(434 days)
No
The device is a transmission gel, a passive medium for ultrasound. The description focuses on its physical properties and biocompatibility, with no mention of AI/ML in its function or processing. The image processing mentioned is standard ultrasound signal processing, not AI/ML.
No.
The device is a transmission gel used for acoustically coupling a transducer to the body during ultrasound procedures, which can be for both therapeutic and diagnostic purposes. The gel itself is not the therapeutic device but rather an accessory to the ultrasound equipment.
No
Explanation: The device, Other-Sonic™ Transmission Gel, is described as a "non-sterile transmission media" and an "ultrasound conducting medium" that facilitates the acoustic coupling of a transducer to the human body. It does not perform diagnostic functions itself but rather enables the diagnostic (and therapeutic) use of an ultrasound scanner. The diagnostic function is performed by the ultrasound scanner that processes the echoes, not the gel.
No
The device is a transmission gel, which is a physical substance used to facilitate ultrasound imaging. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: Other-Sonic™ Transmission Gel is a transmission medium used externally on the body surface to facilitate the transmission of ultrasound waves. It does not interact with or analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures." This is an external application, not an in vitro analysis of bodily fluids or tissues.
While the device is used in conjunction with diagnostic ultrasound procedures, its function is to enable the imaging process, not to perform a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
Other-Sonic™ Transmission 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.
Product codes
MUI
Device Description
Other-Sonic™ Transmission 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 6.80 ± 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
human body surface (skin)
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:
Acoustic Evaluation:
- Other-Sonic™ Transmission Gel was found to have acoustic properties virtually identical to human skin and similar to other commonly used coupling gels in the US.
- Acoustic properties (Sound velocity, Density, Acoustic impedance, Attenuation coefficient) of Other-Sonic™ Transmission Gel were compared to Sonishield™ 100 Antimicrobial Ultrasound Gel, showing virtually identical results despite different measurement temperatures, concluding that these variations are too small to alter performance.
Antimicrobial Effectiveness Testing:
- Passed USP (Category 2) Antimicrobial Effectiveness Test.
- Achieved log reductions greater than 5 for bacterial counts (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027) at 14 and 28 days.
- Yeasts and molds (Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231) did not increase and considerably decreased.
Animal tests:
- Biocompatibility (ISO 10993-10) testing for Skin Irritation and Skin Sensitization.
- Conclusion: Other-Sonic™ Transmission Gel was found to be non-sensitizing and non-irritating.
In Vitro Cytotoxicity:
- Cytotoxicity (ISO 10993-5:2009) testing was conducted.
- Conclusion: Test article meets the requirements of ISO 10993-5:2009 and is not considered cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Log reductions greater than 5 for bacterial counts (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027)
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Pharmaceutical Innovations, Inc. Shirley J. Bergman Vice President 897 Frelinghuvsen Ave. NEWARK, NJ 07114
January 8, 2018
Re: K163023
Trade/Device Name: Other-Sonic TM Transmission 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 (OS) 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
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 medical devices and radiation-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.I 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)
Device Name
Other-Sonic™ Transmission Gel
Indications for Use (Describe)
Other-Sonic™ Transmission 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.
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 featuring a stylized letter 'P' enclosed within a rounded square. The 'P' is formed by two vertical lines connected by a curved top, all outlined in blue. The square border is also blue, providing a clean and simple design. The logo appears to be for a company or organization whose name starts with the letter 'P'.
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".
Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax:
510(k) Summary
Other-Sonic™ Transmission 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: Other-Sonic™ Transmission Gel
Classification Name: Diagnostic ultrasonic transducer (accessory) (21 CFR 892.1570)
Regulatory Class: II
Product Code: MUI
III. PREDIČATE DEVIČE
Device Name: Sonishield™ 100 Antimicrobial Ultrasound Gel
Classification Name: Diagnostic ultrasonic transducer. (21 CFR 892.1570)
Regulatory Class: II
Product Code: MUI
510K Number: K151070
Additional Reference Device: Ecogel 100 Ultrasound Gel
Classification Name: Diagnostic ultrasonic transducer. (21 CFR 892.1570)
Regulatory Class: II
Product Code: ITX
510K Number: K961757
4
Image /page/4/Figure/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 with curved tops, creating a sense of depth and dimension. The logo is colored in a light blue hue, which gives it a clean and modern appearance. The overall design is simple yet distinctive, making it easily recognizable.
Image /page/4/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 reads 'PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING'. The logo appears to be an award or recognition for excellence in exporting.
venue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242
IV. DEVICE DESCRIPTION
Other-Sonic™ Transmission 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 6.80 ± 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:
Other-Sonic™ Transmission 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. The product 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 'H' is formed by two parallel lines with curved tops, giving it a unique and modern look. The oval shape encircles the top part of the 'H', adding depth to the design. The entire logo is rendered in a light blue color, providing a clean and professional appearance.
