(434 days)
UltraPhonic® 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.
Ultra/Phonic® 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 4L Cubitainers, 5L Cubitainers, 250 mL bottles, and 250 mL tubes.
The request asks for specific details about the acceptance criteria and the study proving the device meets them. However, the provided document describes an ultrasonic conductivity gel, not an AI/ML device, and therefore does not contain information typically found in a study for AI/ML device performance.
Therefore, most of the requested fields cannot be filled from the provided text as they are not applicable to the type of device described.
Here's a breakdown of what can and cannot be extracted:
Device Type: Ultrasonic Conductivity Gel (not an AI/ML device)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acoustic properties "virtually identical to human skin" | Sound velocity: 1594.2 ms-1 at 22.5°C (compared to predicate's 1497 ms-1 at 30°C) |
| Acoustic properties "similar to other coupling gels" | Density: 1061 kg/m3 at 22.5°C (compared to predicate's 1023 kg/m3 at 30°C) |
| Acoustic impedance: 1.69 MRayls at 22.5°C (compared to predicate's 1.53 MRayls at 30°C) | |
| Attenuation coefficient a/f (dB/(cm-MHz)): 0.05 + 0.01148 f^1.213 (compared to predicate's 0.04 ± 0.0042 f) | |
| Antimicrobial effectiveness (USP <51> Category 2) | Passed with 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. |
| Non-sensitizing (ISO 10993-10) | Found to be non-sensitizing. |
| Non-irritating (ISO 10993-10) | Found to be non-irritating. |
| Not cytotoxic (ISO 10993-5:2009) | Meets the requirement of the test and is not considered cytotoxic. |
| pH level (Product Characteristic) | 6.25 ± 0.25 @ 25°C (compared to predicate Sonishield™ 100: 4.5 - 6.5; Ecogel 100: 6.5 ± 0.75) |
| Viscosity (Product Characteristic) | 600,000 ± 300,000 CPS (compared to predicate Sonishield™ 100: 80,000 - 120,000 CPS; Ecogel 100: 35,000 - 40,000 CPS) |
| Density (Product Characteristic) | 1.061 g/mL (compared to predicate Sonishield™ 100: 1.009 g/mL; Ecogel 100: 0.99 g/mL) |
| Boiling point (Product Characteristic) | > 200°C (compared to predicate Sonishield™ 100: > 200°C; Ecogel 100: 100°C) |
| Other characteristics (non-sensitizing, non-irritating, etc.) | Non-sensitizing, non-irritating, water-soluble, non-staining, easily cleanable, no oil or fatty matter, no odor, does not damage the probe, resists thinning, shear-thinning gel, high viscosity for thick application. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The performance data for this product is based on physicochemical and biological testing in a laboratory setting, not on a test set of patient data.
- Data Provenance: The acoustic testing used the Ultra/Phonic® Conductivity Gel and the predicate Sonishield™ 100 Antimicrobial Ultrasound Gel. Biocompatibility and cytotoxicity tests were conducted on the Ultra/Phonic® Conductivity Gel. The document does not specify the country of origin for the testing data. The studies are non-clinical performance evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not an AI/ML device that requires expert ground truth labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/ML. The "ground truth" for this device's performance is based on established laboratory testing standards (e.g., USP <51> for antimicrobial effectiveness, ISO 10993 for biocompatibility and cytotoxicity) and physical property measurements.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
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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
Re: K163024
Trade/Device Name: Ultra/Phonic 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);
January 8, 2018
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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® Conductivity Gel
Indications for Use (Describe)
UltraPhonic® 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.
| 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 blue outline of a square. Inside the square is a stylized letter 'P' that is also outlined in blue. The 'P' is partially encircled by an oval shape, also outlined in blue, that adds a sense of motion or dynamism to the design.
Image /page/3/Picture/3 description: The image shows a logo for the President of the United States Highest Award for Excellence in Exporting. The logo includes a flag with the letter E and a star on it. The text is in blue and is arranged in a way that emphasizes the importance of exporting.
Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (97
510(k) Summary
Ultra/Phonic® 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® 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. (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
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Image /page/4/Figure/1 description: The image shows a logo with a stylized letter 'H' inside a rounded square. The 'H' is formed by two vertical lines connected by a horizontal stroke, with curved elements at the top. An oval shape surrounds the top portion of the 'H', adding a sense of motion or emphasis. The logo is outlined in blue, providing a clean and distinct appearance against a white background.
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 appears to be an award for excellence in exporting.
Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242
IV. DEVICE DESCRIPTION
Ultra/Phonic® 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 4L Cubitainers, 5L Cubitainers, 250 mL bottles, and 250 mL tubes.
Major characteristics include:
- Non-sensitizing, non-irritating ●
- Water soluble, non-staining, and easily cleanable
- Does not contain oil or fatty matter
- Has no odor
- 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® 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. The product is indicated for prescription use only.
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Image /page/5/Figure/1 description: The image is a logo that features a stylized letter 'P' enclosed within an oval shape, all contained within a square border. The letter 'P' is designed with sharp angles and a double-line effect, giving it a modern and geometric appearance. The oval shape encircles the top portion of the 'P', adding a sense of enclosure and unity to the design. The entire logo is rendered in a light blue color, which contributes to a clean and professional aesthetic.
