(60 days)
The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester or polyethylene suture through soft tissue in endoscopic and other limited access procedures.
The Opus® SmartStitch™Suture Device with PerfectPasser™ Connector is designed to allow the surgeon the option to place a simple stitch or a mattress stitch.
The provided text describes a 510(k) premarket notification for a medical device and focuses on its substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them because such details are not present in the given text.
The document does not contain any information regarding:
- Acceptance criteria
- Reported device performance against any criteria
- Sample sizes for test sets or training sets
- Data provenance
- Number or qualifications of experts for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- How ground truth for the training set was established
The document is a regulatory submission for a modified medical device, asserting its "substantial equivalence" to a previously cleared device. The key argument for substantial equivalence is that the modification involves a change to the suture delivery system and alternative materials, but the fundamental technology and principle of operation remain the same. The text explicitly states: "The differences between the Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector and the predicate device does not raise any questions regarding the safety and effectiveness." This indicates that the regulatory pathway relies on demonstrating fundamental similarity and not requiring new clinical performance data.
§ 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.