(29 days)
None
Not Found
No
The summary describes a physical hydrogel pad used for acoustic coupling in ultrasound imaging. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No
The device is described as a coupling agent for ultrasound imaging, facilitating the transmission of sound waves for diagnostic purposes, not for treating any medical condition.
No
Explanation: The device, a coupling pad and fluid, facilitates ultrasound imaging by ensuring proper sound wave transmission. While ultrasound imaging is a diagnostic tool, the pad itself does not perform any diagnostic function; it merely aids in the acquisition of diagnostic images.
No
The device description explicitly mentions a "biocompatible ScanTac Membrane or Pad" which is a physical component (a hydrogel pad) used for acoustic coupling. This is a hardware component, not software.
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.
- Device Function: The description clearly states the device is a "biocompatible ScanTac Membrane or Pad" used to "couple sound waves between the patient's body and medical imaging electronics" during "medical diagnostic ultrasound imaging." It acts as a physical interface to improve the quality of the ultrasound image.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is applied externally to the patient's skin.
Therefore, its function is related to the process of obtaining an in vivo diagnostic image (ultrasound), not performing an in vitro diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The biocompatible ScanTac Membrane or Pad will be used during medical diagnostic ultrasound to couple sound waves between the patient's body and medical imaging electronics by being affixed to the active element of the transducer. The ScanTac is biocompatible, sterile, and, being solid, leaves no residue. It will be used for transcutaneous ultrasound imaging over surgical wounds, during transcutaneous biopsy and to enhance acoustic coupling to difficult geometries. The pad is sufficiently adherent to remain in place during the ultrasound exam. The pad is placed onto the patient, and to the hydrogel. The exposed side of the hydrogel pad will be rendered lubricous with an application of ultrasound coupling sterile fluid, including ScanLube™, water or saline.
Product codes
90 MUI
Device Description
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
Ms. Margaret J. Larson SONOTECH, Inc. 774 Marine Drive BELLINGHAM WA 98225 Re: K031894
Trade/Device Name: ScanTacTM Pad Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 MUI Dated: June 6, 2003
Received: July 1, 2003
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. Ilisting 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 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 contact the Office of Compliance 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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 6 of 17
i i
K031894 510(k) Number (if known) _
t Device Name: ScanTac Pad
Indications For Use:
The biocompatible ScanTac Membrane or Pad will be used during medical diagnostic rtte blocompansio Couple sound waves between the patient's body and medical imaging electronics by being affixed to the active element of the transducer. The Inflaging clectronics by ocatible, sterile, and, being solid, leaves no residue. It will be used for transcutaneous ultrasound imaging over surgical wounds, during used for transoutaneous biopsy and to enhance acoustic coupling to difficult geometries. The transoatuneous blopsy and is sufficiently adherent to remain in place during the r ad is placed onto the patient, and to e hydrogel. The exposed side of the hydrogel pad will be rendered lubricous with an application of ultrasound coupling sterile fluid, including ScanLube™, water or saline.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ાર
Prescription Use √
(Per 21 CFR 801.109)
David A. Lippman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Over-The-Counter Use.
| ・・
(Optional Formal 1-2-96)