(85 days)
Not Found
No
The device is an ultrasound gel, which is a passive coupling medium and does not perform any image processing or analysis. The description focuses on its physical properties and biocompatibility.
No.
This device is an ultrasound gel, which functions as a coupling medium to improve acoustic transmission for diagnostic ultrasound procedures. It facilitates the imaging process but does not provide therapy or treatment itself.
Yes
The device, Ultrasound Gel, is described as an "acoustic couplant" used in "medical diagnostic ultrasound procedures." Its function is to "couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures" to facilitate the creation of the "ultrasound image." This explicitly links the device's function to the process of diagnosis through imaging.
No
The device is described as a gel, which is a physical substance used as a coupling medium. The description focuses on its physical properties and performance as an acoustic couplant, not on software functionality.
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 a "coupling contact medium for ultrasonic procedures" used on "external, intact skin." It facilitates the transmission of sound waves for imaging.
- Device Description: The description reinforces its role as an "acoustic couplant" to "couple sound waves between the patient and the medical imaging electronic transducers."
- Lack of Diagnostic Function: The device itself does not perform any diagnostic test on a sample taken from the body (like blood, urine, tissue, etc.). It is an accessory used during a diagnostic imaging procedure, but it doesn't analyze biological samples to provide diagnostic information.
- Anatomical Site: It's used on the external surface of the body, not on internal samples.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This ultrasound gel does not fit that definition.
Yes
The letter explicitly states: "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This sentence directly confirms that the device is a PCCP authorized device.
Intended Use / Indications for Use
Sterile and Non-Sterile Ultrasound Gels is intended to be used on external, intact skin as a coupling contact medium for ultrasonic procedures. The sterile Ultrasound Gel is also used for intra operative, biopsy applications. The Ultrasound Gel can be used during the procedures that involved adults and pediatrics in professional healthcare facility by qualified and trained healthcare professional.
Product codes
MUI
Device Description
The proposed device, Sterile and Non-Sterile Ultrasound Gels, are non- irritating, nonsensitizing 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 proposed device is available in the below sizes:
- 2.20Z (non sterile) Tubes
- 20ml (sterile) Pouches
- Bottles 8.5OZ, 5000ml (non sterile)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic procedures
Anatomical Site
external, intact skin
Indicated Patient Age Range
adults and pediatrics
Intended User / Care Setting
qualified and trained healthcare professional in 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
Bench 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.
Summary of Non-Clinical and Performance Testing:
- Sound Velocity (Acoustic Velocity): Measured at 35°C, value between 1569m/s and 1570m/s. Pass.
- Acoustic Impedance: Measured at 35°C, value between 1.593 x 10^6 Pa·s/m and 1.597 x 10^6 Pa·s/m. Pass.
- Sound Attenuation: Measured at 35°C, values between 0.042dB/(cm·MHz) and 0.049 dB/(cm·MHz). Pass.
- Viscosity: Measured at 25°C, between 8844 cP and 13720 cP. Pass.
- Density: Between 1.021 and 1.022. Pass.
- pH: Between 6.68 and 6.73. Pass.
- Sterility: Pass (after confirmed gamma sterilization).
- Microbiological Growth: TAMC
§ 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
December 15, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.
Jianerkang Medical Co., Ltd % Gu Mike RA Manager Suzhou Device Innovation Medical Consulting Co., Ltd Room 1001, Building 19, No. 3188 Renmin Road Suzhou, Jiangsu 215000 CHINA
Re: K232957
Trade/Device Name: Sterile and Non-Sterile Ultrasound Gels Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: MUI Dated: September 21, 2023 Received: September 21, 2023
Dear Gu Mike:
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.
1
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device. or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
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).
Your device is also subject to, among other requirements, the Quality System (QS) 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
2
(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
Enclosure
3
Indications for Use
510(k) Number (if known) K232957
Device Name Sterile and Non-Sterile Ultrasound Gels
Indications for Use (Describe)
Sterile and Non-Sterile Ultrasound Gels is intended to be used on external, intact skin as a coupling contact medium for ultrasonic procedures. The sterile Ultrasound Gel is also used for intra operative, biopsy applications. The Ultrasound Gel can be used during the procedures that involved adults and pediatrics in professional healthcare facility by qualified and trained healthcare professional.
| 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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510(k) SUMMARY For K232957 Sterile and Non-Sterile Ultrasound Gels
I. SUBMITTER:
Jianerkang Medical Co., Ltd. No.1 Jianerkang Road, Zhixi Town Industrial Zone, Jintan District, Changzhou City, Jiangsu Province, China
Telephone Number: 86-519-82446609 Fax Number: 86-519-82442535
Contact Person: Hongfang Tang Date Prepared: 09/30/2023
II. DEVICE: Name of Device: 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:
HR Pharmaceuticals, Inc., EcoVue® Sterile and Non-Sterile Ultrasound Gels, K181363
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION:
The proposed device, Sterile and Non-Sterile Ultrasound Gels, are non- irritating, nonsensitizing 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.
5
The proposed device is available in the below sizes:
- 2.20Z (non sterile) ● Tubes
- 20ml (sterile) Pouches
- Bottles 8.5OZ, 5000ml (non sterile) ●
V. INDICATIONS FOR USE:
Sterile and Non-Sterile Ultrasound Gels is intended to be used on external, intact skin as a coupling contact medium for ultrasonic procedures. The sterile Ultrasound Gel is also used for intra operative, biopsy applications. The Ultrasound Gel can be used during the procedures that involved adults and pediatrics in professional healthcare facility by qualified and trained healthcare professional.
