(29 days)
No
The device is a sterile ultrasound couplant (gel), which is a passive accessory used to facilitate sound wave transmission. The description and performance studies focus on the physical and acoustic properties of the gel, not on any data processing or algorithmic capabilities. There is no mention of AI, ML, image processing, or training/test sets, which are typical indicators of AI/ML involvement in medical devices.
No.
The device is described as a "sterile ultrasound couplant for use with medical diagnostic ultrasound" and is "intended for non-invasive use in medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics." It is an accessory for diagnostic ultrasound probes, which are used for imaging, not therapy.
No
This device is an ultrasound couplant, an accessory used with diagnostic ultrasound equipment to facilitate the transmission of sound waves. It does not independently perform a diagnostic function.
No
The device is a physical gel intended for use as an accessory with ultrasound probes, not a software application. The description focuses on the physical and acoustic properties of the gel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is an ultrasound couplant. Its function is to facilitate the transmission of sound waves between an ultrasound probe and the patient's body for diagnostic imaging. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "non-invasive use in medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics." This is a physical coupling function, not an in vitro diagnostic test.
Therefore, this device is an accessory used in a diagnostic imaging procedure, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
Sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended for non-invasive use in 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.
Gel will be sold in sterile packets for single patient/procedure, disposable use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
a. Cytotoxicity
b. Irritation/Intracutaneous Toxicity
c. Sensitization - Bench testing
a. Sound Velocity
b. Acoustic Impedance
c. Sound Attenuation - Physical measurements
a. Viscosity
b. 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 cvtotoxicity Sonotech's Natural Image Couplant.
Sheathing Technologies's ultrasound gel has equivalent acoustical performance to the predicate Sheathing Technologies gel and to the UltraBio™ predicate 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
1130041
FEB 0 6 2013
Section 5: 510(K) Summary
(As required by 21 CFR 807.92)
Sterile Ultrasound Gel
January 30, 2013
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, Maryland 20993-0002
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.
| Classification: | The FDA has classified ultrasound gel as a
Class II device in the Code of Federal
Regulations (CFR) 892.1570, Diagnostic
ultrasonic transducer. |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Panel: | Radiology |
| Classification Procode: | MUI |
| 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
5-1
1
1-408-782-2720
Richard Stevens VP, Research & Development 1-408-782-2720
Trade Name:
Common Name:
Classification Name:
Equivalence:
Labeling and Usage:
Device Description:
Sheathes™ Sterile Ultrasound Gel
Sterile Ultrasound Gel
Ultrasonic pulsed echo imaging system accessorv
Sonotech Clear Image™ Sterile Scanning Gel, K931909 Sheathing Technologies Ultrasound Gel, K112827 Sonotech UltraBio™ Sterile Ultrasound Imaging Couplant, K042619.
The following information will be found on each box/bag:
-
- Proprietary name
- Quantity of gel 2.
-
- Name and Location of Manufacturer
-
- Statement of Sterility
-
- 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.
Gel will be sold in sterile packets for single patient/procedure, disposable use.
5-2
2
Substantial Equivalence:
The Sheathing Technologies, Inc. Ultrasound gel is identified as substantially equivalent to Sonomed/Sonotech's Clear Image Sterile Scanning Gel, K931909, to Sheathing Technologies's Ultrasound Gel, K112827, and to Sonotech/Sonomed's UltraBio Sterile Ultrasound Imaging Couplant, K042619.
Non-Clinical Tests:
-
- Biocompatibility
- a. Cytotoxicity
- b. Irritation/Intracutaneous Toxicity
- c. Sensitization
-
- Bench testing
. :
- a. Sound Velocity
- b. Acoustic Impedance
- c. Sound Attenuation
-
- Physical measurements
- a. Viscosity
- b. 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 cvtotoxicity Sonotech's Natural Image Couplant.
Sheathing Technologies's ultrasound gel has equivalent acoustical performance to the predicate Sheathing Technologies gel and to the UltraBio™ predicate gel, and the density and viscosity are within the range measured in the predicate devices.
5-3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2013
Sheathing Technologies, Inc c/o Jennifer Downing Senior Manager of Quality & Research 18431 Technologies Inc. MORAN HILL CA 95037
Re: K130041.
Trade/Device Name: Sterile Ultrasound Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: January 5, 2013 Received: January 8, 2013
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. 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 vour 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.
4
Page 2- Ms. Downing
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sean M. Boyd -S for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Ultrasound Gel
Indications for Use: Sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended for non-invasive use in 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sean M. Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K130041 510(k)
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