(470 days)
As stated on Label: Contact medium for ultrasonic and electrical transmission gel.
Konix® Sterile Gel is sterilized by gamma irradiation and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterlility and in vivo biocompatibility are required. It can be used on the skin where the risk for infections is especially high, especially with oven tissue Doppler applications; and can be used for cystoscopic and ultrasound examinations.
Konix® Serile Gel can be used on the skin or in open tissue where there is a risk for infections, such as in open tissue Doppler applications. It can be used during surgery; for cystoscopic and vaginal ultrasound and Doppler examinations; for cardiac surgery and ultrasound procedures; and as a lubricant in biopsy applications
Konix® Sterile Gel is an in vivo biocompatible sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. It is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures such as transcutaneous ultrasound image guided biopsy and aspiration, doppler examinations of organ and tissue intraoperative ultrasound imaging, intra-cavity ultrasound imaging, and gel infusion sonography.
Major characteristics include:
- No toxic effects; produced as a completely harmiess material .
- Hypoallergenic; non-irritating; no cytotoxicity .
- Water soluble, non-staining and easily cleanable
- Does not contain any lipid components .
- Free from formaldehyde and salt .
- Odorless .
- Gamma radiated to assure sterility .
- Will not damage the probe .
- Does not contain air bubbles .
- pH = 7 .
The provided document is a 510(k) Summary for the Konix® Sterile Gel, an ultrasound coupling gel. The submission is not for an AI/ML device, but for a medical device that establishes substantial equivalence to a predicate device. Therefore, many of the typical acceptance criteria and study design details for AI/ML performance evaluation (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable here.
Instead, the submission focuses on demonstrating the physical, chemical, and biological properties of the Konix® Sterile Gel are substantially equivalent to a legally marketed predicate device (Sterile Aquasonic® 100 Ultrasound Gel).
Here's an analysis of the provided information, framed as closely as possible to your requested structure, while acknowledging the nature of this submission:
Acceptance Criteria and Device Performance for Konix® Sterile Gel
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Konix® Sterile Gel are implicitly defined by its physical, chemical, and performance characteristics being comparable to, or within acceptable ranges relative to, the predicate device and established standards for sterile ultrasound gels.
| Characteristic | Acceptance Criteria (Predicate/Standard) | Reported Konix® Sterile Gel Performance | Meets Criteria? |
|---|---|---|---|
| General Properties | Sterile, Hypoallergenic, Non-cytotoxic, Non-sensitizing, Water soluble, Non-staining, Easily cleanable, No lipid components, Free from formaldehyde and salt, Odorless, Will not damage probe, No air bubbles | All reported as met/present | Yes |
| pH | Predicate: 6.5 - 6.95; Release Specification: 6.50-7.50 | 6.5 ± 0.75 | Yes |
| Density (g/cm³) | Predicate: 1.03; Release Specification: 0.683-1.283 | 0.983 | Yes |
| Acoustic Impedance (10⁵gm/cm²) | Predicate: 1.60; Close to human dermis (1.6 kg/m²s) | 1.45 (1.49 kg/m²s in performance test) | Yes (similar) |
| Speed of Sound (m/s) | Close to skin (1518 m/s) | 1516 | Yes (similar) |
| Viscosity (cp) | High viscosity (Predicate is viscous); Performance: 100,000-200,000 | 100,000-200,000 | Yes |
| Sterility | Gamma radiated to assure sterility; Zero CFU/Gm | Confirmed sterile post-radiation | Yes |
| Shelf-Life | Stable for three years | Stable for three years | Yes |
| Cytotoxicity | Non-cytotoxic | Proved negative | Yes |
| Sensitization | Non-sensitizing | Proved negative | Yes |
| Irritation | Non-irritating | Proved negative | Yes |
| Systemic Toxicity | Not toxic | Proved negative | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: Not applicable in the context of an AI/ML performance evaluation with a "test set" of cases. The "testing" here refers to laboratory and biocompatibility tests of the gel's properties.
- Data Provenance: The document does not specify the country of origin for the reported test results, but the submitter is from Turkey. The data appears to be from laboratory testing related to the product's physical, chemical, and biological characteristics, performed prospectively as part of product development and regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" for this device relates to established scientific and medical standards for gel properties (e.g., pH, density, sterility) and biocompatibility testing interpretation, not expert consensus on medical image interpretations. The "ground truth" is determined by validated laboratory methods and standard toxicology protocols.