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 proposed 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 ●
Additionally, side-by-side testing confirmed that the subject devices are substantially equivalent to the predicate devices. A more detailed comparison of the predicate and subject devices is presented in the table below.
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| | | Proposed Device
EcoVue® Sterile and Non-Sterile Ultrasound
Gels | Predicate Device
Sheathes Sterile Ultrasound Gel (K181363) |
|-----------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | Jianerkang Medical Co., Ltd | HR Pharmaceuticals, Inc. |
| Device Name | | Media, Coupling, Ultrasound | Media, Coupling, Ultrasound |
| Description | | Diagnostic ultrasonic transducer
(accessory) | Diagnostic ultrasonic transducer
(accessory) |
| Medical Specialty | | Radiology | Radiology |
| Product Code | | MUI | MUI |
| Reg Number | | 892.1570 | 892.1570 |
| Class | | 2 | 2 |
| Indications for Use | | Sterile and Non-Sterile Ultrasound Gels is intended
to be used on external, intact skin as a coupling
contact medium for ultrasonic procedures. The
sterile Ultrasound Gel is also used for intra
operative, biopsy applications. The Ultrasound Gel
can be used during the procedures that involved
adults and pediatrics in professional healthcare
facility by qualified and trained healthcare
professional. | 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 | | Water-based gel (sterile and non-
sterile) | Water-based gel (sterile) |
| Sizes | | Tubes 2.2OZ (non sterile)
Pouchs 20ml (sterile)
Bottle 8.5OZ, 5000ml (non sterile ) | 20g individual packets (both sterile and non-sterile)
250g pouch (non-sterile) |
| Physical
and
Chemical
Properties | Appearance | Colorless or light transparent gel, no or only a few
bubbles, non-soluble foreign bodies | Clear to Hazy Color; free from foreign
matter |
| | Sound
Velocity
(Acoustic
Velocity) | 15201620m/s | 1398-1750 m/s |1.7×10^6$ | 1.40-1.80 Mrayl | |
| Proposed Device
EcoVue® Sterile and Non-Sterile Ultrasound
Gels | Predicate Device
Sheathes Sterile Ultrasound Gel (K181363) | | |
| Acoustic
Impedance | $1.5×10^6
| 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 | ≥4000 cP (1000 Cp=1Pa.s) | >35,000 cP | |
| Density | 0.85-1.15 g/cm³ | 0.85-1.15 g/cm³ | |
| pH | 5.5-8 | 5.5 - 7.8 | |
| Biocompatibility | | Meets ISO 10993-1:2018 requirements for irritation,
sensitization, and cytotoxicity | Meets ISO 10993-1:2009 requirements for irritation,
sensitization, and cytotoxicity |
| Utility | | Single-Use (20ml pouch, sterile packet)
Multi-Use (2.2OZ tube, non-sterile packet; 8.5OZ,
5000ml bottles, non-sterile packet ) | Single-Use (20g sterile and non-sterile packets)
Multi-Use (250g pouch) |
| Sterility (Method) | | Sterile (Gamma);
Non-Sterile | Sterile (Gamma);
Non-Sterile |
| Environment of Use | | Healthcare Facility | Healthcare Facility |
| Target Population | | Adult and Pediatric | Adult and Pediatric |
| Labeling | | Prescription Use | Prescription Use |
| Shelf Life | | 3 year | 1 year |
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- Values obtained from performance testing conducted per HR Pharmaceuticals' protocols.
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.
Summary of non-clinical and performance testing Bench 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.
| Test Item | Description | Test Results |
|---|---|---|
| Sound Velocity | ||
| (Acoustic | ||
| Velocity) | Measured at 35°C ,The Sound Velocity | |
| (Acoustic Velocity) shall be 1520 ~ 1620m/s | 1569m/s~1570m/s | |
| Pass | ||
| Acoustic | ||
| Impedance | Measured at 35°C ,Acoustic Impedance | |
| shall be $1.5\times10^6$ ~ $1.7\times10^6$ Pa·s/m | $1.593\times10^6$ Pa·s/m | |
| ~ $1.597\times10^6$ Pa·s/m | ||
| Pass | ||
| Sound | ||
| Attenuation | Measured at 35°C ,Sound Attenuation shall | |
| be ≤0.1dB/(cm·MHz) | 0.042dB/(cm·MHz) | |
| -0.049 dB/(cm·MHz) | ||
| Pass | ||
| Viscosity | Measured at 25°C, ≥4000cP(1000 | |
| Cp=1Pa.s) | 8844 cP ~13720 cP | |
| Pass | ||
| Density | The density of the product shall be | |
| 0.85-1.15 | 1.021-1.022 | |
| Pass | ||
| pH | The pH value of the product should be | |
| 5.5~8.0 | 6.68~6.73 | |
| Pass | ||
| Sterility | The product should be sterile after being | |
| sterilized by confirmed gamma sterilization. | Pass | |
| Microbiological | ||
| Growth | TAMC≤100CFU/g | |
| TYMC≤100CFU/g | TAMC |