(28 days)
The DEFENDO EUS Air/Water Valve is intended to control the air/water function of an endoscope during an GI Endoscopic procedure.
The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endosocpe during a GI Endoscopic procedure.
The DEFENDO EUS Air/Water Valve and the DEFENDO EUS Suction Valve are accessories to an echoendoscope.
The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope
The DEFENDO EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.
Both devices are single-use devices, supplied sterile.
The provided text describes a 510(k) premarket notification for the DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS. It concludes that the device is substantially equivalent to a predicate device based on its construction, materials, and non-clinical performance data.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance |
|---|---|
| Air/Water Valve | |
| The EUS Air/Water Valve shall not leak. | Pass |
| The valves shall stay seated on the air/water port once placed. | Pass |
| Suction Valve | |
| The valve shall maintain suction capability and strength. | Pass |
| The valve must not be able to be inserted incorrectly into EUS scope's suction port. | Pass |
| The Suction Valve shall withstand repeated actuation. | Pass |
| The Suction Valve shall be used without any sticking. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of devices tested) for each of the non-clinical performance tests. It also does not explicitly state the data provenance in terms of country of origin or whether the data was retrospective or prospective. Given that this is a premarket notification for a new device, the testing would generally be prospective, conducted by the manufacturer.
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 non-clinical performance tests for this device (valves for an endoscope) appear to be functional engineering tests rather than studies requiring expert interpretation of medical images or patient outcomes. Therefore, "ground truth" in the clinical sense, established by medical experts, is not applicable to these types of tests.
4. Adjudication method for the test set
This information is not applicable for the reported non-clinical performance testing. The tests described are objective functional assessments (e.g., leakage, proper seating, strength, resistance to sticking, correct insertion) which would typically have predefined pass/fail criteria, not requiring adjudication by multiple readers or decision-makers.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is typically performed for AI-powered diagnostic or assistive devices that impact human clinical decision-making. The DEFENDO Single Use Valve Kit is a mechanical device for controlling functions of an endoscope, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone (algorithm only) performance study. This is not an AI device, so such a study would not be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" would be established by engineering specifications and predefined pass/fail criteria for each functional test (e.g., no measurable leakage, successful actuation, correct fit). It is not based on expert consensus, pathology, or outcomes data, as these are functional tests of a mechanical device.
8. The sample size for the training set
This information is not applicable. This device is a mechanical 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 is no training set for this device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.