Konix® Ultrasound Gel is intended for general use as a nonsterile transmission media for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.

Device Description

Konix® Ultrasound Gel consists of deionized water, carbomer, triethanolamine, monopropylene glycol, 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3 one and is a type of conductive medium, i.e., scanning gel, used in ultrasound diagnostic techniques. A scanning gel acts as a couplant that provides an acoustic pathway between the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin.

The major characteristics of Konix® Ultrasound Gel include:

. Hypoallergenic, non-irritating
Water soluble, non-staining and easily cleanable .
Does not contain oil and fatty matter .
Free from formaldehyde and salt .
No toxic effects .
Produced as a completely harmless material .
No smell ◆
Vacuum treated production .
Not-damageable to the probe .
. Does not contain air bubbles
pH level is 7 .

AI/ML Overview

The Konix® Ultrasound Gel is a medical device designed for general use as a non-sterile transmission medium for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. The device's acceptance criteria and studies are primarily focused on demonstrating its acoustic performance and equivalence to existing predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for Konix® Ultrasound Gel were based on its acoustic properties being virtually identical to human skin and other commonly used coupling gels in the United States.

Acceptance Criteria / Characteristic	Target Value (based on human skin/optimal average)	Reported Device Performance (Konix® Ultrasound Gel)
Sound velocity (m/sec) at 30°C	1,518 (human skin), 1,520 (optimal average)	1,516
Density (kg/m³) at 30°C	Not specified as clear target, but comparable	0.98 x 10-3
Acoustic impedance (kg/m² sec) at 30°C	1.6 (human skin)	1.49
Attenuation coefficient as a function of frequency, a/f (dB/(cm-MHz))	Not explicitly stated, but "low" is desired	< 0.05

2. Sample Size and Data Provenance

The document does not specify a separate "test set" and corresponding sample size for the acoustic performance evaluation. The acoustic properties (Sound velocity, Density, Acoustic impedance, Attenuation coefficient) were measured for the Konix® Ultrasound Gel.

The data provenance for the comparison values (e.g., human skin sound velocity and acoustic impedance) is from published scientific literature:

Ogura, I., Kidikoro, T., linuma, K., Tanaka, K. and Matsuda, A. "Measurement of Acoustic Impedance of Skin" Ultrasound in Medicine, Vol. 4, RC 78.7, U4 A 5a, page 535 (1978).

The study for Konix® Ultrasound Gel itself appears to be a prospective measurement of its physical properties. The country of origin of the device manufacturer is Turkey.

3. Number of Experts and Qualifications for Ground Truth

This type of device (ultrasound gel) does not typically involve expert review for establishing ground truth in the way medical imaging algorithms do. The "ground truth" for comparison for acoustic properties comes from established scientific literature regarding human skin properties. Therefore, there were no "experts" in the traditional sense involved in establishing ground truth for a test set of images or clinical outcomes.

4. Adjudication Method

Not applicable. The study involved direct measurements of the physical properties of the gel and comparison to published scientific data. There was no adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is suitable for AI algorithms that assist human readers in interpreting medical images, which is not applicable to an ultrasound gel.

6. Standalone Performance Study

Yes, a standalone study was performed. The non-clinical performance evaluation focused on directly measuring the acoustic properties of the Konix® Ultrasound Gel itself, rather than its performance in conjunction with human interpretation. The study states: "Konix® Ultrasound Gel was evaluated for its acoustic performance."

7. Type of Ground Truth Used

The ground truth used was established scientific literature and physical properties of human skin and other commonly used ultrasound coupling gels. For example, the reported longitudinal velocity of skin (1,518 m/sec) and acoustic impedance of skin (1.6 kg/m²s) were referenced from a scientific publication (Ogura, 1978).

8. Sample Size for the Training Set

Not applicable. This device is an ultrasound gel, not an AI algorithm that requires a training set. The "study" here involves physical property measurements and comparison, not machine learning model training.

9. How Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI algorithm, there was no training set or ground truth established for such a set.

Summary

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K101952

510(k) Summary

MAY 2 7 2011

General information

510(k) owner's name, etc. .
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunleri San, Ve Tic: Ltd. Sti Saadetdere Mah. 67 No. 3 Esenyurt Istanbul, Turkey (T) 90 212 428 68 48 (F) 90 212 428 68 53

Contact person .

Michael Scott (US Agent) Director Science, Toxicology + Technology 88 McFaul Way PO Box 10324 Zephyr Cove, NV 89448 (T) 415-441-2163 (F) 415-441-3201 Email: MScott@STTResearch.com

Prepared on May 25, 2011 �

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Device names

Trade name

Konix® Ultrasound Gel

Common name

Acoustic gel

Classified name

Diagnostic ultrasonic transducer/acoustic gel (21 CFR § 892.1570, Product code ITX)

Predicate device

Eco-Med Pharmaceuticals' Ecogel 100 Ultrasound Gel (K961757)

Device description

The major characteristics of Konix® Ultrasound Gel include:

. Hypoallergenic, non-irritating
Water soluble, non-staining and easily cleanable .
Does not contain oil and fatty matter .
Free from formaldehyde and salt .
No toxic effects .
Produced as a completely harmless material .
No smell ◆
Vacuum treated production .
Not-damageable to the probe .
. Does not contain air bubbles
pH level is 7 .

