(60 days)
The water container MAJ-901 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.
Do not use this instrument for any purpose other than its intended use.
The water container MAJ-902 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.
Do not use this instrument for any purpose other than its intended use.
The MAJ-901 and MAJ-902 have been designed to be used with Olympus light sources and endoscopes to allow gas insufflation and water feeding from the endoscope.
MAJ-901 and MAJ-902 are both comprised of a Lid, Container, O-ring, and Container Protector. Other than Lid, the devices are the same.
MAJ-902 also includes a "gas tube connector" in the lid for carbon dioxide gas delivery. Additionally, MAJ-902 includes a Caution tag that the MAJ-901 does not.
This is a 510(k) summary for a medical device (Water Container MAJ-901 and MAJ-902), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new therapeutic might.
Based on the provided document, here's what can be extracted regarding acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document mentions that all subject devices met design specifications and performed as intended in the non-clinical tests. However, it does not provide a table with specific quantitative acceptance criteria or the numerical performance results of these tests. Instead, it offers a high-level summary of the types of tests conducted:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Flow Rate within specification | Met design specifications |
| Durability (GA) | Met design specifications |
| Durability (AC) | Met design specifications |
| Biocompatibility | Met design specifications |
| Reprocessing effectiveness | Met design specifications |
| Human Factors | Met design specifications |
| Overall intended performance | Performed as intended |
| Not raising new safety/effectiveness questions despite differences from predicate | Substantially equivalent to predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample sizes used for each of the non-clinical tests (e.g., how many water containers were tested for flow rate, durability, etc.). Similarly, it does not specify the country of origin of the data or whether the tests were retrospective or prospective. It is implied these were prospective bench tests conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of 510(k) submission. The "ground truth" for non-clinical bench testing often refers to established engineering standards or internal design specifications, verified through objective measurements, rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there's a need to resolve discrepancies in expert opinions. This document describes bench testing where performance against technical specifications is directly measured.
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
Not applicable. This is a medical device for water and gas feeding in endoscopes, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a water container, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned, the "ground truth" would be the engineering design specifications and recognized industry standards for flow rate, durability, biocompatibility, and reprocessing effectiveness. Performance was measured against these predefined technical parameters.
8. The sample size for the training set
Not applicable. This device is 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 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.