(115 days)
The device is indicated for use in patients eligible for treatment via general laparoscopic surgical procedures.
The Candidate Device consists of a hand-held trumpet valve suction-irrigator designed to provide pinpoint suction and irrigation to the surgical site during general laparoscopic procedures. This device is designed for use with legally-marketed irrigation pumps, irrigant bags and bottles, and legallymarketed suction sources.
The provided document is a 510(k) summary for the Trump-It II™ and Magnum 250 Trumpet Valve Suction-Irrigation Handpieces. This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.
The document primarily covers:
- Submitter's Name and Contact
- Device Name and Classification
- Predicate Device identification (Nezhat-Dorsey Hydro-Dissection System & Accessories, K951086)
- Device Description (function, scientific basis, physical/performance characteristics like sterile, disposable, single-use, and materials are proprietary)
- Intended Use Statement (general laparoscopic surgical procedures for eligible patient populations)
- Technological Characteristics Summary
- FDA's 510(k) clearance letter confirming substantial equivalence.
- Indications For Use statement.
It specifically states that the device provides "pinpoint suction and irrigation to the surgical site during general laparoscopic procedures" by combining a hand-held trumpet valve suction-irrigator and a laparoscopic probe. The basis of the 510(k) is substantial equivalence to an existing device, rather than explicit performance criteria described by a detailed study in this document.
§ 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.