(470 days)
The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the VIDEO NASO-PHARYNGO-LARYNGOSCOPE VNL9-CP and VIVIDEO VIDEO PROCESSOR CP-1000. It is intended to be used with a medical video monitor for endoscopic examination between the upper respiratory tracts of the nasal passage and the vocal cords. This PENTAX Medical VIVIDEO ENT Videoscope Solution must only be used in a clinical or ambulatory medical environment.
The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the video processor CP-1000 and the video nasopharyngo-laryngoscope VNL9-CP. The naso-pharyngoscope consists of a handheld device with a flexible thin insertion tube. The illuminating LED is integrated in the handle while light is transmitted to the distal end through a bundle of fiber optic cables within the insertion tube. A CMOS video sensor is located at the bendable distal tip. The video signal of the sensor is transferred to the CP-1000 Video Processor for video image together with other information on an attached monitor and for recording video sequences or still images to a USB storage device.
The provided text describes the PENTAX Medical VIVIDEO ENT Videoscope Solution and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria for device performance, nor does it detail a study proving the device meets specific performance criteria related to diagnostic accuracy or clinical outcomes.
The "Acceptance Criteria and Reported Device Performance" section below can only detail the general categories of testing performed, as specific performance metrics and their corresponding acceptance thresholds are not explicitly stated in the document.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Category of Testing | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Optical Testing | No differences from predicate device in specified optical properties. | "All results show that there are no differences between the subject device, PENTAX Medical VIVIDEO ENT Videoscope Solution, and the predicate device, KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System" for signal to noise ratio, spatial resolution (MTF), distortion, and spectral distribution. |
| Reprocessing Validation | Effectiveness of reprocessing procedures for cleaning and High-Level Disinfection (HLD) in accordance with FDA's 2015 Reprocessing Guidance and AAMI TIR 30:2011. Acceptance criteria focused on residual soil accumulation and extraction efficiency. | "Simulated use testing, cleaning, high level dising (after cleaning and after HLD) validation studies of the VIVIDEO ENT Videoscope Solution and its accessories were conducted and confirmed the effectiveness of reprocessing procedures... Acceptance criteria were met after each phase of reprocessing." |
| Sterilization | Validation of System 1E liquid chemical sterilization for the device. | "PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for sterilization of the VIVIDEO ENT Videoscope Solution." (Device is not provided sterile, so shelf-life is not applicable.) |
| Biocompatibility | Acceptable levels of cytotoxicity, sensitization, intracutaneous reactivity, and local toxicity for patient contact materials (less than 24 hours contact with mucosal membrane), in accordance with ISO 10993-1, 5, and 10. Risk level of colorant (carbon black and titanium oxide) to be "Very Low" and local toxicity to be "Acceptable". | "Biocompatibility of direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity... The risk level of colorant was determined as 'Very Low'... The risk level of local toxicity was determined as 'Acceptable' as a result of the biocompatibility testing." |
| Software | Compliance with FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Classified as Class A under IEC 62304:2006, with a "Moderate" level of concern. Cybersecurity risks assessed and mitigated per FDA Guidance. | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." "The software is classified as CLASS A... and the software level of concern is 'Moderate'..." "Cybersecurity risks have been assessed and mitigated according to the FDA Guidance..." |
| EMC and Electrical Safety | Acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) according to specified IEC standards (IEC 60601-1-2:2001, A1:2004; IEC 60601-1:2005+CORR 1:2007+AM 1:2012; and IEC 60601-2-18:2009). | "The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX VIVIDEO ENT Videoscope Solution were confirmed by the following standards..." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical diagnostic performance or image data. The testing described (optical, reprocessing, biocompatibility, software, EMC/ES) primarily relates to engineering and safety performance, not clinical diagnostic accuracy. Therefore, information on sample size and data provenance for a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as there is no mention of a clinical test set or ground truth established by experts for diagnostic performance.
4. Adjudication method for the test set
This information is not provided as there is no mention of a clinical test set or adjudication process.
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
This information is not provided. The device is an ENT Videoscope Solution, an imaging device, and the submission focuses on its equivalence to a predicate imaging device. There is no mention of AI features or a comparative effectiveness study involving human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is described as an imaging tool for endoscopic examination; there is no indication of it being an AI algorithm that performs standalone diagnoses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided, as there is no mention of a clinical ground truth for diagnostic performance. The ground truth for the performance tests (e.g., optical properties, reprocessing effectiveness) would be established by the respective testing standards and methodologies.
8. The sample size for the training set
This information is not provided, as there is no mention of an AI component or a training set for an algorithm.
9. How the ground truth for the training set was established
This information is not provided, as there is no mention of a training set.
§ 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.