Advance Medical Designs, Inc. Sterile Ultrasound Gel

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked vertically, creating a sense of unity and collaboration. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 25, 2017 Advance Medical Designs, Inc. % Mr. David Mackie QA/RA Manager 1241 Atlanta Industrial Drive MARIETTA GA 30066 Re: K163050 Trade/Device Name: Advance Medical Designs, Inc. Sterile Ultrasound Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: October 9, 2017 Received: October 10, 2017 Dear Mr. Mackie: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | | FOR FOR FOR 3888 (8/14<br>Page 1 of 1 | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | a proved on the results on the pribrish works includes in other word in the news the<br>ədi bulbuları ,əsnoqsər rəq sunor et bətənirəs si noitəmini in noixəllər sinfi 10 noitəlif və əmii nəbrud ərt<br>of this information collection, including suggestions for reduction in this burder, to:<br>ə bir mənələrin mənisi ədədir. Bu məşğul gəlir. Bu məşğul və qarşı və qalan mənisə olan mənisə olan mən<br>of the count<br>. WOJER SSAREDA JIAMS FIATS ARA SHT OT MAOT GATTINGS AND OGS<br>See to to to A notibuben yourseas and to stremeringer of your seildqs noileas sing<br>i<br>Office of Chief Information Officer<br>Destment of Heath and Human Services<br>PRASStaff@fda.hhs.goov<br>State<br>Food and Drug Administration | | | כסתרות שנוש את הקרי PAGE FF NEEDED | | I Over-The-Counter Use (2) CFR 80 1 Suppart C) | Type of Use (Select one or both, as applicable)<br>A Presscription Use (Fart 21 CFR 801 Subpart D | | | | | | ຣາ, 1 ເຂົ້າມາອອດເຕີ ສິບເຂົ້າມາ ວ່າງອອກສຽງ ເຮຍາລະວັນທຸກ ລວຍງານຣ<br>ylub əsri notiqi sənd və bələdinin sinfini və bulunan buna mərkət əsərlər təsir. Əhalisi ətrafında ələ<br>າດີ ຄ່ຳອາກ ກວ່າຮະເຫລາຍສະຫຼາຍ 107 bebreini ຂ່າ ໄອວ ປັດເທດຂະໜຸໄປ ອປ່າຈາກ , ຂອງບັນອົດ ໄລວ່ເວລາ ປະຈຳນອາ<br>Indications for Use (Describe) | | | Advance Medical Designs, Inc. Sterile Ultrasound Gel<br>Device Name | | | K163050<br>510(k) Number (if known | | Form Approved: OMB No. 0810-0120<br>ee PRA Statement below.<br>xpiration Date: January 31, 2017 | DEPARTMENT OF HEALTH AND HUMMA SERVICES<br>ndications for Use<br>Food and Drug Administration | {3}------------------------------------------------ 510(k) Summary Advance Medical Designs, Inc. Sterile Ultrasound Gel Common Name: Ultrasound Gel Product Code: MUI Device classification: Class II 21 CFR 892.1570 Traditional 510(k) Submission October 20, 2017 ## General Information - 510(k) owner's name: 0 Advance Medical Designs, Inc. 1241 Atlanta Industrial Drive Marietta, GA 30066 USA (770) 422-3125 - o Contact person: David Mackie, QA/RA Manager at Advance Medical Designs, Inc. (770) 422-3125 ext. 244 mackied@advmeddes.com . Prepared on October 20, 2017 ### Device Name 0 - 0 Trade name: Advance Medical Designs, Inc. Sterile Ultrasound Gel - o Common Name: Ultrasound Gel - Classified Name: Diagnostic ultrasonic transducer/acoustic gel (21 CFR 892.1570, Product code MUI) ### Predicate Device - Konix® Ultrasound Gel (K101952) 0 # Device Description Advance Medical Designs, Inc. Sterile Ultrasound Gel consists of deionized water, glycerin, butylene glycol, glyceryl acrylic acid copolymer, propylene glycol, carbomer, phenoxyethanol, cellulose gum, sodium hydroxide, hydroxyethlcellulose, ethylhexylglycerin. It is a type of conductive medium (i.e.) scanning gel used in ultrasound therapeutic and diagnostic imaging techniques. A scanning {4}------------------------------------------------ gel acts as a couplant that provides an acoustic pathway between transducer and the intact skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts to the contours of the probe to the intact skin. The major characteristics of Advance Medical Designs, Inc. Sterile Ultrasound Gel: - 0 Hypoallergenic, non-irritating - 0 Water soluble, non-staining and easily cleanable - 0 Free from formaldehyde and salt - 0 Does not contain oil or fatty matter - o No toxic effects - 0 Vacuum treated production - 0 Produced as a completely harmless material - 0 Does not damage the probe - 0 Does not contain air bubbles ## Intended Use Advance Medical Designs, Inc. Sterile Ultrasound Gel is intended for general use as a sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's intact skin prior to initiating an ultrasound examination. It is indicated for prescription use only. ## Technological Characteristics: Advance Medical Designs, Inc. Sterile Ultrasound Gel has substantially the same technological characteristics as the predicate device. ## Conclusions The comparisons of the technological and non-clinical performance characteristics indicate that Advance Medical Designs, Inc. Sterile Ultrasound Gel is almost identical to the predicate device and therefore substantially equivalent to it and other coupling gels commonly used in the United States today.