VIVOSONIC

K984562 · Sonotech, Inc. · ITX · Jun 8, 1999 · Radiology

Device Facts

• Record ID: K984562
• Device Name: VIVOSONIC
• Applicant: Sonotech, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jun 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices. Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging. Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.

Device Story

VivoSonic is a sterile, biocompatible ultrasound coupling gel/fluid. It acts as an acoustic medium to facilitate sound wave transmission between the patient and ultrasound transducer during invasive diagnostic procedures. It also serves as a lubricant for the insertion and passage of imaging devices. Used by clinicians in clinical settings (e.g., OR, diagnostic imaging suites) during transcutaneous, intraoperative, endocavity, and ophthalmic ultrasound procedures. It is applied directly to the transducer or patient site, often in conjunction with transducer covers (latex, polyurethane, or polyethylene). The device ensures acoustic coupling and patient comfort/safety during invasive imaging, supporting accurate diagnostic visualization.

Clinical Evidence

No clinical data provided; device is a coupling medium for diagnostic ultrasound.

Technological Characteristics

Sterile, biocompatible ultrasound coupling gel/fluid. Designed for acoustic coupling and lubrication in invasive diagnostic ultrasound. Compatible with latex, polyurethane, and polyethylene transducer covers.

Indications for Use

Indicated for use in invasive diagnostic ultrasound procedures requiring sterile, biocompatible coupling media, including transcutaneous image-guided biopsy/aspiration, intraoperative, endocavity, and ophthalmic ultrasound imaging. Used for coupling sound waves and lubricating imaging device insertion/passage.

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.

Submission Summary (Full Text)

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**UMAN SERVICE**

**JUN .8 1999**

Bellingham, WA 98227-2189

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re:

K984562 VivoSonic (Diagnostic Ultrasound Imaging Coupling Media) Dated: April 1, 1999 Received: April 9, 1999 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Ms. Larson:

Margaret J. Larson

President

Sonotech. Inc.

P.O. Box 2189

We have reviewed your Section 510(k) 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 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). 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 II (Special Controls) or 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 (QS) 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 531 through 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 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 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/dsma/dsmamain.html".

Sincerely yours,

Dan Petit, M.D.

CAPT Daniel G. Schultz, M.D. Acting 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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Image /page/1/Picture/1 description: The image shows the word "SONOTECH" in bold, sans-serif font. To the left of the word is a logo of a dolphin jumping out of the water, with a sun in the background. The logo and the word are both in black and white. The image is clear and easy to read.

Sonotech, Inc. 774 Marine Drive, Bellingham, WA 98225 360/671-9121 fax: [phone] [e-mail]

Registration # 2523891

8 1899 JUN

510(k) Application: VivoSonic - In Vivo Biocompatible Sterile Ultrasound Imaging Couplant

Page 6 of 16

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510(k) Number (if known):

VivoSonic In Vivo Biocompatible Sterile Ultrasound Imaging Couplnat Device Name:

Indications For Usc:

(Pcr 21 CFR 801.109)

Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices.

Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging.

Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.

(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 | K984562 |
|---------------|---------|
|---------------|---------|

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

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