(86 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.
The ERBEFLO® 2 Disposable Tubing System products are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The devices consist of tubing sets, port connectors, channel adapter, and back flow valve to deliver sterile water source through designated pumps and to/or through a scope channel of various endoscopes for irrigation in endoscopy procedures. Clinicians connect the associated products to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO® 2 Disposable Tubing System are provided sterile and are disposable.
The ERBEFLO® 2 Disposable Tubing System, as described in K190469, is intended to provide a sterile water source through an irrigation pump and an endoscope for endoscopic procedures. The information provided outlines several evaluation and testing types that address different aspects of the device's performance, safety, and efficacy. However, it does not present a formal table of acceptance criteria with corresponding reported performance for each criterion. It rather lists the types of tests performed and general conclusions about meeting performance specifications or demonstrating adequacy.
Here's an attempt to structure the information based on the provided text, while acknowledging that a direct "acceptance criteria" table is not explicitly given:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from testing type) | Reported Device Performance |
|---|---|
| Biocompatibility (no issues with materials) | Demonstrated no biocompatibility issues with materials used. |
| 2X Sterilization Functional Testing: | |
| Visual inspection | Met established performance specifications. |
| Flow testing | Met established performance specifications. |
| Back flow pressure testing | Met established performance specifications. |
| Tensile strength testing | Met established performance specifications. |
| Durability testing | Met established performance specifications. |
| Connections testing | Met established performance specifications. |
| Endoscopy Port Connectors for Pentax® Scopes (2X Sterilization Functional Testing): | |
| Visual inspection upon aging | Met established performance specifications. |
| Connections testing upon aging | Met established performance specifications. |
| Packaging Evaluation (adequacy and integrity) | Demonstrated the adequacy and integrity of the packaging. |
| Sterilization Evaluation (product sterility, ethylene oxide residual requirements) | Demonstrated product sterility and met ethylene oxide residual requirements. |
| Barrier Integrity and Simulated Use Testing (sufficient back flow protection, 24-hour multi-patient use) | Showed that Erbe port connectors with an Erbe tubing set provide sufficient back flow protection and verified 24-hour multi-patient use. |
| Human Factors Engineering/Usability Engineering Testing (intended use by following NOU) | Demonstrated that Erbe's port connectors can be used as intended by following ERBEFLO® 2 Disposable Tubing System's Notes On Use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the described tests (e.g., number of tubing systems, connectors, or test cycles). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are primarily engineering and performance evaluations, not diagnostic accuracy studies involving expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (functional, mechanical, sterility), an adjudication method in the context of expert consensus is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on the safety and efficacy of the device itself through various engineering and sterilization tests, not on its impact on human readers' performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the ERBEFLO® 2 Disposable Tubing System is a physical medical device (tubing system), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Established performance specifications (for visual inspection, flow, pressure, tensile strength, durability, connections).
- Recognized standards (for biocompatibility, sterilization, packaging, ethylene oxide residuals).
- Demonstrated functional properties (sufficient back flow protection, 24-hour multi-patient use, usability according to instructions).
8. The Sample Size for the Training Set
This information is not applicable as the product is a medical device, not an AI or machine learning model 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.