(78 days)
For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
The Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to minipulate tissue, irrigate and aspirate, and coagulate blood. It consists of the following: A connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic Fiber and fine insulated electrical wires run. A Delrin handpiece with a 20 GA stainless steel needle at the distal end. An insulated inner blunt needle running through the handprece and outer stainless needle, protruding beyond the tip approximately 2.5mm. Electrical connection for RF current is made via fine insulated wires from the inner and outer needles to the solderless connectors which attach to the coagulator. A 30" length of silicone tubing with a luer connector at the proximal end of the handpiece. The luer connector may be attached to a syringe for irrigation asperation The 2.5mm extension may be used for tissue manipulation.
This document is a 510(k) Premarket Notification for the Peregrine Fiber Optic Multi-Function Manipulator, indicating it's a submission for clearance to market a medical device, not a study reporting on the device's performance against acceptance criteria.
The provided text does not contain acceptance criteria or detailed information about a study proving the device meets specific performance metrics. It's a regulatory submission document for market clearance based on substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details. This information is typically found in design verification and validation reports, clinical study reports, or specific performance testing summaries, which are not present in this 510(k) summary.
The document primarily states:
- Device Description: Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to manipulate tissue, irrigate and aspirate, and coagulate blood.
- Indications for Use: For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
- Predicate Device: Grieshaber & Co. 3-Function Manipulator. The document presents a comparison of features between the two devices but no performance data.
- Sterilization: The device will be ETO sterilized using the AAMI Overkill Method for validation.
- Regulatory Status: The FDA found the device substantially equivalent to pre-amendment devices for its stated indications for use.
§ 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.