(268 days)
Not Found
No
The device is a simple ultrasound coupling gel, and the summary contains no mention of AI, ML, or any software-based image processing or analysis.
No
The device is described as an "accessory used on diagnostic ultrasound probes" and is intended "to couple sound waves between a patient and the medical imaging electronics" for "diagnostic ultrasound procedures". Its function is to facilitate imaging, not directly treat a medical condition.
No
The device description clearly states "This device is an accessory used on diagnostic ultrasound probes." It is a couplant gel, not the diagnostic imaging device itself. Its purpose is to facilitate the diagnostic process by coupling sound waves, not to perform diagnosis.
No
The device description clearly states it is a water-based gel, which is a physical substance, not software. The performance studies also focus on physical and biological properties of the gel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "couple sound waves between a patient and the medical imaging electronics" during diagnostic ultrasound procedures. This is a physical function to facilitate the imaging process, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description confirms it's a "water-based coupling agent" and an "accessory used on diagnostic ultrasound probes." Its purpose is to improve the transmission of sound waves, not to analyze biological samples for diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or any other processes typically associated with in vitro diagnostics.
The device is a medical device accessory used to facilitate a diagnostic imaging procedure, but it is not a diagnostic device itself, and specifically not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.
Product codes
MUI
Device Description
Sheathing Technologies, Inc Ultrasound Gel is a water-based coupling agent for diagnostic ultrasonic procedures. This device is an accessory used on diagnostic ultrasound probes. The material is a water-based gel. Product categories/models include Individual packets (non-sterile) and Bulk bottles (non-sterile). Gel is for single patient/procedure, disposable use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
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
Non-Clinical Tests:
- Biocompatibility
- Cytotoxicity
- Irritation/Intracutaneous Toxicity
- Sensitization
- Bench testing
- Sound Velocity
- Acoustic Impedance
- Sound Attenuation
- Physical measurements
- Viscosity
- Density
Conclusions from Non-Clinical Tests:
Sheathing Technologies's ultrasound gel meets the ISO 10993-1:2009 biocompatibility standard for both Irritation/intracutaneous toxicity and sensitization. The cytotoxicity of the ultrasound gel is equivalent to the cytotoxicity Sonotech's Natural Image Couplant (toxicology report is attached.) Sheathing Technologies's ultrasound gel has equivalent acoustical performance to the predicate Konix Ultrasound Gel, and the density and viscosity are within the range measured in the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K11.2827
Section 5: 510(K) Summary
JUN 2 2-2012
(As required by 21 CFR 807.92)
Ultrasound Gel
June 13, 2012
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
To Whom it may Concern:
This letter, along with the attached materials is to notify your office of the intention of Sheathing Technologies to market the following device starting on or after (90) days from this date.
Device/Specification Developer:
Sheathing Technologies, Inc. 18431 Technology Drive Morgan Hill, CA 95037
Establishment Registration No.: 2950776
Contact Persons:
Jennifer Downing Manager of Quality & Research 1-408-782-2720
Richard Stevens VP, Research & Development 1-408-782-2720
Trade Name:
Common Name:
Sheathes™ Ultrasound Gel
Ultrasound Gel
5-1
1
Classification Name:
Equivalence:
Labeling and Usage:
Device Description:
Substantial Equivalence:
Ultrasonic pulsed echo imaging system accessory
Sonotech Natural Image Ultrasonic Couplant. 510K#K883917 Konix Ultrasound Gel, 510K#K101952
The following information will be found on each box/bag . (See Attachment E):
- Proprietary name 1.
- Quantity of gel 2.
-
- Name and Location of Manufacturer
-
- Expiration date
-
- Prescription Statement: "Caution: Federal law restricts this device to sale by or on the order of a physician or a practitioner trained in its use."
Sheathing Technologies, Inc Ultrasound Gel is a water-based coupling agent for diagnostic ultrasonic procedures.
This device is an accessory used on diagnostic ultrasound probes.
The material is a water-based gel.
Product categories/models include
- Individual packets (non-sterile) 1.
-
- Bulk bottles (non-sterile)
Gel is for single patient/procedure, disposable use.
The Sheathing Technologies, Inc. Ultrasound gel is identified as substantially equivalent to Sonomed/Sonotech's Natural Image Ultrasound Couplant, 510K#K883917, and to Konix Ultrasound Gel, 510K#K101952.
5-2
2
Non-Clinical Tests:
- Biocompatibility
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- a. Cytotoxicity
- b. Irritation/Intracutaneous Toxicity
- Sensitization C.
- Bench testing
- a. Sound Velocity
- b. Acoustic Impedance
- c. Sound Attenuation
- Physical measurements
- a. Viscosity
- b. Density
Conclusions from Non-Clinical Tests:
gel meets the ISO 10993-1:2009 biocompatibility standard for both Irritation/intracutaneous toxicity and sensitization. The cytotoxicity of the ultrasound gel is equivalent to the cytotoxicity Sonotech's Natural Image Couplant (toxicology report is attached.)
Sheathing Technologies's ultrasound
Sheathing Technologies's ultrasound gel has equivalent acoustical performance to the predicate Konix Ultrasound Gel, and the density and viscosity are within the range measured in the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an 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
JUN 2 2 2 2012
Ms. Jennifer Downing Senior Manager of Quality & Research Sheathing Technologies, Inc. 18431 Technology Drive MORGAN HILL CA 95037
Re: K112827
Trade/Device Name: Ultrasound Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: June 13, 2012 Received: June 14, 2012
Dear Ms. Downing:
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, additional colluble. In Links (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
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Section 4: Indications for Use Statement
510(k) Number (if known):
Device Name: Ultrasound Gel
Indication For Use: Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.
Prescription Use X (21 CFR Part 801 Subpart D) Subpart C)
And/Or
Over the Counter Use (21 CFR Part 801
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Andrew D. Ohm
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)K112827