← Product Code [MUI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUI) · K102637 # DYNAREX ULTRASOUND GEL (K102637) _Dynarex Corporation · MUI · Feb 16, 2011 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUI/K102637 ## Device Facts - **Applicant:** Dynarex Corporation - **Product Code:** [MUI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUI.md) - **Decision Date:** Feb 16, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1570 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective prenatal scans. Dynarex Ultrasound Gel is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel is intended to facilitate projecting a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only. Not for use with defibrillators. ## Device Story Dynarex Ultrasound Gel is a viscous, water-soluble, blue coupling medium; applied to external, intact skin to facilitate transmission of pulsed sound beams during ultrasound imaging. Device functions by providing acoustic coupling between transducer and body tissue; enables projection of sound beams to determine tissue interface depth/location and measure acoustic pulse duration. Used in clinical settings during diagnostic and elective prenatal ultrasound procedures. Applied by clinicians; removed post-procedure with tissue or towel. Benefits patient by ensuring effective acoustic signal transmission for imaging. Not for use with defibrillators. ## Clinical Evidence Bench testing only. No clinical data presented. Performance metrics compared against predicate include acoustic speed (1530.1 m/s vs 1549.5 m/s), acoustic attenuation (0.04 +/- 0.018 dB/cm/MHz vs < 0.05 dB/cm/MHz), acoustic impedance (1.505 MRayl vs 1.561 MRayl), and electroconductivity (1.930 +/- 0.026 mS/cm vs 1.349 +/- 0.003 mS/cm). Biocompatibility testing performed per ISO 10993. ## Technological Characteristics Viscous, water-soluble, blue gel. Acoustic coupling medium. Key technical specs: Acoustic speed 1530.1 m/s; Acoustic attenuation 0.04 +/- 0.018 dB/cm/MHz; Acoustic impedance 1.505 MRayl; Electroconductivity 1.930 +/- 0.026 mS/cm. Biocompatibility tested per ISO 10993. ## Regulatory 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. ## Predicate Devices - LiquaSonic Ultrasound Gel ([K841871](/device/K841871.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510263 FEB 1 6 2011 ## 510(K) SUMMARY (as required by 807.92(c)) Submitter of 510(k): Dynarex Corporation 10 Glenshaw Street Orangeburg, NY 10972 USA Phone: (845) 365-8200 Fax: (845) 365-8201 Contact Person: Daniel Consaga Date of Summary: Classification Name: December 20, 2010 Dynarex Ultrasound Gel. Trade/Proprietary Name: Diagnostic Ultrasonic Transducer Product Code: MUI #### Intended Use: Dynarex Ultrasound Gel is intended for use as the coupling medium for ultrasound procedures on external, intact skin. Not for use with defibrillators. ### Device Description: Dynarex Ultrasound Gel is a viscous, clear blue, water soluble gel. Typical packaging configurations for the Dynarex Ultrasound Gel is 250 ml plastic bottle, 1 Liter plastic bottle and 5liter plastic container. Other sizes may become available. #### Predicate Device: LiquaSonic Ultrasound Gel 510k Number K841871 manufactured by CHESTER LABS, INC. Erlanger, KY 41018. ### Substantial Equivalence: The Dynarex Ultrasound Gel provides an effective coupling between the tissue being examined and the ultrasound unit. Its function and performance are similar to the predicate device as presented in this 510(k) #### Safety and Effectiveness of the device: This device is as safe and effective as the predicate device cited above. This is better expressed in the Test Report for ISO 10993 and Test Report Number HIA_DYN_GEL_AM Dated August 27, 2008. {1}------------------------------------------------ ## 510(K) SUMMARY (as required by 807.92(c)) Summary comparing technological characteristics with other predicate device: Dynarex Ultrasound Gel is similar in terms of intended use and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound devices to skin. The device is substantially equivalent with respect to indications for use and other physical characteristics to predicate devices in terms of section 510(k) substantial equivalency. Please find below a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution. | TECHNOLOGICAL CHARACTERISTICS | Dynarex Gel Comparison
to
LiquaSonic Ultrasound Gel - 510K # K841871 | |-------------------------------|----------------------------------------------------------------------------| | Indications for use | Substantially Equivalent | | Target Population | Substantially Equivalent | | Materials | Substantially Equivalent | | Biocompatibility | Substantially Equivalent | | Anatomical sites | Substantially Equivalent | ## Performance Summary: FDA has not established special controls or performance standards for this device. | TECHNOLOGICAL CHARACTERISTICS
Performance | Dynarex
Ultrasound Gel
510K # K102637 | LiquaSonic
Ultrasound Gel
510K # K841871 | |------------------------------------------------------------|---------------------------------------------|------------------------------------------------| | Acoustic Speed Measurement (m/s) | 1530.1 | 1549.5 | | Acoustic Attenuation Coefficient - Avg. 3 Lots (dB/cm/MHz) | 0.04 +/- 0.018 | < 0.05 | | Acoustic Impedance Measurement (MRayl) | 1.505 | 1.561 | | Electroconductivity Avg. 3 Lots (mS/cm) | 1.930 +/- 0.026 | 1.349 +/- 0.003 | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines above it. ### 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 Mr. Daniel Consaga Quality Engineer Dynarex Corporation 10 Glenshaw Street ORANGEBURG NY 10962 FEB 1 6 2 34 Re: K102637 Trade/Device Name: Dynarex Ultrasound Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasound transducer Regulatory Class: II Product Code: MUI Dated: December 20, 2010 Received: January 10, 2011 ### Dear Mr. Consaga: 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 of {3}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) 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 Viro 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/ReportalProblem/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 S Postel Mary Pastel, ScD. Director · Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K102637 Device Name: Dynarex Ultrasound Gel Indications for Use: Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective prenatal scans. Dynarex Ultrasound Gel is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel is intended to facilitate projecting a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only. Contraindications: Not for use with defibrillators. Prescription Use X (Part 21 CFR 801 Subpart D) AND/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 (@GE) (JYV Michael D'Ohm 510K K1026637 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUI/K102637](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUI/K102637) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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