(54 days)
Not Found
No
The device is a gel used to facilitate ultrasound imaging and does not involve any data processing or algorithmic analysis.
No
The device is an ultrasound transmission gel used to couple sound waves for diagnostic imaging, not for treating a condition.
No
The device, Ultrasound Transmission Gels, is explicitly described as an "accessory" and a "couplant" used to facilitate sound wave transmission in diagnostic ultrasound procedures. It does not perform the diagnostic imaging or interpretation itself.
No
The device is a physical gel, not software. The description details its chemical composition, packaging, sterilization, and physical properties as an acoustic couplant.
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 gels are used "on intact skin during non-invasive 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 by explaining the gel's function as an "acoustic couplant" and a "conductive medium" to improve the transmission of sound waves for image creation.
- Lack of In Vitro Activity: An IVD is a device intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. This device does not interact with or analyze any bodily specimens. It is applied externally to the skin.
- Focus on Physical Coupling: The entire description centers around the physical properties of the gel that enable sound wave transmission, not on any chemical or biological analysis of bodily fluids or tissues.
In summary, this device is an accessory used during a diagnostic imaging procedure (ultrasound), but it does not perform any diagnostic testing itself on specimens from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ultrasound Transmission 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. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.
Product codes (comma separated list FDA assigned to the subject device)
MUI
Device Description
The Ultrasound Transmission Gels, which shall be colorless or light-colored transparent , are non-irritating, 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.
The Ultrasound Transmission Gels are composed of purified water, glycerin, polyethylene glycol, carbomer, sodium hydroxide and phenoxyethanol. It 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 subject device is available in the below sizes: 5q/baq, 10g/baq, 15q/baq, 16q/baq, 20g/bag, 22g/bag, 25g/bag, individual, single-use packet.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's Gamma sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intact skin
Indicated Patient Age Range
adults and pediatrics
Intended User / Care Setting
professional 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)
Summary of non-clinical and performance testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 10993-1, ISO 11137-1, ISO 11607-1. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
6.1 Sterilization and shelf life - Ultrasound Transmission Gels are delivered sterile and have successfully been tested according to 11137-1; the packaging after accelerated aging for terminally sterilized devices has been verified per ISO 11607- 1. The label shelf life is 3 years.
6.2 Biocompatibility testing - Ultrasound Transmission Gels have successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, and material medicated pyrogenicity Testing. The test results verify that the biocompatibility criteria given in ISO 10993-1 are fulfilled. Ultrasound Transmission Gels are non-toxic and biocompatible.
6.3 Performance testing - Bench The performance of Ultrasound Transmission Gels has been verified. Tests as described in table 1 have been completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sound Velocity (Acoustic Velocity): 1538.4m/s ~1538.4m/s, Pass
- Acoustic Impedance: 1.56 x 10^6 Pa-s/m ~ 1.63 x 10^6 Pa-s/m, Pass
- Sound Attenuation: 0.01dB/(cm • MHz), Pass
- Viscosity: 100Pa-s~103Pa-s, Pass
- Density: 1028.61kg/m³~1033.39kg/m³, Pass
- pH: 6.76~6.83, Pass
- Antimicrobial Effectiveness: Pass (Bacteria: Not less than a 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days count at 28 days Yeast and Molds: No increase from the initial calculated count at 14 and 28 days)
- Sterility: Pass
- Appearance: Pass
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
August 29, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hony Medical Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801. No. 161 East Luiiazui Rd., Pudong Shanghai, Shanghai 200120 CHINA
Re: K221999
Trade/Device Name: Ultrasound Transmission Gels Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: MUI Dated: May 25, 2022 Received: July 7, 2022
Dear Boyle Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Michael D. O'Hara, Ph.D. Deputy Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221999
Device Name Ultrasound Transmission Gels
Indications for Use (Describe)
Ultrasound Transmission 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. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.
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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3
510(k) Summary K221999
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Hony Medical Co., Ltd. |
|---|---|
| Address: | No.12,9Road,Changlong Ind.Zone,Taishan City,Guangdong |
| China 529222 | |
| Tel: | +86 15916327827 |
| Contact: | Zhu Huina |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date submitted: Aug.10,2022
2.0 Device Information
| Trade name: | Ultrasound Transmission Gels |
|---|---|
| Common name: | Diagnostic ultrasonic transducer |
| Classification name: | Media, Coupling, Ultrasound |
| Production code: | MUI |
| Regulation number: | 21 CFR 892.1570 |
| Classification: | Class II |
| Panel: | Radiology |
3.0 Predicate Device Information
| Manufacturer: | HR Pharmaceuticals, Inc. |
|---|---|
| Trade/Device Name: | EcoVue® Sterile and Non-Sterile Ultrasound Gels |
| 510(k) number: | K181363 |
4.0 Device Description
4
The Ultrasound Transmission Gels, which shall be colorless or light-colored transparent , are non-irritating, 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.
The Ultrasound Transmission Gels are composed of purified water, glycerin, polyethylene glycol, carbomer, sodium hydroxide and phenoxyethanol. It 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 subject device is available in the below sizes: 5q/baq, 10g/baq, 15q/baq, 16q/baq, 20g/bag, 22g/bag, 25g/bag, individual, single-use packet.
As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's Gamma sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
5.0 Indication for Use Statement
Ultrasound Transmission 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.
The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.
