Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective prenatal scans.

Dynarex Ultrasound Gel is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel is intended to facilitate projecting a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.

Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only.

Contraindications: Not for use with defibrillators.

Device Description

Dynarex Ultrasound Gel is a viscous, clear blue, water soluble gel. Typical packaging configurations for the Dynarex Ultrasound Gel is 250 ml plastic bottle, 1 Liter plastic bottle and 5liter plastic container. Other sizes may become available.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Dynarex Ultrasound Gel, seeking substantial equivalence to a predicate device, LiquaSonic Ultrasound Gel. The study focuses on demonstrating the new device's technological characteristics are comparable to the predicate.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

Technological Characteristics / Metric	Acceptance Criteria (Predicate Device K841871)	Reported Device Performance (Dynarex Ultrasound Gel K102637)
Acoustic Speed Measurement (m/s)	1549.5	1530.1
Acoustic Attenuation Coefficient - Avg. 3 Lots (dB/cm/MHz)	< 0.05	0.04 +/- 0.018
Acoustic Impedance Measurement (MRayl)	1.561	1.505
Electroconductivity Avg. 3 Lots (mS/cm)	1.349 +/- 0.003	1.930 +/- 0.026
Indications for use	Implicit: Similar to predicate	Substantially Equivalent
Target Population	Implicit: Similar to predicate	Substantially Equivalent
Materials	Implicit: Similar to predicate	Substantially Equivalent
Biocompatibility	Implicit: Similar to predicate	Substantially Equivalent (supported by Test Report for ISO 10993)
Anatomical sites	Implicit: Similar to predicate	Substantially Equivalent

Acceptance Criteria Notes: For the performance metrics (Acoustic Speed, Acoustic Attenuation, Acoustic Impedance, and Electroconductivity), the acceptance criteria are not explicitly stated with a range or threshold. Instead, the comparison relies on demonstrating that the Dynarex Ultrasound Gel's performance is "substantially equivalent" to the predicate device's measured values, implying that the predicate's values serve as the de facto acceptance target. For qualitative characteristics like "Indications for use" and "Materials," the acceptance criterion is "Substantially Equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Avg. 3 Lots" for Acoustic Attenuation Coefficient and Electroconductivity measurements for the Dynarex Ultrasound Gel, implying testing across three production lots. For the predicate device, it only lists a single value or a range.

Test Set Sample Size: For quantitative performance metrics, at least 3 lots were tested for the Dynarex product. The sample size for the predicate device's data is not specified beyond a single reported value or range.
Data Provenance: Not explicitly stated. The tests were performed as part of a 510(k) submission by Dynarex Corporation, an American company. The "Test Report for ISO 10993 and Test Report Number HIA_DYN_GEL_AM Dated August 27, 2008" suggests laboratory testing was conducted, but the location or whether it was internal or external is not specified. It is prospective testing performed for the purpose of the submission.

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)

This study involves the physical and acoustic characteristics of an ultrasound gel, not diagnostic interpretations of medical images. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for the performance metrics would have been established by standard laboratory testing methodologies and equipment, presumably operated by qualified technicians or engineers, but no specifics are provided regarding the number or qualifications of such personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a scientific and engineering performance comparison of physical properties, not a diagnostic study requiring human adjudication of results.

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 a study involving human readers, AI assistance, or diagnostic performance on cases. It's a comparison of a medical device's physical and acoustic properties.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This product is an ultrasound gel, not an algorithm or a software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the test set is based on objective laboratory measurements of physical and acoustic properties (Acoustic Speed, Acoustic Attenuation, Acoustic Impedance, Electroconductivity) using standard scientific methods and equipment. For biocompatibility, the ground truth would be established by the results of ISO 10993 testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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510263 FEB 1 6 2011

510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k):

Dynarex Corporation 10 Glenshaw Street Orangeburg, NY 10972 USA Phone: (845) 365-8200 Fax: (845) 365-8201

Contact Person:

Daniel Consaga

Date of Summary:

Classification Name:

December 20, 2010

Dynarex Ultrasound Gel.

Trade/Proprietary Name:

Diagnostic Ultrasonic Transducer

Product Code:

MUI

Intended Use:

Dynarex Ultrasound Gel is intended for use as the coupling medium for ultrasound procedures on external, intact skin. Not for use with defibrillators.

Device Description:

Predicate Device:

LiquaSonic Ultrasound Gel 510k Number K841871 manufactured by CHESTER LABS, INC. Erlanger, KY 41018.

Substantial Equivalence:

The Dynarex Ultrasound Gel provides an effective coupling between the tissue being examined and the ultrasound unit. Its function and performance are similar to the predicate device as presented in this 510(k)

Safety and Effectiveness of the device:

This device is as safe and effective as the predicate device cited above. This is better expressed in the Test Report for ISO 10993 and Test Report Number HIA_DYN_GEL_AM Dated August 27, 2008.

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510(K) SUMMARY (as required by 807.92(c))

Summary comparing technological characteristics with other predicate device: Dynarex Ultrasound Gel is similar in terms of intended use and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound devices to skin. The device is substantially equivalent with respect to indications for use and other physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.

Please find below a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution.

TECHNOLOGICAL CHARACTERISTICS	Dynarex Gel ComparisontoLiquaSonic Ultrasound Gel - 510K # K841871
Indications for use	Substantially Equivalent
Target Population	Substantially Equivalent
Materials	Substantially Equivalent
Biocompatibility	Substantially Equivalent
Anatomical sites	Substantially Equivalent

Performance Summary:

FDA has not established special controls or performance standards for this device.

TECHNOLOGICAL CHARACTERISTICSPerformance	DynarexUltrasound Gel510K # K102637	LiquaSonicUltrasound Gel510K # K841871
Acoustic Speed Measurement (m/s)	1530.1	1549.5
Acoustic Attenuation Coefficient - Avg. 3 Lots (dB/cm/MHz)	0.04 +/- 0.018	< 0.05
Acoustic Impedance Measurement (MRayl)	1.505	1.561
Electroconductivity Avg. 3 Lots (mS/cm)	1.930 +/- 0.026	1.349 +/- 0.003

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines above it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Daniel Consaga Quality Engineer Dynarex Corporation 10 Glenshaw Street ORANGEBURG NY 10962

FEB 1 6 2 34

Re: K102637

Trade/Device Name: Dynarex Ultrasound Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasound transducer Regulatory Class: II Product Code: MUI Dated: December 20, 2010 Received: January 10, 2011

Dear Mr. Consaga:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Postel

Mary Pastel, ScD. Director · Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K102637

Device Name: Dynarex Ultrasound Gel

Indications for Use:

Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective prenatal scans.

Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only.

Contraindications: Not for use with defibrillators.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (@GE) (JYV

Michael D'Ohm

510K K1026637

Regulation Number and Section

§ 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.