(59 days)
The Disposable Suction Irrigation Tubing Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation normal saline to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site to aid visualization.
The Disposable Suction Irrigation Tubing Set consists of a grip body equipped with two trumpet style valves, a probe, and connecting lines of tubing; one set designed to attach a supply of irrigation normal saline, and the other designed to attach to suction equipment (aspiration pump). The valves allow for control of irrigation and aspiration during a surgical procedure. The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. The device is packaged as sterile with a shelf life of 3 years and is for single use only.
The provided text describes a 510(k) premarket notification for a medical device called "Suction Irrigation Tubing Set." This type of submission is for medical devices, not AI/machine learning (ML) enabled devices. The document does not contain any information about acceptance criteria or studies involving AI/ML performance, human readers, ground truth establishment for AI/ML, or training/test sets for AI/ML models.
Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets those criteria in the context of AI/ML, as the provided document pertains to a traditional medical device (Suction Irrigation Tubing Set) and its physical properties and functionality.
The document discusses:
- Device Name: Suction Irrigation Tubing Set
- Regulation Number & Name: 21 CFR 876.1500, Endoscope And Accessories
- Product Code: GCJ
- Indications for Use: Used in laparoscopic surgical procedures to deliver sterile irrigation and evacuate fluids/debris/smoke.
- Device Description: Consists of a grip body with valves, a probe, and connecting tubing for irrigation and suction.
- Predicate Device: K141592, Unimicro Suction Irrigation Tubing Set
- Non-clinical Tests Performed: Air tightness, smooth test, tensile strength, tubing collapse, irrigation/aspiration fluid flow test. These are typical physical and performance tests for medical tubing, not AI/ML performance metrics.
- Conclusion: The device is substantially equivalent to the predicate device, raising no new questions of safety or effectiveness based on technological comparison and nonclinical testing.
None of this information relates to the typical acceptance criteria or study methodologies used for AI/ML medical devices (sensitivity, specificity, AUROC, MRMC studies, expert adjudication for image interpretation, etc.).
§ 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.