← Product Code [OCT](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCT) · K190864 # Konix Anti-Fog Solution (K190864) _Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · OCT · Aug 27, 2020 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCT/K190864 ## Device Facts - **Applicant:** Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler - **Product Code:** [OCT](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCT.md) - **Decision Date:** Aug 27, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use 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. ## Device Story Konix Anti-Fog Solution is a sterile, single-use laparoscopic accessory; consists of a 6 ml polyethylene bottle containing anti-fog solution and a polyurethane foam pad. Used in hospital operating rooms by surgeons/clinicians. Principle of operation: physical wetting agent; transforms water droplets on lens surface into flat, transparent water sheets to maintain clear visualization. Applied by wiping the distal end of the lens with the solution-soaked sponge prior to and during procedures. Benefits include maintained clear operating field during endoscopic/laparoscopic surgery. ## Clinical Evidence Bench testing only. Biocompatibility testing per ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous Reactivity) passed. Sterilization validated per ISO 11137-2 (Gamma-radiation, SAL 10^-6). Shelf life (3 years) validated per ASTM F1980-16, including package integrity (ASTM F1929-15), seal strength (ASTM F88/F88M-15), and fog resistance performance testing. ## Technological Characteristics Materials: Polyurethane foam pad, polyethylene bottle, PET film/Medical Kraft paper packaging. Non-energy device. Sterilization: Gamma-radiation (10^-6 SAL). Standards: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 11137-2, ISO 11737-1/2, ASTM F1980-16, ASTM F1929-15, ASTM F88/F88M-15. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Dr Fog ([K932449](/device/K932449.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 27, 2020 Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler % Ronald J. Amen Director ST&T Research, Inc. 18101 Catherine Circle Villa Park, CA 92861 Re: K190864 > Trade/Device Name: Konix Anti-Fog Solution Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCT Dated: July 6, 2020 Received: July 28, 2020 Dear Ronald J. Amen: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. \$10(k) Number (if known) K190864 Device Name KONIX(R) Anti-Fog Solution #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| |
☒ Prescription Use (Part 21 CFR 801 Subpart D)
|
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### ST&T DEPARTMENTS: **PHARMACOLOGY/TOXICOLOGY RESEARCH** **INTERNATIONAL REGULATORY CONSULTATION** **PRODUCT DEVELOPMENT & CLINICAL RESEARCH** **PRE-POST MARKET CONSUMER PRODUCT RESEARCH** **FDA~FTC~EPA~CUSTOMS LABELING & CLAIMS COMPLIANCE** ☐ INFORMATION & CONSULTING: 800-869-4636 Image /page/3/Picture/2 description: The image shows the logo for S&T International, Inc. The logo features the letters 'S' and 'T' in a stylized, interconnected design, with a red bar above the 'S' and 'T'. Below the letters, the words 'INTERNATIONAL, INC.' are written in a smaller, sans-serif font. # 510(k) Summary Date prepared: August 26, 2020 I. SUBMITTER Official Contact Person: Ronald J Amen ST&T International Inc. On Behalf of: Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasal Ürünler San. Ve Tic. A.S Yakuplu Mah. Birlik Cad. No:32/1 Beylikduzu-Istanbul 34524 Turkey Phone: 90-212-428 6848 FAX: 90-212-4286853 Contacts: Nurhan Irmak # II. DEVICE INFORMATION Name of Device: Konix Anti-Fog Solution Common or Usual Name: Endoscope Anti-fogging Device 510(k) Number K190864 Regulation Name and Number: Endoscope and accessories (21 CFR 876.1500) Regulatory Class: II Classification Panel: Gastroenterology/Urology Product Code: OCT III. PREDICATE DEVICE Trade/Device Name: Dr Fog Common or Usual Name Endoscope Anti-fogging Device 510(k) Number K932449 Regulation Name and Number: Endoscope and accessories (21 CFR 876.1500) Product Code: OCT Submitter: O.R Concepts, INC. Submitter address: 200 N. Oak St. Roanoke, TX 76262 {4}------------------------------------------------ K190864 # IV. DEVICE DESCRIPTION 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'. # V. INDICATIONS FOR USE 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. # VI. COMPARISON OF TECHNICAL CHARACTERISTICS WITH PREDICATE DEVICE Konix Anti-Fog Solution is designed to prevent the lenses of the imaging, that is the same as the predicate device. A comparison of the device features, technological characteristics, intended use, and other information demonstrates that Konix Anti-Fog Solution is substantially equivalent to the predicate device. The substantially equivalent comparison table was summarized in Table 5.1 | | Proposed Device | Predicate Device | | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Device Name | Konix Anti-Fog
Solution | Dr. Fog Anti-Fog
Solution | Comment | | Indication for Use | 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. | Dr. Fog Anti-Fog
Solution is designed to
clear fog from
endoscopic camera
lenses in order to
maintain a clear
operating field. | Same | | Reusable/Disposable | Disposable | Disposable | | | Target Patient
Population | The patient who treated
by endoscopic and
laparoscopic surgery | The patient who
treated by
laparoscopic surgery | Same | {5}------------------------------------------------ | Where Used | Hospital O.R. room | Hospital O.R. room | Same | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Contraindications | There are no known
contraindications to the
patient. | | | | Method of
Introduction | Wiping distal end of the
lens by sponge with
solution. | Wiping distal end of
the lens by
sponge
with solution. | Same | | Safety | The following
biocompatibility tests
were conducted.
