(29 days)
The biocompatible ScanTac Membrane or Pad will be used during medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics by being affixed to the active element of the transducer. The pad 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 procedure. The pad is placed onto the patient, and is a 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.
Not Found
The provided text is an FDA 510(k) clearance letter for a device called "ScanTacTM Pad." This document does not contain the information requested about acceptance criteria and the study proving device performance.
The letter is a notification of substantial equivalence for marketing the device. It focuses on regulatory classifications, general controls, and compliance requirements, rather than detailed performance study results.
Therefore, I cannot provide the requested table and information based on the given input.
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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.
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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 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
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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)
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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.
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(Optional Formal 1-2-96)
§ 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.