(43 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 Endo QuickConnect Scope Port Connectors will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, solvent, etc. The devices respectively adjoin an irrigation line of an ERBEFLO tubing/cap set to a designated gastrointestinal video endoscope. This line is a conduit for water to irrigate in endoscopic procedures. Each Port Connector has a standard female luer lock connection that attaches to an ERBEFLO tubing/cap set, backflow valve, and a scope specific connector (for an Olympus® or Pentax® Scope). The Port Connectors are provided sterile and are disposable.
The provided text describes the regulatory clearance of a medical device, the ERBEFLO® 2 Endo QuickConnect Scope Port Connectors, and outlines the testing conducted to demonstrate its safety and efficacy. However, it does not contain the level of detail requested for acceptance criteria and a structured study demonstrating performance against those criteria.
Specifically, it does not include:
- A table of acceptance criteria with specific performance metrics and reported values.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance, as these are typically relevant for AI/software devices. This device is a hardware accessory.
- Details on the training set or its ground truth establishment, again, not relevant for this type of hardware device.
Instead, the document focuses on comparative testing against a legally marketed predicate device (ERBEFLO® 2 Disposable Tubing System, K103235) to establish substantial equivalence for regulatory approval.
Here's a summary of the available information and an explanation of why many of your specific requests cannot be fully addressed from this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes evaluations and testing without providing specific numeric acceptance criteria or detailed quantitative results in a table format. The reported performance is qualitative and comparative.
| Acceptance Criterion (Inferred from text) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility | "no biocompatibility issues with the materials used" |
| Flow Performance | "flow performance of the proposed products was comparable to the predicate devices" |
| Leakage | "no leaks" (during feasibility testing and proper connection) |
| Backflow Pressure Resistance | "withstood the same backflow pressure as the current Connectors" |
| Sterilization (2X) | "met established performance specifications" |
| Packaging Integrity | "adequacy and integrity of the packaging" |
| Sterility & Ethylene Oxide Residuals | "demonstrated product sterility as well as meeting acceptable ethylene oxide residual levels" |
| Proper Connection (for different endoscopes) | "no flow issues (including no leaks)" upon following proper connecting instructions for Olympus and Pentax scopes. |
| Safety and Efficacy | "did not adversely affect safety or effectiveness" (overall conclusion) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The "Performance Feasibility Testing" and "2X Sterilization Functional Testing" imply that a sample of the new connectors was tested, but the exact number isn't provided.
- Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective) for a hardware accessory. The testing was likely conducted in a controlled lab environment 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:
- Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not relevant for the performance testing of a sterile scope port connector. The "ground truth" for this device's performance would be engineering specifications and established test protocols (e.g., measuring flow rate, pressure resistance, sterility).
4. Adjudication method for the test set:
- Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used for interpreting results from human observations or AI outputs in areas like radiology. The testing described here involves objective physical and biological measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this type of study was not done. MRMC studies are usually for evaluating diagnostic imaging software/AI's impact on human readers, which is not applicable to a physical medical device like a scope port connector.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a passive hardware accessory, not an algorithm or software. Its "performance" is inherent in its physical properties and function, not an algorithmic output.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on engineering specifications, material science standards (biocompatibility), and established test methodologies for fluid dynamics (flow, pressure, leaks), sterility, and packaging integrity. It's not based on expert consensus, pathology, or outcomes data in the usual clinical sense.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing are based on established engineering principles and prior device experience (predicate device).
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.
In conclusion: The provided document is a regulatory approval letter and 510(k) summary for a physical medical device. It successfully demonstrates "substantial equivalence" to a predicate device through various engineering and material tests. However, the nature of this device (a connector, not an AI, diagnostic, or therapeutic system) means that many of the detailed questions regarding acceptance criteria, ground truth, and study methodologies (especially those related to AI/software performance) are not directly applicable or documented in the format you've requested. The regulatory submission focused on proving that the new device is as safe and effective as the existing, legally marketed device through direct comparison of features and performance characteristics.
§ 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.