Search Results

The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel).

Device Description

The OE-B14 is attached onto the air/water feeding cylinder of the control body of PENTAX Medical endoscope. The endoscope is linked to non-flammable gas cylinder and the water bottle assembly via air/water feeding circuit.

The device descriptions for the PENTAX Medical EPK-i8020c Video Imaging System remain unchanged from K231249. They include the PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, and PENTAX Medical Video Colonoscope EC38-i20cL.

AI/ML Overview

The provided text describes the regulatory clearance of the PENTAX Medical Gas/Water Feeding Valve OE-B14, an accessory for GI endoscopes. The device's clearance is based on its substantial equivalence to a predicate device. The information provided focuses on non-clinical performance data rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an accessory device and the review focuses on substantial equivalence based on non-clinical performance, the "acceptance criteria" here refer to meeting standards for reprocessing, sterilization, biocompatibility, and system/mechanical performance. There are no specific quantifiable clinical performance metrics like sensitivity/specificity for a diagnostic device.

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance
Reprocessing Validation	Cleaning, High-Level Disinfecting, Rinsing (after cleaning and HLD) validation studies; assessed against AAMI TIR 30: 2011/(R)2016 for residual soil accumulation and extraction efficiency.	All acceptance criteria were satisfied, confirming effectiveness of reprocessing procedures.
Sterilization & Shelf Life	Steam sterilization validation (conducted with Nelson Laboratories, LCC).	Validated for steam sterilization. Device is unsterile, so shelf-life is not applicable.
Biocompatibility	Assessment of cytotoxicity, sensitization, and intracutaneous reactivity in accordance with ISO 10993-1: 2018.	Risk levels of local toxicity determined as "acceptable" based on risk evaluation criteria.
Software & Cybersecurity	Not applicable; device does not contain software.	No software testing was performed as the device does not contain software.
Electrical Safety & EMC	Not applicable; device is not an electrical accessory.	No testing of electrical safety or electromagnetic compatibility was performed.
System Performance	Bench testing to demonstrate performance for gas/water feeding procedure.	Bench testing results "demonstrated the performance enough to conduct the gas/water feeding procedure in a clinical use."
Mechanical Performance	Verification by comparing to predicate device (OF-B194) in combination with a compatible endoscope.	Mechanical performance was verified through comparison.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical bench testing and validation studies, not a clinical trial with human subjects. Therefore, the concept of a "test set" in the context of clinical data or patient samples, sample size, or data provenance (country of origin, retrospective/prospective) is not applicable here as it would be for a diagnostic or therapeutic device. The "test set" would refer to the physical devices subjected to the various non-clinical tests (reprocessing, mechanical, etc.), for which specific numerical sample sizes are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable. The device underwent non-clinical performance testing and validation against recognized standards and internal criteria. There was no "ground truth" derived from expert clinical opinion on patient data as would be for an AI/diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical test set requiring expert adjudication for ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device is an accessory that feeds gas/water, not a diagnostic or AI-assisted tool that would involve human readers interpreting cases.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical accessory.

7. The Type of Ground Truth Used

For this device, the "ground truth" for proving its safety and effectiveness was established through:

Compliance with recognized consensus standards: (e.g., AAMI TIR 30: 2011/(R)2016 for reprocessing, ISO 10993-1: 2018 for biocompatibility).
Achievement of pre-defined acceptance criteria for bench testing of functions, performance, and safety (e.g., residual soil levels, successful steam sterilization, acceptable toxicity levels, sufficient gas/water feeding performance, verified mechanical performance).
Comparison to a legally marketed predicate device (PENTAX Gas/Water Feeding Valve OF-B194) to demonstrate substantial equivalence, particularly regarding intended use and technological characteristics.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical accessory, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there was no training set for an AI/ML algorithm.

Ask a Question

Ask a specific question about this device

Page 1 of 1