(270 days)
The da Vinci® SonicPro™ Cleaning System is intended for the automated cleaning of reusable EndoWrist Instruments and Accessories used with the da Vinci and da Vinci S surgical systems. The Cleaning System when used in accordance with its labeling provides an automated cleaning method as part of the re-processing sequence for the EndoWrist Instruments and Accessories.
The da Vinci SonicPro Cleaning System is intended for the automated cleaning of the reusable EndoWrist Instruments and Accessories only. The cleaning system is intended to provide an automated method for the cleaning step as part of the reprocessing procedure for the Intuitive Surgical EndoWrist Instruments and Accessories. This system is not intended to perform disinfection.
The SonicPro Cleaning System is a floor standing model comprised of an ultrasonic tank, fluid pumps, flushing tubing, various sensors and controllers, and a basket to hold the devices intended to be cleaned using this system. Using pressurized water, an enzymatic cleaning agent and ultrasonic agitation, the SonicPro provides an automated cleaning process. Effective cleaning of the EndoWrist Instruments and Accessories is achieved through qualified and controlled process parameters, and pre-programmed cycle configurations.
After completion of the cleaning cycle, the devices are to be removed from the cleaning system, dried and further prepared for sterilization. The SonicPro cleaning system has been tested for use ONLY with the Intuitive Surgical® devices as detailed in the instructions for use document provided with the cleaning system.
The provided text describes a medical device, the "da Vinci SonicPro Cleaning System," and its 510(k) summary for FDA clearance. However, the document does not contain specific acceptance criteria, performance metrics, or details of a study that directly proves the device meets those criteria.
Instead, it states that:
- "Design analysis and testing is conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate device cited, and that design output meets the design input requirements."
- "Simulated-Use test is conducted to evaluate the cleaning efficacy of the SonicPro Cleaning System in effectively cleaning the devices intended to be used with the system."
- "Based on cleaning efficacy, steps and process parameters of the cleaning cycle, the SonicPro Cleaning System is equivalent to the currently used manual cleaning method for reprocessing of EndoWrist Instruments and Accessories cleared under K063220 and K021036."
Given the limitations of the provided text, I cannot extract the detailed information requested in the prompt. The text focuses on establishing substantial equivalence to predicate devices and manual cleaning methods, rather than presenting a performance study against predefined quantitative acceptance criteria.
Therefore, I cannot populate the table or provide specific answers for most of the requested points. Below is what can be inferred or explicitly stated based on the text provided:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in text | "Effective cleaning of the EndoWrist Instruments and Accessories" |
| Not specified in text | "Equivalent to the currently used manual cleaning method for reprocessing of EndoWrist Instruments and Accessories" (in terms of cleaning efficacy, steps, and process parameters) |
2. Sample sized used for the test set and the data provenance:
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The study type is referred to as "Simulated-Use test."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not mention experts or ground truth establishment in the context of the "Simulated-Use test."
4. Adjudication method for the test set:
- Not specified.
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 device is an automated cleaning system, not an AI-assisted diagnostic or interpretive device involving human "readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "Simulated-Use test" likely reflects a standalone performance of the cleaning system as an automated process, but specific metrics are not provided. The system is designed for automated cleaning without human intervention during the cleaning cycle itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For a cleaning efficacy study, ground truth would typically involve objective measurements of cleanliness (e.g., residual soil, protein, hemoglobin) rather than expert consensus on images or pathology. The document only mentions "cleaning efficacy."
8. The sample size for the training set:
- Not applicable. The description does not suggest a machine learning model that would require a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.