(33 days)
Not Found
No
The device is a simple ultrasound transmission gel, an accessory for ultrasound procedures. The description focuses on its physical and acoustic properties, and the performance studies are bench tests evaluating these properties and biocompatibility. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
No
This device is an ultrasound couplant gel used for diagnostic imaging procedures, not for therapy. It facilitates sound wave transmission for imaging, it does not treat conditions.
No
The device is an ultrasound transmission gel, an accessory used to couple sound waves for diagnostic ultrasound procedures, but it does not perform the diagnosis itself.
No
The device is a physical gel, not software. The description explicitly details its physical properties and packaging sizes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be 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, explaining it's an "acoustic couplant" 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."
- Lack of Biological Sample Analysis: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information about a patient's health. This device does not interact with or analyze any biological samples.
- Focus on Physical Coupling: The function of the gel is purely physical – to improve the transmission of sound waves. It does not perform any diagnostic analysis itself.
Therefore, the Non-sterile Ultrasound Transmission Gels are considered a medical device, specifically an accessory to an ultrasound imaging system, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Non-sterile 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
MUI
Device Description
The proposed device, Non-Sterile Ultrasound Transmission Gels, 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. 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 improve the acoustic transmission of sound waves to create the ultrasound image.
The subject device is available in the below sizes: 20g/bag,250ml/bottle, 1000ml/bottle,2000ml/bottle,5000ml/bottle,250g/bottle,1000g/bottle,2000 g/bottle,5000g/bottle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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 Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. 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 Shelf life –The label shelf life of the Non-sterile Ultrasound Transmission Gels is 2 years. An accelerated aging test was conducted per ASTM F1980. The service life is 2 years is reasonable and effective.
6.2 Biocompatibility testing - Non-Sterile Ultrasound Transmission Gels have successfully been tested for sensitization, intracutaneously irritation, and Acute Systemic Toxicity Test Testing. The test results verify that the biocompatibility criteria given in ISO 10993-1 are fulfilled. Non-Sterile Ultrasound Transmission Gels are non-sensitizing, non-irritating and non-acute systemic toxicity.
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: Sound Velocity (Acoustic Velocity); Description: Measured at 35 degrees C ,The Sound Velocity (Acoustic Velocity) shall be 1520-1620m/s; Test Results: 1538.1m/s 1540.3m/s Pass 1.60x10^6 Pa·s/m Pass
Test Item: Acoustic Impedance; Description: Measured at 35 degrees C ,Acoustic Impedance shall be 1.5x10^6 ~ 1.7x10^6 Pa·s/m; Test Results: 1.59x10^6 Pa·s/m
Test Item: Sound Attenuation; Description: Measured at 35 degrees C ,Sound Attenuation shall be
§ 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 shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hony Medical Co., Ltd. % Wang Boyle General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai. 200120 CHINA
Re: K241789
Trade/Device Name: Non-Sterile Ultrasound Transmission Gels Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: MUI Dated: June 21, 2024 Received: June 21, 2024
Dear Wang Boyle:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
July 24, 2024
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team 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
2
Indications for Use
Submission Number (if known)
Device Name
Non-Sterile Ultrasound Transmission Gels
ndications for Use (Describe)
The Non-sterile 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
K241789 510(k) Summary
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.12,9 Road,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: Mar.28,2024
2.0 Device Information
| Trade name: | Non-Sterile 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
The proposed device, Non-Sterile Ultrasound Transmission Gels, are non- irritating,
4
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 improve the acoustic transmission of sound waves to create the ultrasound image.
The subject device is available in the below sizes: 20g/bag,250ml/bottle, 1000ml/bottle,2000ml/bottle,5000ml/bottle,250g/bottle,1000g/bottle,2000 g/bottle,5000g/bottle.
5.0 Indication for Use Statement
The Non-sterile 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 Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. 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 Shelf life –The label shelf life of the Non-sterile Ultrasound Transmission Gels is 2 years. An accelerated aging test was conducted per ASTM F1980. The service life is 2 years is reasonable and effective.
