K Number
K163027
Device Name
Ultra/Phonic Free Conductivity Gel
Date Cleared
2018-01-09

(435 days)

Product Code
Regulation Number
892.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultra Phonic® Free Conductivity 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 ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.
Device Description
Ultra/Phonic® Free Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 5L Cubitainers and 250 mL bottles. Major characteristics include: - Non-sensitizing, non-irritating - Water soluble, non-staining, and easily cleanable - Does not contain oil or fatty matter - Does not damage the probe - pH level is 6.25 ± 0.25 @ 25°C - Resists thinning and decomposition when exposed to perspiration and body heat - Sheer thinning gel is easy to apply, but doesn't run or drip - High viscosity allows for thick application, adapting to contours and hair to minimize interference
More Information

No
The device is a conductivity gel, a passive medium for ultrasound transmission. The description focuses on its physical and chemical properties, not on any data processing or algorithmic capabilities. The mention of image processing refers to the ultrasound scanner, not the gel itself.

No.
The device is a conductivity gel, which is an accessory used for ultrasound imaging procedures for diagnostic and therapeutic purposes, but it does not directly provide therapy.

No

Explanation: This device is ultrasound gel, which serves as a transmission media for ultrasound imaging procedures by providing an acoustic pathway. It facilitates imaging but does not perform diagnostic functions itself. The diagnostic function is performed by the ultrasound scanner and the healthcare professional.

No

The device is a conductivity gel, which is a physical substance used to facilitate ultrasound transmission, not a software program.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's a "transmission media for acoustically coupling a transducer to a human body surface during external therapeutic ultrasound imaging procedures." This describes a device used on the body for imaging, not a device used to examine specimens from the body.
  • Device Description: The description reinforces its role as an "ultrasound conducting medium for use during non-invasive ultrasonic medical procedures." It facilitates the transmission and reception of sound waves through the body.
  • Lack of Specimen Analysis: IVD devices are designed to examine specimens such as blood, urine, tissue, etc., to provide information about a person's health. This gel does not perform any analysis on biological specimens.
  • Focus on Physical Properties: The key metrics listed are physical properties related to sound transmission (sound velocity, density, acoustic impedance, attenuation coefficient, pH, viscosity, boiling point). These are relevant to its function as an ultrasound coupling medium, not to diagnostic analysis of biological samples.

In summary, the Ultra Phonic® Free Conductivity Gel is an accessory used with an ultrasound imaging system to improve the quality of the images obtained from the body. It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an IVD.

N/A

Intended Use / Indications for Use

Ultra Phonic® Free Conductivity 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 ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.

Product codes (comma separated list FDA assigned to the subject device)

MUI

Device Description

Ultra/Phonic® Free Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals.

It is packaged in 5L Cubitainers and 250 mL bottles.

Major characteristics include:

  • Non-sensitizing, non-irritating ●
  • Water soluble, non-staining, and easily cleanable
  • . Does not contain oil or fatty matter
  • Does not damage the probe
  • pH level is 6.25 ± 0.25 @ 25°C
  • Resists thinning and decomposition when exposed to perspiration and body heat
  • Sheer thinning gel is easy to apply, but doesn't run or drip
  • High viscosity allows for thick application, adapting to contours and hair to minimize interference

Mentions image processing

That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

human body surface

Indicated Patient Age Range

Pediatric and adult

Intended User / Care Setting

health care professionals / Hospital

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)

Non-clinical performance:
Ultra/Phonic® Free Conductivity 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.
  2. Similar to other coupling gels commonly used in the United States.
    The acoustic properties of Ultra/Phonic® Free Conductivity Gel and Sonishield™ 100 Antimicrobial Ultrasound Gel are as follows:
    |Property|Ultra/Phonic® Free Conductivity Gel|Sonishield™ 100 Antimicrobial Ultrasound Gel|
    |---|---|---|
    |Sound velocity (m/sec)|1488 ms-1 at 22.5°C|1497 ms-1 at 30°C|
    |Density (kg/m3)|1018 kg/ m3 at 22.5°C|1023 kg/ m3 at 30°C|
    |Acoustic impedance (kg/m2 sec)|1.51 MRayls at 22.5°C|1.53 MRayls at 30°C|
    |Attenuation coefficient as a function of frequency, a/f (dB/cm-MHz)|0.0185 + 0.01335 f^1.0894|0.04 ± 0.0042 f|

The acoustic properties of the predicate gel and Ultra/Phonic® Free Conductivity Gel are virtually identical. Although the analysis was conducted at different temperatures, both are well within the range of temperatures encountered during clinical use (72.5°F - 80°F). Such variations in temperature do not induce more than small changes in the listed acoustic properties, too small to alter performance, or cast doubt upon the conclusions of this comparison.

