(386 days)
The Port-site Protector may be utilized in conjunction with devices intended for general laparoscopic cannula/trocar procedures.
The device contains an elastomeric mechanism, which tethers the device to the inside of the abdominal wall. This mechanism affords the device a known insertion depth as well as a conductive path to the abdominal wall.
This is an FDA premarket notification (510(k)) for a medical device called the "Port Site Protector". This document is a clearance letter, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical trial report or a performance validation study.
The FDA 510(k) pathway is primarily to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through extensive clinical trials.
Therefore, I cannot provide the requested information based solely on the provided input. The input is a clearance letter, not a scientific study or a detailed technical documentation with performance metrics.
To answer your questions accurately, I would need access to the actual 510(k) submission document (which is usually much more extensive than this clearance letter) or publicly available summaries of its contents, if they exist and include performance data.
Based on the provided clearance letter (K992182) for the "Port Site Protector", I can state the following, but cannot fill in the details regarding acceptance criteria and study particulars because they are not present in this document:
- Device Name: Port Site Protector
- Regulatory Class: II
- Product Code: GCJ
- Regulatory Pathway: 510(k) Premarket Notification
- FDA Determination: Substantially Equivalent to predicate devices. This means the FDA agreed that the device is as safe and effective as a legally marketed device that existed before May 28, 1976, or has been reclassified.
I cannot create the requested table or answer the specific questions about sample size, ground truth, expert qualifications, etc., because those details are not in the provided clearance letter. These are generally found in the actual 510(k) submission, which would have included performance data or rationale for substantial equivalence.
In summary, the provided document does not contain the information requested to describe the acceptance criteria and the study that proves the device meets them. The letter confirms the FDA's decision but does not detail the evidence presented in the submission.
§ 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.