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510(k) Data Aggregation
(125 days)
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors ancillary equipment for gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.
The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.
The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.
The provided text describes the 510(k) submission for the PENTAX Medical Video Processor EPK-i8020c. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with a defined ground truth.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly provided in the document, as the submission relies on non-clinical performance data and a comparison to an already cleared predicate device.
However, I can extract information related to the device's performance testing and the nature of the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional and Safety Standards Compliance | The PENTAX Medical EPK-i8020c Video Imaging System has been successfully tested for its functions, performance, and safety as per FDA recognized consensus standards. This includes: |
| - Reprocessing Validation (for non-reprocessed devices) | Not required, as the subject device is not reprocessed and provided non-sterile. Reprocessing procedures for reference devices (video bronchoscopes) remain unchanged. |
| - Sterilization and Shelf Life (for non-sterile devices) | Not required, as the subject device is not reprocessed and is not provided sterile. |
| - Biocompatibility (for devices without direct/indirect patient contact) | Not required, as the subject device does not contain any direct or indirect patient contact components. Materials of reference devices (video bronchoscopes) remain unchanged. |
| - Software and Cybersecurity Compliance | Software verification and validation, including cybersecurity assessments, were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff documents on software and cybersecurity in medical devices. |
| - Electrical Safety (ES) and Electromagnetic Compatibility (EMC) | Confirmed by IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009. |
| - System Performance Equivalence to Predicate | The system performance of the subject device demonstrated equivalence to the predicate device. |
| - Optical Performance Equivalence to Predicate and Reference | Optical properties of imaging and illumination performances were measured. All results show that the optical characteristics of the subject device are equivalent to those of the predicate device and the reference device. |
| - Ability to visualize vascularity and mucosal surface | An animal image capture study indicated that the subject device is able to visualize vascularity and mucosal surface for targeted anatomical areas as well as the predicate device and the reference device. This was performed as part of optical and color performance testing. "This study raised no issues of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device." (From section 7) |
| - Substantial Equivalence to Predicate | The subject device is deemed "as safe and effective as the predicate device" with "no differences in indications for use and intended use" and "technological differences... are not substantive." |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document refers to "performance testing" and an "animal image capture study" but does not quantify the number of cases or animals involved.
- Data provenance: For the "animal image capture study," the data provenance is from an animal study. The country of origin is not specified but implicitly assumed to be from within PENTAX Medical's research and development. This was a non-clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The animal study evaluated the device's ability to "visualize vascularity and mucosal surface," implying an objective assessment rather than a diagnostic interpretation requiring expert ground truth establishment for a specific medical condition. The study aimed to assess optical and color performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Given the nature of the "animal image capture study" for optical and color performance, an adjudication method for diagnostic agreement with a ground truth is not described as the primary objective was visualization capability comparison.
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. The device (PENTAX Medical Video Processor EPK-i8020c) includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)." However, the submission does not describe a human-in-the-loop study to evaluate the effectiveness of these enhancements or how human readers' performance improves with or without these features. The statement is that these technologies are "intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance assessment was done for various system components, including software and optical performance. The "animal image capture study" can be considered a standalone assessment of the device's imaging capabilities (optical and color performance) in a biological setting, comparing it to predicate/reference devices. This was an evaluation of device capability itself, not an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "animal image capture study," the "ground truth" was the objective presence of vascularity and mucosal surface in the animal model. The assessment was likely based on the visual quality and clarity of these features as captured by the device, compared to the predicate and reference devices. It was not a ground truth for a diagnostic condition established by pathology or expert consensus.
8. The sample size for the training set:
- Not applicable/Not specified. This submission does not describe a machine learning algorithm that would require a distinct training set. The device contains "digital post-processing imaging enhancement technology (PENTAX i-Scan™)," which might involve algorithms, but the development and training of these are not detailed as part of this 510(k) submission.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as no training set is discussed in this context.
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(206 days)
PENTAX Medical Video Bronchoscope EB11-J10
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.
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