(108 days)
The Erbe Tubing/Cap/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.
Erbe's Tubing/Cap Sets are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The ERBEFLO CleverCap® devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air for insufflation; whereas, the ERBEFLO AeroRinse® devices provide a conduit for water for endoscopic lens cleaning as well as air for insufflation. There are four (4) and three (3) variants of Erbe's Tubing/Cap Sets for each group respectively (i.e., ERBEFLO CleverCap® and ERBEFLO AeroRinse®). All of the Sets respectively interface with a specified brand of scope (i.e., Pentax®, Olympus®, Fujifilm®, and Fujinon® Gastrointestinal Video Endoscopes). The Sets consist of tubing segment(s) and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, an irrigation tubing line (segment) of a Set (as applicable- only for the ERBEFLO CleverCap® Sets) interfaces with a designated peristaltic pump and via an ERBEFLO connector accessory attaches to the specified endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified endoscope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube in which the endoscope is used to pressurize the water bottle for functionality (air and water to the endoscope)]. Also, for the Pentax Set there is an additional air inlet tube that directs air from the endoscope's processor. For each Set, the irrigation tubing segment (as applicable) as well as the air/water tubing segment has a back flow check valve. The irrigation (as applicable) and air/water segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's Tubing/Cap Sets are provided sterile and are disposable.
The provided text describes the 510(k) premarket notification for Erbe's Tubing/Cap Sets. This submission is for a Class II medical device (Product Code OCX) which is tubing and cap sets for endoscopes. The submission demonstrates substantial equivalence to legally marketed predicate devices, not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance (such as sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, standalone performance, and expert adjudication) is not applicable to this document.
However, based on the provided text, the acceptance criteria and supporting studies for the Erbe's Tubing/Cap Sets can be summarized as follows:
1. A table of acceptance criteria and the reported device performance
| Test/Evaluation Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biological Evaluation | No biocompatibility issues (per recognized standard) | Demonstrated that there were no biocompatibility issues with the materials used for the Sets. |
| 2X Sterilization Functional Testing | Meet established performance specifications after 2X sterilization for visual inspection, flow, back flow pressure, pressure decay, tensile strength, connection, and durability (including no leaks and connectability upon stressing) | Visual inspection, flow testing, back flow pressure testing, pressure decay testing, tensile strength testing, connection testing, and durability testing (including ensuring no leaks and connectability upon stressing Sets) confirmed that the Devices upon 2X sterilization met established performance specifications. |
| Packaging Inspection/Testing (Current Pouching) | Maintain integrity (sterile barrier) | Maintained their integrity. (Note: Inspection/Testing of the pouch (sterile barrier) was included in many of the previous ERBEFLO cleared 510(k)s including the predicate submissions. Visual packaging inspection as well as dye penetration, burst, and seal strength testing were used to evaluate, qualify the various size pouches). |
| Packaging Inspection/Testing (New Automated System - Soft Pouch Trays) | Maintained suitability after 2X sterilization, handling/transit simulation, and aging for package integrity (visual & barcode readability), dye penetration, bubble leak, burst, and seal strength. | Inspection (visual for package integrity and barcode readability), dye penetration, bubble leak testing, burst testing, seal strength tensile testing) were performed on soft pouch trays upon 2X sterilization (as well as after handling/transit simulation), and upon aging. Inspection/Testing demonstrated the suitability of the new pouch trays for the Sets. |
| Sterilization Evaluation | Demonstrate product sterility and meet ethylene oxide residual requirements (per recognized standard) | The evaluation was performed using the current recognized standard to demonstrate product sterility as well as that the products met ethylene oxide residual requirements. |
| New Fujifilm Scopes (700 Series Endoscope) Compatibility | Set meets specifications for fitting (attaching/detaching) to the new Scope Series. | Inspection/Testing demonstrated that the Set met specifications. (This refers to a minor change in the air/water scope connector for a new Fujifilm scope series). |
The following information is not applicable as the device is not an AI/ML powered device.
- Sample sized used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: 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 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.