(117 days)
ECO SUPERGEL® is a transmission gel media used with ultrasonic pulsed echo imaging systems. The gel, when applied on the defined area of the body, facilitates the use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.
The ECO SUPERGEL is a water-soluble gel (transmission DESCRIT TYON of the I therapies involving ultrasound systems.
This submission describes the ECO SUPERGEL®, an ultrasound gel, and asserts its substantial equivalence to the Parker Laboratories AQUASONIC 100. The provided documents focus on the regulatory approval process and do not include the detailed study design, acceptance criteria, or performance metrics typically found for AI/ML-based medical devices.
Therefore, the following information cannot be extracted or inferred from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with or without AI assistance.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation.
- The sample size for the training set.
- How the ground truth for the training set was established.
Based on the provided text, the device is an ultrasound gel, not an AI/ML-based medical device that would have acceptance criteria related to classification, detection, or other diagnostic performance metrics generated by an algorithm interacting with human data.
The "SUMMARY of TESTING" section in the submission outlines the tests performed to demonstrate the safety and fundamental properties of the ultrasound gel, ensuring it is equivalent to the predicate device. These tests are relevant to the physical and biological characteristics of the gel, not its performance in an AI/ML context.
Summary of Testing Performed (as per the document for the ultrasound gel):
| Test Type | Description |
|---|---|
| Bench Testing | Comparative pH and viscosity. |
| Stability Tests | Evaluation of stability to light, ambient temperature, heating, cooling, and thermal shocks. |
| Challenge Test | Evaluation of microbiological stability. |
| TVC Test | "Evaluation of total vital count, of yeast and moulds test." |
| Biocompatibility Test | - Test on the standard ISO 10993. |
- Repeated Patch Test (Clinical evaluation of irritating potency of a product for the skin and of its sensitization potency). |
The FDA's review confirms substantial equivalence to a legally marketed predicate device (Parker Laboratories AQUASONIC 100) based on these types of tests, indicating that the device meets the safety and
performance characteristics expected for an ultrasound gel.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.