WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL by NATIONAL THERAPY PRODUCTS INC.

The provided FDA 510(k) document for "Wavelength Multi-Purpose Ultrasound Gel" is a clearance letter, not a study report or a detailed submission containing acceptance criteria and performance data. Therefore, it does not contain the specific information requested regarding device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bocurely be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the device was cleared based on its substantial equivalence to an already legally marketed device, not necessarily through a new de novo study with acceptance criteria and performance metrics.

Therefore, I cannot provide the requested information from the provided text.

To answer your questions, I would need access to the actual 510(k) submission document or a detailed study report for the "Wavelength Multi-Purpose Ultrasound Gel" that outlines its performance testing.

However, I can extract the following relevant information from the provided document:

Trade/Device Name: Wavelength Multi-Purpose Ultrasound Gel
Regulation Number: 21 CFR 892.1570
Regulation Name: Diagnostic Ultrasound transducer (This is the regulation for the device the gel is used with, not directly the gel itself, but indicates its intended context.)
Product Code: 90 ITX
Indications For Use: "Wavelength Multi-Purpose Ultrasound Gel is intended to be used as a coupling medium for ultrasound transmission."

In a typical 510(k) submission for a device like an ultrasound gel, "acceptance criteria" and "device performance" would primarily revolve around:

Physical and Chemical Properties: Viscosity, pH, acoustic impedance, absence of air bubbles, stability over time, microbial purity, cytotoxicity, skin irritation, and sensitization.
Acoustic Transmission: Demonstration that the gel effectively transmits ultrasound waves without significant attenuation or interference. This would typically be compared to a predicate device.

The study that "proves the device meets the acceptance criteria" would likely be a series of bench tests and possibly biocompatibility studies comparing the gel's properties to those of a legally marketed predicate ultrasound gel. However, the details of such tests are not present in this clearance letter.

Summary

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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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page ⓘ of ⓘ

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](https://510k.innolitics.com/search/K012522) Over-The-Counter Use

Prescription Use (Per 21 CFR 801.109)

NEEDED)

(Optional Formal 1-2-96)

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.