(270 days)
The Scope-Assist Flushing Sink is indicated for flushing the channels of flexible endoscopes according to the endoscope manufacturer's instructions.
The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushing portion of an endoscope's manual cleaning process. The sink facilitates compliance with endoscope manufacturer's cleaning requirements by:
• Providing a means of flushing flexible endoscope channels with detergent solution
• Providing a means of flushing endoscope channels with water
• Providing an environment for soaking and manual wiping/brushing of flexible endoscope exterior surfaces and accessories
• Providing an environment to perform wet leak testing of endoscopes
The Scope-Assist Flushing Sink is designed:
• To be used where the facility performs its endoscope cleaning functions, such as in soiled utility rooms, central processing decontamination areas, or endoscope cleaning (reprocessing) areas.
• To be used with Tergal 800 Detergent
The Scope-Assist Flushing Sink is not designed:
● To be used at bedside, in critical care units, or in sterile environments
● To be used as a terminal process or as part of the manual high level disinfection process
This document describes a 510(k) premarket notification for the "Scope-Assist Flushing Sink" device. It is a device intended to mechanically assist the channel flushing portion of an endoscope's manual cleaning process. The information provided is for regulatory approval and does not contain a study of the type you're asking for (e.g., related to AI or diagnostic accuracy improvements). Therefore, many of your requested items regarding acceptance criteria and study details cannot be answered based on this document.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance (Summary from document) |
|---|---|
| Flushing performance meets or exceeds endoscope manufacturer's requirements in specified flushing times. | Device is able to meet or exceed the endoscope manufacturer's flushing requirements in the specified flushing times. (Specific quantitative results not provided) |
| Detergent injection delivers correct amount of detergent consistently and reliably. | Device is able to consistently and reliably deliver the correct amount of detergent. (Specific quantitative results not provided) |
| Tergal detergent is compatible with materials in the flow path of the sink. | Use of Tergal detergent is compatible with the materials in the flow path of the sink. (Specific test results not provided) |
| Electrical safety according to IEC 61010-1. | Electrical safety testing according to IEC 61010-1 was conducted and demonstrated substantial equivalence. (Specific parameters/results not provided) |
| Electromagnetic compatibility according to IEC 60601-1-2. | Electromagnetic compatibility testing according to IEC 60601-1-2 was conducted and demonstrated substantial equivalence. (Specific parameters/results not provided) |
| Amount of fluid delivered is sufficient to meet or exceed endoscope manufacturer's requirements for volume. | Amount sufficient to meet or exceed the endoscope manufacturer's requirements for volume of fluid delivery through endoscope channels. |
| Length of fluid circulation time is sufficient to deliver fluid volumes that meet or exceed endoscope manufacturer's requirements. | Variable, the length of the fluid circulation time is sufficient to deliver fluid volumes that meet or exceed the endoscope manufacturer's requirements. |
2. Sample size used for the test set and the data provenance:
This document describes performance testing for a medical device (a flushing sink), not a diagnostic or AI algorithm. Therefore, the concept of a "test set" in the context of data (like medical images or patient records) does not apply here. The testing would have involved physical devices and potentially endoscopes, but no sample size or data provenance is specified in terms of clinical or image data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical device, and ground truth in the context of expert review for data is not part of this submission. The "ground truth" would be established by engineering specifications and industry standards for flushing efficacy.
4. Adjudication method for the test set:
Not applicable. No expert adjudication process for a data test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, What was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical medical device, not an AI or diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
For the performance tests described (flushing, detergent injection, compatibility), the "ground truth" would likely be derived from:
- Endoscope manufacturer's instructions/specifications: for required flushing volumes, times, and cleaning protocols.
- Engineering specifications and standards: for detergent delivery accuracy, material compatibility.
- International standards (IEC 61010-1, IEC 60601-1-2): for electrical safety and electromagnetic compatibility.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not an AI algorithm.
§ 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.