Sonishield™ 100 Antimicrobial Ultrasound Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external and therapeutic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.

Device Description

Sonishield™ 100 Antimicrobial Ultrasound Gel consists of deionized water, hydroxyethylcellulose, propanediol and benzalkonium chloride. 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 the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin.

The major characteristics of Sonishield™ 100 Antimicrobial Ultrasound Gel include:

Hypoallergenic, non-irritating
Water soluble, non-staining and easily cleanable
. Does not contain oil or fatty matter
Free from formaldehyde and salt ●
No toxic effects
Produced as a completely harmless material
Has no odor
Vacuum treated production
Does not damage the probe
Does not contain air bubbles
pH level ranges from 4.5 to 6.5 at 25°C ●

AI/ML Overview

The document describes the Sonishield™ 100 Antimicrobial Ultrasound Gel and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance in a diagnostic task.

However, from the provided text, we can infer some "acceptance criteria" through the non-clinical performance tests and the comparison to predicate devices. The study detailed is primarily a non-clinical performance evaluation to demonstrate safety and functional equivalence, not a clinical trial evaluating diagnostic accuracy with human interpretation.

Here's the breakdown of information based on your request, extracting what's available from the provided text:

1. Table of Acceptance Criteria (Inferred from Non-Clinical Performance) and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Sonishield™ 100 Antimicrobial Ultrasound Gel)
Acoustic Properties:
Sound velocity (m/sec) at 30°C	1497
Density (kg/m³) at 30°C	1.023 X 10⁻³
Acoustic impedance (kg/m² sec) at 30°C	1.53
Attenuation coefficient as a function of frequency, a/f (dB/cm-MHz)	0.04 ± 0.0042
Comparison to predicate gels	Virtually identical to predicate Konix® Ultrasound Gel (Konix® values: 1516 m/sec, 0.98X 10⁻³ kg/m³, 1.49 kg/m² sec, <0.05 f dB/cm-MHz)
Antimicrobial Effectiveness:
Log reduction > 4 from initial count at 14 days post-inoculation (for specified bacteria)	Achieved log reduction > 4 for S. Aureus, Pseudomonas aeruginosa, E.coli, S.Aureus (MRSA), and K. pneumoniae at 14 days and 28 days.
Biocompatibility - Skin Irritation (ISO 10993-10):	Non-irritating
Biocompatibility - Skin Sensitization (ISO 10993-10):	Non-sensitizing
Clinical Tolerance - Cutaneous Irritation:	No signs of cutaneous irritation
Clinical Hypoallergenic (Human Repeat Insult Patch Test - HRIPT):	Considered hypoallergenic; no pertinent reaction to test product during challenge phase. (Note: 9/55, 1/55, 2/55 volunteers showed 'barely noticeable' to Grade 2 erythema during induction phase, but this did not lead to a 'pertinent reaction' in the challenge phase for the overall conclusion of hypoallergenic.)

2. Sample size used for the test set and the data provenance

Acoustic Testing: Not explicitly stated, but the values are physical properties, likely measured in a lab setting. Data provenance is not specified beyond "Sonishield™ 100 Antimicrobial Ultrasound Gel was evaluated for its acoustic performance."
Antimicrobial Effectiveness Testing: Not explicitly stated for specific sample counts of the gel, but performed using USP <51> Category 2 as a guide. Data provenance is not specified.
Animal Biocompatibility (Skin Irritation and Sensitization): Standard animal testing for ISO 10993-10. Not explicitly stated how many animals were used. Data provenance is not specified.
Clinical Tolerance Study: "two part study." No specific number of participants mentioned. Data provenance is not specified.
HRIPT (Hypoallergenic study): 55 volunteers. Data provenance is not specified.

All studies mentioned appear to be prospective in nature, as they were conducted to evaluate the performance of the Sonishield™ 100 gel. The country of origin for the data is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the studies described are non-clinical performance evaluations and biocompatibility/tolerance tests for an ultrasound gel, not diagnostic accuracy studies involving medical image interpretation or human diagnoses. Therefore, "ground truth" in the diagnostic sense (e.g., confirmed disease status) and "experts" (e.g., radiologists) in that context are not relevant to the described tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable for the reasons stated above (non-clinical performance and biocompatibility studies).