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Intended use

Technological characteristics

Konix® Ultrasound Gel has substantially the same technological characteristics as the predicate device. The two are compared below.

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	KONIX® ULTRASOUND GEL	ECOGEL 100 ULTRASOUND GEL (K961757)
Intended Use	External	External
INGREDIENTS	Salt free	Salt free
	Dye free	Green color
	Alcohol free	Alcohol free
	Formaldehyde free	Formaldehyde free
	Perfume free or not free (with IFRA certificate)	Perfume free
PHYSICALPROPERTIES	Twist cap for accurate dispensing	Twist cap for accurate dispensing
	Flip-top can for quick refilling	Flip-top cap for quick refilling
	Very high clarity	Good clarity
	Hypoallergenic, bacteriostatic, and non-sensitizing	Hypoallergenic, bacteriostatic, and non-sensitizing
	pH = 6.5 ± 0.75	pH = 6.5 ± 0.75
CHEMICALPROPERTIES	Density (g/cm³) = 0.983	Density (g/cm³) = 0.99
	Very clear screen image with high viscosity and vacuumprocess. No rapid melting from high-viscosity gel. Viscosity:100000-200000 cp	It has low viscosity. It melts immediately fromlow viscosity. Viscosity: 35000-45000 cp
	Boiling Point > 200°FWater soluble high polymerNo irritation	Boiling Point = 100°CWater soluble polymerNo irritation
PROCESS	It has very quick production process	Normal process
	Our product has a very soft bottle that provides ease of use.	It is made with a standard bottle
	Our production system is a closed-loop system so pollution oftransmission is not in question. Products are manufacturedvery cleanly.	Standard process
	Konix® Ultrasound Gel is produced in a clean room with Hepafilters (1/100000 class)	Standard production area

Substantial Equivalence Discussion

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	Konix® Ultrasound Gel is manufactured with high technologythat includes a vacuum process. The product does not containbubbles. This is important because bubbles can cancel thescreen image.	Standard process
LABEL	Very clear information on label. The label is made withPolyethylene so that the label information is not deleted toquickly.	Standard label information
DESIGN	Bottle diameter designed according to the ultrasound deviceBottle cap has been designed to easily open and close forsingle-handedness.	Conical cap
SAFETY	Konix® Ultrasound Gel's label contains all the safety signs(Latex free, PVC free, etc.)	Contains standard signs
ENVIRONMENTOF USE	Hospital	Hospital
TARGETPOPULATION	Pediatric and adult	Pediatric and adult
ANATOMICALSITE	Body (abdomen)	Body (abdomen)
USE	Multiple use	Multiple use
MATERIAL(PACKAGE)	Polyethylene	Polyethylene
PATIENTCONTACTMATERIALS	Probe	Probe
ENERGY TYPE	Only electricity for ultrasound device	Only electricity for ultrasound device

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Non-clinical performance

Konix® Ultrasound Gel was evaluated for its acoustic performance. Results indicate that the acoustic properties of the gel:

1. are virtually identical to human skin, and
1. are virtually identical to other coupling gels commonly used today in the United States.

Finally, Konix Ultrasound Gel's acoustic properties are as follows:

Sound velocity (m/sec) at 30°C¹	1,516
Density (kg/m³) at 30°C	0.98 x 10-3
Acoustic impedance (kg/m² sec) at 30°C	1.49
Attenuation coefficient as a function of frequency, a/f (dB/(cm-MHz)	< 0.05

Conclusions

The above-referenced comparisons of the technological and non-clinical performance characteristics indicate that the Konix® Ultrasound Gel is almost identical to its predicate and certainly substantially equivalent to it and other coupling gels commonly used in the United States today.

+ The "longitudinal velocity" of skin is reported to be 1,518. The optimal average is 1,520. (See, e.g., Ogura, I., Kidikoro, T., linuma, K., Tanaka, K. and Matsuda, A. "Measurement of Acoustic Impedance of Skin" Ultrasound in Medicine, Vol. 4, RC 78.7, U4 A 5a, page 535 (1978).

The "Acoustic impendance" of skin is reported to be 1.6 kg/m² s. (See, Ogura (1978)).

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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 features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Turkuaz Saglik Hismetleri Medikal Temizlik Kimyasal c/o Mr. Michael Scott Director Science, Toxicology & Technology 88 McFaul Way, Mailbox: P.O. Box 10324 ZEPHYR COVE NV 89448

MAY 2 7 2011

Re: K101952 Trade Name: Konix®Ultrasound Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: May 4, 2011 Received: May 6, 2011

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K101952

Konix® Ultrasound Gel Device Name:

Indications for Use:

× Prescription Use Over-The-Counter Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patel

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K10/952

Page 1 of

Regulation Number and Section

§ 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.