(21 days)
Eco Vue® Sterile and Non-Sterile Ultrasound couplants intended to be used on intact skin during noninvasive 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 proposed device, EcoVue® Sterile and Non-Sterile Ultrasound Gels, are nonirritating, 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 serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image.
The document describes the acceptance criteria and performance data for EcoVue® Sterile and Non-Sterile Ultrasound Gels, which are coupling media for diagnostic ultrasound.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (EcoVue® Sterile and Non-Sterile Ultrasound Gels) | Reported Device Performance (Predicate Device K130041) | Reported Device Performance (Predicate Device K112827) |
|---|---|---|---|
| Physical & Chemical Properties | |||
| Appearance | Clear to Hazy Color; free from foreign matter | Clear or Blue Color | Clear or Blue Color |
| Sound Velocity (Acoustic Velocity) | 1398-1750 m/s | 1591 m/s* | 1587 m/s* |
| Acoustic Impedance | 1.40-1.80 Mrayl | 1.63 Mrayl* | 1.63 Mrayl |
| Sound Attenuation (5 MHz) | 0.32-0.95 dB/cm | 0.82 dB/cm* | 0.90 dB/cm* |
| Sound Attenuation (7.5 MHz) | 0.65-1.10 dB/cm | 1.16 dB/cm* | 1.57 dB/cm* |
| Sound Attenuation (10 MHz) | 0.85-1.55 dB/cm | 1.46 dB/cm* | 2.19 dB/cm* |
| Viscosity | >35,000 cP | 96,700* | 93,700* |
| Density | 0.85-1.15 g/cm3 | 1.027 g/cm3* | 1.026 g/cm3* |
| pH | 5.5 – 7.8 | 6.7* | 6.7* |
| Biocompatibility | Meets ISO 10993-1:2009 requirements for irritation, sensitization, and cytotoxicity | Meets ISO 10993-1:2009 requirements for irritation/intracutaneous toxicity, sensitization, and cytotoxicity | Meets ISO 10993-1:2009 requirements for irritation/intracutaneous toxicity, sensitization, and cytotoxicity |
| Sterility | Sterility Assurance Level of 10⁻⁶ (for sterile gel) | - | - |
| Antimicrobial Effectiveness | Meets USP | - | - |
| Microbiological Growth | Meets USP | - | - |
| Shelf Life | 1 year | 3 years (for predicate K130041) | 5 years (for predicate K112827) |
* Note: These values for the predicate devices are reported in the comparison table, but the document states they were obtained from performance testing conducted per HR Pharmaceuticals' protocols, implying they are the subject device's performance measured against the predicate, rather than the predicate's reported performance from its own submission. The "Proposed Device" column directly lists the acceptance criteria for EcoVue®. While the table presents them side-by-side, the "Acceptance Criteria" for the subject device are explicitly listed in the first column, indicating what the new device must achieve.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for the performance bench testing (Sound Velocity, Acoustic Impedance, etc.), biocompatibility testing, sterilization validation, or packaging validation. It refers to these tests as "internal methods," "USP ," "USP ," "USP ," "ASTM D445-17a," and various ISO/AAMI/ASTM standards. These standards typically specify minimum sample sizes or allow for statistically sound justifications, but the specific numbers are not provided in this summary.
The data provenance is not specified regarding country of origin; the testing appears to be conducted by or for the device manufacturer, HR Pharmaceuticals, Inc., as indicated by "Values obtained from performance testing conducted per HR Pharmaceuticals' protocols" (Page 7). All testing described is prospective, as it was conducted to support the 510(k) submission for the EcoVue® gels.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable to this type of device (ultrasound gel). The tests conducted are primarily physical, chemical, and biological characterizations according to established standards, not diagnostic performance evaluations requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for this type of device or study. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a medical accessory (ultrasound coupling gel), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a physical product (ultrasound gel), not an algorithm or software. Therefore, standalone algorithm performance was not assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance data of the ultrasound gel is based on:
- Bench Test Standards: Industry-recognized physical and chemical measurement standards (e.g., ASTM D445 – 17a, USP , USP , USP ) and internal methods.
- Biocompatibility Standards: International standards for biological evaluation of medical devices (ISO 10993-1, 10993-5, 10993-10).
- Sterilization Standards: International standards for sterilization validation (ISO 11137 series, ISO 11737 series).
- Packaging Validation Standards: International and national standards for packaging of sterile medical devices and accelerated aging (ISO 11607-1, ASTM F88, ASTM F1886, ASTM F2096, ASTM F1980).
The "ground truth" is adherence to these established scientific and regulatory standards.
8. The sample size for the training set:
This is not applicable. There is no training set mentioned, as this device does not involve machine learning or AI models that require training data.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this device.
§ 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.