(167 days)
Not Found
Not Found
No
The 510(k) summary describes an ultrasound coupling gel, which is a passive material used to facilitate ultrasound imaging. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is described as an "ultrasound imaging couplant" used to facilitate diagnostic ultrasound imaging procedures by coupling sound waves and lubricating imaging devices. Its intended use is solely for diagnostic purposes, not for treating any medical condition or disease.
No
The device is described as an "ultrasound imaging couplant" which is used to enhance the quality of diagnostic ultrasound imaging by coupling sound waves and lubricating imaging devices. It itself is not a diagnostic device; rather, it is an accessory used in diagnostic procedures.
No
The device description clearly identifies the device as a "Couplant," which is a physical substance (gel or fluid) used to facilitate ultrasound imaging. 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 clearly states that the device is used during invasive medical diagnostic ultrasound imaging to couple sound waves and lubricate devices. It is a physical coupling agent and lubricant used in vivo (within the living body) during the imaging procedure itself.
- Device Description: The description "In Vivo Biocompatible Sterile Ultrasound Imaging Couplant" further emphasizes its use within the body.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information about a patient's health status. This device does not analyze any biological specimens.
Therefore, the VivoSonic - In Vivo Biocompatible Sterile Ultrasound Imaging Couplant is a medical device used in vivo during ultrasound procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices.
Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging.
Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.
Product codes
90 ITX
Device Description
VivoSonic In Vivo Biocompatible Sterile Ultrasound Imaging Couplnat
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
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)
Not Found
Reference Device(s)
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
UMAN SERVICE
JUN .8 1999
Bellingham, WA 98227-2189
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re:
K984562 VivoSonic (Diagnostic Ultrasound Imaging Coupling Media) Dated: April 1, 1999 Received: April 9, 1999 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Larson:
Margaret J. Larson
President
Sonotech. Inc.
P.O. Box 2189
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 predicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Dan Petit, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
(98-156)
Image /page/1/Picture/1 description: The image shows the word "SONOTECH" in bold, sans-serif font. To the left of the word is a logo of a dolphin jumping out of the water, with a sun in the background. The logo and the word are both in black and white. The image is clear and easy to read.
Sonotech, Inc. 774 Marine Drive, Bellingham, WA 98225 360/671-9121 fax: 360/671-9024 plarson@nas.com
Registration # 2523891
8 1899 JUN
510(k) Application: VivoSonic - In Vivo Biocompatible Sterile Ultrasound Imaging Couplant
Page 6 of 16
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510(k) Number (if known):
VivoSonic In Vivo Biocompatible Sterile Ultrasound Imaging Couplnat Device Name:
Indications For Usc:
(Pcr 21 CFR 801.109)
Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices.
Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging.
Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
| 510(k) Number | K984562 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Formal 1-2-96)