(42 days)
Not Found
Not Found
No
The 510(k) summary describes a sterile ultrasound coupling gel, not a device that processes or analyzes data using AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an ultrasound coupling gel used for diagnostic imaging procedures, not for treatment or therapy. Its purpose is to facilitate sound wave transmission for imaging, not to treat a condition.
No
Explanation: The device is an ultrasound couplant used to facilitate imaging, not for diagnosing conditions itself. It is a sterile medium used to couple sound waves for diagnostic ultrasound procedures, but it does not perform the diagnosis.
No
The device description clearly states "UltraBio - In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant," indicating a physical substance (couplant) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- UltraBio's Intended Use: UltraBio is described as a "sterile couplant" used to facilitate ultrasound imaging by coupling sound waves between the patient and the transducer. It is applied to the patient's body (transcutaneous and intracavitary) during imaging procedures.
- No Sample Analysis: The description does not mention any analysis of biological samples taken from the patient. UltraBio's function is purely physical – to improve the transmission of ultrasound waves.
Therefore, UltraBio falls under the category of a medical device used in vivo (within the living body) to aid in diagnostic imaging, rather than an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace sterilized transcutaneous scanning gels that are not in vivo biocompatible or in vivo bioeliminated during surgical procedures, biopsies and similar sterile applications.
UltraBio will be used to couple sound waves between the patient and medical imaging electronic transducers during intraluminal, intracavitary and transcutaneous ultrasound imaging procedures. It will be used with transcutaneous and intracavity ultrasound imaging.
UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or fluid alone or in combination with an accessory where sterility, biocompatibility and bioelimination are required.
Product codes
90 MUI
Device Description
UltraBio - In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant
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): 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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2004
Ms. Margret J. Larson President SonoTech, Inc. 77 Marine Drive BELLINGHAM WA 98227-2189 Re: K042619
Trade/Device Name: UltraBio - In Vivo Biocompatible Bioeliminated Sterile Ultrasound Imaging Couplant Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 MUI Dated: October 14, 2004 Received: October 18, 2004
Dear Ms. Larson:
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 reguirements 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 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 Section 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), please 11 you atter of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page & of 14
S 10(k) Number (if known):
UltraBio - In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Device Name: Imaging Couplant
Indications For Use:
UltraBio, as an in vivo biocompatible and bioexcretable steriie couplant, is intended to UltraBio, as an in Wo blocompanible and not in vivo biocompatible or in
replace sterilized transcutaneous scanning gels that are dures, bionsies and replace stemlized transcularleous sozning gols that are and surgical procedures, biopsies and similar sterile applications.
UltraBio will be used to couple sound waves between the patient and medical imaging the UltraBio will be used to couple sound water and intracavitary medical diagnostic electionic transducers during intrasers manscars maus ultrasound image
ultrasound imaging procedures. It will be used with transcutaneous and intracewity ultrasound imaging procedures. Tt will be dood may a virus and intracavity ultrasound imaging.
UltraBio is unit dose packaged, stenlized and intended for use in all diagnostic UltraBio is thit dose packaged, stehlized and intoning gel or fluid alone on in
ultrasound procedures that currently use an ultrasound coupling get or fluid annonyments stori ultrasound procedures that carrently aso an altrans and one where sterility Combination with a latthility and bioelimination are required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Nancy C. Brogdon
(Division Sian-Off Division of Reproductive, Al and Radiological Devices 510(k) Number