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510(k) Data Aggregation
(512 days)
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
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) |
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