(125 days)
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.
§ 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.