(85 days)
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.
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 provided text describes the 510(k) premarket notification for "Sterile and Non-Sterile Ultrasound Gels" by Jianerkang Medical Co., Ltd. This document is a regulatory submission for a medical device accessory, specifically an ultrasound coupling gel, not an AI software or a device that has complex diagnostic or interventional functions.
Therefore, many of the requested elements for AI/imaging device performance studies (like MRMC studies, effect size of human reader improvement with AI, ground truth establishment for training/test sets, number of experts for adjudication, etc.) are not applicable to this type of device and submission.
The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (HR Pharmaceuticals, Inc., EcoVue® Sterile and Non-Sterile Ultrasound Gels, K181363) through bench testing, biocompatibility testing, sterilization validation, and packaging/shelf-life validation. The "study that proves the device meets the acceptance criteria" refers to these non-clinical performance tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating performance similar to or within acceptable ranges compared to the predicate device, and compliance with recognized standards.
| Acceptance Criteria (Requirement Specification) | Reported Device Performance (Test Results) |
|---|---|
| Physical & Chemical Properties (Measured at 35°C): | |
| Sound Velocity (Acoustic Velocity): 1520 ~ 1620 m/s | 1569 m/s ~ 1570 m/s |
| Acoustic Impedance: $1.5 \times 10^6$ ~ $1.7 \times 10^6$ Pa·s/m | $1.593 \times 10^6$ Pa·s/m ~ $1.597 \times 10^6$ Pa·s/m |
| Sound Attenuation: ≤ 0.1 dB/(cm·MHz) | 0.042 dB/(cm·MHz) ~ 0.049 dB/(cm·MHz) |
| Physical Properties (Measured at 25°C): | |
| Viscosity: ≥ 4000 cP (1000 Cp = 1 Pa.s) | 8844 cP ~ 13720 cP |
| Density: 0.85 - 1.15 g/cm³ | 1.021 - 1.022 |
| pH: 5.5 ~ 8.0 | 6.68 ~ 6.73 |
| Compositional/Visual Inspection: | |
| Appearance: Colorless or light transparent gel, no or only a few bubbles, non-soluble foreign bodies | Pass |
| Microbiological Purity (Non-Sterile Gel): | |
| TAMC: ≤ 100 CFU/g |
§ 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.