(320 days)
The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healtheare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use.
The ENDOtube kits are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/or air to an endoscope during a GI endoscopic procedure. The ENDOtube products are compatible with various endoscopes (FujiFilm® 500/600 series and 700 series, OLYMPUS® 140, 160, 180 and 190 and PENTAX®), and irrigation pumps (OLYMPUS®, Erbe® and EMED®). The ENDOtube products include several families: ENDOtube for Wash Bottle, ENDOtube for Insufflation, ENDOtube for Wash Pump, and ENDOtube for Wash Bottle CO2 Insufflation.
Based on the provided text, the device in question, ENDOtube, is an endoscopic tubing kit, not an AI/ML-driven device. Therefore, the information requested about acceptance criteria and studies that prove the device meets those criteria (especially points related to AI/ML, such as ground truth, expert adjudication, MRMC studies, and training/test sets) is not applicable to this document.
The document describes the submission to the FDA for 510(k) premarket notification for a medical device (ENDOtube) which is a combination of tubes, fittings, and valves. The acceptance criteria and the studies performed are related to the performance, safety, and compatibility of this physical medical device, not software or AI/ML algorithms.
Here's an analysis of the "acceptance criteria" and "proof" based on the provided text, adapted to the nature of the device:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML)
The "acceptance criteria" for this device are primarily demonstrated through non-clinical testing to ensure its functionality, safety, and compatibility with other medical equipment. The document reports "Pass" for all tested parameters, indicating the device meets the established criteria.
| Parameter/Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Endoscope Column Compatibility: | |
| OLYMPUS® GI endoscopes 140, 160, 180, 190 compatibility | Pass |
| PENTAX® GI endoscopes compatibility | Pass |
| FUJIFILM® GI 500/600 series and 700 series endoscopes compatibility | Pass |
| Irrigation Peristaltic Pump Compatibility: | |
| Olympus®, Erbe®, EMED® pump compatibility | Pass |
| Insufflator Compatibility: | |
| OLYMPUS® UCR, FUJIFILM® GW-1 and GW-100 compatibility | Pass |
| Universal Water Bottle Cap: | |
| Presence and effectiveness with common sterile water bottle brands | Pass |
| Fluid Supply: | |
| Sterile water; Air; CO2 supply (leak test and usability) | Pass |
| One-way valve (for irrigation pump compatible device): | |
| Presence and effectiveness (cross-contamination test) | Pass |
| Tube Use Period: | |
| Multi-patient use, without reprocessing, up to 24 hours (durability) | Pass |
| One-way Valve Use Period: | |
| Single use, up to 2 hours (operational) | Pass |
| Device Shelf-Life: | |
| 2 years performance | Pass |
| Insufflation Connector Use Period: | |
| Multi-patient use (operational) | Pass |
| Insufflation Connector Processing: | |
| Reprocessable (performance) | Pass |
| Tube and Valve Sterilization: | |
| EO sterilization validation | Pass |
| Main Materials: | |
| Biocompatibility (AAMI/ISO 10993) | Pass |
| Inert metallic materials, elastomers, thermoplastic polymer (biocompatibility) | Pass |
| No DEHP (chemical characterization) | Pass |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: The document does not specify exact sample sizes for each "Connection and usability testing," "Leak test and usability testing," "Cross-contamination test," "Durability test," "Operational test," "Performance test," "Sterilization validation," or "Biocompatibility testing." These are typically standardized tests performed on a representative number of units or materials according to relevant standards (e.g., ISO, AAMI).
- Data Provenance: The tests are non-clinical (laboratory/bench) tests. The manufacturer, Nissha Medical Technologies SAS, is based in France. The tests would likely have been conducted in controlled laboratory environments. The data is prospective in the sense that it's generated for the purpose of the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. This is a non-AI/ML device. "Ground truth" in the context of device performance refers to verified operational parameters and safety compliance, which are established through adherence to engineering specifications and regulatory standards, not expert medical opinion on image interpretation.
4. Adjudication Method for Test Set:
- Not applicable. As this is not an AI/ML diagnostic device, there is no "adjudication" of expert interpretations. Device performance is objectively measured against engineering and safety specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This type of study is relevant for AI/ML diagnostic aids that assist human readers in interpreting medical images. The ENDOtube is a physical medical accessory.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. The ENDOtube is a physical device, not an algorithm.
7. Type of Ground Truth Used:
- Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by engineering specifications, relevant industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. Functional tests confirm the device operates as intended (e.g., no leaks, proper connections, durability).
8. Sample Size for Training Set:
- Not applicable. This device does not involve a training set for an AI/ML algorithm.
9. How Ground Truth for 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.