(92 days)
PENTAX Medical EPK-3000 Video Imaging System consists of PENTAX Medical VIDEO PROCESSOR EPK-3000, PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series, PENTAX Medical Digital Video Capture Modules, PENTAX Medical Laryngeal Strobe, and other ancillary equipment.
- PENTAX Medical Video Processor EPK-3000
The PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngoscopic (ENT) diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-3000 Video Processor includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
- PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series
The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10 and VNL15-J10) are intended to be used with a PENTAX EPK-3000 Video Processor, PENTAX Medical Laryngeal Strobe, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.
PENTAX Medical EPK-3000 Video Imaging System is used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.
The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a video processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the system's control panel. The light from a xenon lamp at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.
The primary components of the system include the following:
- PENTAX Medical Video Processor EPK-3000
- PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series)
- PENTAX Medical Laryngeal Strobe 9400
- PENTAX Medical Digital Video Capture Modules (two models are available: 9310HD/9372HD)
The PENTAX Medical EPK-3000 Video Imaging System is provided with the following accessories:
- Keyboard input device for the video processor
- Foot Switch used to remotely control processor functions
- White Balance Adjuster - used as the object of white balance feature
- Condenser Earth Cable - used to reduce high-frequency noise generated during high-frequency electro cautery device use with Pentax endoscopes
- Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During the reprocessing, it seals the instrument Channel Inlet in order to full the chemical solution inside the channel
- Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination
- Suction Control Valve intended to control suction
Additional accessories for reprocessing are provided with the device. These include Cleaning Adapter, Soaking Cap, Ventilation Cap, Cleaning Brush Kits, Endoscope Cleaning Brush Kits, and replacement O- Rings.
The PENTAX Medical Video Processor EPK-3000 is intended to be used with the PENTAX compatible endoscopes, light sources (including strobe), vide monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation with or without stroboscopy.
PENTAX Medical Video Processor EPK-3000 functions with the PENTAX i-Scan technology, a digital filter-based image enhancement technique with three modes, i-Scan 1, 2, and 3. PENTAX i-Scan™ is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels.
White light is captured from a 150-Watt xenon lamp housed in the EPK-3000 Video Processor. All visualization is done with the white light mode first. White light illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician. The modification of red, green, blue (RGB) components for each pixel occurs when the i-Scan function is turned on in the EPK-3000 Video Processor. The resulting i- Scan image is then displayed on the observation monitor. The PENTAX Medical Video Processor EPK-3000 is compatible with PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series. The PENTAX Medical Video Naso-Pharyngoscope VNL-J10 Series are intended to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy. Three scopes are included in the VNL-J10 Series of scopes that is the subject of this submission: VNL8-J10, VNL11-J10, and VNL15-J10.
The VNL-J10 Series endoscopes are inserted transorally to visualize subjects under illumination transmitted from a video processor with a solid-state image sensor located at the distal end of the endoscope, and provide images of the target anatomy on the video monitor. The endoscopes are flexible which allows the insertion portion to shape according to the body cavity. They are also composed of an Insertion Portion, Control Body, PVE Connector, and Light Guide Plug. The VNL15-J10 can be used with endoscopic devices, each of which is introduced from the instrument channel inlet of the control body. Additionally, suctioning from the instrument channel at the distal end of the endoscope by pressing the suction control valve is available with this model. The VNL8-10 and the VNL11-J10 do not have an instrument channel.
The provided document is a 510(k) premarket notification for the PENTAX Medical EPK-3000 Video Imaging System. This submission focuses on adding two new components (Laryngeal Stroboscope 9400 and High-Definition Digital Video Capture Module) to an existing cleared system (K172156).
The document details non-clinical performance data to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance or comparative effectiveness with human readers using AI. Therefore, most of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this specific submission.
The acceptance criteria and reported device performance discussed relate to the interoperability, safety, and functionality of the expanded system, not its diagnostic accuracy.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| System Interoperability | Satisfy all interoperability verification and validation tests as per FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices". | "The acceptance criteria have been satisfied for all tests." (through Design Verification testing) |
| Cybersecurity | Assess and mitigate cybersecurity risks according to FDA Guidances: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Oct 2, 2014) and "Postmarket Management of Cybersecurity in Medical Devices" (Dec 28, 2016). | Cybersecurity risks "have been assessed and mitigated". |
| EMC and Electrical Safety | Compliance with IEC 60601-1-2:2007; ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, and A2:2010/(R)2012. | "The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical EPK-3000 Video Imaging System were confirmed by [listed standards]." |
| Photobiological Safety | Evaluation of Laryngeal Strobe 9400 lamp systems according to IEC62471, Photobiological Safety of Lamps and Lamp Systems. | "It was determined that the lamp classification group was an Exempt risk group." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission details non-clinical performance testing for system interoperability and safety, not a clinical test set for diagnostic performance. The testing involved verification and validation activities of the hardware and software components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to the non-clinical performance and safety testing described. Test results were based on engineering verification and validation against specified standards and functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations in clinical studies. This submission focuses on non-clinical engineering and safety testing.
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, an MRMC comparative effectiveness study was not done. The PENTAX i-Scan™ technology is mentioned as a digital, post-processing imaging enhancement, but the submission does not present a study on its comparative effectiveness with or without AI assistance for human readers. The new components added (Laryngeal Strobe and Digital Video Capture Modules) are for observation and recording, not for AI-driven diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Described. The i-Scan technology is described as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling," clearly indicating it's not a standalone diagnostic algorithm. No standalone performance evaluation for i-Scan is presented in this document. The other components are hardware for visualization and recording, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the non-clinical tests described, "ground truth" was internal design specifications, regulatory standards (e.g., IEC standards for electrical safety), and established functional requirements for interoperability.
8. The sample size for the training set
- Not Applicable. This document describes a 510(k) submission for device modifications and interoperability, not the development or evaluation of a machine learning algorithm.
9. How the ground truth for the training set was established
- Not Applicable. Since there is no machine learning model training described, this information is not relevant to the content provided.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.