4. Adjudication Method for the Test Set
- Not applicable. This concept relates to resolving disagreements among multiple expert readers in diagnostic classification tasks, which is not relevant for evaluating the physical and biological properties of an ultrasound gel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
- No. This is not an AI/ML device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This term is specific to AI/ML algorithm performance. The Konix® Sterile Gel's "standalone" performance is its intrinsic physical, chemical, and biological properties, which were characterized through various laboratory tests as detailed in the "Performance Test," "Sterility and Shelf-Life," and "Additional Tests" sections.
7. The Type of Ground Truth Used
The ground truth used for evaluating Konix® Sterile Gel consists of:
- Laboratory Measurements: Quantifiable physical and chemical properties (pH, density, viscosity, acoustic impedance, speed of sound).
- Microbiological Standards: Demonstrated absence of microbial growth (sterility) confirmed by standard culture methods.
- Biocompatibility Protocols: Results from in vitro cytotoxicity, in vivo sensitization, irritation tests, and mouse systemic toxicity tests, which are assessed against established pass/fail criteria from standard biological evaluation frameworks (e.g., ISO 10993).
- Shelf-Life Stability: Demonstrated stability over time for specified properties.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI/ML model for this device. The development of the gel involved formulation and testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment in that sense. The "ground truth" for the gel's formulation and development would involve standard chemical engineering and pharmaceutical development processes, ensuring ingredients meet quality standards, and the final product has the desired characteristics.
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K130581
Page 1 of 6
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [21 CFR 807.92(c)]
Date Summary Was Prepared:
June 13, 2014
Submitter:
Official Contact Person: On Behalf of:
Ronald J. Amen, Ph.D Turkuaz SaglikHizmetleriMedikalTemizlik Kimyasal Urunleri San.Ve Tic. Ltd. Sti. SaadetdereMah. 67 Sok No: 3 Esenvurt ISTANBUL TR-34513 Turkey 90-212-4286848 Contacts: Nurhan Irmak
JUN 1 8 2014
Device [807.92(a)(2)]:
Trade or Proprietary Name: Common or Usual Name: Classification Name: (UCD) Product Code: Regulation Number: Device Class Classification Panel
KONIX® Sterile Gel Sterile Ultrasound Gel Transducer, Ultrasonic, Diagnostic
MUI 21 CFR 892.1570 Class II Radiology
By Prescription Only
Predicate Device [80792(a)(3)]:
KONIX® Sterile Gel is substantially equivalent to: Sterile Aquasonic® 100 Ultrasound Gel (Parker Laboratories)
Description of the Device [807.92(a)(4)]:
Konix® Sterile Gel is an in vivo biocompatible sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. It is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures such as transcutaneous ultrasound image guided biopsy and aspiration, doppler examinations of organ and tissue intraoperative ultrasound imaging, intra-cavity ultrasound imaging, and gel infusion sonography.
Page 1
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Maior characteristics include:
- No toxic effects; produced as a completely harmiess material .
- Hypoallergenic; non-irritating; no cytotoxicity .
- Water soluble, non-staining and easily cleanable
- Does not contain any lipid components .
- Free from formaldehyde and salt .
- Odorless .
- Gamma radiated to assure sterility .
- Will not damage the probe .
- Does not contain air bubbles .
- pH = 7 .
Packaging and Labeling
Konix® Sterile Gel is sold in 20 mL (0.67 oz), single-use sachets. The sachets are composed of polyester (12 micron), aluminum foil (7 micron), and polyethylene (80 micron), and are terminally sterilized using gamma irradiation. The sachets are 60 mm wide and 130 mm long. The labeling information on the package complies with the FDA requirements. The shelf package has been examined and found have maintained integrity and sterility over a three year period.
Indications for Use [807.92(a)(6)
As stated on Label: Contact medium for ultrasonic and electrical transmission gel.
Konix® Sterile Gel is sterilized by gamma irradiation and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility and in vivo biocompatibility are required. It can be used on the skin where the risk for infections is especially high, especially with open tissue Doppler applications; and can be used for cystoscopic and vaginal Doppler and ultrasound examinations.
