(261 days)
- PENTAX Medical VIDEO PROCESSOR EPK-3000
The PENTAX Medical VIDEO PROCESSOR EPK-3000 is intended to be used with the PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, light sources (including strobe), video monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation.
The PENTAX Medical VIDEO PROCESSOR EPK-3000 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 (including Light source), 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 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 processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on 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)
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.
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 the combination 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-Pharyngo-Laryngoscope VNL-J10 Series are intended to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endoscopic device 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 or transnasally 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 VNL8-110 and the VNL11-J10 do not have an instrument channel.
The provided text describes the PENTAX Medical EPK-3000 Video Imaging System, a medical device for ENT endoscopic observation. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness on its own. Therefore, much of the information requested, particularly regarding acceptance criteria and detailed study results that prove the device meets specific performance criteria for new features, is not explicitly present in the provided text in the way one might expect for a de novo submission.
However, I can extract information related to the device's technical specifications and the comparison with a predicate device, which forms the basis for its clearance. The "acceptance criteria" here are largely implied by the successful comparison to the predicate device and compliance with various recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) summary focused on substantial equivalence to a predicate device (PENTAX Medical ENT Video Imaging System (K162151)), the "acceptance criteria" are implicitly met by demonstrating that the new device is either identical or equivalent in performance to the predicate and complies with relevant standards. Specific quantitative acceptance criteria for novel image enhancement features like i-Scan are not detailed with numerical thresholds but are instead assessed against the predicate's overall visualization capabilities.
| Acceptance Criteria (Implied by Substantial Equivalence & Standards Compliance) | Reported Device Performance (PENTAX Medical EPK-3000 Video Imaging System) |
|---|---|
| I. Functional Equivalence to Predicate | |
| - Intended Use | Same as predicate. |
| - Fundamental Technology and Operating Principles | Same as predicate. |
| - Visualization of Vascular Structure & Mucosal Surfaces (White Light) | Equivalent to predicate (evaluated by experienced ENT physicians). |
| - Visualization of Vascular Structure & Mucosal Surfaces (i-Scan) | Equivalent to predicate (evaluated by experienced ENT physicians). |
| - Scope Working Length | Identical or equivalent. |
| - Scope Field of View/Depth of Field | Identical or equivalent. |
| - Scope Tip Angulation | Identical or equivalent. |
| - Illumination | Identical or equivalent. |
| - Noise Reduction | Identical or equivalent. |
| - Surface, Contrast, and Tone Enhancement | Identical or equivalent. |
| - Software Requirements | Identical or equivalent. |
| - Power Requirements | Identical or equivalent. |
| II. Reprocessing Validation | |
| - Simulated Use Testing | All acceptance criteria satisfied. |
| - Soil Accumulation | All acceptance criteria satisfied. |
| - Cleaning Efficacy | All acceptance criteria satisfied. |
| - High Level Disinfection (HLD) Efficacy | All acceptance criteria satisfied. |
| - Rinsing Validation | All acceptance criteria satisfied. |
| - STERRAD® NX® Efficacy Study after Cleaning and HLD | All acceptance criteria satisfied. |
| - STERRAD® 100NX® Efficacy Study after Cleaning | All acceptance criteria satisfied. |
| III. Biocompatibility (Patient-Contacting Materials) | |
| - Cytotoxicity Test | Passing results. |
| - Sensitization Test | Passing results. |
| - Intracutaneous Reactivity Test | Passing results. |
| IV. Electrical Safety & EMC | |
| - IEC 60601-1, IEC 60601-2-18 (Medical Electrical Equipment) | Complies with standards. |
| - IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 (EMC) | Complies with standards. |
| - IEC 62304:2006 (Medical Device Software Lifecycle Processes) | Complies with standards. |
| - CISPR 11:2009 (Industrial, scientific and medical (ISM) radio-frequency equipment) | Complies with standards. |
| V. Software Verification and Validation | |
| - Software V&V Testing (Moderate level of concern) | Conducted and documentation provided as recommended by FDA guidance. |
| VI. Optical Bench Performance | |
| - Signal to Noise, Color (IEE), Resolution, Modulation Transfer Function, Distortion, Light Distribution, Spectral Distribution, Total Luminous Flux, Photobiological Safety | Performance of subject and predicate devices concluded to be equivalent. |
| VII. Endoscope Operability, Image Quality, Endotherapy Device Insertability, Single-Use Suction Valve Testing | Verification and validation testing conducted. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The text mentions "A library of images was captured" for the clinical usability test and "side-by-side bench and clinical usability tests." The number of images or cases in the "library" is not quantified.
- Data Provenance: The clinical usability study was performed by PENTAX Medical, implying the data was generated specifically for this submission. The country of origin is not specified, but the submission is to the U.S. FDA by PENTAX of America, Inc. It was a "non-significant risk clinical study with IRB approval," which indicates it was a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated, but referred to as "experienced ENT physicians."
- Qualifications of Experts: "Experienced ENT physicians." Specific details like years of experience or board certification are not provided in this summary.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. The text merely states that "These images were evaluated by experienced ENT physicians." It doesn't describe how consensus or a definitive ground truth was reached from multiple readers' evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Comparative Effectiveness Study: A clinical usability test was performed which compares the subject device's performance to a predicate device, and physicians evaluated images from both. This technically involves multiple readers (experienced ENT physicians) evaluating multiple cases (images from the subject and predicate devices). However, it's not described as a formal "MRMC comparative effectiveness study" in the sense of a rigorous statistical design to quantify human reader improvement with AI vs. without AI assistance.
- Effect Size: No specific effect size is reported for how much human readers improve with AI (i-Scan) vs. without AI assistance (white light). The study concluded that the subject device's ability to visualize vascular structure and/or mucosal surface (both with white light and i-Scan) was equivalent to the predicate device. The i-Scan feature itself is positioned as an "optional adjunct" for enhanced viewing, not as a tool to improve human diagnosis over white light in quantified terms within this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- The i-Scan technology is a "digital, post-processing imaging enhancement technology." While it operates as an algorithm, its performance is described in the context of human evaluation of the resulting images ("i-Scan is intended to give the user an enhanced view..."). The clinical usability study involved human readers evaluating the images enhanced by i-Scan, demonstrating its utility as an adjunct. There is no mention of a standalone diagnostic accuracy study of the i-Scan algorithm without a human reader interpreting the enhanced image against a diagnostic ground truth.
7. The Type of Ground Truth Used:
- For the clinical usability test, there isn't an explicit "ground truth" (e.g., pathology report) against which the device's diagnostic accuracy is measured. Instead, the "ground truth" for the comparison was the expert evaluation/consensus of "experienced ENT physicians" who assessed the ability to visualize vascular structure and/or mucosal surface in images from both the subject and predicate devices. The study aimed to show equivalence in visualization capabilities, not diagnostic accuracy against a definitive disease state.
8. The Sample Size for the Training Set:
- Training Set Sample Size: The document does not mention a training set for the i-Scan algorithm or any other machine learning component in the traditional sense, as it focuses on demonstrating substantial equivalence of a video imaging system. The i-Scan is described as a "digital filter-based image enhancement technique," implying it might use pre-defined filters and algorithms rather than requiring ongoing machine learning with a specific training set.
9. How the Ground Truth for the Training Set Was Established:
- As no training set is mentioned for an AI/ML algorithm requiring ground truth, this information is not applicable and therefore not provided in the document.
§ 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.