(32 days)
The Dyonics® line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic surgical procedures and in endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Dyonics 4mm diameter Arthroscopes/ENT Endoscopes are indicated for use in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
Dyonics Laparoscopes are indicated for use in laparoscopic surgical procedures to provide illumination and visualization of the surgical site.
The 5mm x 300mm Dyonics Laparoscope is also indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.
Dyonics Hysterosocpes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The abrasive cleaning agent is provided as an accessory to the Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes and is intended to be used, when required, to clean the outer surfaces thus maintaining optical integrity and allowing the scopes to perform as per their intended uses.
The Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes are used during various minimally invasive endoscopic procedures to illuminate and visualize the surgical site. The submission describes modified cleaning instructions for these devices and an abrasive cleaning agent accessory.
The provided text describes a 510(k) premarket notification for a modification to cleaning instructions for Smith & Nephew Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes, and Hysteroscopes. This submission is not a study that evaluates the performance of a device against specific acceptance criteria using a test set with ground truth established by experts.
Instead, it's a regulatory submission affirming that updated cleaning instructions for existing devices do not impact their designed safety and efficacy. The submission states: "The modified cleaning instructions defined in this premarket notification submission have no impact on the designed safety and efficacy of the Dvonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes. This conclusion is supported by the following testing: biocompatibility and residual chemical analyses."
Therefore, I cannot extract the requested information in the format provided because the document does not contain a study that meets the criteria of evaluating a device's diagnostic or performance accuracy with a test set, ground truth, or expert review. The "testing" mentioned (biocompatibility and residual chemical analyses) is related to the safety of the cleaning process, not the clinical performance or diagnostic accuracy of the endoscopes themselves.
§ 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.