(55 days)
The Safersonic® Sonography Cover is intended to be used as a sterile, single-use protective cover of an ultrasonic transducer. The Safersonic provides a sterile, microbial barrier between the transducer and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulates to the patient. The Safersonic Covers are for use during procedures with sector, linear, intravaginal and rectal transducers.
Not Found
This document is an FDA 510(k) clearance letter for the Safersonic® Sonography Cover. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The information provided describes a decision by the FDA that the Safersonic® Sonography Cover is substantially equivalent to legally marketed predicate devices for its intended use as a sterile, single-use protective cover for ultrasonic transducers. The letter refers to the device's function as a sterile, microbial barrier to prevent the transfer of microorganisms, body fluids, and particulates.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document as it pertains to the type of device described (a physical medical cover, not an AI/ML algorithm).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Safersonic Medizinprodukte GmbH % Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 5401 S. Cottonwood St. GREENWOOD VILLAGE CO 80121
NOV 1 0 2009
Re: K092858
Trade/Device Name: Safersonic® Sonography Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: September 15, 2009 Received: September 16, 2009
Dear Mr. Walls:
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 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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Irvine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
092858 510(k) Number (if known): __
Device Name: Safersonic® Sonography Cover
Indications for Use: The Safersonic® Sonography Cover is intended to be used as a sterile, single-use protective cover of an ultrasonic transducer. The Safersonic provides a sterile, microbial barrier between the transducer and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulates to the patient. The Safersonic Covers are for use during procedures with sector, linear, intravaginal and rectal transducers.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arry M Whz
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device
:
K022858
510(k) Number
Page 1 of 1
§ 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.