Konix® Serile Gel can be used on the skin or in open tissue where there is a risk for infections, such as in open tissue Doppler applications. It can be used during surgery; for cystoscopic and vaginal ultrasound and Doppler examinations; for cardiac surgery and ultrasound procedures; and as a lubricant in biopsy applications.
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Technological Characteristics [807.92(a)(6)]
Both the predicate device (Parker Laboratories' Sterile Aquasonic® 100 Ultrasonic Gel) and Konix® Sterile Gel have the same technological characteristics. They are both polymer-based gels that contain similar ingredients that allow their use in ultrasonic applications. Independent testing of Konix® Sterile Gel indicated that "the acoustic properties of this gel are very similar to those of other coupling gels commonly employed."
| PHYSICAL ANDCHEMICALPROPERTIES | Very high clarity |
|---|---|
| Hypoallergenic, non-cytotoxic, and non-sensitizing | |
| Sterile | |
| pH = 6.5 ± 0.75 | |
| Density(g/cm3)=0.983 | |
| Very clear screen image with high viscosity and vacuum process. No rapidmelting from high-viscosity gel. Viscosity: 100,000-200,000 cp | |
| Boiling Point> 200°F | |
| Water soluble high molecular weightpolymer |
Substantial Equivalence [807.92(b)(1)]
Turkuaz Konix® Sterile Gel has been determined to be substantially equivalent to Parker Laboratories' Sterile Aquasonic® 100 Ultrasound Gel, a marketed device. The sterility, intended use, active ingredients and other components, and packaging, are substantially equivalent to the predicate device.
| FEATURES | TURKUAZKONIX® STERILE GEL | PARKER LABS STERILEAQUASONIC® 100ULTRASOUND GEL |
|---|---|---|
| • Sterile formula | √ | √ |
| • Aqueous solution willnot stain clothing ordamage transducers | √ | √ |
| • Convenientsingle- use foil | √ | √ |
| • Suitable for broadrange of ultrasoundfrequencies | √ | √ |
| • Viscous ultrasoundtransmission gel | √ | |
| • Hypoallergenic | √ | √ |
| • Bacteriostatic forincreased hygiene | √ | √ |
| • Non-sensitizing andnon-irritating forpatient comfort | √ |
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| • Formuladoesnot | √ | √ | |
|---|---|---|---|
| • Not a spermicide | √ | √ | |
| • Clear, Pale YellowColor | √ | √ | |
| • 20 mL/20 gm | √ | √ | |
| • Ingredients:Polymer,Humectants,Preservatives, Water | √ | √ | |
| • pH Range | 6.5 - 7.5 | 6.5 - 6.95 | |
| • Density | 0.983 g/cm³ | 1.03 g/cm3 | |
| • Acoustic Impedance | 1.45 (10⁵gm/cm²) | 1.60 (10⁵gm/cm²) |
Production
Konix® Sterile Gel is produced in a closed-loop system so that contamination is eliminated. The carbomer and monopropylene glycol are added to water in a mixer. There is an in-process quality control that confirms the correct percentage of ingredients. The preservatives are then added, and the pH is adjusted. A final analysis is conducted on the mixture, and then the product is filled. The product is produced in a 100,000 class clean room with Hepa filters. The process includes a vacuum process so that bubbles cannot form. After production, the sterile gel is gamma irradiated according to accepted standards, to assure sterility. The product has a three year shelf-life.
Ingredients
KONIX® STERILE GEL
| INGREDIENTS | COMMON CHEMICAL NAME | CAS NUMBER | QUANTITY(w/v %) |
|---|---|---|---|
| Carbomer | Acrylates/C10-30 Alkyl AcrylateCrosspolymer | 9003-01-004 | 0.3-1.0 |
| Triethanolamin | Triethanolamin | 102-71-6 | 0.3-1.0 |
| MonoPropylene Glycol | MonoPropylene Glycol | 57-55-8 | 0.5-2.0 |
| 5-chloro-2-methyl-4-isothiazolin-3-one | Methylchloroisothiazolinone (and)Methylisothiazolinone | 26172-55-42682-20-4 | 0.05-0.15 |
| Deionized water | Deionized water | - | Q.S 100 |
{4}------------------------------------------------
Carbomer, triethanolamin, and monopropylene glycol constitute the ingredients that form the gel. These are common ingredients used for this purpose. Methylchloroisothiazolinone (5-chloro-2-methyl-4-isothiazolin-3-one) is a preservative with antibacterial and antifungal effects within the group of isothiazolinones. It is effective against gram-positive and gram-negative bacteria, yeast, and fungi. Methylisothiazolinone, is a powerful general biocide and preservative within the group of isothiazolinones, often used in personal care products.
