(206 days)
The PENTAX Medical Video Bronchoscope EB11-J10 has been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
The subject device is used to provide visualization of, and therapeutic access to, the airways and tracheobronchial tree. There are three models of EB-J10 series: the subject device, and the previously cleared models: EB15-J10 and EB19-J10 (K200678). These models are identical in all parameters and only differ in French size: 11, 15 and 19, respectively.
The subject device is used with cleared PENTAX Video Processors (a software- controlled device). The subject device has a flexible insertion tube, a control body, and PVE connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water and suction.
The control body includes controls for up/ down angulation, air/ water delivery, and an accessory inlet port. The subject device contains light carrying bundles (LCB) to illuminate the body cavity, and a CCD to collect endoscopic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced.
The video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
The subject device is immersible (with the use of supplied cleaning accessories) as described in the endoscope reprocessing instructions.
The PENTAX Medical Video Bronchoscope EB11-J10 is a medical device designed for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. The provided document is a 510(k) summary for the device, seeking clearance based on substantial equivalence to a predicate device, the PENTAX Video Bronchoscope EB-1170K (K131028).
The document does not detail specific acceptance criteria or report performance data in a quantifiable manner for each criterion, nor does it describe a study specifically designed to "prove" the device meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through various performance tests. The focus is on confirming that technological changes do not raise new issues of safety and effectiveness.
Here's an analysis of the available information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria with corresponding device performance metrics. Instead, it lists various non-clinical performance tests conducted to support substantial equivalence. The "performance" is generally described as "effective," "acceptable," or "equivalent to the predicate."
| Test Category | Description of Performance |
|---|---|
| Reprocessing Validation | Simulated use testing, soil accumulation analysis, cleaning, high-level disinfection, and rinsing validation studies confirmed the effectiveness of reprocessing procedures. |
| Sterilization and Shelf Life | Validated the use of STERRAD NX®/100NX® for sterilization. (Device is not provided sterile.) |
| Biocompatibility | Assessed cytotoxicity, sensitization, and intracutaneous reactivity. Risk levels of local toxicity determined as "Acceptable" against risk evaluation criteria. |
| Software | Software verification and validation, including cybersecurity assessments, conducted according to IEC 62304:2006 and FDA Guidances. |
| EMC and Electrical Safety | Confirmed acceptable levels of electromagnetic compatibility and electrical safety by conforming to IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009. |
| Optical Testing | Measured optical properties of imaging and illumination performances with EPK-3000, EPK-i7010, and EPK-i5010 Video Processors. All results show that the optical characteristics are equivalent to the predicate device. |
| Animal Image Capture Study | Performed as part of optical and color performance testing. Results indicate the subject device is able to visualize vascularity and mucosal surface for each anatomical area as well or better than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for most of the performance tests (e.g., reprocessing, biocompatibility, software, EMC/electrical safety, optical testing).
- Animal Image Capture Study: While an animal image capture study was performed, the document does not specify the number of animals used or the specific type of animal. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be prospective as part of design verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the use of experts to establish a "ground truth" for a test set in the context of diagnostic accuracy or clinical decision-making. The studies described are primarily engineering and performance verification tests.
- For the Animal Image Capture Study, clinical observations related to visualization of vascularity and mucosal surface were made, likely by qualified personnel, but the number and qualifications of such experts are not specified.
4. Adjudication Method for the Test Set
Not applicable. The studies described are primarily technical performance and safety evaluations, not human-in-the-loop diagnostic evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in the document. The device is a bronchoscope, a tool for visualization and intervention, not an AI-powered diagnostic system. Therefore, the effect size of human readers improving with AI assistance is not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The device is a physical bronchoscope, not a standalone algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/ML performance studies (e.g., pathology, clinical outcomes) is not directly relevant to the performance tests described for this physical medical device. The "ground truth" for these tests relates to established engineering standards, successful sterilization, acceptable biocompatibility, and the performance characteristics of the predicate device.
- Animal Image Capture Study: The "ground truth" here would be the actual anatomical features (vascularity, mucosal surface) observed, against which the visualization capability of the device is assessed. This is a direct observational "ground truth."
8. Sample Size for the Training Set
Not applicable. The device is a bronchoscope, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.