KONIX ULTRASOUND GEL

K101952 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · ITX · May 27, 2011 · Radiology

Device Facts

• Record ID: K101952
• Device Name: KONIX ULTRASOUND GEL
• Applicant: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
• Product Code: ITX · Radiology
• Decision Date: May 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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 Story

Konix® Ultrasound Gel is a nonsterile, conductive acoustic coupling medium used in external diagnostic ultrasound imaging. It consists of deionized water, carbomer, triethanolamine, monopropylene glycol, and preservatives. The gel is applied to the patient's skin by a clinician to eliminate air gaps between the ultrasound transducer and the body surface, facilitating acoustic transmission. It is manufactured in a clean room using a vacuum-treated, closed-loop process to ensure the absence of air bubbles, which could otherwise interfere with image clarity. The device is packaged in a polyethylene bottle designed for single-handed use. By providing a consistent acoustic pathway, the gel enables the ultrasound transducer to capture clear images, assisting healthcare providers in diagnostic decision-making. It is intended for use in hospital settings.

Clinical Evidence

Bench testing only. Acoustic properties (sound velocity, density, acoustic impedance, and attenuation coefficient) were measured and compared to literature values for human skin and standard coupling gels. Results demonstrate the device's acoustic performance is virtually identical to the predicate and suitable for diagnostic ultrasound applications.

Technological Characteristics

Composition: deionized water, carbomer, triethanolamine, monopropylene glycol, preservatives. Physical properties: pH 6.5 ± 0.75, density 0.983 g/cm³, viscosity 100,000-200,000 cp. Form factor: liquid gel in polyethylene bottle. Manufacturing: vacuum-treated, closed-loop system in ISO-equivalent clean room (HEPA filtered). Energy source: none (passive coupling medium).

Indications for Use

Indicated for pediatric and adult patients undergoing external diagnostic ultrasound imaging procedures. Contraindications: None stated.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

{0}------------------------------------------------

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: [e-mail]

- Prepared on May 25, 2011 �

{1}------------------------------------------------

#### 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

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 .

{2}------------------------------------------------

#### Intended use

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.

#### Technological characteristics

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

{3}------------------------------------------------

| | 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 |
| PHYSICAL<br>PROPERTIES | 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-<br>sensitizing |
| | pH = 6.5 ± 0.75 | pH = 6.5 ± 0.75 |
| CHEMICAL<br>PROPERTIES | Density (g/cm³) = 0.983 | Density (g/cm³) = 0.99 |
| | Very clear screen image with high viscosity and vacuum<br>process. No rapid melting from high-viscosity gel. Viscosity:<br>100000-200000 cp | It has low viscosity. It melts immediately from<br>low viscosity. Viscosity: 35000-45000 cp |
| | Boiling Point > 200°F<br>Water soluble high polymer<br>No irritation | Boiling Point = 100°C<br>Water soluble polymer<br>No 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 of<br>transmission is not in question. Products are manufactured<br>very cleanly. | Standard process |
| | Konix® Ultrasound Gel is produced in a clean room with Hepa<br>filters (1/100000 class) | Standard production area |

Substantial Equivalence Discussion

{4}------------------------------------------------

| | Konix® Ultrasound Gel is manufactured with high technology<br>that includes a vacuum process. The product does not contain<br>bubbles. This is important because bubbles can cancel the<br>screen image. | Standard process |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| LABEL | Very clear information on label. The label is made with<br>Polyethylene so that the label information is not deleted to<br>quickly. | Standard label information |
| DESIGN | Bottle diameter designed according to the ultrasound device<br>Bottle cap has been designed to easily open and close for<br>single-handedness. | Conical cap |
| SAFETY | Konix® Ultrasound Gel's label contains all the safety signs<br>(Latex free, PVC free, etc.) | Contains standard signs |
| ENVIRONMENT<br>OF USE | Hospital | Hospital |
| TARGET<br>POPULATION | Pediatric and adult | Pediatric and adult |
| ANATOMICAL<br>SITE | Body (abdomen) | Body (abdomen) |
| USE | Multiple use | Multiple use |
| MATERIAL<br>(PACKAGE) | Polyethylene | Polyethylene |
| PATIENT<br>CONTACT<br>MATERIALS | Probe | Probe |
| ENERGY TYPE | Only electricity for ultrasound device | Only electricity for ultrasound device |

{5}------------------------------------------------

#### 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
- 2. 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)).

{6}------------------------------------------------

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

{7}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{8}------------------------------------------------

## Indications for Use Form

510(k) Number (if known): K101952

Konix® Ultrasound Gel Device Name:

Indications for Use:

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.

× 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