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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for "Sheathes™ Ultrasound Gel," an ultrasound couplant. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments. It does not involve studies related to device performance in an imaging context that would require ground truth, expert review, or human reader studies.

Therefore, many of the requested sections (2 through 9) related to clinical study design, ground truth, expert involvement, and reader studies are not applicable or cannot be extracted from this document, as this is a non-clinical device that does not perform diagnostic functions.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Device Name: Sheathes™ Ultrasound Gel
Predicate Devices:

Sonotech Natural Image Ultrasound Couplant (510K#K883917)
Konix Ultrasound Gel (510K#K101952)

Criteria Category	Acceptance Criteria (against predicate devices)	Reported Device Performance and Conclusion
Biocompatibility	Meets ISO 10993-1:2009 for Irritation/Intracutaneous Toxicity and Sensitization. Cytotoxicity equivalent to predicate.	Irritation/Intracutaneous Toxicity: Sheathing Technologies's ultrasound gel meets the ISO 10993-1:2009 standard. Sensitization: Sheathing Technologies's ultrasound gel meets the ISO 10993-1:2009 standard. Cytotoxicity: Equivalent to Sonotech's Natural Image Couplant.
Acoustical Performance	Equivalent acoustical performance to predicate devices (specifically Konix Ultrasound Gel).	Sound Velocity: Within the range measured in the predicate devices. Acoustic Impedance: Within the range measured in the predicate devices. Sound Attenuation: Within the range measured in the predicate devices.
Physical Measurements	Density and Viscosity within the range measured in the predicate devices.	Density: Within the range measured in the predicate devices. Viscosity: Within the range measured in the predicate devices.

Regarding the other requested information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The provided document describes non-clinical bench testing and biocompatibility assessments, not a clinical test set with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth was established by experts for a clinical test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an ultrasound couplant, not an AI-powered diagnostic tool, and therefore no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device (ultrasound gel), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this device's performance is based on established ISO standards for biocompatibility and technical specifications (e.g., acoustical properties, density, viscosity) compared against legally marketed predicate devices.
The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.
How the ground truth for the training set was established:
- Not applicable. No training set or associated ground truth was established for this device.

Summary

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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

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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.
1. Name and Location of Manufacturer
1. Expiration date
1. 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.
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.

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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.

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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

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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

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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

Regulation Number and Section

§ 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.