(141 days)
The EndoChoice water bottle cap system is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.
The EndoChoice water bottle cap system is designed to supply sterile water and air to the endoscope during endoscopic procedures.
The provided 510(k) summary for the EndoChoice Water Bottle Cap System details performance testing for substantial equivalence to a predicate device, rather than defining specific acceptance criteria for an AI/CAD/ML device. Therefore, much of the requested information regarding AI/CAD/ML study design (like sample sizes for training/test sets, ground truth establishment, MRMC studies, and expert qualifications) is not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sufficient water flow | Tested to ensure sufficient water flow through the system. |
| No leaking over multiple uses | Tested to ensure no leaking over multiple uses. |
| Biocompatibility | Tested in accordance with ISO 10993. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only states "multiple uses" for the water flow and leaking tests.
- Data Provenance: Not specified. The testing was conducted by EndoChoice, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a hardware device focused on fluid delivery and biocompatibility, not an AI/CAD/ML device requiring expert ground truth for interpretation.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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
- Not Applicable. This device is a water bottle cap system, not an AI/CAD/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 5. The device's performance is inherently standalone in its function (delivering water and air), but not in the context of an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Standard Tests: The "ground truth" for this device's performance relies on meeting engineering specifications for water flow and leak prevention, and compliance with the ISO 10993 standard for biocompatibility. There is no diagnostic ground truth involved.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed as "Performance Data" and "Biocompatibility Data."
- Performance Data: "We tested our EndoChoice Water Bottle Cap System to ensure that our system performs as well as the predicate device. The testing included sufficient water flow through the system over multiple uses without leaking." The comparison is against the predicate device (United States Endoscopy Water bottle cap system, K101146) to establish substantial equivalence.
- Biocompatibility Data: "The EndoChoice Water Bottle Cap System was tested for biocompatibility in accordance with ISO 10993."
The submission concludes that, "Based on the technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the water bottle cap system and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness." This statement summarizes the outcome of the performed studies.
§ 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.