(87 days)
The ENDOPATH® Resposable Trocar System has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes.
The ENDOPATH® Resposable Trocar System consists of three main components: a Single Use obturator, a Single Use trocar sleeve housing and a reusable trocar sleeve. 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 reduce the likelihood of injury to internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The trocar sleeve housing has an inner and outer seal to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the cannula during a surgical procedure. Some trocar sleeve housings are provided with a stopcock for insufflating the operative space. Integral threads along the outside diameter of the cannula portion of the trocar sleeve provide a retention mechanism to stabilize the trocar sleeve in tissue. The reusable trocar sleeve, supplied smooth or threaded, is manufactured so that it may be cleaned, sterilized, and reused. The ENDOPATH® Resposable Trocar System shall be provided in a variety of sizes from 5mm to 12mm in diameter and 50mm to 150mm in length. In addition to the size variety they are supplied with or without stopcock for insufflation.
Here's a breakdown of the acceptance criteria and study information for the ENDOPATH® Resposable Trocar System, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text describes pre-clinical laboratory evaluations to demonstrate acceptable performance. However, it does not explicitly state specific quantitative acceptance criteria or detailed performance metrics. Instead, it indicates the device "demonstrated acceptable performance" in comparison to predicate devices across several functional aspects.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mating Obturator with Sleeve | Acceptable performance demonstrated. |
| Insertion into Operative Cavity | Acceptable performance demonstrated. |
| Shield Action to Cover Blade | Acceptable performance demonstrated. |
| Removal of Obturator from Sleeve | Acceptable performance demonstrated. |
| Security of Sleeve in Tissue | Acceptable performance demonstrated. |
| Maintenance of Pneumoperitoneum of Operative Space | Acceptable performance demonstrated. |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "Pre-clinical laboratory evaluations."
- Data Provenance: Not specified. It's likely these were in-house laboratory tests, not human or animal studies, given the nature of the device and the lack of ethical review board mentions. The country of origin for the data is implied to be the US since the submitting company (Ethicon Endo-Surgery, Inc.) is based in Cincinnati, Ohio, and the submission is to the FDA. The studies were retrospective in the sense that they were conducted for this 510(k) submission, but not "retrospective" in terms of analyzing pre-existing patient data.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The pre-clinical laboratory evaluations described likely involved engineering and technical testing against established performance benchmarks or predicate devices, rather than expert interpretation of a 'ground truth' as would be seen in diagnostic imaging.
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Adjudication Method for the Test Set:
- Not applicable. As described, this was a technical performance study, not one requiring expert adjudication of results.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document describes pre-clinical laboratory evaluations, not studies involving human readers or clinical cases.
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If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a surgical instrument, not an algorithm or AI system. Its performance evaluation is based on its physical and functional characteristics.
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The Type of Ground Truth Used:
- The "ground truth" for these pre-clinical evaluations would have been based on engineering specifications, established performance standards for similar predicate devices, and internal quality control benchmarks for mechanical and functional attributes.
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The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set mentioned or implied.
§ 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.