WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL

K012522 · National Therapy Products, Inc. · ITX · Oct 18, 2001 · Radiology

Device Facts

• Record ID: K012522
• Device Name: WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
• Applicant: National Therapy Products, Inc.
• Product Code: ITX · Radiology
• Decision Date: Oct 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

WAVELEWATH MULTI - PURPOSE ULTRASO UND GEL IS INTENDED TO BE USED AS A Coupling MEDUAL FOR ULTRASOUND TRANSMISSION. APPLY WAVELENGTH TO TREATMENT AREA. RESUITE AFTER TREATHENT WITH TISSUE OR TOWEL . CHEAN EQUIPMENT AND RINSE TOWERS IMMEDIATELY AFTER USE. FOR EXTERNAL USE SNLY. NOT FOR USE USE LITH DEFIBERTY CONSELFANTS

Device Story

Wavelength Multi-Purpose Ultrasound Gel is a topical coupling medium applied to the skin to facilitate ultrasound transmission during diagnostic or therapeutic ultrasound procedures. The gel is applied to the treatment area by a clinician or user; it acts as a conductive interface between the ultrasound transducer and the patient's skin to minimize air gaps and improve signal quality. Following the procedure, the gel is removed from the skin and equipment using a tissue or towel. The device is intended for external use only and is contraindicated for use with defibrillators.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Aqueous-based ultrasound coupling gel; viscous liquid form factor; non-sterile; external application; intended for use with diagnostic ultrasound transducers (21 CFR 892.1570).

Indications for Use

Indicated for use as a coupling medium for ultrasound transmission on external body surfaces.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2001

Mr. Paul Hooey President National Therapy Products, Inc. 2-191 Rowntree Dairy Road WOODBRIDGE ONTARIO L4L 8B8 CANADA

Re: K012522

Trade/Device Name: Wavelength Multi-Purpose Ultrasound Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: September 21, 2001 Received: September 24, 2001

Dear Mr. Hooey:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocurely be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regally comment date of the Medical Device Amendments, or to connice. provide in thay 20, 1970, in the provisions of the Federal Food, Drug, devices mat have been resulted in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, manot and include requirements for annual registration, listing of general oonly of the was a wactice, 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 your device is classified (600 a00 v). Existing major regulations affecting your device can be it may be subject to additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any I edelar statutes and roguinents, including, but not limited to: registration and listing Comply with an all the Frequirements, a 801); good manufacturing practice requirements as set (21 CFR Part 607), facemig (21 OFF Part 820); and if applicable, the electronic forth in the quality systems (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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), please contact the Office of Compliance at one of the following numbers, based 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and 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. Srygdon

Nancv 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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K012522 510(k) Number (if known): Device Name: WAVELENG TH NULTI ULTRASSO ULTRASOUND GEL

Indications For Use:

WAVELEWATH MULTI - PURPOSE ULTRASO UND GEL IS INTENDED TO BE USED AS A Coupling MEDUAL FOR ULTRASOUND TRANSMISSION.

APPLY WAVELENGTH TO TREATMENT AREA. RESUITE AFTER TREATHENT WITH TISSUE OR TOWEL . CHEAN EQUIPMENT AND RINSE TOWERS IMMEDIATELY AFTER USE. FOR EXTERNAL USE SNLY. NOT FOR USE USE LITH DEFIBERTY CONSELFANTS (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Snowdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number. OR `K012522` Over-The-Counter Use

Prescription Use (Per 21 CFR 801.109)

NEEDED)

(Optional Formal 1-2-96)