(75 days)
The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The Fengh Medical Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. A Disposable Endoscopic Trocar is mainly composed of Obturator Handle, Outer Seal Release Lever. Trocar Stability Sleeve, Obturator Locking Button, Trocar Stability Sleeve, etc. Materials being used include Stainless 12Cr18Ni9, Stainless 06Cr19Ni10, ABS plastic, PC. All the components of Disposable Endoscopic Trocar are evaluated by cytotoxicity test, sensitization test, intracutaneous mucosa stimulation test, Systemic toxicity(acute) test and Pyrogenicity test. Therefore, it will not cause bad stimulations, allergic reactions or other harm to human tissue or mucosa. Furthermore, no toxic substances will be separated out during the use of Disposable Endoscopic Trocar. Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.
The provided text describes the acceptance criteria and the results of a study for the Fengh Medical Disposable Endoscopic Trocar.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several "Testing" categories and provides specific criteria along with implied performance (meeting those criteria). However, the "Table 2" under "Substantial Equivalence" merges proposed device characteristics with general requirements. I've extracted the acceptance criteria from the "Testing" section and the detailed comparison table, and for performance, the document generally states that the device is "substantially equivalent" because "testing standards are identical" and "the differences between both devices are insignificant in terms of safety and effectiveness," implying the device met these criteria.
| Acceptance Criteria / Test Name | Criterion | Reported Device Performance (Implied) |
|---|---|---|
| Non-Clinical Testing | ||
| Sterility Test | (Implied: Device must be sterile) | Met (Included in tests) |
| Peel Strength | (Implied: Must meet strength requirements) | Met (Included in tests) |
| Flexibility | (Implied: Must meet flexibility requirements) | Met (Included in tests) |
| Fitness | (Implied: Components fit correctly) | Met (Included in tests) |
| Leakage | (Implied: No leakage or minimal leakage as specified) | Met (Included in tests, further detailed below) |
| Roughness | Obturator roughness Ra must not be bigger than 0.4μm. | Met (Included in tests) |
| Dimension | (Implied: Dimensions must be within specified tolerances) | Met (Included in tests) |
| Appearance | (Implied: Must meet visual inspection standards) | Met (Included in tests) |
| Insertion & Cannula Stability | When the obturator pulled out Trocar sleeve, the friction should not exceed 5N. | Met (Included in tests) |
| Trocar sleeve retention force | Apply a pressure of 5N ± 1N on both sides of the thread area, the pull-out force of the sleeve should not less than 10N. | Met (Included in tests) |
| Endoscope Visualization Quality | Accommodate an appropriately sided 0° endoscope. | Met (Included in tests) |
| Obturator & Cannula Compatibility | Sleeve and Obturator should fit well without any interference. Max clearance between sleeve and Obturator: D≤0.3mm. The tip of Obturator should be fully out of sleeve when fit. | Met (Included in tests) |
| Air Leakage as a whole device | There should be no leakage under 4kPa pressure between stopcock and sealing cap. | Met (Included in tests) |
| Air Leakage with obturator withdrawn | Choke valve should have good gas blocking performance. Bubbles should be less than 20 under 4KPa pressure. | Met (Included in tests) |
| Biocompatibility Testing | ||
| In Vitro Cytotoxicity Test | (Implied: Must not show cytotoxicity) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
| Skin Sensitization Test | (Implied: Must not cause skin sensitization) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
| Intracutaneous reactivity Test | (Implied: Must not cause intracutaneous reactivity) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
| Acute Systemic Toxicity | (Implied: Must not cause acute systemic toxicity) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
| Pyrogen Test | (Implied: Must be non-pyrogenic) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., Sterility Test, Peel Strength, Biocompatibility tests). It only lists "Testing" categories and the methods.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The document describes non-clinical and biocompatibility tests, which typically rely on standardized laboratory protocols and measurements rather than expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the tests (non-clinical, biocompatibility), adjudication methods common in diagnostic device studies (like 2+1 or 3+1) are not typically applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or reported in this document. The document focuses on performance testing of the device itself against established criteria and comparison to a predicate device based on technological characteristics and intended use.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This question is not applicable as the device is a physical medical instrument (trocar) and not an algorithm or AI-based diagnostic tool.
7. Type of Ground Truth Used:
For the non-clinical and biocompatibility tests, the "ground truth" would be objective measurements and adherence to pre-defined physical, chemical, and biological standards (e.g., specific force measurements, absence of microbial growth, absence of toxic reactions). These are not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
8. Sample Size for the Training Set:
This question is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
§ 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.