Eco Vue® Sterile and Non-Sterile Ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

Device Description

The proposed device, EcoVue® Sterile and Non-Sterile Ultrasound Gels, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image.

AI/ML Overview

The document describes the acceptance criteria and performance data for EcoVue® Sterile and Non-Sterile Ultrasound Gels, which are coupling media for diagnostic ultrasound.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (EcoVue® Sterile and Non-Sterile Ultrasound Gels)	Reported Device Performance (Predicate Device K130041)	Reported Device Performance (Predicate Device K112827)
Physical & Chemical Properties
Appearance	Clear to Hazy Color; free from foreign matter	Clear or Blue Color	Clear or Blue Color
Sound Velocity (Acoustic Velocity)	1398-1750 m/s	1591 m/s*	1587 m/s*
Acoustic Impedance	1.40-1.80 Mrayl	1.63 Mrayl*	1.63 Mrayl
Sound Attenuation (5 MHz)	0.32-0.95 dB/cm	0.82 dB/cm*	0.90 dB/cm*
Sound Attenuation (7.5 MHz)	0.65-1.10 dB/cm	1.16 dB/cm*	1.57 dB/cm*
Sound Attenuation (10 MHz)	0.85-1.55 dB/cm	1.46 dB/cm*	2.19 dB/cm*
Viscosity	>35,000 cP	96,700*	93,700*
Density	0.85-1.15 g/cm3	1.027 g/cm3*	1.026 g/cm3*
pH	5.5 – 7.8	6.7*	6.7*
Biocompatibility	Meets ISO 10993-1:2009 requirements for irritation, sensitization, and cytotoxicity	Meets ISO 10993-1:2009 requirements for irritation/intracutaneous toxicity, sensitization, and cytotoxicity	Meets ISO 10993-1:2009 requirements for irritation/intracutaneous toxicity, sensitization, and cytotoxicity
Sterility	Sterility Assurance Level of 10⁻⁶ (for sterile gel)	-	-
Antimicrobial Effectiveness	Meets USP <51>	-	-
Microbiological Growth	Meets USP <61>	-	-
Shelf Life	1 year	3 years (for predicate K130041)	5 years (for predicate K112827)

* Note: These values for the predicate devices are reported in the comparison table, but the document states they were obtained from performance testing conducted per HR Pharmaceuticals' protocols, implying they are the subject device's performance measured against the predicate, rather than the predicate's reported performance from its own submission. The "Proposed Device" column directly lists the acceptance criteria for EcoVue®. While the table presents them side-by-side, the "Acceptance Criteria" for the subject device are explicitly listed in the first column, indicating what the new device must achieve.

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 does not explicitly state the sample sizes for the performance bench testing (Sound Velocity, Acoustic Impedance, etc.), biocompatibility testing, sterilization validation, or packaging validation. It refers to these tests as "internal methods," "USP <51>," "USP <71>," "USP <61>," "ASTM D445-17a," and various ISO/AAMI/ASTM standards. These standards typically specify minimum sample sizes or allow for statistically sound justifications, but the specific numbers are not provided in this summary.

The data provenance is not specified regarding country of origin; the testing appears to be conducted by or for the device manufacturer, HR Pharmaceuticals, Inc., as indicated by "Values obtained from performance testing conducted per HR Pharmaceuticals' protocols" (Page 7). All testing described is prospective, as it was conducted to support the 510(k) submission for the EcoVue® gels.

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 information is not applicable to this type of device (ultrasound gel). The tests conducted are primarily physical, chemical, and biological characterizations according to established standards, not diagnostic performance evaluations requiring expert interpretation.

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

This information is not applicable for this type of device or study. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved.

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:

This is not applicable. The device is a medical accessory (ultrasound coupling gel), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is not applicable. The device is a physical product (ultrasound gel), not an algorithm or software. Therefore, standalone algorithm performance was not assessed.

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

The "ground truth" for the performance data of the ultrasound gel is based on:

Bench Test Standards: Industry-recognized physical and chemical measurement standards (e.g., ASTM D445 – 17a, USP <51>, USP <61>, USP <71>) and internal methods.
Biocompatibility Standards: International standards for biological evaluation of medical devices (ISO 10993-1, 10993-5, 10993-10).
Sterilization Standards: International standards for sterilization validation (ISO 11137 series, ISO 11737 series).
Packaging Validation Standards: International and national standards for packaging of sterile medical devices and accelerated aging (ISO 11607-1, ASTM F88, ASTM F1886, ASTM F2096, ASTM F1980).

