(33 days)
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.
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.
This document is a 510(k) Premarket Notification for a non-sterile ultrasound transmission gel, not an AI/ML medical device. Therefore, the information requested in points 1-9 regarding acceptance criteria, study details, expert involvement, and ground truth establishment for AI/ML performance is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (EcoVue® Sterile and Non-Sterile Ultrasound Gels, K181363) through physical, chemical, and performance testing for the ultrasound gel itself.
Here's a breakdown of the relevant information present in the document that aligns with the spirit of your request regarding product validation, but adapted for a non-AI/ML medical device:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML context)
The document presents performance testing results for the Non-Sterile Ultrasound Transmission Gels. The "Acceptance Criteria" here are the specified ranges or conditions that the gel must meet for various physical and chemical properties.
| Test Item | Acceptance Criteria (Specification) | Reported Device Performance (Test Results) | Conclusion |
|---|---|---|---|
| Sound Velocity (Acoustic Velocity) | 1520-1620 m/s (at 35°C) | 1538.1 m/s ~ 1540.3 m/s | Pass |
| Acoustic Impedance | 1.5×10^6 ~ 1.7×10^6 Pa·s/m (at 35°C) | 1.59×10^6 Pa·s/m ~ 1.60×10^6 Pa·s/m | Pass |
| Sound Attenuation | ≤0.1 dB/(cm • MHz) (at 35°C) | 0.06~0.07 dB/(cm • MHz) | Pass |
| Viscosity | ≥ 15 Pa·s (at 25°C) | 101 Pa·s ~ 103 Pa·s | Pass |
| Density | 987-1049 kg/m³ | 1033.42 kg/m³ ~ 1038.46 kg/m³ | Pass |
| pH | 5.5~8.0 | 6.74~6.79 | Pass |
| Antimicrobial Effectiveness | Bacteria: ≥ 2.0 log reduction at 14 days, no increase from 14-day count at 28 days. Yeast and Molds: No increase from initial count at 14 and 28 days. | Pass | Pass |
| Appearance | Colorless or light-colored transparent gel, no insoluble foreign matter. No delamination, mildew, or odor under normal storage. | Pass | Pass |
2. Sample Size and Data Provenance (Non-AI/ML context)
- Sample Size: The document does not specify the exact number of samples used for each bench test. These are typical material property tests, and standard laboratory practices would involve a sufficient number of samples to ensure reproducibility and statistical significance, though the detailed protocol and exact sample counts are not included in this summary.
- Data Provenance: The tests were conducted internally by Hony Medical Co., Ltd. in China. The nature of the study is "bench testing" or "non-clinical testing," implying experimental evaluation in a laboratory setting rather than retrospective or prospective clinical data.
3. Number of Experts and Qualifications (Not Applicable for this type of device)
This concept is not relevant for the validation of an ultrasound transmission gel's physical and chemical properties. The "experts" would be the laboratory personnel conducting and analyzing the bench tests, qualified in chemical and physical analysis.
4. Adjudication Method (Not Applicable)
This is a concept for reconciling disagreements in human annotations for ground truth in AI/ML studies, which is not applicable to bench testing of a physical product.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study (Not Applicable)
This study type is used to assess the impact of AI on human reader performance, which is not relevant for an ultrasound transmission gel. The document explicitly states: "No clinical study is included in this submission."
6. Standalone Performance (Non-AI/ML context)
The performance data provided in Table 1 ("Performance testing summary - Bench") represents the "standalone" performance of the Non-Sterile Ultrasound Transmission Gels as a product, independent of human interaction in an AI context. The device's performance is measured against its own specifications, not as an algorithm assisting a human.
7. Type of Ground Truth (Non-AI/ML context)
The "ground truth" for this device's performance is established by objective laboratory measurements of its physical and chemical properties, compared against predefined specifications based on industry standards (e.g., ASTM F1980 for shelf life, ISO 10993-1 for biocompatibility) and the requirements for effective ultrasound transmission.
8. Sample Size for Training Set (Not Applicable)
This device does not involve a "training set" in the context of machine learning.
9. How Ground Truth for Training Set was Established (Not Applicable)
As there is no training set for this traditional medical device, this question is not applicable.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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, 200120China |
| 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(AcousticVelocity) | Measured at 35°C ,The Sound Velocity(Acoustic Velocity) shall be 1520-1620m/s | 1538.1m/s ~1540.3m/sPass |
| AcousticImpedance | 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/mPass |
| SoundAttenuation | 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·sPass |
| Density | The density of the product shall be 987-1049kg/m³ | 1033.42kg/m³~1038.46kg/m³Pass |
| pH | The pH value of the product should be 5.5~8.0 | 6.74~6.79Pass |
| AntimicrobialEffectiveness | 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 daysYeast 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 |
| IntendedUse/Indication forUse | The Non-sterile UltrasoundTransmission Gels are ultrasoundcouplants intended to be used onintact skin during non-invasivemedical ultrasound procedures tocouple sound waves between apatient and the medical imagingelectronics.The gels are intended for use in alldiagnostic ultrasound procedureswhich require coupling gel or fluid.The gels can be used during theprocedures that involved adultsand pediatrics in professionalhealthcare facility. | EcoVue® Sterile and Non-SterileUltrasound Gels are ultrasoundcouplants intended to be used onintact skin during non-invasivemedical ultrasound procedures tocouple sound waves between apatient and the medical imagingelectronics.The gels are intended for use inall diagnostic ultrasoundprocedures which requirecoupling gel or fluid. |
| Patient-contactingmaterial | Purified water, glycerin,polyethylene glycol, carbomer,phenoxyethanol, triethanolamineand 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 (bothsterile and non-sterile)Multiple Uses:250g pouch (non-sterile) |
| Sterile | Non-sterile | Both in Gamma sterilizationand non-sterile |
| Shelf Life | 2 years | 1 years |
| Appearance | The product is colorless orlight-colored transparent gelwithout insoluble foreign matter. | Clear to Hazy Color; free fromforeign matter |
| Sound Velocity(Acoustic Velocity) | 1520-1620m/s | 1398-1750 m/s |
| AcousticImpedance | $1.5×10^6~1.7×10^6 Pa·s/m$ | $1.40×10^6-1.80 ×10^6 Pa·s/m$ |
| SoundAttenuation | ≤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 10993standards |
{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.
§ 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.