ULTRABIO

K033178 · Sonotech, Inc. · MUI · Aug 4, 2004 · Radiology

Device Facts

• Record ID: K033178
• Device Name: ULTRABIO
• Applicant: Sonotech, Inc.
• Product Code: MUI · Radiology
• Decision Date: Aug 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace non-sterile ultrasound couplants in vivo biocompatible and bioexcretable, but sterilized transcutaneous scanning and similar sterile applications. UltraBio will be used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavity ultrasound imaging, and aspiration, intraoperative ultrasound imaging, and intracavity ultrasound imaging. UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel in the fluid alone or in combination with a latex, and where biocompatibility and bioelimination are required.

Device Story

Ultrabio is a sterile, biocompatible, and bioeliminated ultrasound couplant gel. It functions as an acoustic coupling medium to facilitate the transmission of sound waves between a patient's skin or internal tissue and medical imaging transducers. It is intended for use in diagnostic ultrasound procedures, specifically intraoperative and intracavity applications, where sterile conditions are required. The device is provided in unit-dose packaging to maintain sterility. It is applied by clinicians during ultrasound examinations to ensure optimal image quality by eliminating air gaps between the transducer and the patient. The device is intended for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, biocompatible, bioeliminated ultrasound coupling gel. Unit-dose packaging. Designed for acoustic impedance matching between medical transducers and human tissue. Class II device under 21 CFR 892.1570.

Indications for Use

Indicated for use as a sterile ultrasound coupling medium for patients undergoing diagnostic ultrasound procedures, including intraoperative and intracavity imaging and aspiration, where biocompatibility and bioelimination are required.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2004

Ms. Peg Larson President SONOTECH, Inc. 774 Marine Drive BELLINGHAM WA 98225-1530 Re: K033178

Trade/Device Name: Ultrabio - InVivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 MUI Dated: July 12, 2004 Received: July 20, 2004

Dear Ms. Larson:

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 either class II (Special Controls) or class III (PMA), 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 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you to ogen manies of substantial equivalence of your device to a legally premarket notheation. The Price is 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), please If you desire specific advise at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions of [phone]. Also, please note the regulation entitled, "Misbranding Other or othernes an (enotification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your respensional Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 7 of 19

| 510(k) Number (if known): | K03317 |
|---------------------------|--------|
|---------------------------|--------|

ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND Device Name: IMAGING COUPLANT

Indications For Use:

UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace UltraBlo, as an in Wo bloompatible and brookers on in vivo bioshested on vivo biosxcretable, but sterilized transculaneous sounting gold transmilar sterile applications.

UltraBio will be used to couple sound waves between the patient and medical imaging electronic UltraBlo will be used to couple sound waves between in the material consisted on the consective transducers during intraoperative and intraction in and aspiration, intraoperative ultrasound imaging, and intracavity ultrasound imaging.

UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound Ultration is unlift use packaged, sichiles and interess for fluid alone or in combination with a latex, and procedures that canently use an undaound beaping get in the biocompatibility and bioelimination are required.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use }, (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)

Nancy C. Hodson

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number