Release Specifications
| Item | Specification and Range |
|---|---|
| pH | 6.50-7.50 |
| Density | 0.683-1.283 (g/cm³) |
| Carbomer | 0.3-1.0 (w/v %) |
| Triethanolamin | 0.3-1.0 (w/v %) |
| MonoPropyleneGlyco | 0.5-2.0 (w/v %) |
| 5-chloro-2-methyl-4-isothiazolin-3-one & 2-methyl-4-isothiazolin-3-one | 0.05-0.15 (w/v %) |
| Odor | Odorless |
| Clarity | Clear |
| Microbes | Zero CFU/Gm (Sterile) |
Performance Test
The results of the acoustic tests indicated that "no effect of attenuation or impedance mismatch with the gels could be observed in imaging of the test objects in numerous real time sweeps." The report stated that the acoustic impedance of 1.49 kg/m²s for the Konix® gel is close to the reported mean human dermis of 1.6 kg/m²s, and should minimize reflection loses and generation of reverberant echoes when gel layers of at least 1/4 wavelength are employed. The speed of sound of 1516 m/s is very close to the 1518 m/s reported for skin, and this should minimize refract errors for oblique incidence into skin after passage through finite thicknesses of gel and keep elevation focus for RTV lense material as designed. In conclusion, the researchers stated that the "acoustic properties of this gel are very similar to those of other coupling gels commonly employed.
{5}------------------------------------------------
Sterility and Shelf-Life
Independent testing confirmed that Konix® Sterile Gel is free of microbes following sterilization radiation. No aerobic mesophilic bacteria were present in either tryptone soy broth or fluid thioglycollate medium after 14 days of storage at 30℃.
Storage stability testing at 22° and 40°C indicated that Konix® Sterile Gel is stable for three years at ambient temperatures when pH, density, and appearance were measured. Additionally, examination of packages over a three year period showed that there was no microbial growth, thus confirming long-term package integrity and sterility.
Additional Tests
In vitro cytotoxicity, in vivo sensitization, irritation tests, and mouse systemic toxicity tests were conducted with the Konix® Sterile Gel according to standard protocols. All tests proved negative for cytotoxicity, sensitization, and systemic toxicity.
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with three lines extending from its back, resembling wings or feathers. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenge Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2014
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunleri San. Ve Tic. Ltd. Sti. % Mr. Michael Scott President ST&T Consultants, Inc. 2237 Chestnut Street SAN FRANCISCO CA 94123
Re: K130581
Trade/Device Name: Konix® Sterile Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: May 13, 2014 Received: May 23, 2014
Dear Mr. Scott:
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. 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 mislcading.
lf your device is classified (sec above) into cither 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 i has be additised that i britis in that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any it ederal statures and regimments, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic is form in the quality 5) Steins (Sections 531-542 of the Act); 21 CFR 1000-1050.
{7}------------------------------------------------
Page 2-Mr. Scott
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use
510(k) Number (if known) K 130581
Device Name Konix Sterile Gel r
Indications for Use (Describe)
As stated on Label: Contact medium for ultrasonic and electrical transmission gel.
Konix® Sterile Gel is sterilized by gamma irradiation and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterlility and in vivo biocompatibility are required. It can be used on the skin where the risk for infections is especially high, especially with oven tissue Doppler applications; and can be used for cystoscopic and ultrasound examinations.
Konix® Serile Gel can be used on the skin or in open tissue where there is a risk for infections, such as in open tissue Doppler applications. It can be used during surgery; for
cystoscopic and vaginal ultrasound and Doppler examinations; for cardiac surgery and ultrasound procedures; and as a lubricant in biopsy applications
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Smh.7)
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§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.