(43 days)
The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride coated with parylene. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.
The provided document is a 510(k) premarket notification letter and a 510(k) summary for the NDO Surgical Endoscopic Plication System. It discusses the device's substantial equivalence to a predicate device and mentions performance data were submitted, but it does not provide specific acceptance criteria or an explicit study description with detailed results that prove the device meets these criteria.
Therefore, I cannot populate the table and answer the questions as requested, because this information is not present in the provided text. The document states that "Bench top, In-Vivo simulated use and ex-vivo performance testing were completed in support of the substantial equivalence determination," but it does not detail these tests, their acceptance criteria, or their results.
Key Missing Information:
- Specific acceptance criteria for the device's performance.
- Detailed results from any studies (bench top, in-vivo, or ex-vivo).
- Sample sizes for test sets or training sets.
- Data provenance.
- Information about expert involvement for ground truth, adjudication, or MRMC studies.
- Details on standalone performance or ground truth type.
Without this information, I cannot fulfill your request for a table of acceptance criteria, reported performance, and the details of a study proving compliance.
§ 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.