(11 days)
The Single-Site™ Flexible Bladeless Obturator is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
The Single-Site™ Flexible Bladeless Obturator is a sterile, single-use 5mm diameter X 304 mm length dilating obturator that is used in conjunction with a 5mm Curved Cannula. The Obturator has a cap at the proximal end that locks onto the Curved Cannula rim. The Curved Cannula is designed by Intuitive Surgical, Inc. (ISI) for use with their DaVinci SI robot model.
This 510(k) summary (K101671) describes a medical device, the Single-Site™ Flexible Bladeless Obturator, but it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic or AI-driven aid would.
This document is a premarket notification for a Class II surgical instrument, a device with a known mechanism of action that relies on mechanical performance rather than diagnostic accuracy. The "performance data" section is very brief and focuses on basic functional compatibility rather than a complex performance study with a test set, ground truth, or expert review.
Therefore, the requested information elements related to diagnostic performance (e.g., sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable and not present in the provided text.
Here's a breakdown of what is available and why other sections are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated as Numerical Criteria | Functional Compatibility: The proposed Single-Site™ Flexible Bladeless Obturator is inserted and removed from the Curved Cannula without any evidence of material degradation. (K. Performance Data) |
| Overall Conclusion/Outcome | The test results demonstrate the proposed Single-Site™ Flexible Bladeless Obturator is compatible with the ISI Curved Cannula. The changes made to the proposed Single-Site™ Flexible Bladeless Obturator do not introduce any new issues of safety and effectiveness. (L. Conclusion) |
Explanation: The document does not provide specific numerical acceptance criteria (e.g., >90% success rate,
§ 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.