The "ground truth" is adherence to these established scientific and regulatory standards.

8. The sample size for the training set:

This is not applicable. There is no training set mentioned, as this device does not involve machine learning or AI models that require training data.

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

This is not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized human figure. The second logo is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text to the right of the square.

June 13th, 2018

HR Pharmaceuticals, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K181363

Trade/Device Name: EcoVue® Sterile and Non-Sterile Ultrasound Gels Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: May 18, 2018 Received: May 23, 2018

Dear Mr. Job:

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. Iisting 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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,

Jeff Balyer

for Robert 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)

K181363

Device Name Eco Vue® Sterile and Non-Sterile Ultrasound Gels

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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5.0 510(k) SUMMARY

510(k) SUMMARY for EcoVue® Sterile and Non-Sterile Ultrasound Gels

I. SUBMITTER:

HR Pharmaceuticals, Inc. 2600 Eastern Boulevard, Suite 201 York, PA 17402

Telephone Number:717-252-1110 x104 Fax Number:717-685-2590

Contact Person: Colby Wiesman Date Prepared: 04/26/2018

II. DEVICE:

Name of Device: EcoVue® Sterile and Non-Sterile Ultrasound Gels Common or Usual Name: Media, Coupling, Ultrasound Classification Name: Diagnostic ultrasonic transducer (21 CFR 892.1570) Regulatory Class: II Product Code: MUI

III. PREDICATE DEVICES:

SHEATHING TECHNOLOGIES, Sheathes™ Sterile Ultrasound Gel, K130041 SHEATHING TECHNOLOGIES, Sheathes™ Ultrasound Gel, K112827

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION:

Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image.

Image /page/3/Picture/16 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H-R" in a stylized font. To the right of the letters is the word "Pharmaceuticals, Inc." in a smaller font. Above the "R" is a small circle with a water droplet inside.

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The proposed device is available in the below sizes:

EcoVue® Ultrasound Gel 20g Sterile SafeWrap™ (REF 280); individual, single-. use packet
. EcoVue® Ultrasound Gel 20g Non-Sterile Packet (REF 281); individual, singleuse packet
EcoVue® Ultrasound Gel 250g Non-Sterile FlexPac™ (REF 285); multi-use ● pouch

V. INDICATIONS FOR USE:

EcoVue® Sterile and Non-Sterile Ultrasound Gels are ultrasound couplants intended to be used on intact skin during non-invasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES:

The subject and predicate devices have the same technological principle whereby, the gel is an accessory to the medical imaging equipment acting as a conductive medium that promotes a tight bond between the skin and the transducer, allowing the waves to transmit directly to the body tissues beneath and to the parts that need to be imaged. As such, ultrasound gels are formulated to act as a coupling agent and reduce static.

At a high level, the EcoVue® Ultrasound Gels and the predicate devices are based on the following same elements:

Same Intended Use
Same Technological Characteristics
Similar Physical Characteristics
Similar Performance Specifications ●
Packaged in similar quantities
Provided in both sterile and non-sterile product offerings
Biocompatible
Water-based gels ●

While the indications for use for the subject and predicate devices are not identical, they are similar for purposes of substantial equivalence. The only difference is the indications for use for the subject device clarify that the device is for intact skin since non-invasive procedures can involve both intact skin and compromised skin. This clarification is supported by the biocompatibility testing successfully performed on the subject device and does not impact the safety or effectiveness when the subject device is used as intended.

Image /page/4/Picture/20 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. There is a symbol above the "R" that looks like a water droplet inside of a circle. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the letters.

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Additionally, side-by-side testing confirmed that the subject devices are substantially equivalent to the predicate devices. A more detailed comparison of the predicate and subject devices is presented in the table below.