The USP (Category 2) Antimicrobial Effectiveness Test passed with log reductions greater than 5 for all 14 and 28 day bacterial (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruqinosa ATCC 9027) counts. Yeasts and molds (Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231) did not increase from initial counts, and in fact considerably decreased.

Animal Testing:
Biocompatibility (ISO 10993-10) testing was conducted for Skin Irritation and Skin Sensitization. Conclusions from these studies: Ultra/Phonic® Free Conductivity Gel was found to be non-sensitizing and non-irritating.

In Vitro Cytotoxicity:
Cytotoxicity (ISO 10993-5:2009) testing was conducted.
Conclusion from this study: The test article does not meet the requirement of the test as per The International Organization for Standardization (ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for the In Vitro Cytotoxicity, Reference Number ISO 10993-5:2009), and is considered cytotoxic.
Further testing was conducted to establish the safety of the results of the Human-Repeated-Insult-Patch-Test (RIPT) indicated no potential for dermal irritation or allergic contact sensitization. The results of the RIPT test, combined with the favorable results associated with the sensitization and irritation assays, demonstrate the safety of this product.

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.

K151070

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.

K961757

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Pharmaceutical Innovations, Inc. c/o Shirlev J. Bergman Vice President 897 Frelinghuysen Ave. NEWARK, NJ 07114

january 9, 2018

Re: K163027

Trade/Device Name: Ultra/Phonic Free® Conductivity Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: MUI Dated: December 8, 2017 Received: December 13, 2017

Dear Ms. Bergman:

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 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);

1

Page 2 - Shirley J. Bergman

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K163027

Device Name

Ultra/Phonic® Free Conductivity Gel

Indications for Use (Describe)

Ultra Phonic® Free Conductivity 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 ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.

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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3

Image /page/3/Picture/1 description: The image is a logo with a stylized letter "P" inside of an oval shape. The letter "P" is made up of thick, parallel lines, giving it a modern and bold appearance. The oval shape surrounds the top portion of the "P", adding a sense of enclosure and unity to the design. The entire logo is enclosed within a square border, which provides a defined boundary and enhances the overall structure of the image.

Image /page/3/Picture/3 description: The image shows a logo with a flag on the left side and text on the right side. The flag has the letter "E" and a star on it. The text on the right side reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING". The logo appears to be an award for excellence in exporting.

Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax:

510(k) Summary

Ultra/Phonic® Free Conductivity Gel

I. SUBMITTER

Pharmaceutical Innovations, Inc. 897 Frelinghuysen Ave. Newark, New Jersey 07114-2195 Phone: (973) 242-2900 Fax: (973) 242 0578 Contact Person: Ms. Shirley J Bergman Vice President.

Date Prepared: Friday, October 21, 2016

II. DEVICE

Name of Device: Ultra/Phonic® Free Conductivity Gel

Classification Name: Diagnostic ultrasonic transducer (accessory) (21 CFR § 892.1570)

Regulatory Class: II

Product Code: MUI

III. PREDICATE DEVICE

Device Name: Sonishield™ 100 Antimicrobial Ultrasound Gel

Classification Name: Diagnostic ultrasonic transducer/acoustic gel (21 CFR § 892.1570)

Regulatory Class: II

Product Code: MUI

510K Number: K151070

Reference Device: Ecogel 100 Ultrasound Gel

Classification Name: Diagnostic ultrasonic transducer. (21 CFR 892.1570)

Regulatory Class: II Product Code: ITX

510K Number: K961757

Web: www.pharminnovations.com - Email: info@pharminnovations.com

4

Image /page/4/Figure/1 description: The image shows a logo with a stylized letter 'P' inside a square frame. The 'P' is formed by two parallel vertical lines with curved tops, connected by a curved line that forms the upper part of the letter. The entire logo, including the 'P' and the square frame, is outlined in blue.

Image /page/4/Picture/3 description: The image shows a blue emblem with a flag on the left side and text on the right side. The flag has a large letter "E" and a star on it. The text on the right side reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".

venue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242

IV. DEVICE DESCRIPTION

Ultra/Phonic® Free Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals.

It is packaged in 5L Cubitainers and 250 mL bottles.

Major characteristics include:

  • Non-sensitizing, non-irritating ●
  • Water soluble, non-staining, and easily cleanable
  • . Does not contain oil or fatty matter
  • Does not damage the probe
  • pH level is 6.25 ± 0.25 @ 25°C
  • Resists thinning and decomposition when exposed to perspiration and body heat
  • Sheer thinning gel is easy to apply, but doesn't run or drip
  • High viscosity allows for thick application, adapting to contours and hair to minimize interference

V. INDICATIONS FOR USE

The Indications for Use statement is as follows:

Ultra/Phonic® Free Conductivity 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 or on the transducer prior to initiating an ultrasound examination. It is indicated for prescription use only.

