(42 days)
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 in surgical procedures, biopsies and similar sterile applications.
UltraBio will be used to couple sound waves between the patient and medical imaging electronic transducers during transcutaneous and intracavitary medical diagnostic 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 a latex sheath where sterility and bioelimination are required.
UltraBio - In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant
The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "UltraBio - In Vivo Biocompatible Bioeliminated Sterile Ultrasound Imaging Couplant". This document is an approval letter for a medical device and does not contain information about acceptance criteria, device performance studies, or clinical trial details as requested in your prompt.
The letter explicitly states: "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". This indicates that the device's approval is based on its substantial equivalence to existing predicate devices, rather than a new study proving specific performance against acceptance criteria.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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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.
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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
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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
§ 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.