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		Proposed DeviceEcoVue® Sterile and Non-Sterile	Predicate DeviceSheathes Sterile Ultrasound Gel	Predicate DeviceSheathes Ultrasound Gel
		Ultrasound Gels	(K130041)	(K112827)
Manufacturer		HR Pharmaceuticals, Inc.	Sheathing Technologies, Inc.	Sheathing Technologies, Inc.
Device Name		Media, Coupling, Ultrasound	Media, Coupling, Ultrasound	Media, Coupling, Ultrasound
Description		Diagnostic ultrasonic transducer(accessory)	Diagnostic ultrasonic transducer(accessory)	Diagnostic ultrasonic transducer(accessory)
Medical Specialty		Radiology	Radiology	Radiology
Product Code		MUI	MUI	MUI
Reg Number		892.1570	892.1570	892.1570
Class		2	2	2
Indications for Use		EcoVue® Sterile and Non-SterileUltrasound Gels are ultrasoundcouplants intended to be used on intactskin during non-invasive medicalultrasound procedures to couple soundwaves between a patient and themedical imaging electronics. The gelsare intended for use in all diagnosticultrasound procedures which requirecoupling gel or fluid.	Sterile ultrasound couplant for usewith medical diagnostic ultrasound.It is intended for non-invasive use inmedical diagnostic ultrasoundprocedures to couple sound wavesbetween a patient and the medicalimaging electronics. The gel isintended for use in all diagnosticultrasound procedures which requireultrasound coupling gel or fluid.	Non-sterile ultrasound couplant foruse with medical diagnosticultrasound. It is intended to be usedduring non-invasive medicaldiagnostic ultrasound procedures tocouple sound waves between apatient and the medical imagingelectronics. The gel is intended foruse in all diagnostic ultrasoundprocedures which require ultrasoundcoupling gel or fluid.
Patient-contacting material		Water-based gel(sterile and non-sterile)	Water-based gel (sterile)	Water-based gel (non-sterile)
Sizes		20g individual packets (both sterileand non-sterile)250g pouch (non-sterile)	20ml individual packets (sterile)	20ml individual packets (non-sterile)Bulk bottle (non-sterile)
PhysicalandChemicalProperties	Appearance	Clear to Hazy Color; free from foreignmatter	Clear or Blue Color	Clear or Blue Color
	SoundVelocity(AcousticVelocity)	1398-1750 m/s	1591 m/s*	1587 m/s*
	Proposed DeviceEcoVue® Sterile and Non-SterileUltrasound Gels	Predicate DeviceSheathes Sterile Ultrasound Gel(K130041)	Predicate DeviceSheathes Ultrasound Gel(K112827)
AcousticImpedance	1.40-1.80 Mrayl	1.63 Mrayl*	1.63 Mrayl
SoundAttenuation	0.32-0.95 dB/cm at 5 MHz	0.82 dB/cm at 5 MHz*	0.90 dB/cm at 5 MHz*
	0.65-1.10 dB/cm at 7.5 MHz	1.16 dB/cm at 7.5 MHz*	1.57 dB/cm at 7.5 MHz*
	0.85-1.55 dB/cm at 10 MHz	1.46 dB/cm at 10MHz*	2.19 dB/cm at 10MHz*
Viscosity	>35,000 cP	96,700*	93,700*
Density	0.85-1.15 g/cm3	1.027 g/cm3*	1.026 g/cm3*
pH	5.5 – 7.8	6.7*	6.7*
Biocompatibility		Meets ISO 10993-1:2009 requirementsfor irritation, sensitization, andcytotoxicity	Meets ISO 10993-1:2009requirements forirritation/intracutaneous toxicity,sensitization, and cytotoxicity	Meets ISO 10993-1:2009requirements forirritation/intracutaneous toxicity,sensitization, and cytotoxicity
Utility		Single-Use (20g sterile and non-sterilepackets)Multi-Use (250g pouch)	Single-Use (20ml sterile packets)	Single-Use (20ml sterile and non-sterile packets)Multi-Use (bulk bottle)
Sterility (Method)		Sterile (Gamma);Non-Sterile	Sterile (Hot Water)	Non-Sterile
Environment of Use		Healthcare Facility	Healthcare Facility	Healthcare Facility
Target Population		Adult and Pediatric	Adult and Pediatric	Adult and Pediatric
Labeling		Prescription Use	Prescription Use	Prescription Use
Shelf Life		1 year	3 years	5 years

Image /page/6/Picture/3 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. There is a symbol above the "R" that resembles a water droplet inside of a circle. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the letters.

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*Values obtained from performance testing conducted per HR Pharmaceuticals' protocols.