5

Image /page/5/Figure/1 description: The image shows a logo with a stylized letter 'H' inside an oval shape, all enclosed within a square border. The letter 'H' is designed with sharp angles and a three-dimensional effect, giving it a modern and abstract appearance. The oval shape partially overlaps the 'H', adding depth to the design. The entire logo, including the letter, oval, and square border, is outlined in a light blue color, providing a clean and professional look.

Image /page/5/Picture/3 description: The image shows a logo with a flag on the left and text on the right. The flag has the letter E and a star on it. The text on the right reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING". The logo is likely an award for excellence in exporting.

897 Frelinghuysen Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242-0578

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Ultra/Phonic® Free Conductivity Gel has substantially the same technological characteristics as the predicate device, as well as the reference device. The three are compared below:

| Subject | Ultra/Phonic® Free
Conductivity Gel | Sonishield™ 100
Antimicrobial Ultrasound
Gel | Ecogel 100
Ultrasound Gel |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Intended Use | External | External | External |
| Ingredients | Salt free
Dye Free
Alcohol free
Formaldehyde free
Perfume Free | Salt free
Dye free
Alcohol free
Formaldehyde free
Perfume free | Salt free
Green coloring*
Alcohol free
Formaldehyde free
Perfume free |
| Physical
Properties | Twist cap for accurate
dispensing
(Snap-top on Cubitainers)
Twist-off top for quick
refilling. | Twist cap for accurate
dispensing
Flip-top can for quick
refilling | Twist cap for
accurate
dispensing
Flip-top can for
quick refilling |
| Chemical
Properties | High clarity
Bacteriostatic, nonsensitizing
pH 6.25 ± 0.25
Density (g/mL) = 1.018 | Very high clarity
Hypoallergenic,
bacteriostatic,
nonsensitizing
pH 4.5 – 6.5
Density (g/mL) = 1.009 | Good clarity
Hypoallergenic,
bacteriostatic,
nonsensitizing
pH 6.5 ± 0.75
Density (g/mL) =
0.99 |
| | Stabilized, high viscosity
formulation resists melting
and decomposition from
body heat and perspiration,
providing lasting
conductivity with zero or
minimal reapplication. | Very clear screen image
with high viscosity and
vacuum process. No rapid
melting from high
viscosity gel. | It has low viscosity.
It melts
immediately from
low viscosity |
| | Viscosity 600,000 ± 300,000
CPS | Viscosity 80,000 – 120,000
CPS | Viscosity 35,000 -
40,000 CPS |
| | Boiling Point > 200° C | Boiling point > 200° C | Boiling point 100°
C |
| | Water soluble high MW
polymers
No irritation | Water soluble high MW
polymer
No irritation | Water soluble high
MW polymer
No irritation |
| Process | Normal process | It has a rapid
manufacturing process | Normal process |
| | Standard bottle (Cubitainers
for refilling) | Sonishield™ employs a
soft bottle for ease of use | Standard bottle |
| Subject | Ultra/Phonic® Free
Conductivity Gel | Sonishield™ 100
Antimicrobial Ultrasound
Gel | Ecogel 100
Ultrasound Gel |
| | Normal process | Sonishield™ production
employs a closed-loop
system so there is no
pollution transmission.
Product is manufactured
very cleanly | Normal process |
| | Standard production area | Standard production area | Standard
production area |
| | Standard process
manufactured to release
specifications. | Standard process
manufactured to release
specifications. | Standard process |
| Label | Standard information | Standard information on
polyethylene label to
prevent loss of lettering | Standard
information |
| Design | Conical cap on bottles. Snap
top cap on Cubitainers. | Bottle diameter designed
to be compatible with
ultrasound device. Bottle
cap is designed for ease of
opening and closing with
one hand. | Conical cap |
| Safety | Ultra/Phonic® Free
Conductivity Gel label
contains appropriate
warnings and characteristics | Sonishield™ label contains
appropriate warnings and
characteristics (Latex free,
PVC-free) | Standard
information |
| Environment
of Use | Hospital | Hospital | Hospital |
| Target
Population | Pediatric and adult | Pediatric and adult | Pediatric and adult |
| Use | Multiple Uses | Multiple uses | Multiple uses |
| Material
(Package) | Polyethylene | Polyethylene | Polyethylene |
| Patient
Contact
Materials | Probe | Probe | Probe |
| Energy Type | Electricity only for the
ultrasound device | Electricity only for the
ultrasound device | Electricity only for
the ultrasound
device |

Web: www.pharminnovations.com - Email: info@pharminnovations.com

6

Image /page/6/Picture/1 description: The image shows a logo with a stylized letter 'P' inside a rounded square frame. The 'P' is formed by two parallel lines that create the stem and a curved line that forms the loop. The logo is outlined in blue, giving it a clean and modern appearance.

