(87 days)
The UNISURGE Interface Controller - P is indicated for use in procedures (endo in which the UNIGRIP is used... The Interface Controller with pump is not designed to deliver any type of blood, blood products, or analgesics. It is designed for the administration of sterile irrigation fluid via sterile deposable tubing
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific acceptance criteria. The document is a clearance letter from the FDA regarding a 510(k) submission for the "Unisurge Interface P" device, stating that it is substantially equivalent to legally marketed predicate devices.
The text does include:
- Device Name: Unisurge Interface P (also referred to as UNISURGE Interface Controller - P)
- Indications For Use: "The UNISURGE Interface Controller - P is indicated for use in procedures (endo) in which the UNIGRIP is used..." and "The Interface Controller with pump is not designed to deliver any type of blood, blood products, or analgesics. It is designed for the administration of sterile irrigation fluid via sterile deposable tubing."
- Regulatory Class: II
- Product Code: GCJ
- 510(k) Number: K972178
However, it does not contain any details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any tests.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How training set ground truth was established.
This document is solely an FDA clearance letter confirming substantial equivalence, not a study report.
§ 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.