(104 days)
The EndoWrist® Suction Irrigator is intended for use in all endoscopic surgical applications where the compatible da Vinci Surgical System is indicated.
The EndoWrist Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue.
The EndoWrist® Suction Irrigator is a single-use, disposable instrument developed for use with the da Vinci Surgical System. The instrument provides the surgeon with the ability to activate suction and irrigation directly from the surgeon console or by depressing buttons on the instrument. Activation from the surgeon console will be controlled through the foot pedals on the surgeon console. The suction and irrigation sources are supplied by conventional devices (suction - canister, hospital line, etc.; and irrigation - closet, compressed air, gravity flow, etc.) that are available in an operating room setting.
The provided text describes a 510(k) premarket notification for the Intuitive Surgical EndoWrist® Suction Irrigator. This is a medical device submission that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through extensive studies designed for that purpose. Therefore, many of the requested details about acceptance criteria and study particulars, especially those relevant to AI/algorithm performance, are not present in this document.
However, based on the type of information provided, I can infer and extract some relevant details:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative table with corresponding "reported device performance" as one might find for an AI algorithm's metrics. Instead, it compares the characteristics of the subject device to its predicate. The acceptance is implicitly based on demonstrating that the new device is "substantially equivalent" to the predicate.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device K162973) |
|---|---|---|
| Instrument Shaft OD | 0.33" | 0.33" |
| Shaft Lumen ID | 0.17" | 0.17" |
| Shaft Length | 17.1" | 22.2" |
| Tubing Length | 13' | 13' |
| Tubing ID/OD | 0.25"/0.375" | 0.25"/0.375" |
| Irrigation Flow Rate | $\geq$ 1.75 L/min | $\geq$ 1.75 L/min |
| Valve Function | Sliding Cylinders | Sliding Cylinders |
| Tip Articulation | Pitch/Yaw | Pitch/Yaw |
| Provided Sterile/Single Use | Yes | Yes |
| Sterilization Method | EtO | EtO |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "bench testing" and "clinical models (animals/cadavers)" for design verification and validation. However, it does not specify sample sizes for these tests. It also does not explicitly state the country of origin or whether the data was retrospective or prospective, though animal/cadaver studies are generally prospective in nature for device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" in this context would likely be defined by expert observation and assessment of the device's function during the animal/cadaver studies, but the number or qualifications of these experts are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 such study is mentioned. This is not an AI/algorithm-based device, so MRMC studies in the context of AI assistance are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "Design Verification (bench testing)", the ground truth would be against engineering specifications and measurable performance metrics. For "Design Validation (animal/cadaver)", the ground truth would be based on observations of safety and efficacy in a simulated clinical setting, likely assessed by experts (e.g., surgeons performing the procedures). This isn't explicitly defined as "expert consensus," "pathology," or "outcomes data" but falls more into the category of expert observation of device function and tissue interaction.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires 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.