(512 days)
KONIX Anti-Fog solution is a sterile, disposable, functional, anti-fog solution. The antifog solution is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. KONIX Antifog Solution is used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.
Konix Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is released to the market as sterile and disposable with one polyurethane foam pad in a 6 ml polyethylene bottle. Secondary packaging is composed of PET film and Medical Kraft Sealing Paper.
Konix Anti-Fog Solution is intended to be used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.
The mechanism of defogging or anti-fogging action of Konix Anti-Fog Solution, works by physically changing the water droplets that form on the lens surface from round droplets, to a flat transparent sheet of water, a phenomenon known as 'wetting'.
The provided text describes the Konix Anti-Fog Solution, a device intended to prevent fogging of endoscope and laparoscope lenses. The document is a 510(k) premarket notification summary submitted to the FDA. While it highlights safety and effectiveness, it does not include acceptance criteria or a "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic AI/ML device.
Instead, the performance data presented focuses on biocompatibility, sterilization validation, shelf-life, and a general "fog resistance test." The "acceptance criteria" for these tests are implied by "Pass" results against established standards.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for certain categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria Category | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet requirements of ISO 10993 series (Cytotoxicity, Sensitization, Intracutaneous Reactivity) | All tests passed the requirements as indicated in the applicable standards. |
| Cytotoxicity Test | ISO 10993-5:2009 standards | Pass |
| Sensitization Test | ISO 10993-10:2010 standards | Pass |
| Intracutaneous Reactivity Test | ISO 10993-10:2010 standards | Pass |
| Sterilization Validation | Achieve Sterility Assurance Level (SAL) |
§ 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.