(60 days)
The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO 2, ERBEFLO CleverCap® and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures.
In general; the ERBEFLO® Olympus® Scope Port Connector will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, adhesive, etc. The device adjoins an irrigation line of an of an ERBEFLO 2, ERBEFLO CleverCap®, and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated Olympus ERBEFLO Tubing/Cap Set, check (backflow) valve, and housing (a scope specific connector for an Olympus Scope). The Port Connector is provided sterile, is single patient use and is disposable.
The provided text describes the ERBEFLO® Olympus® Scope Port Connector and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain the specific information requested about acceptance criteria for device performance, the study that proves it meets those criteria, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.
The document focuses on the regulatory clearance process for a physical medical device (a port connector), not a device involving an algorithm or AI. Therefore, most of the requested fields are not applicable or cannot be extracted from this text.
I can, however, extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Evaluation/Test Type) | Reported Device Performance (Conclusion) |
|---|---|
| Biological Evaluation | Demonstrated no biocompatibility issues with materials used. |
| 2X Sterilization Functional Testing | Upon 2X sterilization, visual inspection, connections testing, leak and flow testing, and back flow pressure testing demonstrated that the device met established performance specifications. |
| Packaging Evaluation | Demonstrated adequacy and integrity of the packaging. |
| Sterilization Evaluation | Demonstrated product sterility and that the Connector met ethylene oxide residual requirements based on recognized standards. |
The following requested information is not present in the provided text as the document pertains to a physical medical device and not an AI/algorithmic device:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical connector.
- 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): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The evaluations are for material biocompatibility, functional performance, packaging, and sterility of a physical device.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.