Image /page/7/Picture/4 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet above a flower. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the "R".

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VII. PERFORMANCE DATA

There are no FDA device-specific guidance documents, special controls document, and/or requirements in a device-specific regulation for acoustic coupling gels. Additionally, no performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for acoustic coupling gels as they are accessories to diagnostic ultrasonic medical devices. However, the EcoVue Ultrasound Gels met the acceptance criteria for the following performance testing to support a substantial equivalence determination.

Bench Testing

. Sound Velocity (Acoustic Velocity) per internal method
Acoustic Impedance per internal method
Sound Attenuation per internal method ●
. Viscosity per ASTM D445 – 17a
Density per internal method
. pH per internal method
Antimicrobial Effectiveness per USP <51>
Sterility per USP <71> ●
. Microbiological Growth per USP <61>
Appearance per internal method (both gel and packaging)

Biocompatibility Testing

The biocompatibility evaluation for the Eco Vue® Ultrasound Gel was conducted in accordance with the FDA Final Guidance "Use of International Standard ISO-10993, 'Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, " June 16, 2016, and International Standard ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The biocompatibility testing included the following and yielded acceptable results:

Cytotoxicity ANSI/AAMI/ISO 10993-5:2009 (R) 2014 Biological Evaluation of ● Medical Devices Part 5: Tests for In Vitro Cytotoxicity
Irritation ANSI/AAMI/ISO 10993-10:2010 (R) 2014—Biological Evaluation ● of Medical Devices-Part 5: Tests for Irritation and Skin Sensitization
Sensitization ANSI/AAMI/ISO 10993-10:2010 (R) 2014-Biological . Evaluation of Medical Devices-Part 5: Tests for Irritation and Skin Sensitization

The EcoVue® Ultrasound Gels fall into the category of limited (<24 hour) contact surface devices and are intended for direct contact with intact skin.

Sterilization

EcoVue® Sterile Ultrasound Gel was validated for sterilization using gamma irradiation at a minimum dose of 27.5kGy and a maximum dose of 45kGy to achieve a Sterility Assurance Level of 10 ° in accordance with the following recognized standards:

Image /page/8/Picture/23 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H-R" in a stylized font. To the right of the letters is the word "Pharmaceuticals, Inc." The logo is simple and professional, and it is likely used on the company's website and marketing materials.

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ANSI/ AAMI/ISO 11137-1:2006/(R) 2010. Sterilization of health care products -● Radiation-Part1: Requirements for development validation, and routine control of a sterilization process for medical devices.
ANSI/AAMI/ISO 11137-2:2013. Sterilization of health care products-● Radiation-Part 2: Establishing the sterilization dose.
ANSI/AAMI/ISO 11137-3:2006 (R) 2010. Sterilization of healthcare products -● Radiation-Part 3: Guidance on dosimetric aspects.
ANSI/AAMI/ISO 11737-1: 2006/(R) 2011. Sterilization of health care products, . Microbiological Methods-Part 1: Determination of a population of microorganisms on product.
. ANSI/AAMI/ISO 11737-2: 2009. Sterilization of Medical Devices-Microbiological Methods-Part 2: Tests of sterility Performed in the definition, validation and maintenance of a sterilization Process.
AAMI TIR 17-2008. Compatibility of Materials subject to sterilization.
ANSI/AAMI/ISO TIR13004: 2013. Sterilization of health care products-● Radiation-Substantiation of a selected sterilization dose-Method VDmax50

Packaging Validation and Shelf Life

The EcoVue® Sterile and Non-Sterile Ultrasound Gels underwent packaging validation testing and accelerated aging testing per the below standards in order to support a one year shelf life.

AAMI/ ISO 11607-1: 2006 (R) 2010, Packaging for terminally sterilized medical ● devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems.
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM F1886/F1886M-16. Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection.
ASTM F2096-11, Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Leak).
. ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

VIII. CONCLUSION

All necessary testing has been performed on the EcoVue® Sterile and Non-Sterile Ultrasound Gels to support substantial equivalence. Additionally, the side-by-side performance testing concluded that the subject devices are substantially equivalent to the legally marketed predicate devices.

Image /page/9/Picture/18 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H-R" in a stylized font. To the right of the letters is a symbol that looks like a water droplet above some leaves. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the letters.

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.