5. 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

This is not applicable. The device is an ultrasound gel, not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is an ultrasound gel, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Acoustic Testing: The "ground truth" would be the physically measured acoustic properties of the gel.
Antimicrobial Effectiveness Testing: The "ground truth" is the quantitative bacterial count reduction compared to a baseline, against established microbiological standards (USP <51>).
Animal Biocompatibility: The "ground truth" is the observed biological reaction (or lack thereof) in living tissue, against the criteria of ISO 10993-10.
Clinical Tolerance Study: The "ground truth" is the observed cutaneous reaction (or lack thereof) in human skin, assessed by study personnel.
HRIPT (Hypoallergenic study): The "ground truth" is the observed skin reaction (or lack thereof) in human volunteers, assessed by study personnel, following a standardized protocol.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical product undergoing performance and safety testing, not a machine learning model.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 13, 2016

Quotient Medical % Ms. Marilyn Lockhart President Lockhart Regulatory Services, Inc. 1860 Appleby Line, Suite 348 Burlington, Ontario L7L 7H7 CANADA

Re: K151070

Trade/Device Name: Sonishield™ 100 Antimicrobial Ultrasound Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: January 4, 2016 Received: January 11, 2016

Dear Ms. Lockhart:

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.

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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/Resourcesfor You/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,

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151070

Device Name

Sonishield™ 100 Antimicrobial Ultrasound Gel

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Sonishield 100 Antimicrobial Ultrasound Gel

Common name: Ultrasound gel

MUI Product code

Class II device,

21 CFR 892.1570

Traditional 510(k) Submission

April 15, 2015

General Information

-510(k) owner's name:

Quotient Medical 3365 Harvester Road, Suite 110, Burlington, Ontario, Canada L7N 3N2 Telephone: 416- 843-6177

-Contact person:

Contact person for Quotient Medical: David Okamoto Vice President. Telephone 416-843-6177

Preferred contact person for Quotient Medical: Marilyn Lockhart

President, Lockhart Regulatory Services Inc. Consultant to Quotient Medical Address: 1860 Appleby Line, Suite 348 Burlington, Ontario L7L 7H7 Canada. Telephone: 905-635-2855

-Prepared on March 20, 2015.

Device name

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-Trade name Sonishield™ 100 Antimicrobial Ultrasound Gel

-Common name

Ultrasound gel

-Classified name

Diagnostic ultrasonic transducer/acoustic gel (21 CFR § 892.1570, Product code MUI)

Predicate devices

-Ecogel 100 Ultrasound Gel (K961757) -Konix® Ultrasound Gel (K101952)

Device Description

Sonishield™ 100 Antimicrobial Ultrasound Gel consists of deionized water,

hydroxyethylcellulose, propanediol and benzalkonium chloride. 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 the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin.

The major characteristics of Sonishield™ 100 Antimicrobial Ultrasound Gel include:

Hypoallergenic, non-irritating
Water soluble, non-staining and easily cleanable
. Does not contain oil or fatty matter
Free from formaldehyde and salt ●
No toxic effects
Produced as a completely harmless material
Has no odor
Vacuum treated production
Does not damage the probe
Does not contain air bubbles
pH level ranges from 4.5 to 6.5 at 25°C ●

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Intended use

Sonishield™ 100 Antimicrobial Ultrasound Gel is intended for general use as a non-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 skin prior to initiating an ultrasound examination. It is indicated for prescription use only.

Technological characteristics

Sonishield™ 100 Antimicrobial Ultrasound Gel has substantially the same technological characteristics as the predicate devices. The three products are compared in the table below:

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Substantial Equivalence Discussion

