Ultra/Phonic Free Conductivity Gel

{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) | <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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<br>Conductivity Gel | Sonishield™ 100<br>Antimicrobial Ultrasound<br>Gel | Ecogel 100<br>Ultrasound Gel | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Intended Use | External | External | External | | Ingredients | Salt free<br>Dye Free<br>Alcohol free<br>Formaldehyde free<br>Perfume Free | Salt free<br>Dye free<br>Alcohol free<br>Formaldehyde free<br>Perfume free | Salt free<br>Green coloring*<br>Alcohol free<br>Formaldehyde free<br>Perfume free | | Physical<br>Properties | Twist cap for accurate<br>dispensing<br>(Snap-top on Cubitainers)<br>Twist-off top for quick<br>refilling. | Twist cap for accurate<br>dispensing<br>Flip-top can for quick<br>refilling | Twist cap for<br>accurate<br>dispensing<br>Flip-top can for<br>quick refilling | | Chemical<br>Properties | High clarity<br>Bacteriostatic, nonsensitizing<br>pH 6.25 ± 0.25<br>Density (g/mL) = 1.018 | Very high clarity<br>Hypoallergenic,<br>bacteriostatic,<br>nonsensitizing<br>pH 4.5 – 6.5<br>Density (g/mL) = 1.009 | Good clarity<br>Hypoallergenic,<br>bacteriostatic,<br>nonsensitizing<br>pH 6.5 ± 0.75<br>Density (g/mL) =<br>0.99 | | | Stabilized, high viscosity<br>formulation resists melting<br>and decomposition from<br>body heat and perspiration,<br>providing lasting<br>conductivity with zero or<br>minimal reapplication. | Very clear screen image<br>with high viscosity and<br>vacuum process. No rapid<br>melting from high<br>viscosity gel. | It has low viscosity.<br>It melts<br>immediately from<br>low viscosity | | | Viscosity 600,000 ± 300,000<br>CPS | Viscosity 80,000 – 120,000<br>CPS | Viscosity 35,000 -<br>40,000 CPS | | | Boiling Point > 200° C | Boiling point > 200° C | Boiling point 100°<br>C | | | Water soluble high MW<br>polymers<br>No irritation | Water soluble high MW<br>polymer<br>No irritation | Water soluble high<br>MW polymer<br>No irritation | | Process | Normal process | It has a rapid<br>manufacturing process | Normal process | | | Standard bottle (Cubitainers<br>for refilling) | Sonishield™ employs a<br>soft bottle for ease of use | Standard bottle | | Subject | Ultra/Phonic® Free<br>Conductivity Gel | Sonishield™ 100<br>Antimicrobial Ultrasound<br>Gel | Ecogel 100<br>Ultrasound Gel | | | Normal process | Sonishield™ production<br>employs a closed-loop<br>system so there is no<br>pollution transmission.<br>Product is manufactured<br>very cleanly | Normal process | | | Standard production area | Standard production area | Standard<br>production area | | | Standard process<br>manufactured to release<br>specifications. | Standard process<br>manufactured to release<br>specifications. | Standard process | | Label | Standard information | Standard information on<br>polyethylene label to<br>prevent loss of lettering | Standard<br>information | | Design | Conical cap on bottles. Snap<br>top cap on Cubitainers. | Bottle diameter designed<br>to be compatible with<br>ultrasound device. Bottle<br>cap is designed for ease of<br>opening and closing with<br>one hand. | Conical cap | | Safety | Ultra/Phonic® Free<br>Conductivity Gel label<br>contains appropriate<br>warnings and characteristics | Sonishield™ label contains<br>appropriate warnings and<br>characteristics (Latex free,<br>PVC-free) | Standard<br>information | | Environment<br>of Use | Hospital | Hospital | Hospital | | Target<br>Population | Pediatric and adult | Pediatric and adult | Pediatric and adult | | Use | Multiple Uses | Multiple uses | Multiple uses | | Material<br>(Package) | Polyethylene | Polyethylene | Polyethylene | | Patient<br>Contact<br>Materials | Probe | Probe | Probe | | Energy Type | Electricity only for the<br>ultrasound device | Electricity only for the<br>ultrasound device | Electricity only for<br>the ultrasound<br>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. - 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<br>Conductivity Gel | Sonishield™ 100 Antimicrobial<br>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<br>sec) | 1.51 MRayls at 22.5°C | 1.53 MRayls at 30°C | | Attenuation coefficient as a<br>function of frequency, a/f<br>(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 {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.