(28 days)
The BioGuard Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The BioGuard Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The BioGuard Air/Water Valve and the BioGuard Suction Valve are accessories to an endoscope. The Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel and also controls water used to wash the lens of the endoscope. The Suction valve allows the user to control suction through the scope's accessory channel. The valves are sterile, single-use, disposable devices.
The Air/Water valve consists of a snap cap, stem, gaskets, spring and valve base (skirt and endcap).
The Suction valve consists of a stem, spring and valve base (skirt and endcap).
This document, K203630, is a 510(k) premarket notification for a modification to the STERIS BioGuard Air/Water and Suction Valves. It's a "Special 510(k)" because the modification (adding glue to a component of the air/water valve) is minor and doesn't significantly alter the device's fundamental technology or indications for use.
Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria (especially regarding AI/human interaction, ground truth establishment, training sets, etc.) is not applicable to this type of medical device submission. This submission is for physical, disposable valves, not a diagnostic or AI-driven system.
The study presented here is a pre-clinical performance test, specifically to confirm the safety and effectiveness of the modification to the device (adding glue) and ensure it doesn't negatively impact the device's intended function.
Here's a breakdown of the relevant information provided in the document concerning the device's technical performance:
Acceptance Criteria and Device Performance (for the modification):
The document describes non-clinical performance testing conducted to ensure the safety and effectiveness of adding glue to the air/water valve stem.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Torque (unscrewing) testing of the air/water valve cap to ensure the glue bond meets a set strength. (Specific strength value not provided in this summary, but implies a quantitative target was met.) | The testing was performed and supports the conclusion that the device is "as safe, as effective and performs as well or better than the legally marketed predicate device." Failure to meet the set strength would have required further investigation or redesign. |
| Functional testing that involved repetitive cycling (pushed down and released) of the air/water valve. This simulates actual use testing. (Specific number of cycles or performance metrics not provided, but implies the valve maintained functionality throughout the simulated use.) | This testing ensures the glue bond and the overall valve integrity can withstand repeated action during typical use without compromising function. The successful completion of this test indicates the device performs adequately. |
Study That Proves the Device Meets Acceptance Criteria:
This was a non-clinical performance test focused on the specific design change.
- Sample Size: Not explicitly stated for each test, but standard engineering validation would involve a statistically relevant number of samples for torque and cycling tests.
- Data Provenance: This is internal company testing, likely conducted at STERIS's facilities. The location (Mentor, OH, USA) is provided for the company.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is mechanical/physical testing, not an interpretative diagnostic study requiring expert consensus for ground truth. The "ground truth" here is the physical performance of the valve against engineering specifications.
- Adjudication method: Not applicable. These are quantitative mechanical tests, not subjective interpretations.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an algorithm.
- The type of ground truth used: Engineering specifications and performance standards for mechanical durability and functionality (e.g., specific torque values, successful completion of cycle tests).
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of the document's relevance:
The document describes a Special 510(k) for a physical medical device (endoscope valves), where the primary evidence of safety and effectiveness for a minor modification is through non-clinical bench testing to ensure mechanical integrity and functionality. It does not involve complex clinical studies, AI algorithms, or human reader performance assessments. The "acceptance criteria" are therefore engineering and performance specifications pertinent to the device's mechanical function.
§ 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.