(267 days)
Not Found
No
The device is an ultrasound gel, a passive transmission medium. The description focuses on its physical and chemical properties, not on any computational or analytical capabilities. There is no mention of AI, ML, image processing, or data analysis.
No
The device is an antimicrobial ultrasound gel used as a transmission media for ultrasound imaging procedures, which are diagnostic, not therapeutic. While it is used during "therapeutic ultrasound imaging procedures," its function is solely as a couplant for the imaging process itself, not to deliver therapy.
No
This device is described as a transmission media used in ultrasound imaging procedures; it is not the diagnostic device itself but a necessary component for the diagnostic device to function.
No
The device is a physical gel, not software. The description details its chemical composition and physical properties.
Based on the provided information, Sonishield™ 100 Antimicrobial Ultrasound Gel is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is a "transmission media for acoustically coupling a transducer to a human body surface during external and therapeutic ultrasound imaging procedures." This describes a device used on the patient's body for imaging, not a device used to test samples from the body in a laboratory setting.
- Device Description: The description details its physical properties and function as a "scanning gel used in ultrasound therapeutic and diagnostic imaging techniques." This reinforces its role as a couplant for external ultrasound.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on testing samples in vitro.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Sonishield™ 100's function is to facilitate the physical process of ultrasound imaging on the body.
N/A
Intended Use / Indications for 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 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.
Product codes
MUI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Body (abdomen)
Indicated Patient Age Range
Pediatric and adult
Intended User / Care Setting
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
Acoustic performance evaluation: The acoustic properties of Sonishield™ 100 Antimicrobial Ultrasound Gel were evaluated and found to be virtually identical to human skin and similar to other coupling gels.
Antimicrobial Effectiveness Testing: Performed using USP Category 2 as a guide, demonstrating a log reduction greater than 4 for various bacteria (S. Aureus, Pseudomonas aeruginosa, E.coli, S.Aureus (MRSA), and K. pneumoniae) at 14 and 28 days.
Animal tests (Biocompatibility per ISO 10993-10): Skin Irritation and Skin Sensitization tests concluded the gel was non-sensitizing and non-irritating.
Clinical tests:
- A two-part study on the tolerance of Sonishield™ 100 Antimicrobial Ultrasound Gel concluded that the product produced no signs of cutaneous irritation.
- Another study (HRIPT with 55 volunteers) observed no pertinent reaction during the challenge phase, and the product was considered hypoallergenic. In the induction phase, 9 of 55 volunteers showed "barely noticeable" reactions, 1 of 55 volunteers showed Grade 1, and 2 volunteers showed Grade 2 erythema, while others had no reaction.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a stylized representation of water or wind.
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.
1
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
2
Indications for Use
510(k) Number (if known) K151070
Device Name
Sonishield™ 100 Antimicrobial Ultrasound Gel
Indications for Use (Describe)
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.
| 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
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
4
-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 ●
5
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™ 100
Antimicrobial
Ultrasound Gel | Ecogel 100 Ultrasound
Gel | Konix® 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
Dye free
Alcohol free
Formaldehyde free
Perfume free |
| Physical
Properties | Twist cap for accurate
dispensing
Flip-top can for quick
refilling
Very high clarity
Hypoallergenic,
bacteriostatic, non-
sensitizing | Twist cap for accurate
dispensing
Flip-top can for quick
refilling
Good clarity
Hypoallergenic,
bacteriostatic, non-
sensitizing | Twist cap for accurate
dispensing
Flip-top can for quick
refilling
Hypoallergenic, non-
irritating |
| Chemical
Properties | pH 4.5 - 6.5
Density (g/mL) = 1.009
Very clear screen image
with high viscosity and
vacuum process. No
rapid melting from high-
viscosity gel.
Viscosity 80,000 –
120,000 CPS
Boiling point >200°C
Water soluble high MW
polymer
No irritation | pH 6.5 ± 0.75
Density (g/mL) = 0.99
It has low viscosity. It
melts immediately from
low viscosity
Viscosity 35,000 –
40,000 CPS
Boiling point 100°C
Water soluble high MW
polymer
No irritation | pH 6.5 ± 0.75
Density (g/mL) = 0.983
Very clear screen
image with high
viscosity and vacuum
process. No rapid
melting from high-
viscosity gel.
Viscosity 100,000 –
120,000 CPS
Boiling point >200°C
Water soluble high
MW polymer
No irritation |
| Process | It has a rapid
manufacturing process
Sonishield™ employs a
soft bottle for ease of
use.
Sonishield™ production
employs a closed-loop
system so there is no
pollution transmission.
Product is manufactured
very cleanly.
Standard production
area | Normal process
Standard bottle
Normal process
Standard production
area | a rapid manufacturing
process
employs a soft bottle
for ease of use
production employs a
closed-loop system so
there is no pollution
transmission. Product
is manufactured very
cleanly.
Standard production
area |
| Subject | Sonishield™ 100
Antimicrobial
Ultrasound Gel | Ecogel 100 Ultrasound
Gel | Konix® Ultrasound
Gel |
| | Standard process
manufactured to release
specifications. | Standard process | Manufactured in a
clean room (1/100000
class) |
| Label | Standard information on
polyethylene label to
prevent loss of lettering | Standard information | Standard information
on polyethylene label
to prevent loss of
lettering |
| Design | Bottle diameter
designed to be
compatible with
ultrasound device.
Bottle cap is designed
for ease of opening and
closing with one hand. | Conical cap | Bottle diameter
designed to be
compatible with
ultrasound device.
Bottle cap is designed
for ease of opening and
closing with one hand. |
| Safety | Sonishield™ label
contains appropriate
warnings and
characteristics (Latex-
free, PVC-free) | Standard information | Label contains
appropriate warnings
and characteristics
(Latex-free, PVC-free) |
| Environment of
use | 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 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 |
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8
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:
-
- Virtually identical to that of human skin.
-
- 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) | 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.
9
-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.