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510(k) Data Aggregation
(33 days)
Non-Sterile Ultrasound Transmission Gels
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.
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