(435 days)
UltraPhonic® Scanning 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.
Ultra/Phonic® Scanning 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 4L Cubitainers, 5L Cubitainers, and 250 mL bottles.
Here's a summary of the acceptance criteria and the study details for the Ultra/Phonic® Scanning Gel, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Ultra/Phonic® Scanning Gel Performance |
|---|---|
| Acoustic Properties: - Sound velocity - Density - Acoustic impedance - Attenuation coefficient as a function of frequency | - Sound velocity: 1590 ms-1 at 22.5°C - Density: 1035 kg/m3 at 22.5°C - Acoustic impedance: 1.65 MRayls at 22.5°C - Attenuation coefficient (a/f): 0.06 + 0.01116 f^1.3706 Conclusion: "Virtually identical to that of human skin" and "Similar to other coupling gels commonly used in the United States." Acoustic properties of the predicate gel (Sonishield™ 100) are also provided for comparison and are considered "virtually identical." |
| Antimicrobial Effectiveness (USP <51> Category 2) | - Log reductions > 5 for bacterial counts (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa) at 14 and 28 days. - Yeasts and molds (Aspergillus brasiliensis, Candida albicans) did not increase, and "considerably decreased." |
| Biocompatibility (ISO 10993-10): - Skin Irritation - Skin Sensitization | - Non-sensitizing - Non-irritating |
| In Vitro Cytotoxicity (ISO 10993-5:2009) | - Meets the requirements of the test and is "not considered cytotoxic." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for each specific test (acoustic, antimicrobial, biocompatibility, cytotoxicity). It refers to "evaluations," "tests conducted," and "studies." The provenance of the data is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective, though performance testing is generally prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies performed are non-clinical (laboratory and animal) and do not involve human interpretation or subjective expert ground truth establishment in the traditional sense of diagnostic AI studies.
4. Adjudication Method for the Test Set
Not applicable, as this device does not involve subjective diagnostic interpretations requiring adjudication. The performance criteria are based on objective physical, chemical, and biological measurements.
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 a medical device (ultrasound scanning gel) and not an AI-powered diagnostic tool. Therefore, an MRMC study and evaluation of human reader improvement with AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI model. Its performance is evaluated through direct physical, chemical, and biological testing, not through standalone algorithm performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by recognized scientific and regulatory standards and validated laboratory methods.
- Acoustic Properties: Comparative measurements against human skin properties and other commercially available gels.
- Antimicrobial Effectiveness: Defined log reduction criteria established by USP <51>.
- Biocompatibility: Absence of irritation and sensitization as per ISO 10993-10.
- Cytotoxicity: Meeting negative control requirements and absence of cytotoxic effects as per ISO 10993-5:2009.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI model.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.
Pharmaceutical Innovations Inc. c/o Shirley J. Bergman Vice President 897 Frelinghuysen Ave. NEWARK, NJ 07114
January 9, 2018
Re: K163026
Trade/Device Name: Ultra/Phonic® Scanning 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 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 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.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® Scanning Gel
Indications for Use (Describe)
UltraPhonic® Scanning 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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Image /page/3/Picture/1 description: The image shows a logo with a stylized letter 'P' inside a square frame. The 'P' is formed by two parallel lines with curved tops, creating a sense of flow and elegance. The logo has a clean and modern design, with a focus on simplicity and visual appeal.
Image /page/3/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'.
Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax:
510(k) Summary
Ultra/Phonic® Scanning 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® Scanning 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. (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 is a logo with a blue outline of a square. Inside the square is a stylized letter "P" that is also outlined in blue. The "P" is designed with curved lines and has a three-dimensional appearance. There is also a curved line above the "P" that is also outlined in blue.
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 on it and a star above it. The text on the right reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING". The logo is likely an award or recognition for excellence in exporting.
venue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 24
IV. DEVICE DESCRIPTION
Ultra/Phonic® Scanning 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 4L Cubitainers, 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
- Has no odor
- . Salt (Sodium Chloride) Free
- 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
- Relatively low viscosity, in conjunction with sheer thinning behavior, gives the product the feel and lubricity of oil while providing the performance characteristics and ease of use of an aqueous gel
V. INDICATIONS FOR USE
The Indications for Use statement is as follows:
Ultra/Phonic® Scanning 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.
Web: www.pharminnovations.com - Email: info@pharminnovations.com
Page 2 of 6
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Image /page/5/Figure/1 description: The image shows a logo with a stylized letter 'P' inside an oval shape, all enclosed within a square border. The letter 'P' is formed by two parallel vertical lines connected by a curved top, giving it a modern and abstract appearance. The entire logo 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 appears to be an award for excellence in exporting.
