SCANTAC MEMBRANE OR SCANTAC STRIP

K013170 · Sonotech, Inc. · ITX · Nov 13, 2001 · Radiology

Device Facts

• Record ID: K013170
• Device Name: SCANTAC MEMBRANE OR SCANTAC STRIP
• Applicant: Sonotech, Inc.
• Product Code: ITX · Radiology
• Decision Date: Nov 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The biocompatible ScanTac Strips will be used to couple sound waves between the patient's body and medical imaging electronics. ScanTac Strips are biocompatible, sterile, and, being solid, leave no residue. They are single use and disposable. ScanTac Strips are intended for use in sterile fields substituting for an ultrasound coupling gel or fluid, as currently used, in combination with a latex, polyurethane, polypropylene or other polymeric transducer cover. The ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds and to enhance imaging contact over difficult geometries. The ScanTac Membrane has a backing on one side that is removed prior to transcutaneous scanning. The Membrane is placed onto the patient, and is sufficiently adherent to remain in place during the scan due to the adhesive nature of the hydrogel. Either water or ultrasound scanning gel is used.

Device Story

ScanTac Membrane and ScanTac Strip are solid, biocompatible hydrogel-based ultrasound coupling devices. They function as a substitute for traditional liquid ultrasound coupling gels. The devices are applied to the patient's skin to facilitate the transmission of sound waves between the body and the ultrasound transducer. ScanTac Strips are designed for use in sterile fields in conjunction with transducer covers. ScanTac Membrane is designed for use over wounds or irregular anatomical geometries to ensure consistent contact. Both products are single-use and disposable. They are intended for use by healthcare professionals in clinical settings where ultrasound imaging is performed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid hydrogel-based ultrasound coupling medium. Devices are sterile, single-use, and disposable. ScanTac Membrane features an adhesive backing for skin attachment. ScanTac Strips are designed for use with polymeric transducer covers.

Indications for Use

Indicated for use as an ultrasound coupling medium between the patient's body and medical imaging electronics, specifically for sterile field applications (Strips) and transcutaneous imaging over wounds or difficult geometries (Membrane).

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 (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUM." is arranged in a circular fashion around the left side of the emblem.

## Food and Drug Administration

Public Health Service

9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2001

Ms. Margaret J. Larson President Sonotech, Inc. 774 Marine Drive BELLINGHAM WA 98225 Re: K013170

Kol 3170
Trade/Device Name: ScanTacTM Membrane and ScanTac™ Strip Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: September 20, 2001 Received: September 24, 2001

Dear Ms. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premaise is substantially equivalent (for the indications
referenced above and have determined the device is subservarketed in interstate referenced above and have decembed the uneves is socicate devices marketed in interstate for use stated in the enclosites to tegen manent date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactures assists of the Federal Food. Drug, commerce prior to May 28, 1970, the enactinent with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) mat do not request approve or a prairols provisions of the Act. The Act. The Act. The You may, therefore, market the device, subjor to the gents for amual registration, listing of
general controls provisions of the Act include requirements for amainet misbrand general controls provisions of the Act monde requirement would be and misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see ablve) and critics major regulations affecting your device can be
it may be subject to additional controls. Existing major resplation EDA it may be subject to additional controls. Little 21, Parts 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Farts 800 to 898. In additi found in the Code of Federal Regulations, sour device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subscription with other requirements of the Act
that FDA has made a determination that your device Edgeral accepcies. You must that FDA has made a decemination administered by other Federal agencies. You must or any Federal Statutes and regulations, but not limited to: registration and listing comply with all the Act s requirements, meaning coursective requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requiremle, the ele (2) CFR Part 807); labelling (21 CFR Patis 800); and if applicable, the electronic
forth in the quality systems (QS) regulation (2) CFR Patt 820); and if applicable, the elec forth in the quality systems (QS) rogulation (ST -542 of the Act); 21 CFR, 1000-1050.
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 510(k) premakely This letter will allow you to begin marketing your device to a legally marketed
notification. The FDA finding of substantial equivalerse and vice to a legally marketed notification. The FDA finding of substanial equivaled or Jersian 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 advice for your device of our laceming any and on the regulation number at the top of this 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, for questions on the production and access note the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please note the regulation Office of Compliance at (501) 5944057. Also, 2019.97). Other general information of Small Manufacturers by reference to premarket nouncation (21 CL+++ + C+++++ + Division of Small Manufacturers,
your responsibilities under the Act may be obtained from the [phone] or (301 your responsibilities under the Assistance at its toll-fires mumber [phone] or [phone]
International and Consumer Assistance at its toll-fires manner (800) 638-International and Consumer Hesissa.fo's agov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

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Enclosure

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## NOV 1 3 2001

K013170 510(k) Number (il known):_

SCANTAC MEMBRANE (OR) SCANTAC STRIP Device Name:

Indications For Use:

The biocompatible ScanTac Strips will be used diagnostic ultrasound
The biocompatible Scan between the natient's body and medical imaging The biocompatible Scan'tac Strips will be used and medical imaging in imaging to couple sound waves between the palletic boor and being solid, leave no
electronics. ScanTac Strips are biocompatible, sterile, and, being solid, leave no electronics. ScanTac Strips are biocompanie, strips are intended for use intended for use in
residue. They are single use and disposable. ScanTac Strips are intended for used residue. They are single use and disposable. Scarrely used on fluid, as currently used, in
sterile fields substituting for an ultrasound coupling gel or fluid, as currentl sterile fields substituting for an ultrasound Couping gol of Mara, in other polymeric protective
combination with a latex, polyurethane, polypropylene or other polymeric p transducer cover.

The ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds The ScanTac Membrane is used for transcutaneous unascone maging Membrane has
and to enhance imaging contact over difficult geometries. The ScanTac Membrane has and to enhance imaging contact over diments on to transcutaneous scanning. The Membrane
a backing on one side that is removed prior to transcutaneous scanning the scan a backing on one side that is removed proctories and in place during the scan
is placed onto the patient, and is sufficiently adherent to remain in place during gel is is placed onto the patient, and is sumcently adherent or onultrasound scannound scanning gel is
due to the adhesive nature of the hydroge. Either water or ultrasound scannin due to the adnesive hature of the nyarogen. "Lines and the exposure in the exposure in

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

FDA/CDRH/0DE/NC

Ост 5 1 50 Pl! '01

RECEN'D

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use..

(Optional Format 1-2-96)

(Division
Division o
Abdominal,
510(k) Number
2013120

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