(132 days)
Alcon 27GA Chandelier
The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery.
Alcon 27+ DS Wide Angle Endoilluminator
The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
Alcon 27+ DS Endoilluminator
The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
As part of this premarket notification Alcon presents three new endoilluminators, compatible with the UNITY VCS device cleared in K233876 (clearance date: June 21, 2024).
Alcon 27GA Chandelier: The Alcon 27GA Chandelier provides a hands-free wide field of illumination for vitreoretinal procedures. The distal end of the device incorporates a short, tapered fiber optic to provide wide angle illumination projected from a pars plana position of the eye. The distal end consists of a tapered fiber, which is inserted into the eye through the Alcon 27GA entry system. The fiber is malleable so the physician can shape it to form a stable service loop, position the tip, and minimize interference with the lid speculum.
Alcon 27+ DS Wide Angle Endoilluminator: The Alcon 27+ DS WA Endoilluminator offers wide-angle illumination, featuring a sapphire lens at the distal end of the probe. This design ensures consistent, low-glare illumination across a broad field of view. Additionally, it incorporates a Dynamic Stiffener (DS) element-a retractable stiffener designed to minimize needle deflection at the proximal end of the stainless steel cannula. as opposed to the fixed stiffener used in previous models.
Alcon 27+ DS Endoilluminator: The Alcon 27+ DS Endoilluminator transmits light energy into the eye and incorporates a DS element at the proximal end of the stainless-steel cannula.
This FDA 510(k) summary does not contain the specific acceptance criteria or performance data in a format that directly matches the requested table. This document is a "Substantial Equivalence" submission, which focuses on demonstrating that new devices (Alcon 27GA Chandelier, Alcon 27+ DS Wide Angle Endoilluminator, Alcon 27+ DS Endoilluminator) are as safe and effective as previously cleared predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel device.
The document primarily relies on non-clinical testing to demonstrate substantial equivalence. Here's a breakdown of the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with corresponding performance results in a quantitative manner for specific clinical metrics. Instead, it states that the devices "met ISO 10993" for biocompatibility, "passed the predetermined acceptance criteria" for sterilization and shelf life, and that "safety tests demonstrated the compliance of the subject devices to the appropriate standards" for performance testing. For light hazard testing, it states the devices "meet aphakic and thermal safety standards comparable to the predicate devices."
The comparisons in Tables 1-3 highlight similarities in technological characteristics between the subject devices and their predicates, rather than presenting numeric acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Non-Clinical Testing: The document refers to "tested devices" for sterilization, "tested units" for packaging integrity, and "three subject devices" for light hazard testing. However, specific sample sizes (e.g., number of units tested for biocompatibility, number of sterilization cycles validated) are not provided.
- Data Provenance: All testing described is non-clinical. There is no mention of human subject data, therefore no information on country of origin or retrospective/prospective nature.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as this submission concerns non-clinical testing of medical devices (endoilluminators and a chandelier) for surgical use, not AI/diagnostic devices requiring expert adjudication for ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as this submission concerns non-clinical testing of medical devices (endoilluminators and a chandelier), not AI/diagnostic devices requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This submission is for physical medical devices, not AI software where such studies are typically performed.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Not applicable. This is not an AI device. The "performance testing" referenced is for the physical attributes and safety of the endoilluminators (e.g., light transmission, mechanical integrity, biocompatibility), which are inherently "standalone" in their assessment as device components.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by:
- Biocompatibility: ISO 10993 standards.
- Sterilization: ISO 11135 and ISO 10993-7 standards; achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
- Shelf Life/Packaging: ASTM D4169, ASTM F1980, and ISO 11607-1 standards.
- Performance (General): ISO 14971, ISO 15004-1, ISO 15752, and ANSI Z80.36 standards.
- Light Hazard: ANSI Z80.36 and ISO 15752 standards, and comparability to predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device; therefore, there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set.
Summary of Device Acceptance:
The acceptance of these devices is based on demonstrating substantial equivalence to existing predicate devices (cleared under K875005 and K110951) through a battery of non-clinical tests. The tests confirm they meet established safety and performance standards (ISO, ASTM, ANSI) and have comparable technological characteristics and risk profiles to their predicates, making them safe and effective for their intended use in posterior segment ophthalmic surgery.
§ 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.