6.0 Summary of Non-Clinical Testing
Summary of non-clinical and performance testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 10993-1, ISO 11137-1, ISO 11607-1. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
6.1 Sterilization and shelf life - Ultrasound Transmission Gels are delivered sterile and have successfully been tested according to 11137-1; the packaging after accelerated
5
aging for terminally sterilized devices has been verified per ISO 11607- 1. The label shelf life is 3 years.
6.2 Biocompatibility testing - Ultrasound Transmission Gels have successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, and material medicated pyrogenicity Testing. The test results verify that the biocompatibility criteria given in ISO 10993-1 are fulfilled. Ultrasound Transmission Gels are non-toxic and biocompatible.
6.3 Performance testing - Bench The performance of Ultrasound Transmission Gels has been verified. Tests as described in table 1 have been completed.
| Test Item | Description | Test Results |
|---|---|---|
| Sound Velocity | ||
| (Acoustic | ||
| Velocity) | Measured at 35°C ,The Sound Velocity | |
| (Acoustic Velocity) shall be 1520-1620m/s | 1538.4m/s ~1538.4m/s | |
| Pass | ||
| Acoustic | ||
| Impedance | Measured at 35°C ,Acoustic Impedance | |
| shall be $1.5×10^6$ ~ $1.7×10^6$ Pa-s/m | $1.56×10^6$ Pa-s/m | |
| ~ $1.63×10^6$ Pa-s/m | ||
| Pass | ||
| Sound | ||
| Attenuation | Measured at 35°C ,Sound Attenuation shall | |
| be ≤0.1dB/(cm·MHz) | 0.01dB/(cm • MHz) | |
| Pass | ||
| Viscosity | Measured at 25°C, the viscosity of the | |
| product should not be less than 15Pa-s. | 100Pa-s~103Pa-s | |
| Pass | ||
| Density | The density of the product shall be | |
| 987-1049kg/m³ | 1028.61kg/m³~1033.39kg/m³ | |
| Pass | ||
| pH | The pH value of the product should be | |
| 5.5~8.0 | 6.76~6.83 | |
| Pass | ||
| Antimicrobial | ||
| Effectiveness | Bacteria: Not less than a 2.0 log reduction | |
| from the initial count at 14 days, and no | ||
| increase from the 14 days count at 28 days | ||
| Yeast and Molds: No increase from the | ||
| initial calculated count at 14 and 28 days | Pass | |
| Sterility | The product should be sterile after being | |
| sterilized by confirmed gamma sterilization. | Pass | |
| Appearance | The product is colorless or light-colored | |
| transparent gel without insoluble foreign | ||
| matter. Under normal storage conditions of | ||
| the product, there will be no delamination, | ||
| mildew and odor. | Pass |
Table 1: Performance testing summary - Bench
6
7.0 _Summary of Clinical Testing
No clinical study is included in this submission.
8.0 Technological Characteristic Comparison Table
| Item | Table 2- Comparison of Technology Characteristics
Subject Device | Predicate Device |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Pending | K181363 |
| Product Code | MUI | MUI |
| Regulation No. | 21 CFR 892.1570 | 21 CFR 892.1570 |
| Class | II | II |
| Intended
Use/Indication for
Use | Ultrasound Transmission 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.
The gels can be used during the
procedures that involved adults
and pediatrics in professional
healthcare facility. | 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. |
| Patient-contacting
material | Purified water, glycerin,
polyethylene glycol, carbomer,
sodium hydroxide and
phenoxyethanol. | Water-based gel
(sterile and non-sterile) |
| Model | 5g/bag , 10g/bag , 15g/bag,
16g/bag, 20g/bag, 22g/bag,
25g/bag | 20g individual packets (both
sterile and non-sterile)
250g pouch (non-sterile) |
| Sterile | Gamma sterilization, SAL 10-6 | Both in Gamma sterilization
and non-sterile |
| Shelf Life | 3 years | 1 years |
| Appearance | The product is colorless or
light-colored transparent gel
without insoluble foreign matter. | Clear to Hazy Color; free from
foreign matter |
| Sound Velocity
(Acoustic Velocity) | 1520-1620m/s | 1398-1750 m/s |
| Acoustic
Impedance | $1.5×10^61.7×10^6$ Pa·s/m | $1.40×10^6-1.80 ×10^6$ Pa·s/m |8.0 | 5.5 – 7.8 |
| Sound
Attenuation | ≤0.1dB/(cm·MHz) | 0.32-0.95 dB/cm at 5 MHz
0.65-1.10 dB/cm at 7.5 MHz
0.85-1.55 dB/cm at 10 MHz |
| Viscosity | ≥15Pa·s (15,000 cP) | >35,000 cP |
| Density | 987-1049kg/m³ | 850-1150 kg/cm³ |
| pH | 5.5
| Biocompatibility | Conform with ISO10993-1
(ISO10993-5, ISO10993-10,
ISO10993-11) | Conform with ISO 10993 standards |
Table 2- Comparison of Technology Characteristics
7
The technological characteristics of the subject device are identical to those of
predicate device. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following:
- Same intended use
- · Same indications for use
- · Similar material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods
- · Same fundamental technology/principal of operation/user interface
Physical and Chemical Properties of the subject device are a little different with those of the predicate device, but all the required values are within those of predicate device.
The subject device is just provided in sterile condition while the predicate device is provided both in sterile and non-sterile condition, there is no significant risk raised by the difference.
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K181363 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.