(225 days)
The EndoGator® Advantage CO2 Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The EndoGator Advantage CO2 Insufflator EGA-501 is indicated to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. It is intended to be used for delivery of CO2 via an endoscope system to provide improved visualization during gastrointestinal endoscopic procedures.
The EndoGator Advantage CO2 Insufflator operates by receiving CO2 from a pressurized source and requlating it down to a lower pressure and flow rate by means of a two-stage pressure regulator and flow restrictor system. The device controls delivery of CO2 to an endoscope system for eventual use as a distention media in endoscopic procedures.
The output flow rate is user adjustable and can be set at low, medium or high settings. Flow is controlled by a system of electrical solenoid flow restrictors. The device contains a pressure relief safety valve as a redundant safety backup to the pressure regulator system.
The EndoGator Advantage CO2 Insufflator includes a CO2 warming feature that allows the clinician to modulate and control delivery of CO2 that has been warmed to a target temperature of 37°C. The insufflator warms CO2 using a flow-through heating element with built-in dual redundant resistance temperature detector sensors and an added safety thermostat.
The device design also contains an optional feature that allows for connection of an externally attachable water bottle warmer accessory. The water bottle warmer system design is identical to the design used in the related Endogator Advantage Irrigation Pump EGA-500 (K113119). The feature was included in the insufflator design to provide the user with the option for warm water irrigation in the event that they choose to use an alternative irrigation pump to the EGA-500.
The provided text is a 510(k) summary for a medical device, the EndoGator Advantage CO2 Insufflator EGA-501. It details the device's description, indications for use, comparison to a predicate device, and a summary of non-clinical performance data. However, it does not describe acceptance criteria for specific performance metrics or the detailed study results that prove the device meets these criteria. It lists types of non-clinical tests performed, but not the quantitative outcomes or acceptance thresholds.
Given the information provided, I cannot fulfill all parts of your request. Specifically, the document is a regulatory submission summary, and typically these summaries do not include precise acceptance criteria tables or detailed study results with sample sizes, expert qualifications, or ground truth establishment methods for specific performance metrics. These details would be in the full submission, which is not provided.
Therefore, I can only provide information based on what is available in the text.
Here's what can be extracted and formatted, along with explanations for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with corresponding performance results. It states that "evaluation and testing has been performed to demonstrate that the differences do not impact device safety or performance, and any risks associated with the differences are acceptable." It also lists the types of tests conducted:
| Test Type | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| Simulated insufflation performance comparison | (Implicitly: performance similar to predicate) | (Implicitly: acceptable and safe) |
| CO2 flow and pressure comparison testing | (Implicitly: within safe and effective ranges) | (Implicitly: comparable to predicate) |
| CO2 heater performance | (Implicitly: warms CO2 to target 37°C safely) | (Implicitly: meets target temperature safely) |
| CO2 heater performance with flow shut-off | (Implicitly: safe response to flow shut-off) | (Implicitly: safe operation) |
| CO2 temperature and flow through endoscope system | (Implicitly: safe and effective delivery) | (Implicitly: safe and effective delivery) |
| CO2 pressure relief valve performance | (Implicitly: effective pressure relief) | (Implicitly: functions as safety backup) |
| Risk analysis | (Implicitly: risks are acceptable) | (Implicitly: identified risks are acceptable) |
| Electrical safety IEC 60601-1 | Compliance with standard | (Implicitly: Compliant) |
| Electromagnetic compatibility IEC 60601-1-2 | Compliance with standard | (Implicitly: Compliant) |
| Water bottle warmer performance | (Implicitly: identical to EGA-500 design, functions safely) | (Implicitly: acceptable and safe) |
Explanation for Missing Details: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device ("E-Z-EM Endoscopic CO2 Regulator"). For such submissions, detailed quantitative performance thresholds and results are often contained in the full submission, not in the publicly available summary. The summary confirms that "testing has been performed to demonstrate that the differences do not impact device safety or performance, and any risks associated with the differences are acceptable," indicating that the device did meet unstated acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the non-clinical tests performed. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). Given that the tests are described as "bench testing," they would be performed in a laboratory setting, not with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable and therefore missing. The document describes "bench testing" of a physical device, not an algorithm that requires expert-established ground truth from images or clinical data.
4. Adjudication Method for the Test Set
This information is not applicable and therefore missing. The tests are for a physical device's performance, not an interpretative algorithm requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is a 510(k) submission for a physical medical device (CO2 insufflator), not an AI algorithm that would typically undergo MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical insufflator, not an algorithm. Therefore, "standalone" performance in this context refers to the device operating by itself, which is implicitly what the "bench testing" covers.
7. The Type of Ground Truth Used
For a physical device, "ground truth" typically refers to established engineering specifications, validated measurement techniques, and industry standards. The testing described (e.g., CO2 flow, pressure, temperature, electrical safety) would be validated against these objective physical measurements and standards (e.g., IEC 60601-1). It does not involve "expert consensus, pathology, or outcomes data" in the way an AI diagnostic tool would.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical insufflator, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is 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.