(90 days)
The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
The LAGIS Suction Irrigation System consists of flexible tubing attached to a plastic housing/handle with a spring activated valve/stopper. Attached distally is a stainless steel probe and proximally is a plastic housing cap. When properly connected and operated, the device irrigates and evacuates fluids during laparoscopic procedures. The LAGIS Suction Irrigation System has multiple models, which can be categorized into two types based on the handle design, including direct type (e.g., SA-360C) and trumpet type (e.g., SA-320CT). Despite the different handle designs, all models provide the same function.
The provided document is a 510(k) summary for the LAGIS Suction Irrigation System, which is a medical device, not an AI/ML algorithm. Therefore, the information requested regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device is not applicable to this document.
This document details:
- Device Name: LAGIS Suction Irrigation System
- Intended Use: To provide suction and irrigation functions in laparoscopic procedures to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
- Regulatory Class: Class II (Product Code GCJ - Laparoscope, General & Plastic Surgery)
- Predicate Device: Taiwan Surgical Disposable Suction Irrigation (K150253)
- Performance Tests: The summary lists performance bench tests conducted to verify design characteristics and ensure the device can be used as intended. These include:
- Biocompatibility testing (following ISO 10993-1)
- Sterilization validation (according to ISO 11135)
- Functional and performance characteristics (airtightness, kinking resistance, flattening resistance, bending resistance, and pressing force performances).
- Conclusion: The tests met the predefined acceptance criteria, and no new questions of safety and effectiveness were identified. The device was deemed substantially equivalent to the predicate device.
Since the device is a physical medical instrument (suction irrigation system) and not a software/AI product, the detailed questions about AI model training, test sets, expert ground truth, adjudication methods, and MRMC studies are irrelevant to this submission.
§ 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.