(77 days)
The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.
The End Irrigating Endoilluminator comprises of five basic components. The handpiece tube. The fiberoptic handle. The fiber optic cable sheath and the cable connector.
The provided text is a 510(k) premarket notification for the Syntec, Inc., True Light End Irrigating Endoilluminator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics in the way a novel AI algorithm might.
Therefore, the requested information elements (1-9) which are typically associated with testing and validation of AI/ML-based devices or novel devices with performance claims, are not applicable in this context.
Here's why and what information is available in the document:
- Type of Submission: This is a 510(k) for a medical device (an ophthalmic endoilluminator) that is seeking to demonstrate substantial equivalence to a legally marketed predicate device (Grieshaber Disposable End Irrigating Light Pipe).
- Focus of 510(k): The core of a 510(k) is to show that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device. It does not typically involve proving new performance thresholds or conducting extensive clinical trials with acceptance criteria in the manner requested for AI or highly novel devices.
- "Acceptance Criteria" in this context: For this device, "acceptance" is primarily based on demonstrating substantial equivalence, meaning the device performs similarly to or no worse than the predicate device. The "criteria" are therefore the similarities in intended use, design, materials, and lack of new safety/effectiveness questions.
Information applicable from the document (but not directly answering the AI-centric questions):
- Device Name: Syntec, Inc., True Light End Irrigating Endoilluminator
- Predicate Device: Grieshaber Disposable End Irrigating Light Pipe (K884043)
- Intended Use (for both new and predicate device): To illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.
- Similarities noted: Same clinical purpose, similar design, same materials (except for a zinc connector on the Syntec design), materials meet US Pharmacopoeia Class VI criteria and are widely used, device is biocompatible, sterilized using ethylene oxide (validated by overkill method), and the light output intensity and spot size are the same as the predicate device.
- Differences noted: "The only device differences are cosmetic." (This strongly supports substantial equivalence).
In summary, none of the specific questions regarding acceptance criteria tables, sample sizes, ground truth, expert adjudication, or MRMC studies are addressed or relevant to this 510(k) submission document. The document aims to demonstrate equivalence, not to establish new performance criteria through a study.
§ 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.