(151 days)
MiniLap instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp. hold, and manipulate other soft internal tissues, as well as items such as hernia mesh, during pediatric and adult surgery.
The MiniPolar Instruments are used to cut and cauterize soft tissue during pediatric and adult surgery.
The MiniLap System with MiniGrip Handles grasping instruments have applications in a variety of general, thoracic, gynecologic, urologic, laparoscopic procedures for manipulation of tissue, as well as items such as hernia mesh, during pediatric and adult surgery.
Bipolar Grasper instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic, and endoscopic procedures for manipulation and coagulation of tissue and for manipulation of items such as hernia mesh during pediatric and adult surgery.
The Teleflex MiniLap® Percutaneous Surgical System is a family of minimally invasive surgical devices that provide a surgeon with the means to penetrate soft tissue to access certain areas of the human anatomy, then grasp, hold and manipulate other soft internal tissue within the body that are related to the surgical procedure.
The MiniLap Percutaneous Surgical System has two families presented in this 510(k). The first is the MiniLap ThumbGrip Instruments, which have a thumb grip handle to control the instrument tips. These instruments are available in electrosurgical and non-electrosurgical configurations. The second product family discussed in this 510(k) is the MiniLap MiniGrip Graspers, which have a pistol grip handle that allows single handed device operation to control the jaws.
ThumbGrip Instruments and MiniGrip Graspers are disposable manual instruments designed for direct introduction to the surgical site without the need for a traditional insertion conduit. These instruments are used for grasping, holding and manipulating soft internal tissues. These percutaneous instruments provide the benefit of reduced trauma due to no surgical incision closure and the elimination of one or more trocars.
This document is a 510(k) Premarket Notification from the FDA regarding the Teleflex MiniLap System. It does not describe an AI/ML medical device, but rather a set of minimally invasive surgical instruments. Therefore, the requested information about acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment methods for an AI device cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence of the Teleflex MiniLap System to previously cleared predicate devices based on technological characteristics, materials, and performance data from engineering tests, rather than clinical study results involving AI performance metrics.
Here's a breakdown of why this document doesn't contain the requested information for an AI/ML device:
- Device Type: The Teleflex MiniLap System consists of mechanical and electrosurgical instruments (graspers, probes) for surgical procedures. It is not an AI/ML diagnostic or prognostic tool.
- Performance Data Section: The "K. Performance Data" section refers to "Ship testing" (packaging integrity), "design verification and validation" (engineering tests), and testing to IEC standards for electrosurgical devices. It does not mention any clinical studies involving image analysis, AI algorithms, or human reader performance.
- Substantial Equivalence: The entire submission hinges on demonstrating that the new devices are "substantially equivalent" to existing, legally marketed predicate devices. This regulatory pathway (510(k)) often relies on non-clinical data and comparison to predicates, rather than extensive clinical efficacy trials typically required for novel AI technologies.
In summary, as this document pertains to traditional surgical instruments and not an AI/ML medical device, the specific details requested about AI/ML performance acceptance criteria and study methodologies are not present.
§ 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.