ULTRA IMAGE AND ULTRA SCAN

K981028 · Sonotech, Inc. · ITX · Aug 21, 1998 · Radiology

Device Facts

• Record ID: K981028
• Device Name: ULTRA IMAGE AND ULTRA SCAN
• Applicant: Sonotech, Inc.
• Product Code: ITX · Radiology
• Decision Date: Aug 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body. Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography and general ultrasound scanning procedures. Ultra Giide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.

Device Story

Sono Image and Ultra Glide are medical diagnostic ultrasound coupling gels. They function by facilitating the transmission of sound waves from ultrasound transducers into the patient's body. The two products differ only in polymer (thickener) content, resulting in high viscosity (Sono Image) and low viscosity (Ultra Glide) formulations. They are free of silicon, mineral oil, and surfactants to prevent damage to transducer materials. Used by sonographers in clinical settings during diagnostic ultrasound exams; viscosity is selected based on user preference. The gel acts as a conductive medium to ensure acoustic coupling, enabling clear image acquisition for diagnostic assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Aqueous-based ultrasound coupling gels. Formulated without silicon, mineral oil, or surfactants to ensure compatibility with ultrasound transducer materials. Available in high viscosity (Sono Image) and low viscosity (Ultra Glide) variants. Non-sterile, topical application.

Indications for Use

Indicated for use as coupling agents in medical diagnostic ultrasound procedures, including echocardiography, vascular, abdominal, OB/GYN, and general scanning. No specific patient population contraindications noted.

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

• Natural Image Scanning Gel (K883917/B)
• Clear Image Sterile Scanning Gel (K931909)
• SonoMix Scanning Gel (K931908/SI)

Submission Summary (Full Text)

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SONO 774 Marine Drive Bellingham, WA 9822 Registration #2523891 510(k) Number K981028 Sono Image and Ultra Glide

AUG 21 1998

## 510(k) SUMMARY - #K981028

as required by 807.92(c)

## SONOTECH, INC.

774 Marine Drive

Bellingham, WA 98225

Telephone: [phone]

Fax: [phone]

E-mail: [e-mail]

Contact person: Margaret J. Larson

Date Prepared: August 3, 1998

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## SONOTECH, INC.

774 Marine Drive Bellingham, WA 98225 Registration #2523891 510(k) Number K981028 Sono Image and Ultra Glide

## General Information

Reason for Premarket Notification: New device

Trade name of device: Sono Image and Ultra Glide

Common or usual name: Medical diagnostic ultrasound scanning gel

Regulatory Classification: II

Legally marketed devices to which we claim equivalence (see Comparison Table for further information): Natural Image Scanning Gel, K883917/B, reviewed and clearance received 3/31/89 Clear Image Sterile Scanning Gel, K931909, reviewed and clearance received 3/21/94 SonoMix Scanning Gel, K931908/SI, reviewed and clearance received 12/13/94

ﻤﺴﺎﻫﺎ Description: Sono Image and Ultra Glide are medical diagnostic ultrasound scanning gels that transmit sound waves into the body through the skin and whose formulas are identical except for the polymer (thickener) content. Sono Image and Ultra Glide do not contain silicon, mineral oil, surfactants or any chemicals which are considered harmful to ultrasound transducer material (see Sono Image and Ultra Glide product formulation).

Intended Use: Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body. Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography and general ultrasound scanning procedures. Ultra Giide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.

Note: viscosity does not affect the safety or performance of a scanning gel. Scanning gels are selected by sonographers based on viscosity preference.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered in the image and is the only element present.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 21 1998

Katie Monty Products and Sales Manager Sonotech, Inc. P.O. Box 2189 Bellingham, WA 98227-2189 Re:

K981028 Sono Image and Ultra Glide Dated: July 29, 1998 Received: August 6, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Ms. Monty:

We have reviewed your Section 510%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510Ks) 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kiliai Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K981028

Device Name: SONO IMAGE & ULTRA GLIDE

Indications For Use:

Sono Image and Ultra Glide are coupling gels and will be used in conjunction with Sono Image and offra Sirae are Coupaing genotic ultrasound to couple sound waves into the patient's body.

Sono Image is a high viscosity scanning gel suitable for echocardiography, bono finage is a high visuosaby and general ultrasound scanning procedures.

Ultra Glide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.

viscosity does not affect the safety or performance of a scanning gel. Note: Scanning gels are selected by sonographers based on viscosity preference.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K981028 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|

(Optional Formal 1-2-96)