(102 days)
This device is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or minimally invasive procedures to establish a path of entry for minimally invasive instruments.
The NexPort™ Trocar System is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed devices are available to accommodate 5mm and 10mm surgical instruments.
The 5mm NexPort™ Trocar System is consisted of:
- Obturator Shaft a)
- Cannula Cap b)
- Seal c)
- Duckbill Valve d)
- e) Cannula Body
- f) Luerlock Cap
- g) Obturator Tip Protector
- Cannula Tip Protector h)
The 10mm NexPort™ Trocar System is consisted of:
- a) Obturator Shaft
- Cannula Cap b)
- Seal c)
- Cannula Intermediate Plate d)
- Duckbill Valve e)
- f) Cannula Housing
- Stopcock g)
- Face Seal h)
- i) Cannula Sleeve
- Reducer j)
- Adaptor Cap k)
- I) Adaptor Top Body
- m) Adaptor Seal
- n) Adaptor Bottom Body
This is a 510(k) premarket notification for a medical device called the "NexPort™ Trocar System". This document does not describe a study that uses AI or machine learning. Therefore, most of the requested information regarding acceptance criteria and study design for AI/ML performance evaluation is not available in this document.
However, I can provide the available information related to the device's validation and comparison to predicate devices, as well as the non-clinical tests performed.
Current Device: NexPort™ Trocar System
Summary of Device Validation and Performance (based on provided text):
The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a standalone performance study with specific acceptance criteria that would typically be seen for an AI/ML device. The validation involves non-clinical tests and comparison to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML algorithm with metrics like sensitivity, specificity, or AUC. Instead, it details that the device has undergone various non-clinical tests and has been found to conform to applicable medical device safety standards.
The relevant "performance" is implicitly demonstrated through:
- Identical Intended Use/Indications for Use as predicate devices.
- Identical Principles of Operation as predicate devices.
- Identical Application Sites as predicate devices.
- Identical Single Use nature and Operation Mode (Manually) as predicate devices.
- Identical Sterilization Assurance Level (SAL) ($
§ 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.