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® Scanning 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® Scanning Gel | Sonishield™ 100AntimicrobialUltrasound Gel | Ecogel 100Ultrasound Gel |
|---|---|---|---|
| IntendedUse | External | External | External |
| Ingredients | Salt free | Salt free | Salt free |
| Green coloring | Dye free | Green coloring* | |
| Alcohol free | Alcohol free | Alcohol free | |
| Formaldehyde free | Formaldehyde free | Formaldehydefree | |
| Perfume free | Perfume free | Perfume free | |
| PhysicalProperties | Twist cap for accurate dispensing(Snap-top on Cubitainers) | Twist cap for accuratedispensing | Twist cap foraccuratedispensing |
| Twist-off top for quick refilling. | Flip-top can for quickrefilling | Flip-top can forquick refilling | |
| ChemicalProperties | High clarity | Very high clarity | Good clarity |
| Bacteriostatic, nonsensitizing | Hypoallergenic,bacteriostatic,nonsensitizing | Hypoallergenic,bacteriostatic,nonsensitizing | |
| $pH 6.25 \pm 0.25$ | $pH 4.5 - 6.5$ | $pH 6.5 \pm 0.75$ | |
| Density (g/mL) = 1.035 | Density (g/mL) =1.009 | Density (g/mL) =0.99 | |
| Stabilized, sheer thinningformulation resists melting anddecomposition from body heat andperspiration, providing lastingconductivity with zero or minimalreapplication. | Very clear screenimage with highviscosity and vacuumprocess. No rapidmelting from highviscosity gel. | It has lowviscosity. It meltsimmediately fromlow viscosity | |
| Viscosity 200,000 ± 100,000 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 highMW polymer | Water solublehigh MW polymer | |
| No irritation | No irritation | No irritation | |
| Process | Normal process | It has a rapidmanufacturingprocess | Normal process |
| Subject | Ultra/Phonic® Scanning Gel | Sonishield™ 100AntimicrobialUltrasound Gel | Ecogel 100Ultrasound Gel |
| Standard bottle (also available intubes, and Cubitainers for refilling) | Sonishield™ employsa soft bottle for easeof use. | Standard bottle | |
| Normal process | Sonishield™production employs aclosed-loop system sothere is no pollutiontransmission. Productis manufactured verycleanly | Normal process | |
| Standard production area | Standard productionarea | Standardproduction area | |
| Standard process manufactured torelease specifications. | Standard processmanufactured torelease specifications. | Standard process | |
| Label | Standard information | Standard informationon polyethylene labelto prevent loss oflettering | Standardinformation |
| Design | Conical cap on bottles and tubes.Snap top cap on Cubitainers. | Bottle diameterdesigned to becompatible withultrasound device.Bottle cap is designedfor ease of openingand closing with onehand. | Conical cap |
| Safety | Ultra/Phonic® Scanning Gel labelcontains appropriate warnings andcharacteristics | Sonishield™ labelcontains appropriatewarnings andcharacteristics (Latexfree, PVC-free) | Standardinformation |
| Environmentof Use | Hospital | Hospital | Hospital |
| TargetPopulation | Pediatric and adult | Pediatric and adult | Pediatric andadult |
| Use | Multiple Uses | Multiple uses | Multiple uses |
| Material(Package) | Polyethylene | Polyethylene | Polyethylene |
| Subject | Ultra/Phonic® Scanning Gel | Sonishield™ 100AntimicrobialUltrasound Gel | Ecogel 100Ultrasound Gel |
| PatientContactMaterials | Probe | Probe | Probe |
| Energy type | Electricity only for the ultrasounddevice | Electricity only for theultrasound device | Electricity onlyfor theultrasound device |
Web: www.pharminnovations.com - Email: info@pharminnovations.com
Page 3 of 6
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Image /page/6/Figure/1 description: The image is a logo that features a stylized letter 'P' enclosed within a rounded square. The 'P' is designed with thick, blue lines and has a unique, flowing shape. An oval shape is above the 'P', adding to the logo's distinctive appearance. The logo is simple yet elegant, with a clean and modern aesthetic.
Image /page/6/Picture/3 description: The image shows a logo with a flag on the left side that has the letter 'E' and a star on it. To the right of the flag, there is text that reads 'PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING'. The text is in a simple, sans-serif font and is arranged in a stacked format.
897 Frelinghuysen Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242-0578
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 'P' inside a square frame. The 'P' is formed by two parallel vertical lines connected by curved lines at the top, creating an oval shape above the vertical lines. The entire logo, including the 'P' and the square frame, is outlined in blue, giving it a clean and simple appearance.
Image /page/7/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, along with a star. The text reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING."
Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax:
- 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.
VII. PERFORMANČE DATA
The following performance data was provided in support of the substantial equivalence determination.
Non-clinical performance
Acoustic:
Ultra/Phonic® Scanning 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® Scanning Gel and Sonishield™ 100 Antimicrobial Ultrasound Gel are as follows:
| Property | Ultra/Phonic®Scanning Gel | Sonishield™ 100AntimicrobialUltrasound Gel |
|---|---|---|
| Sound velocity (m/sec) | 1590 ms-1 at 22.5°C | 1497 ms-1 at 30°C |
| Density (kg/m3) | 1035 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 offrequency, a/f (dB/(cm-MHz)) | $0.06 + 0.01116 f^{1.3706}$ | $0.04 \pm 0.0042 f$ |
The acoustic properties of the predicate gel and Ultra/Phonic® Scanning 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.
Web: www.pharminnovations.com - Email: info@pharminnovations.com
Page 5 of 6
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Image /page/8/Figure/1 description: The image shows a logo with a stylized letter 'P' inside a rounded square. The 'P' is formed by two parallel lines with curved tops, connected by a curved line above. The entire logo, including the 'P' and the square border, is outlined in blue. The background inside the square is white.
Image /page/8/Picture/3 description: The image shows the logo for the President's "E" Award. The logo features a flag with the letter "E" on it, along with a star. To the right of the flag, the text reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".
enue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (97
Antimicrobial Effectiveness Testing:
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 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: Ultra/Phonic® Scanning Gel was found to be non-sensitizing and nonirritating.
In Vitro Cytotoxicity:
Cytotoxicity (ISO 10993-5:2009) testing was conducted.
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 Ultra/Phonic® Scanning 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
Page 6 of 6
§ 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.