Image /page/5/Picture/3 description: The image shows a logo with a flag and text. The flag has 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'.
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® 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® ConductivityGel | Sonishield™ 100Antimicrobial UltrasoundGel | Ecogel 100Ultrasound Gel |
|---|---|---|---|
| Intended Use | External | External | External |
| INGREDIENTS | Contains salt | Salt free | Salt free |
| Green coloring | Dye free | Green coloring* | |
| Alcohol free | Alcohol free | Alcohol free | |
| Formaldehyde free | Formaldehyde free | Formaldehyde free | |
| Perfume free | Perfume free | Perfume free | |
| PHYSICALPROPERTIES | Twist cap for accuratedispensing(Snap-top on Cubitainers) | Twist cap for accuratedispensing | |
| Twist-off top for quickrefilling. Tubes are notrefillable. | Flip-top can for quickrefilling | Flip-top can forquick refilling | |
| High clarity | Very high clarity | Good clarity | |
| Bacteriostatic,nonsensitizing | Hypoallergenic,bacteriostatic,nonsensitizing | Hypoallergenic,bacteriostatic,nonsensitizing | |
| pH 6.25 ± 0.25 | pH 4.5 - 6.5 | pH 6.5 ± 0.75 | |
| CHEMICALPROPERTIES | Density (g/mL) = 1.061 | Density (g/mL) = 1.009 | Density (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 lowviscosity. It meltsimmediately fromlow viscosity | |
| Viscosity 600,000 ± 300,000CPS | 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 MWpolymers | Water soluble high MWpolymer | Water soluble highMW polymer | |
| No irritation | No irritation | No irritation | |
| PROCESS | Normal process | It has a rapidmanufacturing process | Normal process |
| Subject | Ultra/Phonic® ConductivityGel | Sonishield™ 100Antimicrobial UltrasoundGel | Ecogel 100Ultrasound Gel |
| Standard bottle (alsoavailable in tubes, andCubitainers for refilling) | Sonishield™ employs asoft bottle for ease ofuse. | Standard bottle | |
| 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 andtubes. Snap top cap onCubitainers. | Bottle diameter designedto be compatible withultrasound device. Bottlecap is designed for easeof opening and closingwith one hand. | Conical cap |
| SAFETY | Ultra/Phonic® ConductivityGel label containsappropriate warnings andcharacteristics | Sonishield™ labelcontains appropriatewarnings andcharacteristics (Latexfree, 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 |
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Image /page/6/Figure/1 description: The image shows a logo with a stylized letter 'H' inside a square with rounded corners. An oval shape surrounds the top portion of the 'H', adding a dynamic element to the design. The logo is outlined in blue, providing a clean and professional look.
CEUTICAL PHARN INNING TONS, INC
Image /page/6/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".
897 Frelinghuysen Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242-0578
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Image /page/7/Figure/19 description: The image is a logo that features a stylized letter "P" enclosed within an oval shape, all rendered in blue lines. The "P" is designed with a unique, almost double-lined effect, giving it a modern and abstract appearance. The oval shape surrounds the "P", adding a sense of containment and focus to the central element. The entire logo is set against a white background, which provides a clean and contrasting backdrop that makes the blue lines stand out.
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 and a star above 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: (97
| Subject | Ultra/Phonic® ConductivityGel | SonishieldTM 100Antimicrobial UltrasoundGel | Ecogel 100Ultrasound Gel |
|---|---|---|---|
| ENERGY TYPE | Electricity only for theultrasound device | Electricity only for theultrasound device | Electricity only forthe ultrasounddevice |
- 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® 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® Conductivity Gel and Sonishield™ 100 Antimicrobial Ultrasound Gel are as follows:
| Property | Ultra/Phonic®Conductivity Gel | Sonishield™ 100AntimicrobialUltrasound Gel |
|---|---|---|
| Sound velocity (m/sec) | 1594.2 ms-1 at 22.5°C | 1497 ms-1 at 30°C |
| Density (kg/m3) | 1061 kg/ m3 at 22.5°C | 1023 kg/ m3 at 30°C |
| Acoustic impedance (kg/m2 sec) | 1.69 MRayls at 22.5°C | 1.53 MRayls at 30°C |
| Attenuation coefficient as a function offrequency, a/f (dB/(cm-MHz) | $0.05 + 0.01148 f^{1.213}$ | $0.04 \pm 0.0042 f$ |
The acoustic properties of the predicate gel and Ultra/Phonic® 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.
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.
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Image /page/8/Figure/1 description: The image shows a logo with a stylized letter 'H' inside a square frame. An oval shape surrounds the top of the 'H', adding a dynamic element to the design. The logo is rendered in a light blue color, providing a clean and professional appearance.
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. The text on the right reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".
Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242
Animal tests:
Biocompatibility (ISO 10993-10) testing was conducted for Skin Irritation and Skin Sensitization. Conclusions from these studies: Ultra/Phonic® Conductivity Gel was found to be non-sensitizing and non-irritating.
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® 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.