(62 days)
The Pilling Weck Secondary Flexible Sleeve with Cap and Trocar are manual surgical instruments used to support a cut down ( has approach) on secondary puncture placement.
The Trocar is used in Endoscopic Surgery (Gmecologic, general and other laparoscopic procedures and thoracic) for incision and peritoneal access for positioning of the hollow flexible sleeve.
Once the Trocar is removed, the port of entry provided by the sleeve through the cap, is used with manual instruments, laproscopes, and probes.
The device consists of Trocar and Sleeves, with integral and separately available Single Use Disposable Caps. The Sterile Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Optional Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.
The Trocar, sizes 3mm .- 15mm .. is constructed with a polymer hub and shaft with stainless steel tip and is available in pyramidal style.
The Sleeve, proportionally sized, is made of polymer and comes with or accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
This 510(k) summary (K971334) for the Pilling Weck Secondary Flexible Sleeve and Trocar does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria.
510(k) summaries for Class II devices primarily focus on establishing substantial equivalence to legally marketed predicate devices, rather than presenting de novo clinical study results against specific performance acceptance criteria.
The provided document describes:
- The device and its intended use.
- The predicate devices to which it claims substantial equivalence.
- General technological characteristics of the device and how they compare to predicates.
- The FDA's determination of substantial equivalence.
Therefore, I cannot extract the following requested information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or provide performance data.
- Sample size used for the test set and the data provenance: No test set or study data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method for the test set: No test set or adjudication is mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a physical medical device (trocar and sleeve), not an AI/software device, so an MRMC study is not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical device, so "standalone algorithm performance" is not applicable.
- The type of ground truth used: No ground truth is mentioned.
- The sample size for the training set: No training set is mentioned as this is a physical device.
- How the ground truth for the training set was established: No training set or ground truth is mentioned.
In summary, the provided 510(k) document is a regulatory submission focused on substantial equivalence, not a clinical study report detailing performance against pre-defined acceptance criteria.
§ 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.