(55 days)
The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of I he Onlinoomiss indoscopic Donector atheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals.
The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications:
Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy
The OmniSonics Endoscopic Deflector assists in the delivery of small diameter flexible; instruments, catheters, probes, and endoscopes. The device deflects these instruments to aid in the direction and delivery of the product to a specific surgical site that is not in line with the axis of the instrument. The purpose of the OmniSonics Endoscopic Deflector is to provide a means to deliver small diameter instruments to areas that would be difficult to access with a straight instrument.
The OmniSonics Endoscopic Deflector works in a similar fashion to steerable endoscopes. This instrument is different in that it only contains lumens for the introduction of ancillary instrumentation and does not possess an integral visualization system. The user must insert all of the additional capabilities desired through the OmniSonics Endoscopic Deflector central lumen.
Products that are capable of working with the OmniSonics Endoscopic Deflector are flexible, malleable or bendable and must be capable of obtaining a bend radius of 30 mm or less. They must also have an outer diameter compatible with the inner diameter of the unit selected. The actual deflection produced at the end of the device will depend upon the stiffiess of the inserted instrument.
The OmniSonics Deflector is constructed with the following major components:
Outer sheath tube: A rigid, stainless steel tube that provides rigidity for insertion into the body
Deflection tube: A flexible, polyurethane, kink resistant tube that bends when the deflection handle is activated.
Deflection wire: A stainless steel wire that pulls the tip of the deflection tube to cause deflection.
Deflection handle: An ABS handle that has mechanisms for rotation of the shaft, articulation of the deflection tube, movement of the inserted device in and out and sealing of the inserted device.
The provided text does not contain information about acceptance criteria or a study that proves the specified device (OmniSonics Endoscopic Deflector) meets them.
The document is a 510(k) premarket notification summary from the FDA, detailing the device's substantial equivalence to other legally marketed devices. It focuses on the device's intended use, description, and comparison to predicate devices, but lacks details on performance testing or clinical study results as they relate to acceptance criteria.
Specifically, the document states: "Performance Testing The OmniSonics Deflector conforms to IEC 60601-18 All materials used are biocompatable". This is a very high-level statement and does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, or type of ground truth for any test set.
- Sample size or ground truth establishment for a training set.
The document's purpose is to establish substantial equivalence for market clearance, not necessarily to provide detailed performance study results against specific acceptance criteria.
§ 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.