(51 days)
The ERBEFLO™ 2 Disposable Tubing System is intended to provide sterile water from a water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.
The ERBEFLO™ 2 Disposable Tubing System consists of tubing sets, port connectors, channel adapter, and backflow valve to deliver sterile water from a water source through designated pumps and to/or through a scope channel of various endoscopes. Clinicians connect the associated Product(s)/Component(s) to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO™ 2 Disposable Tubing System is provided sterile and is disposable.
The provided text describes a 510(k) submission for the ERBEFLO™ 2 Disposable Tubing System. While it mentions that performance testing was conducted, it does not provide specific acceptance criteria or detailed results of those tests. Instead, it broadly states that "performance testing involving flow rates, back flow pressure, internal pressure, and durability testing was performed" and that the device had "comparable dimensional, flow, back flow pressure, internal pressure, and durability characteristics" to the predicate device.
Therefore, I cannot fully complete the requested table and answer all questions due to the lack of detailed information in the provided document.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Expected Performance) | Reported Device Performance |
|---|---|
| Flow Rates: (Specific values not provided) | Performance testing was performed. Conclusion: "comparable ... flow ... characteristics" to the predicate (EndoGator® System). The document does not specify the numerical flow rates achieved or the acceptance thresholds. |
| Back Flow Pressure: (Specific values not provided) | Performance testing was performed. Conclusion: "comparable ... back flow pressure ... characteristics" to the predicate. The document does not specify the numerical back flow pressure achieved or the acceptance thresholds. |
| Internal Pressure: (Specific values not provided) | Performance testing was performed. Conclusion: "comparable ... internal pressure ... characteristics" to the predicate. The document does not specify the numerical internal pressure achieved or the acceptance thresholds. |
| Durability: (Specific criteria not provided, e.g., number of cycles, resistance to damage) | Performance testing was performed. Conclusion: "comparable ... durability characteristics" to the predicate. The document does not specify the durability test results or the acceptance thresholds. |
| Biocompatibility: (Compliance with ISO 10993 or equivalent) | "Biocompatibility of the specific materials for the Products/Components of the ERBEFLO™ 2 Disposable Tubing System was evaluated." The document does not provide the specific acceptance criteria or results. |
| Sterility: (Sterile via Ethylene Oxide) | "Provided sterile" and "sterilized via Ethylene Oxide." No specific test results or acceptance criteria are provided in terms of sterility assurance levels (e.g., SAL). |
| Dimensional Characteristics: (Specific dimensions not provided) | "The physical aspects and overall length of the proposed System were comparable to the predicate System." The document does not provide specific dimensional criteria or measurements. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only states that "performance testing" was performed.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). This was an internal test performed by the manufacturer, ERBE USA, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The device is a disposable tubing system, and its performance (flow rates, pressure, durability) would typically be evaluated through objective engineering and laboratory tests, not by human expert assessment of images or clinical outcomes that require a "ground truth" to be established by experts.
4. Adjudication method for the test set
- This question is not applicable, as it relates to expert review for subjective assessments, which is not relevant for this type of device's performance testing.
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
- This question is not applicable. The ERBEFLO™ 2 Disposable Tubing System is a medical device for fluid delivery, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
- This question is not entirely applicable in the same way as for AI/diagnostic devices. For engineering performance tests like flow rates, pressure, and durability, the "ground truth" is typically the measured physical properties against predefined engineering specifications and regulatory standards. The document implies comparison to the predicate device's characteristics as a benchmark.
8. The sample size for the training set
- This question is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as above.
§ 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.