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 on it and a star above it. The text on the right says "PRESIDENT OF THE UNITED STATES HIGHEST 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
Other-Sonic™ Transmission Gel has substantially the same technological characteristics as the predicate device, as well as the reference device. The three are compared below:
| Subject | Other-Sonic™ Transmission
Gel | Sonishield™ 100
Antimicrobial Ultrasound
Gel | Ecogel 100
Ultrasound Gel |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended Use | External | External | External |
| Ingredients | Salt free | Salt free | Salt free |
| | Blue coloring | Dye free | Green coloring* |
| | Alcohol free | Alcohol free | Alcohol free |
| | Formaldehyde free | Formaldehyde free | Formaldehyde free |
| | Contains fragrance | Perfume free | Perfume free |
| Physical
Properties | Twist cap for accurate
dispensing
(Snap-top on Cubitainers) | Twist cap for accurate
dispensing | Twist cap for
accurate
dispensing |
| | Twist-off top for quick
refilling. | Flip-top can for quick
refilling | Flip-top can for
quick refilling |
| Chemical
Properties | High clarity | Very high clarity | Good clarity |
| | Bacteriostatic, nonsensitizing | Hypoallergenic,
bacteriostatic,
nonsensitizing | Hypoallergenic,
bacteriostatic,
nonsensitizing |
| | pH 6.80 ± 0.25 | pH 4.5 - 6.5 | pH 6.5 ± 0.75 |
| | Density (g/mL) = 1.033 | Density (g/mL) = 1.009 | 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 966,000 ± 483,000
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 | Water soluble high MW
polymer | Water soluble high
MW polymer |
| | No irritation | No irritation | 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 | Other-Sonic™ Transmission
Gel | Sonishield™ 100
Antimicrobial Ultrasound
Gel | Ecogel 100
Ultrasound Gel |
| Normal process | 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
production area |
| Standard process
manufactured to release
specifications. | 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 | Other-Sonic™ Transmission
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 |
6
Image /page/6/Picture/11 description: The image is a logo with a stylized letter 'H' inside a rounded square. The 'H' is formed by two vertical lines with a curved element connecting them at the top, resembling a stylized oval. The entire logo, including the 'H' and the square border, is outlined in blue.
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' and a star on it. The text on the right reads 'PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING'. The logo appears to be an award or recognition 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.
7
Image /page/7/Picture/25 description: The image is a logo with a blue outline of a square. Inside the square is a stylized letter 'H', also in blue. The 'H' is designed with curved lines and has a three-dimensional appearance, with the left and right sides of the 'H' appearing to be slightly offset from each other. An oval shape surrounds the top portion of the 'H', adding to the logo's unique design.
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" and a star on it. The text on the right side says "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".
ue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (9
VII. PERFORMANČE DATA
The following performance data was provided in support of the substantial equivalence determination.
Non-clinical performance
Acoustic:
Other-Sonic™ Transmission 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 Other-Sonic™ Transmission Gel and Sonishield™ 100 Antimicrobial Ultrasound Gel are as follows:
| Property | Other-Sonic™
Transmission Gel | Sonishield™ 100
Antimicrobial
Ultrasound Gel |
|-------------------------------------------------------------------------|----------------------------------|----------------------------------------------------|
| Sound velocity (m/sec) | 1601 ms-1 at 22.5°C | 1497 ms-1 at 30°C |
| Density (kg/m3) | 1033 kg/ m3 at 22.5°C | 1023 kg/ m3 at 30°C |
| Acoustic impedance (kg/m2 sec) | 1.65 MRayls at 22.5°C | 1.53 MRayls at 30°C |
| Attenuation coefficient as a function of
frequency, a/f (dB/(cm-MHz) | 0.19 + 0.0000105 $f^{2.974}$ | 0.04 ± 0.0042 $f$ |
The acoustic properties of the predicate gel and Other-Sonic™ Transmission 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.
Antimicrobial Effectiveness Testing:
The USP (Category 2) Antimicrobial Effectiveness Test passed with log reductions greater than 5 for all 14 and 28 day bacterial (Staphylococus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa 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 tests:
Biocompatibility (ISO 10993-10) testing was conducted for Skin Irritation and Skin Sensitization. Conclusions from these studies: Other-Sonic™ Transmission Gel was found to be non-sensitizing and non-irritating.
In Vitro Cytotoxicity:
Cytotoxicity (ISO 10993-5:2009) testing was conducted.
8
Image /page/8/Figure/1 description: The image is a logo featuring a stylized letter "H" enclosed within a rounded square frame. The "H" is formed by two vertical lines with curved tops, connected by an oval shape that loops over the top. The entire logo, including the frame and the letter, is outlined in a light blue color, creating a clean and simple design.
Image /page/8/Picture/2 description: The image shows the text "PHARMACEUTICAL INNOVATIONS, INC." in a bold, sans-serif font. The text is a blue color, and the words are stacked on top of each other. There are two horizontal lines below the text.
Image /page/8/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".
nghuysen Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242-0578
Conclusion from this study: The test article meets 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 not considered cytotoxic.
VIII. CONCLUSIONS
The above-referenced comparisons of the technological and non-clinical performance characteristics indicate that the Other-Sonic™ Transmission 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.
Web: www.pharminnovations.com - Email: info@pharminnovations.com
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