(60 days)
The CO2mbi LED SCB is a combination of an LED light source, intended to provide illumination, and an insufflation/ irrigation pump, intended to insufflate CO2 or air as a distention media in the gastronitestional tract or water irrigation for lens cleaning when used in conjunction with flexible endoscopes for GI endoscopic procedures.
CO2mbi LED SCB is a portable and compact all-in-one LED Light source and insufflation unit that includes a touchscreen control display, an insufflation pump and internal LED light source, intended to be connected to a compatible GI Videoendoscope and CCU for illumination and insufflation purposes. It is also equipped with a water bottle and lid with tube to provide irrigation for lens cleaning.
The provided text describes a medical device, the CO2mbiLED SCB, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of clinical performance. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical data.
Therefore, many of the requested details cannot be extracted from this document, as the document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria for clinical performance because it did not conduct a clinical study. Instead, it refers to:
- Compliance with FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, IEC 62471).
- Software Verification and Validation Testing guided by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" with a "Level of concern: Moderate."
- Additional bench testing "to ensure the device met its design specifications."
The reported device performance, in terms of its functions, is stated as having:
- Different flow rates and flow rate settings compared to predicates.
- Slightly different operating pressures and pressure to activate the pressure relief valve (CO2) compared to predicates.
The summary then concludes that these differences "do not raise different questions of safety and effectiveness because the intended use, operating principles, technological characteristics, and features are significantly similar, if not identical. Both systems also comply with identical standards and safety testing, where applicable. Substantial equivalence on the effectiveness of the subject device is supported by the comparison of the flow rate, flow rate settings operating pressure and pressure to activate pressure relief valve (Table F) and bench testing to show that the subject device function as intended (Section 21 – Performance Testing)."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available because no clinical test set was used for a substantial equivalence determination in this document. The evaluation was based on non-clinical bench testing and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available because no clinical test set requiring expert-established ground truth was part of this submission for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available because no clinical test set requiring adjudication was part of this submission.
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
An MRMC comparative effectiveness study was not done. The device is an endoscope accessory (light source and insufflation/irrigation pump), not an AI-powered diagnostic tool for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm, but a hardware device (light source and pump).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance, the "ground truth" was established by design specifications for the device, and compliance with recognized consensus standards.
8. The sample size for the training set
This information is not available as the device is not an AI/machine learning algorithm that requires a training set. The evaluation was based on non-clinical bench testing.
9. How the ground truth for the training set was established
This information is not available as the device is not an AI/machine learning algorithm requiring a training set with established ground truth.
§ 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.