(28 days)
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The provided text describes a 510(k) premarket notification for an "Irrigation Channel Tubing System" (Model 100135) by Byrne Medical, Inc. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and device performance metrics as would typically be found in an AI/software device submission.
Therefore, many of the requested sections about acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets are not applicable to this type of regulatory submission. This document describes a physical medical device, not a software algorithm.
However, I can extract the relevant information regarding the testing performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flow Rate | Not explicitly stated, but implied to be within acceptable range for intended use. | Minimum pump setting: 155 ml/min |
| Maximum pump setting: 650 ml/min | ||
| Measurement error: +/- 4% | ||
| Pressure | Withstand pressure up to 10 PSI without leaking or any other failure. | Withstood 10 PSI without leaking or failure. |
| (Note: Pump manufacturer's stated maximum pressure is 4.4 PSI, so 10 PSI is a safety margin). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data. The testing described is bench testing of the physical device.
- Sample Size: Not explicitly stated how many units were tested for flow and pressure, nor how many "pump cycles" were performed. It generally refers to "the system" being tested.
- Data Provenance: N/A (Bench testing, not human data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
N/A. This was bench testing of a physical device, not an AI/software device requiring expert-established ground truth for interpretation.
4. Adjudication Method for the Test Set
N/A. This was bench testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
N/A. This was bench testing of a physical device, not an AI/software device. No human readers or comparison with/without AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
N/A. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the bench tests was derived from empirical measurements against engineering specifications and the performance of the known predicate devices.
- Flow Rate: Measured volume over time.
- Pressure: Observation of leaks/failures.
8. The Sample Size for the Training Set
N/A. This is a physical device, not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable as there is no training set for a physical device.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The study described is bench testing conducted by Byrne Medical, Inc. on their Irrigation Channel Tubing System, Model 100135.
- Testing Method:
- Bench testing utilized Meditron UGI-3000B™ GI Endoscopy Pumps and EndoGator™ Cartridge and tubing sets.
- Flow testing: Measured total volume over time at minimum and maximum pump settings.
- Pressure testing: The system was tested to a pressure of 10 PSI.
- Results:
- Flow testing demonstrated flow rates of 155 ml/min at the minimum pump setting and 650 ml/min at the maximum pump setting, with a measurement error of +/- 4%.
- Pressure testing showed the system withstood 10 PSI without leaking or any other failure, exceeding the pump manufacturer's stated maximum pressure of 4.4 PSI.
- Conclusion: Based on these bench tests, the manufacturer concluded that the Byrne Medical Endo Gator™ Irrigation Channel Tubing system is equivalent in safety and efficacy to its predicate devices.
§ 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.