(24 days)
The Cannulas and accessories are to be used with a Dexide seal package and spike for creating a point of entry for laparoscopic instruments into the abdominal cavity and maintaining pneumoperitoneum.
MultAport Cannulas:
The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity.
AccuPort 5-12mm Seal:
The AccuPort Seal is a single-used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm.
Orbital Reducer Seal:
The Orbital Reducer is a single used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments of equal and smaller size.
Blunt Spike:
The reusable Blunt Trocar spike is used with the MultAport Cannulas and AccuPort or Orbital Reducer Seal for creating a point of entry for laparoscopic instruments into the abdominal cavity.
Sealing Cone:
The Sealing Cone is a reusable product designed for use during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum.
Shaft Seal (replacement part for Sealing Cone):
The Sealing Cone is a reusable product designed for used during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum. The shaft seal is designed for use when sealing the cone to the cannula.
The "candidate device" is a reusable, stainless steel Cannula anc disposable, single-use reduction seal system that threads into the Cannula. The reducer system is composed of silicon rubber, thermoplastic rubber, and plastics. The reusable Sealing Cone and its Seal accommodate the cannula to assist the surgical procedure.
This document is a 510(k) summary for the MultAport™ Cannula, Reducer and Accessories. It focuses on the substantial equivalence of this device to a previously cleared predicate device (K981941) rather than presenting a de novo study with detailed acceptance criteria and performance data in the typical sense for an AI/ML medical device.
Therefore, the requested information points (1-9) regarding acceptance criteria and a study proving performance as one might expect for a novel AI/ML diagnostic or prognostic device are not present in this document.
This 510(k) submission establishes equivalence based on:
- Identical Intended Use and Operating Principle: Both the candidate and predicate device are used for creating an entry point for laparoscopic instruments and maintaining pneumoperitoneum.
- Similar Basic Design Principles and Materials: The devices share fundamental design and material compositions.
- Same Shelf Life, Similar Packaging, and Identical Sterilization Instructions: These aspects are also comparable.
Because this is a 510(k) for a physical medical device (cannula, reducer, accessories) claiming substantial equivalence to an existing device, it does not involve AI/ML components, clinical studies for diagnostic accuracy, or performance metrics like sensitivity, specificity, AUC, or the need for ground truth establishment.
In summary, none of the requested information points (1-9) can be extracted from the provided text because the document is a 510(k) for a conventional medical device seeking clearance through substantial equivalence, not a performance study of a novel device (especially not an AI/ML device).
§ 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.