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510(k) Data Aggregation
(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 | < 10 CFU/g |
| TYMC: ≤ 100 CFU/g | < 10 CFU/g |
| Sterility (Sterile Gel): | |
| Product should be sterile after being sterilized by confirmed gamma sterilization. | Pass (Confirmed by validation per ISO 11137-1, -2, -3) |
| Biocompatibility: | |
| Meets ISO 10993-1:2018 requirements for irritation, sensitization, and cytotoxicity. | Acceptable results (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogen tests per ISO 10993 series) |
| Packaging and Shelf Life: | |
| Packaging integrity to maintain sterility and product quality for 3 years. | Passed packaging validation and accelerated aging testing confirming 3-year shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench test (e.g., how many batches were tested for viscosity or pH) but rather reports ranges or single values, implying sufficient testing was performed to establish these properties. For biocompatibility, the tests (e.g., cytotoxicity, irritation) are typically performed on a statistically relevant number of samples (e.g., extracts from the product) as per ISO standards, which is implied by the "acceptable results" statement. For sterilization validation, specific sample sizes are required by ISO 11137, though not explicitly stated in the summary.
- Data Provenance: The data is derived from non-clinical bench testing conducted by Jianerkang Medical Co., Ltd. No specific country of origin for the data is mentioned for testing labs, but the manufacturer is based in China. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate the device's properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For a device like ultrasound gel, "ground truth" as it relates to clinical outcomes or image interpretation (which would typically involve experts like radiologists) is not relevant. The "ground truth" in this context is the physical, chemical, and biological properties of the gel itself, established by standardized laboratory testing methods and measurements. These tests are performed by trained laboratory personnel, not clinical experts for diagnostic interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. As the "test set" consists of laboratory measurements and not clinical image interpretations, there is no need for an adjudication method. Test results are objective quantitative measurements or qualitative observations (e.g., "Pass" for appearance).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. This device (ultrasound gel) is an accessory and does not involve image interpretation or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is an ultrasound gel, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established through objective, standardized measurement of its physical, chemical, and biological properties as defined by relevant ISO and ASTM standards (e.g., sound velocity, pH, sterility, biocompatibility). It is not based on expert consensus, pathology, or outcomes data, as these are clinical validation methods for diagnostic/therapeutic devices, which an ultrasound gel is not.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of an ultrasound gel. This is not an AI/machine learning device. The product formulation development (analogous to "training") would involve R&D and quality control processes to achieve the desired properties, but this is not a data-driven training process in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no "training set" as understood in AI/machine learning, this question doesn't apply. The "ground truth" for developing the gel's formulation is the target specification for its physical, chemical, and biological properties, informed by regulatory requirements for safety and effectiveness as an ultrasound coupling medium.
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