(57 days)
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-use device 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.
The "candidate device" is a reusable, stainless steel Cannula and disposable, single-use reduction seal system that threads into the Cannula. The reducer system is composed of silicon rubber, thermoplastic rubber, and plastics. Accessories: Cannulas & Reduction Systems
The provided text is a 510(k) summary for a medical device (Cannula, Reducer and Accessories) and does not contain the information requested to describe acceptance criteria or a study proving the device meets acceptance criteria.
Specifically, the document focuses on:
- Identifying the submitter, contact person, and date prepared.
- Naming the device and its common name.
- Listing predicate devices.
- Describing the device and its accessories.
- Stating its intended use.
- Claiming substantial equivalence to predicate devices based on comparable technological characteristics (materials and mode of action).
- Mentioning conformance to voluntary standards but noting no mandatory existing performance standards.
- Presenting the FDA's clearance letter for marketing the device.
- Detailing the Indications For Use for the MultAport Cannulas, AccuPort Seal, and Orbital Reducer Seal.
There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This is typical for predicate device submissions from this era (1998), which often relied on comparative analysis to existing devices rather than extensive clinical studies with specified performance metrics in the 510(k) summary itself. The clearance is based on "substantial equivalence" to legally marketed predicate devices, implying that if the predicate devices were safe and effective, and the new device is sufficiently similar, it also meets those standards.
§ 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.