(12 days)
Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
The Byrne Medical, Inc., EndoGator Endoscopy Irrigation Pump is used for Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
The EGP-100 pump will provide an adjustable flow-rate from 0-550ml/min, which is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. A foot pedal activated air switch controls the running or stopping of the purnp motor and a peristaltic pump head. These parts will not cause contamination of sterile water during deliverance.
The provided document states that the Byrne Medical, Inc. EndoGator Endoscopy Irrigation Pump is substantially equivalent to its predicate device, the Meditron Endolav Model EL-100 (K882048), based on a comparison of specifications and the successful completion of EMI and Safety Testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device's performance in the traditional sense of a clinical study. Instead, it compares the specifications of the EndoGator EGP-100 to its predicate device, the Meditron Endovav EL-100, as part of demonstrating substantial equivalence. The "acceptance criteria" here are implied to be achieving comparable or superior performance to the predicate device for relevant parameters, and meeting safety/EMC standards.
| Parameter | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (EndoGator EGP-100) | Meets Criteria? |
|---|---|---|---|
| Indications for Use | Endoscopic irrigation for use with washing catheters, integral endoscope water jet channels, and endoscope working channels. | Endoscopic irrigation for use with washing catheters, integral endoscope water jet channels, and endoscope working channels. | Yes |
| Regulation # | 21 CFR 876.1500 | 21 CFR 876.1500 | Yes |
| Target Population | Male/Female pediatric to adult | Male/Female pediatric to adult | Yes |
| Prescription Device | Yes | Yes | Yes |
| Dimensions (H x W xD) | 4.5" x 5" x 8" | 3.5" x 6" x 8" | Not directly "same," but considered acceptable for substantial equivalence (smaller size) |
| Classification | Class I, Type BF, Ordinary Equipment for Continuous operation | Class I, Type BF, Ordinary Equipment for Continuous operation | Yes |
| Min flow rate | 15 ml/min | 0 ml/min | Not directly "same," but an improvement (lower minimum) and considered acceptable. |
| Max flow rate | 650 ml/min | 550 ml/min | Not directly "same," but within a comparable range and considered acceptable. |
| Min Pressure | 2 PSI | 0 PSI | Not directly "same," but an improvement (lower minimum) and considered acceptable. |
| Max Pressure | 40 PSI | 48 PSI | Not directly "same," but an improvement (higher maximum) and considered acceptable. |
| Pump type | Peristaltic | Peristaltic | Yes |
| EMI and Safety Testing | Meet specified acceptance criteria | Successfully conducted and expected to meet specified acceptance criteria (as stated in Conclusions) | Yes, planned and accepted as part of the overall submission. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical data or patient samples. The evaluation is based on a comparison of device specifications and the results of engineering tests (EMI and Safety). Therefore, there is no sample size for a test set, nor data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As there is no clinical "test set" with ground truth established by experts, this information is not provided. The substantial equivalence relies on comparing technical specifications and engineering test results.
4. Adjudication method for the test set
Not applicable. There is no clinical "test set" requiring an adjudication method.
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 an irrigation pump, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance, in the context of this 510(k) submission, is established through:
- Comparison to a legally marketed predicate device's established performance and specifications.
- Engineering standards and testing: Specifically, EMI (Electromagnetic Interference) and Safety Testing (referred to as "Test Review" and affirmed in the "Conclusions"). These tests verify the device's electrical and mechanical integrity against recognized standards.
8. The sample size for the training set
Not applicable. This device is a mechanical pump, not a learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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.