(428 days)
The CORE-Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.
The CORE-Trocar has a port to insert endoscopic instruments during endoscopic procedures. It consist of a cannula and a obturator. The Trocar is available in nine (9) models(IC-TC02, IC-TC02S, IC-TC03, IC-TC03S, IC-TC05S, IC-TC05S, IC-TC08, IC-TC10, IC-TC12) and the models are divided into six (6) types according to the kinds of diameter Type : 2mm Type(IC-TC02, IC-TC02S), 3mm Type(IC-TC03, IC-TC03S), 5mm Type(IC-TC05, IC-TC05S), 8mm Type(IC-TC08), 10mm Type(IC-TC10) and 12mm Type(IC-TC12). The cannula assembly have seals(main, secondary), a valve and a stopcock. The obturator has non-bladed tip. Sterilization is done with EO gas and Sterilization Assurance Level(SAL) 10-6. The seals prevent loss of CO2 pneumoperitoneum pressure when instruments are inserted or withdrawn.
The provided text is a 510(k) summary for the CORE-Trocar device and describes acceptance criteria and performance data from various tests. However, it does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop performance evaluation or a standalone AI algorithm performance study. It focuses on the mechanical, biological, and physical/chemical properties of the trocar itself.
Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as they pertain to the performance evaluation of AI/ML-based medical devices, which the CORE-Trocar is not.
Here's the information that can be extracted from the provided text:
Acceptance Criteria and Reported Device Performance
The device underwent various non-clinical performance bench tests and comparative tests against a predicate device.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Test | ||
| Sterility | 10⁻⁶ SAL (Sterility Assurance Level); No evidence of microbial growth. | Passed. No evidence of microbial growth found. |
| Biocompatibility (various tests) | Compliance with ISO 10993-1:2018 (Cytotoxicity, Maximization Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen). | Passed all tests. Device is considered tissue contacting for |
§ 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.