(87 days)
The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.
The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.
I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. The document is an FDA 510(k) clearance letter for the SimpleSnip Endoscopic Suture Cutter, detailing its substantial equivalence to a predicate device. It includes information about the device description, indications for use, comparison with a predicate device, and performance/biocompatibility/sterilization testing conducted.
Specifically, it states:
- "No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." This means there isn't a clinical study with acceptance criteria and reported performance in the context of human data.
- The performance data mentioned is primarily bench testing and functional testing, as well as comparative testing against the predicate device for certain mechanical aspects (rotation, actuation, bending stiffness). These tests are designed to verify specifications and show equivalence, not necessarily to meet pre-defined clinical performance acceptance criteria against human outcomes.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance for a clinical study.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth for a clinical study.
- Sample size for a training set.
- How ground truth for the training set was established.
This document focuses on demonstrating substantial equivalence through non-clinical data and comparison to a predicate device, which is common for 510(k) submissions where clinical studies are not deemed necessary.
§ 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.