(30 days)
GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures. Similar to the predicate GlideScope® BFlex™ 5.0 Single-Use Bronchoscope, the GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitor) for purposes of image display.
This document describes the FDA's 510(k) clearance for the Verathon GlideScope® BFlex™ 5.8 Single-Use Bronchoscope. It is a PMA (Premarket Approval) submission, which means it evaluates the substantial equivalence of a new device to a predicate device already on the market. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through performance testing, rather than a clinical trial for diagnostic accuracy or effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "Performance testing has been completed to demonstrate that the proposed GlideScope® BFlex™ 5.8 Single-Use Bronchoscope meets the safety and performance requirements established in the design specifications." and "Results: All testing resulted in acceptance criteria passed."
However, the specific acceptance criteria and detailed performance results (e.g., numerical values for each test) are not provided in this summary. The table below lists the types of performance tests conducted, implying that the acceptance criteria are related to the successful outcome of these tests as defined in the design specifications.
| Performance Test Category | Implicit Acceptance Criteria (Pass/Fail) | Reported Device Performance |
|---|---|---|
| Full System Requirements Testing | Device meets all defined system requirements | Passed |
| Electrical Safety (AAMI/ANSI ES60601-1, IEC 60601-2-18) | Compliance with specified electrical safety standards | Passed |
| Electromagnetic Compatibility (ANSI AAMI IEC 60601-1-2) | Compliance with specified EMC standards | Passed |
| Optical Testing (ISO 8600-1, 8600-3, 8600-4) | Compliance with specified optical performance standards (e.g., field of view, depth of field) | Passed |
| Biocompatibility (ANSI AAMI ISO 10993-1) | Biocompatibility according to specified standards | Passed |
| Aging Performance Testing | Device maintains performance over its intended lifespan | Passed |
| Sterile Packaging Integrity Testing | Packaging maintains sterility and integrity | Passed |
| Cleaning Testing | Not applicable for a single-use device, likely refers to residual testing for manufacturing materials or for the reusable monitor if mentioned. (The document states: "Similar to the predicate GlideScope® BFlex™ 5.0 Single-Use Bronchoscope, the GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is distributed sterile and is for single use only." so "Cleaning Testing" likely refers to the cleaning validation of the reusable components of the system if any, or general manufacturing cleanliness standards.) | Passed |
| Design Validation | Device meets its intended use and design requirements | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the performance tests. It states that "The GlideScope® BFlex™ 5.8 Single-Use Bronchoscope, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This implies that the testing was primarily lab-based performance testing of the device and its components, rather than human clinical data. Therefore, data provenance in terms of patient data (country, retrospective/prospective) is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. The "ground truth" for this device, being a bronchoscope, is primarily its physical and functional performance according to engineering and safety standards, not a diagnostic accuracy against a clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 are used in clinical studies where expert consensus is needed for ground truth establishment. This submission focuses on engineering and performance validation.
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 study was done. This is a medical device (bronchoscope) clearance based on substantial equivalence, not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm, so "standalone" performance in that context is not applicable. The device's "standalone" performance is its ability to physically function according to its specifications, which was tested during performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established engineering, safety, and performance standards (e.g., ISO, IEC, AAMI standards) and the specifications derived from the predicate device. This is primarily objective, measurable test results, not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.