(308 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on its function as a couplant for ultrasound imaging, not on data processing or analysis.
No
The device, UltraBio, is described as a sterile couplant for medical imaging (ultrasound) to facilitate sound wave transmission, not to provide therapy. Its intended use focuses on diagnostic procedures.
No
The device is a couplant for medical imaging, specifically ultrasound. It facilitates the sound waves between the patient and medical imaging equipment but does not itself provide a diagnosis.
No
The device is described as a sterile couplant, which is a physical substance used to facilitate ultrasound transmission. This is a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that UltraBio is a "sterile couplant" used to "couple sound waves between the patient and medical imaging electronic transducers" during various ultrasound procedures. This describes a device used on the patient for imaging, not a device used to test samples from the patient in a laboratory setting.
- Nature of the Device: The description focuses on the physical properties of the couplant (biocompatible, bioexcretable, sterile) and its function in transmitting sound waves. This is consistent with a medical device used externally or internally for imaging, not a diagnostic test performed on biological samples.
- 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 laboratory testing.
Therefore, UltraBio is a medical device used in conjunction with ultrasound imaging, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace other in vivo biocompatible and bioexcretable, but not sterilized transcutaneous acoustic coupling gels or similar sterile applications.
UltraBio will be used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavity ultrasound imaging, biopsy and aspiration, intraoperative ultrasound imaging, 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 alone or in combination with a latex, and in which biocompatibility and bioelimination are required.
Product codes
90 MUI
Device Description
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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
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2004
Ms. Peg Larson President SONOTECH, Inc. 774 Marine Drive BELLINGHAM WA 98225-1530 Re: K033178
Trade/Device Name: Ultrabio - InVivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 MUI Dated: July 12, 2004 Received: July 20, 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 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 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
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you to ogen manies of substantial equivalence of your device to a legally premarket notheation. The Price is 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 If you desire specific advise at one of the following numbers, based on the regulation number at the top of the 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, 101 questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or othernes an (enotification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your respensional 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. Bugden
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 7 of 19
| 510(k) Number (if known): | K03317 |
|---|---|
| --------------------------- | -------- |
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND Device Name: IMAGING COUPLANT
Indications For Use:
UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace UltraBlo, as an in Wo bloompatible and brookers on in vivo bioshested on vivo biosxcretable, but sterilized transculaneous sounting gold transmilar sterile applications.
UltraBio will be used to couple sound waves between the patient and medical imaging electronic UltraBlo will be used to couple sound waves between in the material consisted on the consective transducers during intraoperative and intraction in and aspiration, intraoperative ultrasound imaging, and intracavity ultrasound imaging.
UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound Ultration is unlift use packaged, sichiles and interess for fluid alone or in combination with a latex, and procedures that canently use an undaound beaping get in the biocompatibility 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 }, (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
Nancy C. Hodson
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number