(57 days)
The Endo SmartCap™ is intended to supply sterile water to series 10, 100 and 130 Olympus endoscopes when connected to a commercially available sterile water bottle.
The Endo SmartCap™ consists of two tubes, arranged coaxially, with a fitting on one end and a hottle cap adapter on the other. On one end, the tubes engage a coaxial fitting designed to replicate the fitting of the predicate device and how it engages with the receptacle on the Endoscope. The fitting is designed to receive air from the Endoscope and direct the flow through the annulus between the inner and outer tubes. The opposite end of the outer tube is connected to a bottle cap adapter by means of a compression fitting to form an airtight scal. The inner tube passes through the compression fitting and extends beyond the cap adapter. When assembled with a bottle of sterile water, the device allows air from the Endoscope to pressurize the bottle and motivate water out of the bottle through the inner tube. The inner tube terminates at the coaxial fitting where water is directed through a separate channel of the receptacle to feed the Endoscope. The Endo SmartCap™ is sold as a sterile, single patient use device. It will be individually packaged in a Chevron-style sterile barrier pouch with the product label affixed to the clear side of the package, or the label pre-printed on the Tyvek® side of the pouch.
The provided text describes the Endo SmartCap™, a sterile water bottle adapter for endoscopes, and its performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Water Flow Rate | |
| (Compared to predicate device) | The applicant's device delivers the same flow rate as the predicate device under a variety of pressure settings, within reasonable measurement error (+/-4%). |
| Static Pressure Rating | |
| (Ability to withstand pressure without leaking/failure) | The applicant's device was tested to 10 PSI using sterile water bottles from three manufacturers (Abbott, Baxter, McGaw) without leaking or any other failure. This is more than twice the maximum pressure the Endoscope air pump is rated to produce (0.32 kg/cm² or 4.4 PSI). |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify an exact number of units or individual test runs. It mentions "a variety of pressure settings" for flow rate tests and testing with "sterile water bottles from the three largest sterile water manufacturers (Abbott, Baxter and McGaw)" for pressure tests.
- Data Provenance: The testing was "Bench Testing" performed by the applicant ("Endo SmartCap™ Company"). The provenance is internal company testing, likely prospective, as it was conducted specifically for this submission. The country of origin is implicitly the United States, given the company's address and the FDA submission context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study is a bench test comparing the functional performance of the new device against a predicate device and engineering specifications. It does not involve human interpretation of medical images or clinical outcomes that would require expert adjudication to establish ground truth.
4. Adjudication method for the test set
This information is not applicable, as there was no expert review or adjudication process for this type of bench testing. The results were quantitative measurements (flow rate, pressure resistance).
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
This is not applicable. This device is a sterile water bottle adapter, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical accessory, not an algorithm. Bench testing was performed to evaluate its physical performance.
7. The type of ground truth used
The "ground truth" for this engineering bench testing was established by:
- Predicate device performance: The flow rate of the Endo SmartCap™ was compared directly to that of the Olympus MD-431 Water Container.
- Engineering specifications/known parameters: The pressure test used the maximum rated pressure of the Olympus Endoscope air pump (0.32 kg/cm² or 4.4 PSI) as a reference point for acceptable performance. The device needed to withstand at least this pressure.
8. The sample size for the training set
This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the AI sense.
9. How the ground truth for the training set was established
This is not applicable as there is no 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.