(73 days)
The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.
This Special 510(k) discloses the modifications to the steps to carry out surface disinfection of the model 4500 handle that was reviewed and cleared in K232837. The Uro-G HD Flexible Cystoscope is a handheld, battery- operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. When fully assembled, the Uro-G HD Flexible Cystoscope- cannula and handle-has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.
This document describes a Special 510(k) submission for the Uro-G HD Flexible Cystoscope, focusing on a minor modification to its surface disinfection process. There is NO mention of an AI/ML device or algorithm. Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of AI/ML.
The provided text only discusses the equivalence of the modified device to its predicate, based on unchanged intended use, indications for use, and technological characteristics, except for the disinfection process.
Here's what I can extract regarding the device performance and the "study" mentioned, which is not an AI/ML study but rather microbiology testing for disinfection:
1. A table of acceptance criteria and the reported device performance:
Since the document focuses on a change in the disinfection process and asserts that other performance characteristics remain unchanged from the predicate, and does not provide specific acceptance criteria values for the disinfection, I cannot create a table with specific numbers. Instead, I can describe the nature of the change and the demonstrated outcome.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Surface Disinfection | • Efficacy: Achieve sufficient log reductions of tested pathogens. | |
| • Compatibility: Allow the use of Super Sani-Cloth or CaviWipe towelettes. | ||
| • Process Efficiency: Potentially reduce contact and air-dry times while maintaining disinfection efficacy. | • Efficacy: "Testing found that 3 minutes contact with the disinfecting agent on the wipes was sufficient for log reductions of ≥ 3 and ≥ 6 of tested pathogens." | |
| • Compatibility: The Super Sani-Cloth is now an approved option in addition to CaviWipe. | ||
| • Process Efficiency: Contact time reduced from 6 minutes to 3 minutes, and air dry time reduced from 20 minutes to 5 minutes. The document implies these reduced times are now sufficient for effective disinfection. | ||
| Other Performance | (Implicitly aligned with Predicate Device's performance, as no changes were made) | |
| • Tip angulation | ||
| • Tip angulation radius | ||
| • Lever force for tip angulation | ||
| • Rotation torque | ||
| • Rotation angles | ||
| • Distention flow rate | ||
| • Cannula leaking | ||
| • Tip temperature | ||
| • Field of view | ||
| • Direction of view | ||
| • Image quality | ||
| • Electrical Safety (IEC 60601-2-18 compliant) | ||
| • EMC Safety (IEC 60601-1-2 and IEC 60601-2-18 compliant) | "Performance tests reviewed in K232837 were not repeated for this submission since the minor change in the surface disinfection process of the handle does not affect device performance." | |
| The device "continues to meet the compliance requirements" for electrical safety and EMC. |
Regarding the study that proves the device meets the acceptance criteria:
The study referenced is a microbiology testing study conducted to evaluate the effectiveness of the revised surface disinfection process for the reusable handle of the Uro-G HD Flexible Cystoscope.
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 specified in the provided text. The document refers to "testing" that "found" specific results for log reductions.
- Data provenance: Not specified.
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)
- This is not applicable to a microbiology disinfection study. The "ground truth" would be established by the standardized protocols and results of the microbiological tests themselves, rather than expert consensus on interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to a microbiology disinfection study.
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. This is not an AI/ML device, and no MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the disinfection efficacy, the "ground truth" was established through microbiology testing results demonstrating "log reductions of ≥ 3 and ≥ 6 of tested pathogens." This is a quantitative measure of antimicrobial effectiveness.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
In summary, the provided document describes a regulatory submission for a medical device (a cystoscope) focusing on a change in its disinfection instructions. The "study" mentioned is a microbiology test to validate the effectiveness of the new disinfection protocol. There is no information related to AI/ML or an algorithm in the provided text.
§ 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.