(57 days)
Sterile and Non-Sterile Ultrasonic Coupling Agent are ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to cound 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 subject device, Sterile and Non-Sterile Ultrasonic Coupling Agent, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. The Ultrasonic Coupling Agent 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 Ultrasonic Coupling Agent is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.
The document describes the premarket notification (510(k)) for a medical device called "Sterile and Non-Sterile Ultrasonic Coupling Agent." It provides information about its intended use, technical characteristics, and performance testing to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, formatted to answer your questions:
Acceptance Criteria and Study Proving Device Meets Criteria
The device under review is an "Ultrasonic Coupling Agent," which is a gel used to facilitate ultrasound imaging. The acceptance criteria for this type of device are primarily based on its physical and chemical properties, biocompatibility, and sterilization effectiveness (for sterile versions). The study proving the device meets these criteria is a series of non-clinical bench tests and compliance with recognized consensus standards, demonstrating substantial equivalence to a legally marketed predicate device. No clinical study was performed.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table summarizing performance testing (bench tests) for the subject device against specified acceptance criteria.
| Test Item & Acceptance Criteria (Requirement Specification) | Reported Device Performance (Test Results) | Meets Criteria? |
|---|---|---|
| Sound Velocity (Acoustic Velocity) | ||
| Measured at 35°C, 1520-1620 m/s | 1541.8 m/s ~ 1551.7 m/s | Pass |
| Acoustic Impedance | ||
| Measured at 35°C, 1.5x10^6 ~ 1.7x10^6 Pa·s/m | 1.58x10^6 Pa·s/m ~ 1.59x10^6 Pa·s/m | Pass |
| Sound Attenuation | ||
| Measured at 35°C, ≤0.1 dB/(cm·MHz) | 0.04 dB/(cm · MHz) ~ 0.07 dB/(cm · MHz) | Pass |
| Viscosity | ||
| Measured at 25°C, ≥15 Pa·s | 42 Pa·s ~ 50 Pa·s | Pass |
| Density | ||
| 987-1049 kg/m³ | 1024.5 kg/m³ ~ 1029.7 kg/m³ | Pass |
| pH | ||
| 5.5 ~ 8.0 | 6.62 ~ 6.86 | Pass |
| Microbial Limit (Non-sterile Ultrasonic Coupling Agent) | ||
| Total aerobic bacteria ≤10² cfu/g; Fungi and yeast ≤10¹ cfu/g; Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans cannot be detected. | Pass | Pass |
| Sterility (Sterile Ultrasonic Coupling Agent) | ||
| Sterile after confirmed gamma sterilization. | Pass | Pass |
| Appearance | ||
| 1) Generally colorless or light-colored transparent gel without insoluble foreign matters. |
- Free from stratification, mildew, and odor under normal storage conditions. | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of batches, number of samples per batch) used for each bench test. These are typically detailed in the full test reports, which are summarized here.
The data provenance is from non-clinical bench testing performed by the manufacturer, Anhui Deepblue Medical Technology Co., Ltd., located in Hefei, Anhui, PEOPLE'S REPUBLIC OF CHINA. The testing is retrospective in the sense that it was conducted as part of the product development and regulatory submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a premarket notification for an ultrasonic coupling agent, which is a physical material, not an AI/software device that generates diagnostic outputs requiring expert interpretation. Therefore, the concept of "ground truth established by experts" in the context of image interpretation (e.g., radiologists) does not apply to this submission. The "ground truth" for the performance tests (e.g., sound velocity, pH) is established by the validated measurement methods and equipment used in the laboratory.
4. Adjudication Method for the Test Set
As this is a submission for a physical medical product based on laboratory bench testing and not an AI or diagnostic imaging device requiring human expert consensus for "ground truth," an "adjudication method" involving multiple experts is not applicable. The results are determined by instrumental measurements and standardized material testing procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human readers interpret cases, and the AI's impact on their performance is evaluated. For an ultrasonic coupling gel, this type of study is not relevant or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the sense of an algorithm's performance without human interaction was not done. This device is a passive material, not an algorithm. Its "performance" is its physical and chemical properties and ability to conduct ultrasound waves.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective physical and chemical measurements obtained through validated laboratory testing methods (bench tests) and compliance with recognized standards. This includes:
- Physical properties (Sound Velocity, Acoustic Impedance, Sound Attenuation, Viscosity, Density, pH) measured by instruments.
- Microbial limits and sterility confirmed by microbiological testing.
- Biocompatibility assessed against ISO 10993 standards.
- Packaging and shelf-life validated per ISO 11607-1, ASTM F88/F88M-15, ASTM D3078.
There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for a coupling agent's performance in the same way it would be for a diagnostic tool or treatment.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this submission. This device is a physical product (ultrasound gel), not an AI algorithm that undergoes training on a dataset. The formulation and manufacturing processes are developed and validated, but there isn't a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this physical device, this question is not applicable.
§ 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.