(76 days)
The Smith & Nephew Suture Lok is indicated for use in open und endoscopic proc : iures, The Smith & Nephew Same Cor is moremes for cedures and general surgery. Th : including thoracoscopic surgery, contraception tubal ligation.
Intended Use:
The Smith & Nephew Suture Lok is intended for use in conjunction with USP size !! 2-0 and 3-0 Braided silk, nylon or polyester non-absorbable sunures in the managemen of and 3-0 Braided silk, hylon of poryester from asservatures during open and endose: pic procedures.
The Smith & Nephew Suture Lok is intended for use in the management of soft vessel ligation and/or fixation of soft tissue structures during open and endoscopic procedures.
The Smith & Nephew Lok is indicated for use in endoscopic procedures, including thoracoscopic surgery and laparoscopic procedures.
The Smith & Nephew Suture Lok comprises three main components:
• the suture Lok implant (ring and pin),
• the disposable cartridge assembly with threader, and
• the reusable delivery instrument.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance studies, or ground truth establishment for a device.
The document is a 510(k) premarket notification letter from the FDA regarding the "Smith & Nephew Suture Lok." It primarily focuses on the device's substantial equivalence to predicate devices, its indications for use, and regulatory adherence. It lists a "510k Summary" with information about the device's name, submitter, contact, predicate devices, device description, intended use, indications, and a comparison table.
The comparison table (7.9 and the one spanning pages 4-5) highlights similarities between the "Suture Lok" and a "Suture Collet" in terms of product labeling, materials, indications, indicated sutures, intended use, and sterilization methods. However, these are design and functional comparisons, not performance metrics based on clinical or technical studies that would establish acceptance criteria.
To answer your request, I would need a different type of document that details performance testing and its results.
§ 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.