(13 days)
No
The 510(k) summary describes an ultrasound coupling gel, which is a passive material and does not involve any computational processing, including AI or ML.
No
The device, Embrace™ Gel Pad, is described as an ultrasound coupling medium. Its intended use is to facilitate the operation of an ultrasound tomography system by providing a coupling medium between the breast tissue and the system. While it aids in a diagnostic procedure, it does not directly treat a disease or condition, which is the defining characteristic of a therapeutic device. It is analogous to Aquasonic 100 Ultrasound Trans Gel, which is also an ultrasound coupling agent.
No
The device, Embrace Gel, is an ultrasound coupling media. It facilitates the use of a diagnostic device (the Embrace™ 3D Ultrasound Tomography System), but it does not independently perform a diagnostic function.
No
The device description clearly states it is an "expandable polymer" used as a coupling medium, which is a physical substance, not software.
Based on the provided information, the Embrace Gel is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use as an ultrasound coupling media with an ultrasound system. It facilitates the physical process of ultrasound imaging by providing a medium for sound waves to travel through.
- Device Description: The description reinforces its role as a physical coupling medium. It doesn't perform any diagnostic testing on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information based on chemical, immunological, or other biological tests.
IVDs are devices used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. The Embrace Gel's function is purely physical and related to the imaging process itself, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
Embrace Gel is intended for use as an ultrasound coupling media for use with the Embrace™ 3D Ultrasound Tomography System K070477.
Product codes (comma separated list FDA assigned to the subject device)
MUI
Device Description
Embrace™ Gel Pad is en expandable polymer used to provide a coupling medium between breast tissue and the Embrace™ 3D Ultrasound Tomography System K070477. The gel is prepared just prior to scanning by placing the gel pad in the dome and adding hydrating fluid. The gel pad expands and fills the voids between the probe and breast tissue. After the ultrasound scan is completed, the gel is removed from the dome in one piece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Breast tissue
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.
Aquasonic 100 Ultrasound Trans Gel K802146
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.
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
510(K) SUMMARY (as required by 807.92(c))
SEP 2 0 2007
| Submitter of 510(k): | Orison Corporation
121 Boone Ridge Dr, Suite 2004
Johnson City, TN 37615
USA |
|-------------------------|---------------------------------------------------------------------------------------|
| | Phone: (423) 282-5919
Fax: (423) 282-6320 |
| Contact Person: | Al Sandy |
| Date of Summary: | April 4, 2007 |
| Trade/Proprietary Name: | Embrace Gel |
| Classification Name: | Diagnostic, Ultrasonic, Transducer |
| Product Code: | MUI |
Intended Use:
Embrace Gel is intended for use as an ultrasound coupling media for use with the Embrace™ 3D Ultrasound Tomography System K070477.
Device Description:
Embrace™ Gel Pad is en expandable polymer used to provide a coupling medium between breast tissue and the Embrace™ 3D Ultrasound Tomography System K070477. The gel is prepared just prior to scanning by placing the gel pad in the dome and adding hydrating fluid. The gel pad expands and fills the voids between the probe and breast tissue. After the ultrasound scan is completed, the gel is removed from the dome in one piece.
Predicate Device:
Aquasonic 100 Ultrasound Trans Gel K802146
Substantial Equivalence:
The Embrace 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)
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter of the circle. Inside the circle is a stylized image of an eagle. The eagle is drawn with three curved lines that form the body, wing, and head.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 0 2007
Orison Corporation % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K072515
Trade/Device Name: Embrace Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: September 6, 2007 Received: September 7, 2007
Dear Mr. Lehtonen:
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 (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a large, stylized "FDA" in bold letters. Underneath the letters, the word "Centennial" is written in a cursive font. At the bottom of the logo, there are three stars arranged horizontally.
Prosoting and Promoting Publio Statte
2
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); 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.
This letter will allow you to begin markeung 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
072515 510(k) Number (if known):
Device Name: Embrace Gel
Indications for Use:
Embrace Gel is intended for use as an ultrasound coupling media for use with the Embrace™ 3D Ultrasound Tomography System (K070477)
Prescription Use Yes (Part 21 CFR 801 Subpart D)
Over-The-Counter Use N/A AND/OR (21 CFR 801 Subpart C)
e-Counter Use N/A
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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072515
7 of 47