(55 days)
The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, as well as illumination, during surgery.
The iScience Surgical Ophthalmic Microcannula, or iTRACK, is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.
This document is for an Ophthalmic Microcannula, a physical surgical device, and not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as acceptance criteria, study details, ground truth, sample sizes for training/test sets, MRMC studies, etc.) are not applicable here.
The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through:
- Device Description: Outlining the design and function of the iScience Surgical Ophthalmic Microcannula (iTRACK).
- Indication for Use: Stating its purpose for fluid infusion and aspiration, and illumination during surgery.
- Predicate Devices: Identifying existing devices it claims substantial equivalence to (American Medical Devices Endolight, Syntec True Light, Micron Surgical Weiss Retinal Cannula).
- Technological Characteristics: Asserting that its intended use and technological features do not differ from predicate devices, using similar materials and methods of operation.
- Performance Data (Non-AI/ML): Mentioning conformance to standards for sterilization, shelf-life, and packaging integrity (e.g., ANSI/AAMI/ISO 11137-1994, ANSI/AAMI/ISO 10993, ANSI/AAMI/ISO 11607-1997). This "performance data" refers to compliance with manufacturing and safety standards, not AI model performance.
- Conclusion: Stating that due to meeting stated standards and similar technological characteristics to predicate devices, it is substantially equivalent, safe, and effective.
Since the device is not an AI/ML product, it does not have "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way an AI/ML model would to demonstrate diagnostic accuracy or clinical effectiveness. Instead, acceptance is based on demonstrating substantial equivalence to existing, legally marketed devices, and adherence to relevant safety and manufacturing standards for medical devices.
§ 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.