(435 days)
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.
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
This document describes the premarket notification (510(k)) for the Ultra/Phonic® Free Conductivity Gel, a diagnostic ultrasonic transducer accessory. The focus of the provided text is on demonstrating the substantial equivalence of the new device to existing predicate devices, rather than a detailed algorithm performance study for an AI-powered device. Therefore, many of the requested elements for AI/algorithm performance (e.g., test set sample size, ground truth details, MRMC studies) are not applicable or not present in this document.
Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate and reference devices, as the goal is to demonstrate "substantial equivalence." The reported performance focuses on acoustic properties and biocompatibility.
| Property | Acceptance Criteria (Predicate/Reference) | Reported Performance (Ultra/Phonic® Free Conductivity Gel) | Met/Not Met |
|---|---|---|---|
| Acoustic Properties | Similar to Sonishield™ 100 & Ecogel 100 | Virtually identical to human skin; Similar to other coupling gels | Met |
| Sound velocity (m/sec) | Sonishield™ 100: 1497 ms-1 at 30°C | 1488 ms-1 at 22.5°C | Met (considered virtually identical despite temp diff) |
| Density (kg/m3) | Sonishield™ 100: 1023 kg/ m3 at 30°C | 1018 kg/ m3 at 22.5°C | Met (considered virtually identical despite temp diff) |
| Acoustic impedance (kg/m2 sec) | Sonishield™ 100: 1.53 MRayls at 30°C | 1.51 MRayls at 22.5°C | Met (considered virtually identical despite temp diff) |
| Attenuation coefficient (a/f) | Sonishield™ 100: 0.04 ± 0.0042 f | 0.0185 + 0.01335 $f^{1.0894}$ | Met (considered virtually identical) |
| Biocompatibility | Non-sensitizing, non-irritating | Non-sensitizing, non-irritating | Met |
| USP <51> Antimicrobial Effectiveness Test | Log reductions > 5 for bacterial, no increase yeast/molds in 14/28 days | Log reductions > 5 for all 14 and 28 day bacterial counts; yeasts and molds decreased | Met |
| In Vitro Cytotoxicity (ISO 10993-5:2009) | Pass | Not met (considered cytotoxic) | Not Met (but mitigated by RIPT) |
| Human-Repeated-Insult-Patch-Test (RIPT) | No potential for dermal irritation/allergic sensitization | No potential for dermal irritation or allergic contact sensitization | Met (mitigated cytotoxicity concern) |
| Physical/Chemical Properties | (Based on comparison table with predicates) | (See detailed characteristics in comparison table) | Met |
| Ingredients (Salt free, Dye free, Alcohol free, Formaldehyde free, Perfume Free) | Similar to Sonishield™ 100 (Ecogel had green coloring) | All free | Met |
| pH | Sonishield™ 100: 4.5 – 6.5; Ecogel 100: 6.5 ± 0.75 | 6.25 ± 0.25 @ 25°C | Met |
| Viscosity (CPS) | Sonishield™ 100: 80,000 – 120,000; Ecogel 100: 35,000 - 40,000 | 600,000 ± 300,000 | Met (difference acknowledged, but deemed equivalent in function) |
| Boiling Point | Sonishield™ 100: > 200°C; Ecogel 100: 100°C | > 200°C | Met |
2. Sample size used for the test set and the data provenance:
- Acoustic performance: The document states that the acoustic properties of the gel were evaluated and compared to human skin and other coupling gels. No specific sample size (number of gels tested, or number of measurements) is provided for this evaluation. The data provenance is implied to be laboratory testing.
- Antimicrobial Effectiveness Test: The test followed USP <51> (Category 2) standards, involving specific bacterial and fungal strains (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231). The sample size typically refers to the number of replicates per microbial challenge, which are standard for this test method.
- Biocompatibility (Skin Irritation, Skin Sensitization, Cytotoxicity): These refer to ISO 10993-10 and ISO 10993-5:2009 standards. These are in vitro or animal tests that follow specific protocols for sample sizes of cells or animals. The document does not specify the exact number of animals or cell cultures used but confirms that tests were conducted according to the stated ISO standards.
- Human-Repeated-Insult-Patch-Test (RIPT): This is a human clinical study. The document does not specify the number of human subjects used but indicates that such testing was performed. Data provenance is likely the testing laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a medical accessory (ultrasound gel), not an AI-powered diagnostic algorithm requiring expert "ground truth" for classification. The "truth" is established by physical/chemical measurements and biological assays.
4. Adjudication method for the test set:
Not applicable (refer to point 3).
