(104 days)
The EndoGator™ system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).
The Byrne Medical EndoGator™ System is composed of the following:
-
- EndoGator™ Irrigation Tubing, and
-
- EndoGator™ Irrigation Accessories
The EndoGator™ System consists of a bottle cap/tube set/connector made from materials that are appropriate for the application. The EndoGator™ Cartridge is a replacement for some predicate device water systems.
The provided text describes a 510(k) premarket notification for the “EndoGator™ System,” a device intended to provide irrigation during GI endoscopic procedures. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement. Therefore, many of the requested elements for a detailed study description are not available in the provided document.
Here's a breakdown of the information that can be extracted or inferred, and what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Functionally equivalent in safety and efficacy to predicate devices. | "Flow and pressure testing was completed with representative scopes and evaluated based on various pump settings; real-time flow rate data was collected." |
| Appropriate materials for the application. | "made from materials that are appropriate for the application." |
| Provides water to irrigator pumps or cauterizing units. | "The EndoGator™ System and all predicate devices provide water to irrigator pumps or cauterizing units." |
Explanation: The document does not specify quantitative acceptance criteria (e.g., minimum flow rate, maximum pressure deviation). Instead, the primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to existing legally marketed devices (predicates). The reported performance is a qualitative statement that the device was tested for flow and pressure and found to be functionally equivalent.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "representative scopes" were used for flow and pressure testing.
- Data Provenance: Not specified, but likely internal testing by Byrne Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth for this type of device (a water bottle adapter for irrigation) is physical performance (flow, pressure, material compatibility) rather than diagnostic accuracy requiring expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process is described or implied for the performance testing of this mechanical device.
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 not an AI-powered diagnostic or assistive tool, so an MRMC comparative effectiveness study involving human readers and AI is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing would be established engineering standards and validated measurement techniques for flow rate and pressure, combined with material science evaluations. The document refers to "extensive safety, performance, and validations" and "real-time flow rate data was collected," indicating a focus on physical performance rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
§ 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.