(402 days)
The EndoStream™ tubing is intended to provide irrigation via sterile water supply during gastrointestinal (GI) endoscopic procedures when used in conjunction with an irrigation pump.
The EndoStream™ is available in two (2) configurations: PFE130 and PFE230. The EndoStream™ is used to convey sterile water from an external water source to a flexible endoscope to aid its function. This sterile water is used to clean the lens of the flexible endoscope during operation or to assist in improving the flexible endoscopes visual field. The device consists of PVC tubing and an endoscope connector with a medical grade plastic check valve. It functions by using a single lumen in conjunction with a peristaltic pump to provide water to the flexible endoscope. EndoStream™ connects a sterile water supply into the proximal end of an endoscope. Once connected, EndoStream™ allows sterile water to flow into the endoscope which carries it into the Gastrointestinal (GI) tract to flush out the GI tract during endoscopic procedures. It is a tubing with a cap which directly screws onto a sterile water bottle. The tubing extremity connects to the endoscope via the pump head on a peristaltic irrigation pump. A back flow valve is integrated in the extremity of each EndoStream™ tubing ensuring the unidirectional flow from the sterile water bottle to the endoscope, thus guaranteeing the prevention of risks of cross contamination.
The EndoStream™ tubing is intended to provide irrigation via sterile water supply during gastrointestinal (GI) endoscopic procedures when used in conjunction with an irrigation pump. The performance data section indicates that the device underwent several tests to demonstrate functionality and performance integrity.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Validation (ISO 11135) | Not explicitly stated what was measured as performance, but the test was completed "per respective standards." The implication is that the sterilization process successfully rendered the device sterile and met the requirements of ISO 11135. |
| Shelf-Life / Aging Testing (ASTM 1980) | Not explicitly stated what was measured as performance, but the test was completed "per respective standards." This included: |
- Dye Penetration
- Seal Strength Testing
- Visual Seal
The implication is that the device maintained its integrity and functionality over its claimed shelf-life. |
| Biocompatibility (ISO 10993) | Tested for: - Cytotoxicity
- Intracutaneous Irritation Test
- Sensitization
The implication is that the materials used are biocompatible and met the requirements of ISO 10993. |
| Functionality & Performance Integrity | The EndoStream™ product was also tested to demonstrate functionality and performance integrity. Specific quantitative metrics are not provided, but the conclusion states "Any differences do not raise any new issues of safety or effectiveness," suggesting successful performance. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the sterilization validation, shelf-life/aging, biocompatibility, or functionality tests. No information is provided regarding the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical accessory (tubing for irrigation), and the described tests are primarily engineering and material science evaluations, not clinical performance studies requiring expert interpretation of results for ground truth establishment.
4. Adjudication method for the test set
Not applicable. The tests mentioned (sterilization, shelf-life, biocompatibility, functionality) are objective measurements conducted according to established standards. They do not involve subjective interpretation or a need for adjudication methods like 2+1 or 3+1.
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
Not applicable. The EndoStream™ is an irrigation tubing, not an AI-powered diagnostic or assistive device. Therefore, an MRMC study comparing human readers with or without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The EndoStream™ is a physical medical device (tubing), not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the tests performed would be defined by the specifications and acceptance criteria of the respective standards (ISO 11135, ASTM 1980, ISO 10993) and the device's own functional requirements. For example:
- Sterilization: Ground truth is the absence of viable microorganisms after the sterilization process, confirmed by biological indicator tests or sterility assurance levels defined by ISO 11135.
- Shelf-Life/Aging: Ground truth is the device maintaining its physical and functional properties (e.g., no dye penetration, specified seal strength, no visual degradation) over the tested period, according to ASTM 1980.
- Biocompatibility: Ground truth is the absence of cytotoxic effects, irritation, or sensitization as per the criteria of ISO 10993.
- Functionality: Ground truth would be the device's ability to consistently and reliably convey sterile water from the source to the endoscope without leaks, blockages, or failure of the check valve, as designed.
8. The sample size for the training set
Not applicable. This document describes performance testing for a physical medical accessory, not the development or training of an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set was used as this is not an AI/algorithm-based device.
§ 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.