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 compliance. | "All evaluation acceptance criteria were met." |
| Biocompatibility | ISO 10993-1 compliance, specifically: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous reactivity test (ISO 10993-10). | "All tests were passed." (for Cytotoxicity, Sensitization, Intracutaneous reactivity) Cytotoxicity: "Comply with ISO 10993-5, no cytotoxicity effect." Irritation: "Comply with ISO 10993-10, not an irritant." Sensitization: "Comply with ISO 10993-10, not a sensitizer." |
| Shelf Life | ASTM F1980 compliance, including Performance test and Sterile Packaging Integrity. | "All tests were passed." |
| Sterile Barrier Systems | ISO 11607-1:2019 compliance. | "Evaluated in accordance with ISO 11607-1:2019." (Implied acceptance met for submission) |
| Sterilization Process | ISO 11135:2014 compliance, demonstrating achievement of required SAL of 10-6 using half cycle overkill approach. | "The WiScope® Single-Use Digital Flexible Bronchoscope is sterile with a determination of lethal rate of the sterilization process to demonstrate achievement of the required SAL of 10° is in accordance to half cycle overkill approach." (Implied acceptance met) |
| Technological Characteristics / Performance (per ISO 8600 and relevant functions) | Functions as intended, including: Appearance, Working length of the shaft, Minimum bending radius, Working channel diameter, Outer Shaft Diameter, Depth of field, Field of view, Direction of view, Rigid Distal Tip Temperature, Tensile Force Testing, Resolution, Illumination, Angulation range, Working channel free from leakage, Water proof, Suction. (Implied compliance with ISO 8600 standards where applicable for these parameters) | "All tests were passed." |
| Simulated Shipping Distribution | ASTM D4169-16 compliance. | "All tests were passed." |
| Software Development | ISO 13485 compliance (development), IEC 62304:2006 compliance (verification and validation). | "Software is developed according to ISO 13485 standard. It is verified and validated according to IEC 62304:2006." (Implied acceptance met) |
| Cybersecurity Assessment | FDA Cybersecurity Guidance compliance. | "Cybersecurity Assessment is completed according to FDA Cybersecurity Guidance." (Implied acceptance met) |
Since the submission explicitly states "No clinical study is included in this submission," the following points directly related to clinical studies or AI/human-in-the-loop performance cannot be addressed from the provided text.
2. Sample size used for the test set and the data provenance: Not applicable for clinical data. For non-clinical, the sample sizes would refer to the number of devices or components tested, which is not specified but implied by the "All tests were passed" statements for various categories (e.g., biocompatibility testing of specific materials, sterilization validation on a batch of devices). Data provenance is not described for these non-clinical tests (e.g., where manufacturing/testing was performed).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there are no clinical studies or ground truth established by experts for such studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for clinical studies.
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: Not applicable, as there is no clinical study and no mention of AI assistance. The device is a physical bronchoscope system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a physical system, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical data. For non-clinical tests, the "ground truth" is adherence to national and international testing standards (e.g., ISO, ASTM, IEC).
8. The sample size for the training set: Not applicable, as there is no AI component requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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.