(358 days)
Not Found
No
The device is a sterile ultrasound gel, a passive transmission medium, and the description contains no mention of AI or ML capabilities.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the sterile ultrasound gel is intended for use during "external therapeutic and diagnostic ultrasound imaging procedures."
No
This device is a sterile ultrasound gel used as a transmission media for acoustically coupling a transducer to the body during ultrasound procedures. It does not perform diagnostic functions itself, but rather facilitates diagnostic imaging.
No
The device is a sterile ultrasound gel, which is a physical substance used as a transmission medium. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is a gel applied to the surface of the body to facilitate ultrasound imaging. It acts as a physical coupling agent, not a tool for analyzing biological specimens.
- Intended Use: The intended use clearly states it's for "acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures." This is an external application, not an in vitro test.
Therefore, based on the provided information, this sterile ultrasound gel is a medical device used externally for imaging purposes, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MUI
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 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:
- Hypoallergenic, non-irritating
- Water soluble, non-staining and easily cleanable
- Free from formaldehyde and salt
- Does not contain oil or fatty matter
- No toxic effects
- Vacuum treated production
- Produced as a completely harmless material
- Does not damage the probe
- Does not contain air bubbles
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
human body surface / intact skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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| I Over-The-Counter Use (2) CFR 80 1 Suppart C) | Type of Use (Select one or both, as applicable)
A Presscription Use (Fart 21 CFR 801 Subpart D |
| | |
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Indications for Use (Describe) |
| | Advance Medical Designs, Inc. Sterile Ultrasound Gel
Device Name |
| | K163050
510(k) Number (if known |
| Form Approved: OMB No. 0810-0120
ee PRA Statement below.
xpiration Date: January 31, 2017 | DEPARTMENT OF HEALTH AND HUMMA SERVICES
ndications for Use
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.