Image /page/6/Picture/3 description: The image shows a logo with a flag on the left and text on the right. The flag has the letter E on it and a star above it. The text on the right reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".

ghuysen Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242-0578

  • The predicate device 510K (K151070) summary lists Ecogel 100 as not containing dye, while the Konix Ultrasound Gel (K101952) 510K summary, which also used Ecogel 100 as a predicate, lists Ecogel 100 as being dyed green. It is in fact, dyed green.

Web: www.pharminnovations.com - Email: info@pharminnovations.com

7

Image /page/7/Figure/1 description: The image is a logo that features a stylized letter 'H' enclosed within a rounded square. The 'H' is formed by two parallel lines that curve inward at the top and bottom, creating a sense of flow and movement. The logo is outlined in a light blue color, which gives it a clean and modern appearance. The overall design is simple yet elegant, making it suitable for a variety of applications.

Image /page/7/Picture/3 description: The image shows a logo with a flag on the left side and text on the right side. The flag has the letter "E" on it, and there is a star above the flag. The text on the right side reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING."

enue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242

VII. PERFORMANČE DATA

The following performance data was provided in support of the substantial equivalence determination.

Non-clinical performance

Ultra/Phonic® Free Conductivity 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 Ultra/Phonic® Free Conductivity Gel and Sonishield™ 100 Antimicrobial Ultrasound Gel are as follows:

| Property | Ultra/Phonic® Free
Conductivity Gel | Sonishield™ 100 Antimicrobial
Ultrasound Gel |
|---------------------------------------------------------------------------|----------------------------------------|-------------------------------------------------|
| Sound velocity (m/sec) | 1488 ms-1 at 22.5°C | 1497 ms-1 at 30°C |
| Density (kg/m3) | 1018 kg/ m3 at 22.5°C | 1023 kg/ m3 at 30°C |
| Acoustic impedance (kg/m2
sec) | 1.51 MRayls at 22.5°C | 1.53 MRayls at 30°C |
| Attenuation coefficient as a
function of frequency, a/f
(dB/cm-MHz) | 0.0185 + 0.01335 $f^{1.0894}$ | 0.04 ± 0.0042 $f$ |

The acoustic properties of the predicate gel and Ultra/Phonic® Free Conductivity Gel are virtually identical. Although the analysis was conducted at different temperatures, both are well within the range of temperatures encountered during clinical use (72.5°F - 80°F). Such variations in temperature do not induce more than small changes in the listed acoustic properties, too small to alter performance, or cast doubt upon the conclusions of this comparison.

The USP (Category 2) Antimicrobial Effectiveness Test passed with log reductions greater than 5 for all 14 and 28 day bacterial (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruqinosa ATCC 9027) counts. Yeasts and molds (Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231) did not increase from initial counts, and in fact considerably decreased.

Animal Testing

Biocompatibility (ISO 10993-10) testing was conducted for Skin Irritation and Skin Sensitization. Conclusions from these studies: Ultra/Phonic® Free Conductivity Gel was found to be non-sensitizing and non-irritating.

ALL PRODUCTS ARE MANUFACTURED TO ISO 9001:2008, ISO 13485:2003, CE AND USA APPLICABLE STANDARDS.

Page 5 of 6

FDA EST. #9200860

8

Image /page/8/Figure/1 description: The image is a logo with a blue border and a stylized letter "H" inside. The "H" is formed by two parallel lines with a curved shape above them, resembling a stylized "P". The logo has a clean and simple design, with the blue color providing a sense of professionalism.

Image /page/8/Picture/3 description: The image shows a logo for the President of the United States Highest Award for Excellence in Exporting. The logo features a flag with the letter "E" on it, along with a star. The text is in blue and is arranged in a way that emphasizes the importance of exporting.

enue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (97

In Vitro Cytotoxicity:

Cytotoxicity (ISO 10993-5:2009) testing was conducted.

Conclusion from this study: The test article does not meet the requirement of the test as per The International Organization for Standardization (ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for the In Vitro Cytotoxicity, Reference Number ISO 10993-5:2009), and is considered cytotoxic.

Further testing was conducted to establish the safety of the results of the Human-Repeated-Insult-Patch-Test (RIPT) indicated no potential for dermal irritation or allergic contact sensitization. The results of the RIPT test, combined with the favorable results associated with the sensitization and irritation assays, demonstrate the safety of this product.

VIII. CONCLUSIONS

The above-referenced comparisons of the technological and non-clinical performance characteristics indicate that the Ultra/Phonic® Free Conductivity Gel is comparable to its predicate and reference devices and certainly substantially equivalent to them and other ultrasonic coupling gels commonly used in the United States today.