(512 days)
Not Found
No
The device is a chemical solution and foam pad for preventing lens fogging, with no mention of software, algorithms, or data processing.
No.
The device is used to prevent fogging of imaging equipment, not to treat a medical condition or provide therapy to a patient.
No
Explanation: The device is an anti-fog solution used to prevent lenses from fogging during endoscopic and laparoscopic procedures. Its function is to improve visibility for the imaging device, not to diagnose any medical conditions or interpret medical data.
No
The device description clearly states it is a "single-use, sterile, and biocompatible laparoscopic accessory device" and includes physical components like a bottle and foam pad. It is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Konix Anti-Fog solution is applied to the lens of an imaging device (endoscope/laparoscope) to prevent fogging during surgical procedures. It does not interact with or analyze samples from the human body.
- Intended Use: The intended use clearly states it's for preventing fogging of the scope lens during procedures, not for diagnosing or analyzing patient samples.
- Device Description: The description focuses on the physical properties and application of the solution to the lens.
- Performance Studies: The performance studies evaluate biocompatibility, sterilization, shelf life, and fog resistance – all related to the device's function as an anti-fog agent for the scope, not its ability to diagnose or analyze patient samples.
Therefore, the Konix Anti-Fog solution is a medical device used to facilitate imaging during procedures, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
OCT
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'.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital O.R. room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
The tests performed were:
- Cytotoxicity Test per ISO 10993-5:2009. Result: Pass.
- Sensitization Test per ISO 10993-10:2010. Result: Pass.
- Intracutaneous Reactivity Test per ISO 10993-10:2010. Result: Pass.
All of the test studies listed above showed that Konix Anti-Fog Solution did not raise any safety issues and is biocompatible.
B. Sterilization Validation and Shelf Life Study
Product is designed to perform gamma-radiation sterilization.
a. Gamma-Radiation Sterilization Validation Study
Performed per ISO 11137-2:2013, ISO 11737-1:2018, and ISO 11737-2:2019.
Method used: ISO 11137-2 Method 1 multiple production batches (7.2), since the product bioburden was less than 1 CFU/sample.
Results: 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
§ 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.
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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
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.
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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
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3
ST&T DEPARTMENTS:
PHARMACOLOGY/TOXICOLOGY RESEARCH
INTERNATIONAL REGULATORY CONSULTATION
PRODUCT DEVELOPMENT & CLINICAL RESEARCH
PRE-POST MARKET CONSUMER PRODUCT RESEARCH
FDAFTCEPA~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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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