(36 days)
SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.
The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.
The provided text describes the acceptance criteria and a summary of performance data for the SCOPE BUDDY PLUS Endoscope Flushing Aid.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Delivery Flow Rate Verification | Meet manufacturers minimum requirements for individual channel flushing volumes. | PASS |
| Tubing Durability Verification | The 24-hour tubing shall withstand at least 40 full automatic cycles without leaking. | PASS |
| Software Verification | Verification steps outlined in procedure must be met for acceptance of the protocol. | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing to demonstrate substantial equivalence to the predicate has been completed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described (Fluid Delivery Flow Rate, Tubing Durability, Software Verification) appear to be engineering/performance tests rather than tests requiring expert human interpretation or ground truth establishment based on clinical observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as the tests described are technical performance verifications and do not involve human adjudication for ground truth.
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 electro-mechanical flushing aid for endoscopes, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to this device. It is an electro-mechanical device with software control, not an algorithm performing a standalone diagnostic or interpretative function. The software verification confirms the software's functionality within the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests appears to be engineering specifications and defined performance metrics.
- For Fluid Delivery Flow Rate, the ground truth is the "manufacturers minimum requirements for individual channel flushing volumes."
- For Tubing Durability, the ground truth is the specified requirement to "withstand at least 40 full automatic cycles without leaking."
- For Software Verification, the ground truth is the "verification steps outlined in procedure."
These are objective, measurable criteria rather than clinical ground truth established by experts.
8. The sample size for the training set
The document does not mention a "training set" as this device is not a machine learning or AI model.
9. How the ground truth for the training set was established
This question is not applicable as there is no mention of a training set.
§ 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.