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:
Not applicable. This is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used:
The "ground truth" for this device revolves around its physical, chemical, and biological properties:
- Acoustic Properties: Measured values (sound velocity, density, acoustic impedance, attenuation coefficient).
- Biocompatibility: Results of standardized in vitro and in vivo tests adhering to ISO 10993 guidelines, and the USP <51> antimicrobial test.
- Functional Properties: pH, viscosity, ingredients, etc., measured via standard laboratory methods.
8. The sample size for the training set:
Not applicable. This is not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable (refer to point 8).
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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);
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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
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Indications for Use
510(k) Number (if known)
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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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
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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.
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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® FreeConductivity Gel | Sonishield™ 100Antimicrobial UltrasoundGel | Ecogel 100Ultrasound Gel |
|---|---|---|---|
| Intended Use | External | External | External |
| Ingredients | Salt freeDye FreeAlcohol freeFormaldehyde freePerfume Free | Salt freeDye freeAlcohol freeFormaldehyde freePerfume free | Salt freeGreen coloring*Alcohol freeFormaldehyde freePerfume free |
| PhysicalProperties | Twist cap for accuratedispensing(Snap-top on Cubitainers)Twist-off top for quickrefilling. | Twist cap for accuratedispensingFlip-top can for quickrefilling | Twist cap foraccuratedispensingFlip-top can forquick refilling |
| ChemicalProperties | High clarityBacteriostatic, nonsensitizingpH 6.25 ± 0.25Density (g/mL) = 1.018 | Very high clarityHypoallergenic,bacteriostatic,nonsensitizingpH 4.5 – 6.5Density (g/mL) = 1.009 | Good clarityHypoallergenic,bacteriostatic,nonsensitizingpH 6.5 ± 0.75Density (g/mL) =0.99 |
| Stabilized, high viscosityformulation resists meltingand decomposition frombody heat and perspiration,providing lastingconductivity with zero orminimal reapplication. | Very clear screen imagewith high viscosity andvacuum process. No rapidmelting from highviscosity gel. | It has low viscosity.It meltsimmediately fromlow viscosity | |
| Viscosity 600,000 ± 300,000CPS | Viscosity 80,000 – 120,000CPS | Viscosity 35,000 -40,000 CPS | |
| Boiling Point > 200° C | Boiling point > 200° C | Boiling point 100°C | |
| Water soluble high MWpolymersNo irritation | Water soluble high MWpolymerNo irritation | Water soluble highMW polymerNo irritation | |
| Process | Normal process | It has a rapidmanufacturing process | Normal process |
| Standard bottle (Cubitainersfor refilling) | Sonishield™ employs asoft bottle for ease of use | Standard bottle | |
| Subject | Ultra/Phonic® FreeConductivity Gel | Sonishield™ 100Antimicrobial UltrasoundGel | Ecogel 100Ultrasound Gel |
| Normal process | Sonishield™ productionemploys a closed-loopsystem so there is nopollution transmission.Product is manufacturedvery cleanly | Normal process | |
| Standard production area | Standard production area | Standardproduction area | |
| Standard processmanufactured to releasespecifications. | Standard processmanufactured to releasespecifications. | Standard process | |
| Label | Standard information | Standard information onpolyethylene label toprevent loss of lettering | Standardinformation |
| Design | Conical cap on bottles. Snaptop cap on Cubitainers. | Bottle diameter designedto be compatible withultrasound device. Bottlecap is designed for ease ofopening and closing withone hand. | Conical cap |
| Safety | Ultra/Phonic® FreeConductivity Gel labelcontains appropriatewarnings and characteristics | Sonishield™ label containsappropriate warnings andcharacteristics (Latex free,PVC-free) | Standardinformation |
| Environmentof Use | Hospital | Hospital | Hospital |
| TargetPopulation | Pediatric and adult | Pediatric and adult | Pediatric and adult |
| Use | Multiple Uses | Multiple uses | Multiple uses |
| Material(Package) | Polyethylene | Polyethylene | Polyethylene |
| PatientContactMaterials | Probe | Probe | Probe |
| Energy Type | Electricity only for theultrasound device | Electricity only for theultrasound device | Electricity only forthe ultrasounddevice |
Web: www.pharminnovations.com - Email: info@pharminnovations.com
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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
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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:
-
- Virtually identical to that of human skin.
-
- 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® FreeConductivity Gel | Sonishield™ 100 AntimicrobialUltrasound 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/m2sec) | 1.51 MRayls at 22.5°C | 1.53 MRayls at 30°C |
| Attenuation coefficient as afunction 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 <51> (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
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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.
§ 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.