(28 days)
The ERBEFLO 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.
In general; the ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector will be manufactured with materials or agents that can be used in the medical device industry such as plastics, silicone, solvent, etc. The device adjoins an irrigation line of an of an ERBEFLO Tubing/Cap Set designated for a Pentax Scope to a Pentax Gastrointestinal Video Endoscope with a forward water jet channel for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated ERBEFLO Tubing/Cap Set for Pentax Scopes, back flow (check) valve, and housing (a scope specific connector for a Pentax Scope). The Port Connector is provided sterile, is single patient use, and is disposable.
The provided text describes a 510(k) premarket notification for the ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector, which is an accessory to an endoscopic irrigation system. This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving de novo clinical effectiveness or diagnostic accuracy of an AI/ML device. Therefore, the questions related to AI/ML comparative effectiveness studies, standalone algorithm performance, and ground truth establishment for complex medical imaging interpretations are not applicable to this submission.
However, I can extract the relevant information from the document regarding the acceptance criteria and the studies performed to demonstrate the device meets these criteria.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Biocompatibility: No biocompatibility issues with materials. | The evaluation was performed per the current recognized standard and demonstrated that there were no biocompatibility issues with the materials used for the proposed Port Connector. |
| Post 2X Sterilization Functionality: Visual inspection, connections, leak, and flow meet established specifications. | Visual inspection, connections testing, as well as leak and flow testing demonstrated that the proposed device upon 2X sterilization met established performance specifications. |
| Sterility: Product sterility demonstrated, and connector meets ethylene oxide residual requirements. | The evaluation was performed using current recognized standards and demonstrates product sterility as well as the Connector meets ethylene oxide residual requirements. |
Detailed Information as per Request:
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A table of acceptance criteria and the reported device performance:
(See table above) -
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 specify exact sample sizes for the functional and sterilization tests, nor does it refer to "test sets" in the context of clinical data/images. The evaluations focus on the physical device itself and its materials. There is no mention of data provenance (e.g., country of origin) as this is a device clearance based on engineering and biological testing, not clinical data from patients. -
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. This submission is for an accessory device based on engineering and materials testing, not for an AI/ML diagnostic or imaging device requiring expert ground truth for interpretation. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set or adjudication process is mentioned for this device. -
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 not an AI-assisted device, and no MRMC study was conducted. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI-driven algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of clinical ground truth. The "ground truth" for this device's performance would be established through industry standards for biocompatibility (e.g., ISO 10993), sterilization (e.g., ISO 11135), and functional testing (e.g., ISO 594 for luer connections). -
The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI/ML device. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML model.
§ 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.