(90 days)
The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed to be used with an video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)." TJF-Q190V is also compatible with Olympus system "EVIS X1 Video System Center OLYMPUS CV-1500 (K222584)."
The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images.
The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.
There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion section to elevate endo therapy accessories for endoscopic treatment.
A sterile, single-use distal cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182, K202661 and K220587.
The provided 510(k) clearance letter for the Olympus TJF-Q190V Duodenoscope indicates that the clearance is based on adhesive modifications to the device. This implies that the acceptance criteria and the study proving the device meets these criteria would primarily relate to the durability and safety of the new adhesive material and its impact on the overall performance of the endoscope, particularly concerning reprocessing and material integrity.
However, the provided text does not contain the detailed information typically found in a clinical study report or a summary of non-clinical performance data that would explicitly list acceptance criteria and device performance in the format requested. The document states:
- "Verification/validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Olympus Quality Management System."
- "Results of the following testing demonstrate that the changes to the device do not adversely affect device performance: Performance Testing - Bench, Sterilization and Shelf-Life - Residual Toxicity of Reprocessing Chemicals, Biocompatibility Evaluation."
- "No clinical data were collected."
This means the clearance was based on non-clinical (bench) testing. Therefore, I cannot provide information on clinical performance metrics, multi-reader multi-case studies, or the establishment of ground truth by human experts, as these were not part of the submission for this particular change.
Given the limited information, I will infer the implied acceptance criteria based on the described non-clinical tests.
Implied Acceptance Criteria and Reported Device Performance
Based on the provided information, the acceptance criteria would be related to the non-clinical performance of the device with the new adhesive, ensuring it is equivalent or superior to the predicate device, especially concerning durability against reprocessing and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance (Inferred)
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred from "demonstrate that the changes... do not adversely affect device performance") |
|---|---|
| Material Durability/Mechanical Performance (Bench Testing): The modified device, including the new adhesive, must maintain its structural integrity and functionality after repeated reprocessing cycles, comparable to or better than the predicate device. | The changes to the device (adhesive modifications) were verified/validated, and results demonstrate that they "do not adversely affect device performance" in terms of mechanical integrity and functionality after testing. The device performs "as well as or better than the predicate device." |
| Sterilization and Shelf-Life - Residual Toxicity of Reprocessing Chemicals: The new adhesive must not retain toxic residues from reprocessing chemicals above acceptable limits, nor should it degrade in a way that compromises safety or effectiveness over its shelf-life. | Testing for residual toxicity of reprocessing chemicals was performed, and results indicate no adverse effect, confirming safety and chemical compatibility. |
| Biocompatibility: The new adhesive material must be biocompatible according to established standards, ensuring it does not elicit adverse biological responses when in contact with tissue. | Biocompatibility evaluation was performed, and results demonstrate no adverse effect, meaning the new adhesive material meets biocompatibility standards. |
| Overall Performance Equivalence: No adverse changes to optical or electrical performance, or other device specifications, compared to the predicate device. | "There are no changes in contents of the indications for use, conditions of use, compatible components or accessories to be marketed/used with the device, or device specifications for TJF-Q190V, including optical or electrical performance." This implies equivalence was maintained. |
Study Proving Device Meets Acceptance Criteria:
The study involved non-clinical, bench-level verification and validation activities.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. For bench testing, this would typically involve a defined number of devices or components subjected to various tests (e.g., durability cycles, chemical exposure). The exact number of units or test replicates is not provided in the summary.
- Data Provenance: The manufacturing site is Aizu Olympus Co., Ltd., Japan. The testing would have been conducted in a controlled lab environment. This was a retrospective evaluation of a design modification, and the data would be laboratory-generated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable as "No clinical data were collected." The "ground truth" for non-clinical bench testing would be defined by engineering specifications, material standards, and validated test methods, rather than expert human interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set:
- Not applicable. As no clinical data or human evaluations were involved for this specific submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC study was not done. The document explicitly states, "No clinical data were collected." Therefore, there is no information on how human readers might improve with or without AI assistance, as AI is not mentioned and no human reading study was conducted.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a duodenoscope, a physical medical instrument, not an AI algorithm. There is no mention of a software algorithm or standalone performance in the context of AI.
7. Type of Ground Truth Used:
- For the non-clinical testing, the "ground truth" would be based on:
- Engineering Specifications: Device design parameters, material specifications.
- Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization, and other relevant performance standards for endoscopes.
- Validated Test Methods: Established laboratory protocols for evaluating material durability, chemical resistance, and device functionality.
- Predicate Device Performance Baseline: The performance characteristics of the legally marketed predicate device (K202661) served as a benchmark for substantial equivalence.
8. Sample Size for the Training Set:
- Not applicable. This submission focuses on a hardware modification (adhesive) to an existing device, not the development or training of a software algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there was no training set for a software algorithm.
N/A