(73 days)
Not Found
Not Found
No
The 510(k) summary describes an ultrasound gel, which is a passive coupling medium and does not involve any processing or analysis of data using AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is described as an ultrasound gel for transmission, not a device that itself provides therapeutic benefits or performs a therapeutic function. It is a coupling medium.
No
The device is described as "WAVELEWATH MULTI - PURPOSE ULTRASO UND GEL IS INTENDED TO BE USED AS A Coupling MEDUAL FOR ULTRASOUND TRANSMISSION." This indicates it is a medium for facilitating ultrasound transmission, not for diagnosing conditions.
No
The device is described as an ultrasound gel, which is a physical substance used for coupling. This is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a coupling medium for ultrasound transmission." This describes a substance used externally to facilitate the transmission of ultrasound waves into the body for imaging or therapy.
- Lack of Diagnostic Purpose: IVDs are devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the analysis of biological specimens for diagnostic information.
- Input Modality: The input modality is Ultrasound, which is an imaging technique applied to the body, not a method for analyzing biological samples.
Therefore, the function of this device is to aid in the physical process of ultrasound transmission, not to perform a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
WAVELEWATH MULTI - PURPOSE ULTRASUND GEL IS INTENDED TO BE USED AS A Coupling MEDUAL FOR ULTRASOUND TRANSMISSION.
Product codes
90 ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH &" are arranged vertically along the left side of the logo, and the words "HUMAN SERVICES" are arranged vertically along the right side of the logo.
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.
1
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
2
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)