(120 days)
The intended use of the New Device is to establish a path of entry for minimally invasive instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.
The ENDOPATH® Dilating Tip Trocar has application in general, thoracic, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.
The ENDOPATH® Dilating Tip Trocar has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.
The ENDOPATH® Dilating Tip Trocar consists of two main sub-assemblies: an obturator sub-assembly and a sleeve sub-assembly.
The obturator consists of a sharp flat blade tip or pyramidal tip and a spring loaded shield. The shield is designed to cover the flat blade or pyramidal tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered.
The sleeve subassembly has an inner gasket seal or flapper door seal and an outer gasket seal to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the cannula during a surgical procedure. Some instruments are provided with a stopcock for insufflating the operative space and a flapper door lever to allow quick desufflation. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue.
The ENDOPATH® Dilating Tip Trocar shall be provided in a variety of sizes from 3mm to 12mm in diameter and 65mm to 150mm in length.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ENDOPATH® Dilating Tip Trocar:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mating of obturator with sleeve | Acceptable performance |
| Insertion into operative cavity | Acceptable performance |
| Removal of obturator from sleeve | Acceptable performance |
| Security of sleeve in tissue | Acceptable performance |
| Maintenance of pneumoperitoneum of the operative space | Acceptable performance |
Note: The document explicitly states "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device..." The acceptance criteria are not quantified with specific thresholds (e.g., "no more than X force required for insertion," "no leaks exceeding Y ml/min"). Instead, the performance is reported as "acceptable" in comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: The studies were "Pre-clinical laboratory evaluations." This suggests the tests were conducted in a laboratory setting, likely in the US (given the submission to the FDA in Cincinnati, Ohio). It is a prospective study as newly manufactured devices were tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. The "ground truth" for this type of device (a surgical trocar) would be based on engineering specifications and functional testing, not expert consensus on medical images or clinical outcomes in the same way an AI diagnostic tool would.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. As noted above, the testing is functional and engineering-based, not reliant on human interpretation or adjudication in the medical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation tools, not for a physical surgical device like a trocar.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical surgical instrument, not a software algorithm.
7. The Type of Ground Truth Used:
- The ground truth (or more appropriately, the standard) for evaluation was likely established through engineering specifications for the device's functional components and comparative performance against a predicate device. The studies "demonstrated acceptable performance to the Predicate Device." This implies the predicate device's established performance served as the benchmark.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI-based device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, there is no "training set."
§ 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.