(89 days)
Endo Assist positions a Laparescope, and is indicated for use laparoxopic, thoracoscopic and pelvic procedures. Laparoscopic: cholecystectory hernia repair Fundaplication Splenectomy appendectiony henicolectory synpathe ctony by oph node dissection hysterectory nysterectomy
EndoAssist is a microprocessor-driven robotic arm which holds a rigid laparoscope for the surgeon during laparoscopic surgical procedures. It stands separately from the operating table, and reaches up and over into the surgical field through a series of motorized mechanical linkages. These motors allow the microprocessor to change the configuration of the linkage.
The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria.
It is a 510(k) summary for the EndoAssist device, which is a robotic arm for manipulating a laparoscope during surgery. The document focuses on:
- Device identification: Proprietary name (EndoAssist), common name, classification name.
- Substantial equivalence claim: Comparison to predicate devices (AESOP and Endex Endoscopy Positioning System).
- Device description: How it works, its components, and its unique technological characteristics compared to predicates.
- Intended use: Mechanical laparoscope holder and manipulator for laparoscopic and thoracoscopic surgery.
- Safety issues: Design features to ensure operational, electrical, and mechanical safety.
- FDA correspondence: The FDA's letter confirming substantial equivalence and allowing the device to be marketed.
- Indications for Use: A list of specific laparoscopic, thoracoscopic, and pelvic procedures for which the device is indicated.
While safety features are mentioned, there is no mention of specific acceptance criteria (e.g., performance metrics, thresholds) or a study that evaluates and reports on these criteria. The determination of substantial equivalence is explicitly stated as "not based on an assessment of clinical performance data."
§ 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.