(153 days)
Not Found
Not Found
No
The 510(k) summary describes an ultrasound lotion, which is a conductive medium, not a device that processes data or images using AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device description states it is for use with "diagnostic and therapeutic ultrasonic transducers and ultrasound monitors," and the intended use mentions "Apply Wavelength to treatment area." While the device itself is a conductive medium and not the transducer, its purpose directly supports the function of therapeutic ultrasound procedures.
No
The device is described as a "conductive medium for use in diagnostic and therapeutic ultrasonic transducers and ultrasound monitors," not as a device that performs a diagnosis itself. It facilitates the function of diagnostic devices but is not one itself.
No
The device description clearly states it is a "conductive medium" and a "lotion," indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "conductive medium for use in diagnostic and therapeutic ultrasonic transducers and ultrasound monitors." This indicates its function is to facilitate the transmission of ultrasound waves, not to perform a diagnostic test on a sample taken from the body.
- Device Description: The description reiterates its function as a conductive medium for ultrasound.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on the analysis of such samples.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This device does not fit that description.
N/A
Intended Use / Indications for Use
Wavelength Ultrasound Lotion is a conductive medium for use in diagnostic and therapeutic ultrasonic transducers and ultrasound monitors. This device is intended to be used as a couplant for ultrasound equipment.
Product codes
90 MUI
Device Description
Wavelength Ultrasound Lotion is a conductive medium intended to be used as a couplant for ultrasound equipment. It is applied to the treatment area and removed after treatment with tissue or towels. For external use only.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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 is a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center. The symbol is a stylized depiction of a human figure embracing a bird. The text "HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2002
Mr. Paul L. Hooey President National Therapy Products, Inc. 2-191 Rowntree Dairy Road Woodbridge, Ontario, L4L 8B8 CANADA
Re: K013212
Trade/Device Name: Wavelength Ultrasound Lotion Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 MUI Dated: February 8, 2002 Received: February 11, 2002
Dear Mr. Hooey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 noutleation. The I Dr I mailing of castion 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 II you desire specific advice 101 your an 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 Additionally, for questions 01 (301-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by relected to promation the Act may be obtained from the Division of Small Manufacturers, your responsional 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. Croydon
Nancy 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 1 of 1
510(k) Number (if known): K013212
Device Name: WAVELENGTH ULTRASOUND LOTION
Indications For Use:
Wavelength Ultrasound Lotion is a conductive medium for use in diagnostic Waveleugur Ultrasound Dotton's a co- . This device is intended to be used as and therapedite ultrasonic transducers and ultrasound monitors.
Apply Wavelength to treatment area. Remove after treatment with tissue or Apply Wavelength to treatment arowels after use. For external use only.
Contraindications: Not for use with defibrillators
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sig Division of Repro and Radiological D 510(k) Num Over-The-Counter Use______ ાર Prescription Use_ (Optional Format 1-2-96 (Per 21 CFR 801 109)