(88 days)
The RIWO System Trays 38201.xxx, 38202.xxx, 38301.xxx have been designed to hold devices during sterile storage, transport, and while undergoing steam and ethylene oxide sterilization.
The devices are assorted open or closed trays for sterilization, storage and transport. The RIWO System Trays are blue in color. The assorted trays vary in size and begin with product number 3820x.xxx. Other characteristics are a base, latched cover and silicone peg mat construction. These trays hold the device to be sterilized and the tray must be wrapped for sterilization and sterile storage. They can be used in steam or ethylene oxide sterilization.
Here's an analysis of the provided 510(k) summary regarding 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 (Implied) | Reported Device Performance |
|---|---|
| Functional Performance after Steam Sterilization | The steam sterilization tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted devices when using the pre-vac method. (This implies that the functional performance after steam sterilization was maintained to an acceptable degree.) |
| Functional Performance after Ethylene Oxide (EO) Sterilization | The EO sterilization tests performed, shows that the ethylene oxide sterilization has no influence on the functional performance of the submitted devices. (This implies that the functional performance after EO sterilization was maintained to an acceptable degree.) |
| Safety and Effectiveness | "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." (This is a general statement from the conclusion, implying that the device met internal safety and effectiveness standards, likely encompassing functional performance after sterilization, material compatibility, and structural integrity for holding and transporting instruments without damage.) |
Note: The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., "no visible deformation," "maintains structural integrity for X cycles"). The reported performance is qualitative, stating "no influence on functional performance."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document refers to "the submitted devices" but does not quantify how many trays of each type/model were tested, or how many sterilization cycles each tray underwent.
- Data Provenance: The tests were "performed by Richard Wolf," meaning they were internal company tests. The country of origin for the testing is not explicitly stated, but since the submitter is based in Illinois, USA, it is likely the tests were conducted there or at a facility managed by Richard Wolf. The tests were prospective, conducted specifically to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a medical accessory (trays for sterilization, storage, and transport), not an AI/diagnostic device that requires expert ground truth for interpretation. The "ground truth" for its performance would be its physical integrity and functionality after sterilization cycles, as determined by engineering/quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As this is not an AI/diagnostic device, there was no need for expert adjudication of results. The performance testing would be objectively measured/observed based on established protocols.
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
- No. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical sense for AI/diagnostic devices. For this device, the "ground truth" for its performance would be the direct observation and measurement of its physical properties and functional integrity (e.g., lack of deformation, continued ability to hold instruments, proper latching of covers) after undergoing sterilization cycles according to specified parameters. This is engineering/performance ground truth, not clinical ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device that requires 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.