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510(k) Data Aggregation
(272 days)
The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
The ED34-i10T, Video Duodenoscope is used with a compatible Video Processor. The ED34-i10T is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion is inserted into the body cavity of patient. The insertion includes the distal end and bending section. The objective lens, light guide, instrument channel, cannula/forceps elevator, and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connected to the video processor via electrical contacts. The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control for position of cannula which is inserted through the Instrument Channel. The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator. The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned. The remote button is used to operate the function of video processor and external device from the control body, as necessary. The detachable and disposable distal cap of ED34-i10T is intended for single use, and is processed with steam sterilization prior to use. It is discarded after use. Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel. The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the body cavity is displayed on the monitor.
This document is a 510(k) summary for the PENTAX Medical ED34-i10T Video Duodenoscope, which is a medical device and not an AI or software-only product. Therefore, much of the requested information regarding AI-specific criteria (like training set size, ground truth for training data, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.
However, I can extract and describe the acceptance criteria and performance data provided for the device as a whole.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria/Methodology | Reported Device Performance |
|---|---|---|
| Detachable Distal Cap | Durability, chemical resistance, autoclave, ultrasonic wave cleaning resistance, operating environment, thermal shock, and vibration resistance. | Results of all testing were within the acceptance criteria. |
| O-Ring Analysis | Design change to achieve a recommended minimum compression of 10% for sealing the Elevator Channel. | Design change created to achieve the recommended minimum compression of 10%. |
| Optical Testing | Measurement of signal-to-noise ratio, spatial resolution (MTF), distribution, and spectral F-distribution for the ED34-i10T in conjunction with the EPK-i5010 video processor. | All results show no differences between the subject device (ED34-i10T) and the predicate device (ED-3490TK). The ED34-i10T has more pixels for optical visualization, but overall optical properties are equivalent. |
| Reprocessing Validation | Simulated use testing, cleaning, high-level disinfection (HLD) validation studies conforming to FDA's 2015 Reprocessing Guidance. Acceptance criteria established per AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency. | Acceptance criteria were met after each phase of reprocessing. The effectiveness of reprocessing procedures was confirmed. A human factors study for reprocessing instructions was also conducted. |
| Biocompatibility | Assessment of cytotoxicity, sensitization, and intracutaneous reactivity of surface device materials (limited contact < 24 hours with mucosal membrane) per ISO 10993-1, 5, and 10. Assessment of carbon black and titanium oxide in patient contact parts. | All biocompatibility assessments confirmed. Risk level for toxicity of colorant (carbon black and titanium oxide) determined as "Very Low," and risk level of local toxicity determined as "Acceptable" by applying risk evaluation criteria. |
| Software | Software verification and validation testing as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software classified as Class B per IEC 62304:2006. Level of concern "Moderate". | Documentation provided. Software is classified as CLASS B under IEC 62304:2006, and the software level of concern is "Moderate" based on FDA guidance. |
| EMC and Electrical Safety | Compliance with IEC 60601-1-2:2001, A1:2004; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+AM 1:2012; and IEC 60601-2-18:2009. | The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX ED34-iT10 Video Duodenoscope were confirmed by these standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for most tests. For reprocessing validation, "simulated use testing" was conducted, but the number of cycles or units is not specified.
- Data Provenance: Not specified, but generally, such tests are conducted internally by the manufacturer (PENTAX Medical) or by certified testing laboratories commissioned by the manufacturer. The document doesn't mention specific countries of origin for the data; it's a submission to the U.S. FDA. The testing conducted is prospective for the new device design.
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 in the document. The tests described are primarily engineering performance and safety tests, not clinical performance studies requiring expert interpretation of results in the traditional sense of AI ground truth. For example, biocompatibility is assessed against ISO standards, and optical properties are measured objectively.
4. Adjudication method for the test set:
- Not applicable as this is not a study involving human interpretation of clinical data that would require an adjudication method. The testing described involves objective measurements and compliance with standards.
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 study was not done. This device is a video duodenoscope, which is an imaging and therapeutic access instrument, not an AI-assisted diagnostic tool for which an MRMC study would typically be conducted. This document makes no mention of AI integration.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an endoscope that requires human operation and interpretation. There is no standalone algorithm being evaluated.
7. The type of ground truth used:
- For the engineering and safety tests, the "ground truth" is defined by the technical specifications, standards (e.g., ISO, IEC, AAMI TIR), and regulatory guidances (e.g., FDA's reprocessing guidance). For instance, for optical testing, the predicate device's performance provides a benchmark for equivalence, and for biocompatibility, the ISO standards define acceptable limits.
8. The sample size for the training set:
- Not applicable. This document describes the validation of a physical medical device (duodenoscope), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no AI algorithm training set mentioned in this document.
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