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 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'.

AI/ML Overview

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) < 10-6 according to ISO 11137-2, ISO 11737-1, ISO 11737-2	Controlled at the dose of no less than 13.9 kGy, meeting SAL < 10-6.
Shelf-Life (3 years accelerated aging)	Maintain package integrity, seal strength, sterility, and product stability (fog resistance) according to ASTM F1980-16, ASTM F1929-15, ASTM F88/F88M-15, ISO 11737-2.	All aging test data showed the product to be safe and effective for 3 years.
Package Integrity Test	ASTM F1929-15 standards	Pass
Seal Peel Strength Test	ASTM F88/F88M-15 standards	Pass
Product Sterility Test	ISO 11737-2:2019 standards	Pass
Product Stability Studies (Fog Resistance Test)	Internal testing protocol met (specific criteria not detailed)	Pass (stated that "Konix Antifog Solution is effective" based on this test)

Regarding the other requested information that is typically relevant for AI/ML devices, this document does not contain that information as it describes an anti-fog solution, not an AI/ML diagnostic device. Therefore, the following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not applicable. The performance tests are laboratory-based for physical and biological properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to meeting established physical, chemical, and biological safety and efficacy standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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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

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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

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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)

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.

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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

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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

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K190864

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

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-FogSolution	Dr. Fog Anti-FogSolution	Comment
Indication for Use	KONIX Anti-Fogsolution is a sterile,disposable, functional,anti-fog solution. Theantifog solution isintended to beused prior to andduring endoscopic andlaparoscopicprocedures to preventfogging of the scopelens. KONIXAntifog Solution isused to prevent thelenses of the imagingdevice from foggingdue to the difference inbody temperaturebefore and duringendoscopic andlaparoscopicprocedures.	Dr. Fog Anti-FogSolution is designed toclear fog fromendoscopic cameralenses in order tomaintain a clearoperating field.	Same
Reusable/Disposable	Disposable	Disposable
Target PatientPopulation	The patient who treatedby endoscopic andlaparoscopic surgery	The patient whotreated bylaparoscopic surgery	Same

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Where Used	Hospital O.R. room	Hospital O.R. room	Same
Contraindications	There are no knowncontraindications to thepatient.
Method ofIntroduction	Wiping distal end of thelens by sponge withsolution.	Wiping distal end ofthe lens byspongewith solution.	Same
Safety	The followingbiocompatibility testswere conducted.- Cytotoxicity Test- Sensitization Test- IntracutaneousReactivity TestAll of the tests passedthe requirements asindicated in theapplicable standards.	Not known	All of thebiocompatibility teststhat are indicated inthe FDA recognizedstandards wereperformed.
SterilizationMethod	Gamma-radiationSterilization(10-6 SAL)	Gamma-radiationSterilization(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 membraneBreached or compromisedsurface	Limited (≤ 24 h)

No.	Test Name	Applicable Standards	Comment
1	Cytotoxicity Test	ISO 10993-5:2009 Biological Evaluation OfMedical Devices - Part 5: Tests For In VitroCytotoxicity	Pass
2	Sensitization Test	ISO 10993-10:2010 Biological Evaluation OfMedical Devices - Part 10: Tests For IrritationAnd Skin Sensitization	Pass
3	Intracutaneous	ISO 10993-10:2010 Biological Evaluation Of	Pass

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	Reactivity Test	Medical Devices - Part 10: Tests For IrritationAnd 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 IntegrityTest(Dye penetrationTest)	ASTM F1929-15 Standard Test Method ForDetecting Seal Leaks In Porous MedicalPackaging By DyePenetration	Pass
2	Seal Peel StrengthTest	ASTM F88/F88M-15 Standard Test MethodFor Seal Strength Of Flexible Barrier Materials	Pass
3	Product SterilityTest	ISO 11737-2:2019 Sterilization Of MedicalDevices -Microbiological Methods - Part 2:Tests Of SterilityPerformed In The Definition,Validation And Maintenance Of ASterilization Process	Pass
4	Product StabilityStudies(Fog Resistance Test)	N/A (followed by the internal testing protocol)	Pass

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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.

Regulation Number and Section

§ 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.