Subject	Sonishield™ 100AntimicrobialUltrasound Gel	Ecogel 100 UltrasoundGel	Konix® UltrasoundGel
Intended Use	External	External	External
Ingredients	Salt freeDye freeAlcohol freeFormaldehyde freePerfume free	Salt freeDye freeAlcohol freeFormaldehyde freePerfume free	Salt freeDye freeAlcohol freeFormaldehyde freePerfume free
PhysicalProperties	Twist cap for accuratedispensingFlip-top can for quickrefillingVery high clarityHypoallergenic,bacteriostatic, non-sensitizing	Twist cap for accuratedispensingFlip-top can for quickrefillingGood clarityHypoallergenic,bacteriostatic, non-sensitizing	Twist cap for accuratedispensingFlip-top can for quickrefillingHypoallergenic, non-irritating
ChemicalProperties	pH 4.5 - 6.5Density (g/mL) = 1.009Very clear screen imagewith high viscosity andvacuum process. Norapid melting from high-viscosity gel.Viscosity 80,000 –120,000 CPSBoiling point >200°CWater soluble high MWpolymerNo irritation	pH 6.5 ± 0.75Density (g/mL) = 0.99It has low viscosity. Itmelts immediately fromlow viscosityViscosity 35,000 –40,000 CPSBoiling point 100°CWater soluble high MWpolymerNo irritation	pH 6.5 ± 0.75Density (g/mL) = 0.983Very clear screenimage with highviscosity and vacuumprocess. No rapidmelting from high-viscosity gel.Viscosity 100,000 –120,000 CPSBoiling point >200°CWater soluble highMW polymerNo irritation
Process	It has a rapidmanufacturing processSonishield™ employs asoft bottle for ease ofuse.Sonishield™ productionemploys a closed-loopsystem so there is nopollution transmission.Product is manufacturedvery cleanly.Standard productionarea	Normal processStandard bottleNormal processStandard productionarea	a rapid manufacturingprocessemploys a soft bottlefor ease of useproduction employs aclosed-loop system sothere is no pollutiontransmission. Productis manufactured verycleanly.Standard productionarea
Subject	Sonishield™ 100AntimicrobialUltrasound Gel	Ecogel 100 UltrasoundGel	Konix® UltrasoundGel
	Standard processmanufactured to releasespecifications.	Standard process	Manufactured in aclean room (1/100000class)
Label	Standard information onpolyethylene label toprevent loss of lettering	Standard information	Standard informationon polyethylene labelto prevent loss oflettering
Design	Bottle diameterdesigned to becompatible withultrasound device.Bottle cap is designedfor ease of opening andclosing with one hand.	Conical cap	Bottle diameterdesigned to becompatible withultrasound device.Bottle cap is designedfor ease of opening andclosing with one hand.
Safety	Sonishield™ labelcontains appropriatewarnings andcharacteristics (Latex-free, PVC-free)	Standard information	Label containsappropriate warningsand characteristics(Latex-free, PVC-free)
Environment ofuse	Hospital	Hospital	Hospital
Target population	Pediatric and adult	Pediatric and adult	Pediatric and adult
Anatomical site	Body (abdomen)	Body (abdomen)	Body (abdomen)
Use	Multiple uses	Multiple uses	Multiple uses
Material(package)	Polyethylene	Polyethylene	Polyethylene
Patient contactmaterials	Probe	Probe	Probe
Energy type	Electricity only for theultrasound device	Electricity only for theultrasound device	Electricity only for theultrasound device

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Non-clinical performance

Acoustic:

Sonishield™ 100 Antimicrobial Ultrasound Gel was evaluated for its acoustic performance. Results indicate that the acoustic properties of the gel are:

1. Virtually identical to that of human skin.
1. Similar to other coupling gels commonly used in the United States.

The acoustic properties of Sonishield™ 100 Antimicrobial Ultrasound Gel are as follows:

• Sound velocity (m/sec) at 30°C	1497
• Density (kg/m³) at 30°C	1.023 X 10-3
• Acoustic impedance (kg/m² sec) at 30°C	1.53
• Attenuation coefficient as a function of frequency, a/f (dB/cm-MHz)	0.04 ± 0.0042

The acoustic properties of the predicate gels are virtually identical. Those properties for the Konix® Ultrasound Gel are provided below:

• Sound velocity (m/sec) at 30°C	1516
• Density (kg/m³) at 30°C	0.98X 10⁻³
• Acoustic impedance (kg/m² sec) at 30°C	1.49
• Attenuation coefficient as a function of frequency, a/f (dB/cm-MHz)	<0.05 f

Antimicrobial Effectiveness Testing:

Using USP <51> Category 2 as a guide, antimicrobial effectiveness testing performed on Sonishield™ 100 Antimicrobial Ultrasound Gel demonstrated the bacteria (S. Aureus, Pseudomonas aeruginosa. E.coli. S.Aureus (MRSA) and K. pneumoniae) showed a log reduction greater than 4 from the initial count at 14 days and at 28 days.

Animal tests:

Biocompatibility (ISO 10993-10) testing was conducted for Skin Irritation and Skin Sensitization. Conclusions from these studies: Sonishield™ 100 Antibacterial Ultrasound Gel was found to be non-sensitizing and non-irritating.

Clinical tests:

In clinical studies using Sonishield™ 100 Antimicrobial Ultrasound Gel, the following were concluded:

-In a two part study of the Tolerance of Sonishield™ 100 Antimicrobial Ultrasound Gel, the product produced no signs of cutaneous irritation.

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-In another study, (HRIPT with 55 volunteers), no pertinent reaction to the test product was observed during the challenge phase of the study and the product can be considered as hypoallergenic. In the induction phase of the study, 9 of 55 volunteers showed "barely noticeable" reactions, 1 of 55 volunteers showed Grade 1 and 2 volunteers showed Grade 2 erythema, while all other volunteers had no reaction to the gel during the induction phase of the study.

CONCLUSIONS

The above-referenced comparisons of the technological and non-clinical performance characteristics indicate that the Sonishield™ Antimicrobial 100 Ultrasound Gel is nearly identical to the predicate gels and certainly substantially equivalent to both and other coupling gels commonly used in the United States.

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.