- Cytotoxicity Test
- Sensitization Test
- Intracutaneous
Reactivity Test
All of the tests passed
the requirements as
indicated in the
applicable standards. | Not known | All of the
biocompatibility tests
that are indicated in
the FDA recognized
standards were
performed. | | Sterilization
Method | Gamma-radiation
Sterilization
(10-6 SAL) | Gamma-radiation
Sterilization
(10-6 SAL) | Same | | Energy Source | No energy source | No energy source | Same | Through the substantially equivalent comparison table, the differences do not raise any different issues on the safety or effectiveness of the product. # VII. PERFORMANCE DATA A series of the studies were performed to evaluate the safety and effectiveness of Konix Anti-Fog Solution. The following test results were provided to confirm the product is safe and effective as indicated. ### A. Biocompatibility Testing The biocompatibility test was evaluated per the FDA recognized consensus standard named "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016, the biocompatibility tests include the following items since the product is classified as the classification. | Nature of Body Contact | Contact Duration | | |------------------------|--------------------------------------------------------|------------------| | Category | Contact | | | Surface Device | Mucosal membrane
Breached or compromised
surface | Limited (≤ 24 h) | | No. | Test Name | Applicable Standards | Comment | |-----|--------------------|-------------------------------------------------------------------------------------------------------------------------|---------| | 1 | Cytotoxicity Test | ISO 10993-5:2009 Biological Evaluation Of
Medical Devices - Part 5: Tests For In Vitro
Cytotoxicity | Pass | | 2 | Sensitization Test | ISO 10993-10:2010 Biological Evaluation Of
Medical Devices - Part 10: Tests For Irritation
And Skin Sensitization | Pass | | 3 | Intracutaneous | ISO 10993-10:2010 Biological Evaluation Of | Pass | {6}------------------------------------------------ | | Reactivity Test | Medical Devices - Part 10: Tests For Irritation
And Skin Sensitization | | |--|-----------------|---------------------------------------------------------------------------|--| |--|-----------------|---------------------------------------------------------------------------|--| All of the test studies listed aboved that Konix Anti-Fog Solution did not raise any safety issues and is biocompatible. # B. Sterilization Validation and Shelf Life Study The product is designed to perform gamma-radiation sterilization prior to place into the market, therefore the following studies should be evaluated by the applicable standards/guidance. # a. Gamma-Radiation Sterilization Validation Study The gamma-radiation sterilization study was performed per the requirements of the FDA recognized consensus standards listed below. - ISO 11137-2:2013 Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose - ISO 11737-1:2018 Sterilization of Medical Devices - Microbiological Methods - Part 1:Determination of A Population of Microorganisms on Products - ISO 11737-2:2019 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in The Definition, Validation And Maintenance Of A Sterilization Process The method used for gamma-radiation validation study was ISO11137-2 Method 1 multiple production batches (7.2), since the product bioburden was less than 1 CFU/sample. The test reports showed that the product can become sterile when the routine sterilization parameter was controlled at the dose of no less than 13,9 kGy, which meets the regulatory requirement of sterile condition (SAL < 10-6). # b. Product Aging Validation Study (Shelf Life Study) The product aging validation study was performed for 3 years standards "ASTM f1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" to determine the shelf life of the product, since the product is supplied in the sterile status. The Aging Validation Study included the following test studies. Since the shelf life of the product is proposed to be stored for 3 years, the aging validation study is performed which included the following test items. | No. | Test Name | Applicable Standards | Comment | |-----|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | 1 | Package Integrity
Test
(Dye penetration
Test) | ASTM F1929-15 Standard Test Method For
Detecting Seal Leaks In Porous Medical
Packaging By Dye
Penetration | Pass | | 2 | Seal Peel Strength
Test | ASTM F88/F88M-15 Standard Test Method
For Seal Strength Of Flexible Barrier Materials | Pass | | 3 | Product Sterility
Test | ISO 11737-2:2019 Sterilization Of Medical
Devices -Microbiological Methods - Part 2:
Tests Of SterilityPerformed In The Definition,
Validation And Maintenance Of A
Sterilization Process | Pass | | 4 | Product Stability
Studies
(Fog Resistance Test) | N/A (followed by the internal testing protocol) | Pass | {7}------------------------------------------------ All of the aging test data showed that the product can be safe and effective during its predetermined shelf life. Hence, the sterile assurance level and the functional specification of the firm's definition and regulatory requirement, the shelf life of the product is 3 years. ### C. Product Performance Test: The test result of the fog resistance test shows that Konix Antifog Solution is effective. ### VIII. CONCLUSIONS Based on the previous data and comparison to the predicate device, Konix Anti Fog Solution is as safe and effective as the predicate device and do not raise any new issues of safety and effectiveness. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCT/K190864](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCT/K190864) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com