(244 days)
The ASC TriPort 15 Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
The ASC TriPort 15 Laparoscopic Access Device is a faparoscopic multi-instrument port which performs the following two functions:
- Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery.
- Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical . procedure, whether or not one or more laparoscopic instruments are passing through the device.
The ASC TriPort 15 Laparoscopic Access Device is comprised of the following three components:
- An introducer component, which delivers the Distal Ring through a pre-made incision, . into the abdominal cavity.
- A refractor component, which retracts an abdominal incision to allow the passage of . laparoscopic instruments.
- A valve component which maintains the pneumoperitoneum established for the surgical . procedure.
The minor design changes to the cleared TriPort+ (K110004) device to create the TriPort 15 are as follows:
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- Changing the valve configuration from a four valve (3 x 5mm & 1 x 10mm) to a three valve (2 x 5mm & 1 x 15mm) configuration.
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- The introduction of a new colorant for the 15mm Valve Cap. Note that this portion of the device does not contact the patient.
The changes made to the parent TriPort+ Laparoscopic Access Devices to produce the TriPort 15 are minor and do not represent changes to its intended use, or the operating principles or mechanism of action of the device.
The ASC TriPort 15 Laparoscopic Access Device is sterile and disposable.
The provided text is a 510(k) summary for the ASC TriPort 15 Laparoscopic Access Device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert reviews in terms of clinical performance metrics like sensitivity, specificity, or reader improvement.
Therefore, the requested information, which is typical for a study validating the diagnostic accuracy or clinical effectiveness of a device, is not present in the provided text.
Specifically, the document states:
"Sterilization and shelf life testing, biocompatibility testing, design validation testing, and animal testing of the TriPort 15 was conducted to verify that the changes to the technological characteristics do not affect safety or effectiveness. In all instances, the TriPort 15 functioned as intended."
And:
"Performance data demonstrate that the TriPort 15 is as safe and effective as the predicate device."
This indicates that the "acceptance criteria" were related to verifying safety and effectiveness through non-clinical performance testing (sterilization, shelf life, biocompatibility, design validation, animal testing) to ensure the minor changes from the predicate device did not introduce new safety concerns or alter its intended function.
Since this is a submission for a laparoscopic access device (a surgical tool, not a diagnostic or AI-driven device), the nature of the "acceptance criteria" is fundamentally different from a diagnostic device that would involve human reader performance, ground truth establishment by experts, and statistical metrics like sensitivity and specificity.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format requested (which implies clinical performance metrics), nor details about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/diagnostic device.
The study described is an engineering validation and non-clinical performance study to demonstrate that the modified device (TriPort 15) is as safe and effective as its predicate (TriPort+), primarily through bench testing and animal studies, not through clinical trials involving human subjects or expert interpretations of images.
§ 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.