DYNAREX ULTRASOUND GEL

• K Number: K102637
• Device Name: DYNAREX ULTRASOUND GEL
• Manufacturer: DYNAREX CORPORATION
• Date Cleared: 2011-02-16 ( 155 days)
• Product Code: MUI
• Regulation Number: 892.1570

Intended 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. 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.

Predicate Devices

K841871

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple ultrasound coupling gel, and the summary contains no mention of AI or ML capabilities.

Therapeutic

No.
Explanation: The device is an ultrasound coupling media used to facilitate image acquisition, not to treat a medical condition.

Diagnostic

No

This device is an ultrasound coupling gel, which facilitates the operation of an ultrasound system. It is not the diagnostic device itself, but rather an accessory used in diagnostic procedures.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "viscous, clear blue, water soluble gel" and mentions physical packaging configurations (bottles and containers), indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the gel is for use as an ultrasound coupling media to facilitate projecting sound beams into body tissue for imaging purposes. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically involving testing of samples like blood or urine).
• Device Description: The description focuses on the physical properties of the gel and its packaging, consistent with a topical application.
• Performance Studies: The performance studies measure acoustic and electrical properties relevant to ultrasound transmission through tissue, not diagnostic measurements of biological samples.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This ultrasound gel does not perform such a function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

MUI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

external, intact skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Acoustic Speed Measurement (m/s): Dynarex Ultrasound Gel 1530.1; LiquaSonic Ultrasound Gel 1549.5
Acoustic Attenuation Coefficient - Avg. 3 Lots (dB/cm/MHz): Dynarex Ultrasound Gel 0.04 +/- 0.018; LiquaSonic Ultrasound Gel

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.

Summary

0

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: [phone] Fax: [phone]

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:

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.

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.

1

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 Comparison
to
LiquaSonic 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 CHARACTERISTICS
Performance | Dynarex
Ultrasound Gel
510K # K102637 | LiquaSonic
Ultrasound Gel
510K # K841871 |
|------------------------------------------------------------|---------------------------------------------|------------------------------------------------|
| Acoustic Speed Measurement (m/s) | 1530.1 | 1549.5 |
| Acoustic Attenuation Coefficient - Avg. 3 Lots (dB/cm/MHz) | 0.04 +/- 0.018 |