(21 days)
Purelmage™ Sterile Ultrasound Transmission Gel is intended for use as the coupling medium for ultrasound procedures where sterility of the ultrasound transmission gel is preferred. The PureImage™ Sterile Ultrasound Transmission Gel is intended for use with imaging procedures only. As such it is indicated for use with transabdominal or transvaginal ultrasound diagnostic procedures.
PureImage™ Sterile Ultrasound Transmission Gel
The provided document is a 510(k) premarket notification letter from the FDA regarding a sterile ultrasound transmission gel. This type of document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/device performance study.
Ultrasound transmission gels are Class II medical devices used as a coupling medium for ultrasound procedures. Their regulatory clearance focuses on aspects like sterility, biocompatibility, and acoustic properties to ensure they perform their intended function without causing harm or interfering with the ultrasound signal. The evaluation typically involves:
- Sterility testing: To ensure the gel is free from viable microorganisms.
- Biocompatibility testing: To ensure the gel does not cause adverse biological reactions when in contact with the body.
- Acoustic impedance testing: To ensure the gel effectively transmits ultrasound waves between the transducer and the patient's skin.
- Viscosity and pH testing: To ensure the gel has appropriate physical characteristics for its intended clinical use.
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 marketed in interstate commerce prior to May 28, 1976..." This means the device was cleared based on substantial equivalence to existing devices, not necessarily on a novel performance study proving its diagnostic accuracy in the way an AI algorithm for image interpretation would be evaluated.
Therefore, I cannot extract the requested information from this document. The document describes a traditional medical device clearance, not an AI or diagnostic performance study.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
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
FEB - 8 2012
Mr. Matt Clausen Regulatory Affairs Specialist Medline, Industries, Inc. One Medline Place MUNDELEIN IL 60060
Re: K120156
Trade/Device Name: PureImage™ Sterile Ultrasound Transmission Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II -Product Code: ITX Dated: January 16, 2012 Received: January 18, 2012
Dear Mr. Clausen: .
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
PureImage™ Sterile Ultrasound Transmission Gel
Indications For Use:
Purelmage™ Sterile Ultrasound Transmission Gel is intended for use as the coupling medium for ultrasound procedures where sterility of the ultrasound transmission gel is preferred.
The PureImage™ Sterile Ultrasound Transmission Gel is intended for use with imaging procedures only. As such it is indicated for use with transabdominal or transvaginal ultrasound diagnostic procedures.
Contraindications: Not for use with defibrillators.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation
510K. K120156
§ 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.