(21 days)
No reference devices were used in this submission.
No
The device is an ultrasound coupling gel, which is a passive accessory used to improve acoustic transmission. The description focuses on the physical properties of the gel and its function as a lubricant and conductive medium. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is an ultrasound couplant, which is an accessory used to facilitate diagnostic imaging. It does not directly treat or diagnose a condition.
No
This device is an ultrasound gel, which is an accessory used to facilitate diagnostic ultrasound procedures by coupling sound waves. It does not itself perform any diagnostic function.
No
The device is a physical gel intended to couple sound waves, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "on intact skin during noninvasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics." This describes a device used externally on the body to facilitate an imaging procedure.
- Device Description: The description reinforces this, stating it's an "acoustic couplant" and "lubricant" to improve "acoustic transmission of sound waves to create the ultrasound image." It's an accessory to the ultrasound machine, not a device that analyzes biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is an accessory used in an imaging procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
MUI
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Healthcare Facility
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)
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
- Sterility per USP ●
- . Microbiological Growth per USP
- 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
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:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known)
K181363
Device Name Eco Vue® Sterile and Non-Sterile Ultrasound Gels
Indications for Use (Describe)
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.
| 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:
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.
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.
4
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.
5
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.
6
| | | Proposed Device
EcoVue® Sterile and Non-Sterile | Predicate Device
Sheathes Sterile Ultrasound Gel | Predicate Device
Sheathes 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-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. | Sterile ultrasound couplant for use
with medical diagnostic ultrasound.
It is intended for non-invasive use in
medical diagnostic ultrasound
procedures to couple sound waves
between a patient and the medical
imaging electronics. The gel is
intended for use in all diagnostic
ultrasound procedures which require
ultrasound coupling gel or fluid. | Non-sterile ultrasound couplant for
use with medical diagnostic
ultrasound. It is intended to be used
during non-invasive medical
diagnostic ultrasound procedures to
couple sound waves between a
patient and the medical imaging
electronics. The gel is intended for
use in all diagnostic ultrasound
procedures which require ultrasound
coupling 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 sterile
and non-sterile)
250g pouch (non-sterile) | 20ml individual packets (sterile) | 20ml individual packets (non-sterile)
Bulk bottle (non-sterile) |
| Physical
and
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* |
| | Proposed Device
EcoVue® Sterile and Non-Sterile
Ultrasound Gels | Predicate Device
Sheathes Sterile Ultrasound Gel
(K130041) | Predicate Device
Sheathes Ultrasound Gel
(K112827) | |
| Acoustic
Impedance | 1.40-1.80 Mrayl | 1.63 Mrayl* | 1.63 Mrayl | |
| Sound
Attenuation | 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 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 |
| Utility | | Single-Use (20g sterile and non-sterile
packets)
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.
7
*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".
8
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
- Sterility per USP ●
- . Microbiological Growth per USP
- 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 (