6.2 Biocompatibility testing - Non-Sterile Ultrasound Transmission Gels have successfully been tested for sensitization, intracutaneously irritation, and Acute Systemic Toxicity Test Testing. The test results verify that the biocompatibility criteria given in ISO 10993-1 are fulfilled. Non-Sterile Ultrasound Transmission Gels are non-sensitizing, non-irritating and non-acute systemic toxicity.
6.3 Performance testing - Bench The performance of Ultrasound Transmission Gels has been verified. Tests as described in table 1 have been completed.
5
| Test Item | Description | Test Results |
|---|---|---|
| Sound Velocity | ||
| (Acoustic | ||
| Velocity) | Measured at 35°C ,The Sound Velocity | |
| (Acoustic Velocity) shall be 1520-1620m/s | 1538.1m/s ~1540.3m/s | |
| Pass | ||
| Acoustic | ||
| Impedance | Measured at 35°C ,Acoustic Impedance shall be $1.5×10^6$ ~ $1.7×10^6$ Pa·s/m | $1.59×10^6$ Pa·s/m~ $1.60×10^6$ Pa·s/m |
| Pass | ||
| Sound | ||
| Attenuation | Measured at 35°C ,Sound Attenuation shall be ≤0.1dB/(cm • MHz) | 0.06~0.07dB/(cm • MHz) |
| Pass | ||
| Viscosity | Measured at 25°C, the viscosity of the product should not be less than 15Pa-s. | 101Pa·s~103Pa·s |
| Pass | ||
| Density | The density of the product shall be 987-1049kg/m³ | 1033.42kg/m³~1038.46kg/m³ |
| Pass | ||
| pH | The pH value of the product should be 5.5~8.0 | 6.74~6.79 |
| 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 | |
| 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 | ||
|---|---|---|
7.0 _Summary of Clinical Testing
No clinical study is included in this submission.
8.0 Technological Characteristic Comparison Table
Table 2- Comparison of Technology Characteristics
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(k) No. | K241789 | K181363 |
6
| Product Code | MUI | MUI |
|---|---|---|
| Regulation No. | 21 CFR 892.1570 | 21 CFR 892.1570 |
| Class | II | II |
| Intended | ||
| Use/Indication for | ||
| Use | The Non-sterile 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, | ||
| phenoxyethanol, triethanolamine | ||
| and methylparaben. | Water-based gel | |
| (sterile and non-sterile) | ||
| Target Population | Pediatric and adult | Pediatric and adult |
| Environment of Use | Healthcare Facility | Healthcare Facility |
| Model | Single Use:20g/bag, | |
| Multiple Uses: | ||
| 250ml/bottle,500ml/bottle,1000ml/ | ||
| bottle,2000ml/bottle, | ||
| 5000ml/bottle,250g/bottle, | ||
| 500g/bottle,1000g/bottle, | ||
| 2000g/bottle,5000g/bottle. | 20g individual packets (both | |
| sterile and non-sterile) | ||
| Multiple Uses: | ||
| 250g pouch (non-sterile) | ||
| Sterile | Non-sterile | Both in Gamma sterilization |
| and non-sterile | ||
| Shelf Life | 2 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 | $1.5×10^6~1.7×10^6 Pa·s/m$ | $1.40×10^6-1.80 ×10^6 Pa·s/m$ |
| 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 | $\ge$ 15Pa·s (15,000 cP) | >35,000 cP |
| Density | 987-1049kg/m³ | 850-1150 kg/cm³ |
| pH | 5.5~8.0 | 5.5 – 7.8 |
| Biocompatibility | Conform with ISO10993-1 | |
| (ISO10993-10, ISO10993-11) | Conform with ISO 10993 | |
| standards |
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
- Same Technological Characteristics
- · Same Similar Physical Characteristics
- · Same Similar Performance Specifications
- Biocompatible
- · Water-based gels
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 predicate's Ultrasound Gels are including sterile and non-sterile Ultrasound Gels in its 510(k) clearance under K181363. Only Non-sterile Ultrasound Transmission Gels are included in this current 510(k). The subject device's indications are compared to the Ultrasound Gels. The proposed device's Indications for Use are, therefore, more narrow than the Indications for Use stated in K181363, which applied to both the sterile and non-sterile Ultrasound Gels, as the subject device's indications are only applicable to the Non-sterile Ultrasound Transmission Gels, 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.