SCANFLEX SOLID COUPLANT MEMBRANE

K983691 · Sonotech, Inc. · ITX · May 5, 1999 · Radiology

Device Facts

• Record ID: K983691
• Device Name: SCANFLEX SOLID COUPLANT MEMBRANE
• Applicant: Sonotech, Inc.
• Product Code: ITX · Radiology
• Decision Date: May 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

ScanFlex Solid Couplant Membranes is intended for use during transcutaneous (external) and invasive (intraoperative and/or endocavity) medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanFlex Solid Couplant Membranes are intended for use in sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures which currently use an ultrasound coupling gel or fluid in combination with a latex, polyurethane or polypropylene protective transducer cover. ScanFlex is intended for use in non-sterile transcutaneous applications where a solid couplant would be advantageous.

Device Story

ScanFlex Solid Couplant Membrane acts as an acoustic coupling medium for diagnostic ultrasound. It replaces traditional liquid/gel couplants and protective transducer covers (latex, polyurethane, polypropylene) in both sterile and non-sterile clinical environments. The membrane facilitates sound wave transmission between the patient's body and the ultrasound transducer. Used by clinicians during imaging procedures to improve workflow and maintain sterile fields. Benefits include elimination of messy gels and simplified setup for intraoperative or endocavity imaging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid membrane acoustic couplant. Designed for use as an interface between ultrasound transducers and patient tissue. Replaces liquid/gel couplants and protective covers. Non-electronic, passive device.

Indications for Use

Indicated for patients undergoing diagnostic ultrasound imaging, including transcutaneous, intraoperative, and endocavity procedures. No specific age or gender restrictions; contraindicated only where ultrasound imaging itself is contraindicated.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 5 1999

Margaret J. Larson President Sonotech, Inc. P.O. Box 2189 Bellingham, WA 98227-2189 RE:

K983691 ScanFlex Solid Couplant Membrane Dated: February 10, 1999 Received: April 6, 1999 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Ms. Larson:

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 redassified 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 (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,

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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510(k) NUMBER (IF KNOWN) : k 983691

DEVICE NAME : ScanFlex Solid Couplant Membrane

INDICATIONS FOR USE:

ScanFlex Solid Couplant Membranes is intended for use during transcutaneous (external) and invasive (intraoperative and/or endocavity) medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanFlex Solid Couplant Membranes are intended for use in sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures which currently use an ultrasound coupling gel or fluid in combination with a latex, polyurethane or polypropylene protective transducer cover. ScanFlex is intended for use in non-sterile transcutaneous applications where a solid couplant would be advantageous.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96

Stinid le. Segman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyic 510(k) Number