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Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or liquid or fluid.

The SOLID GEL PAD is ultrasound gel of the solid-state, generally used for ultrasound scanning for imaging diagnosis or ultrasound stimulator for treatment. The gel pad will be sold for single patient/procedure, disposable use. The SOLID GEL PAD is 9cm x 9cm aqueous, flexible. disposable ultrasound standoff for use in difficult to visualize and near field areas, or when gels alone won't do. Disposability eliminates the risk of cross contamination in diagnostic and therapeutic ultrasound procedures. It requires only gentle, even pressure. The SOLID GEL PAD is especially very useful for using ultrasound over areas that are bony such as fingers, hands, wrists, elbows, and ankles. It also allows visualization of superficial structures.

This K131905 submission describes the SOLID GEL PAD, an ultrasound gel pad designed for medical diagnostic ultrasound. The provided document focuses on demonstrating the device's substantial equivalence to existing predicate devices rather than presenting a study to prove meeting specific acceptance criteria for a novel performance claim.

Here's a breakdown based on the provided text, while acknowledging that many of the requested elements are not applicable or explicitly stated as this is a substantial equivalence submission for a relatively low-risk device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for any of the performance tests. The document refers to "tests" and "test results" but does not detail the number of units or samples tested for each criterion.
• Data Provenance: Not explicitly stated. The document indicates the submitter is from the Republic of Korea, suggesting the testing might have occurred there, but this is not confirmed. The clinical nature (retrospective/prospective) is not applicable as this is not a clinical study, but rather a set of non-clinical, laboratory-based tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This submission focuses on non-clinical performance data (biocompatibility and physical properties) and substantial equivalence, not on establishing ground truth for diagnostic accuracy with expert consensus.

4. Adjudication Method

• Not applicable. This is not a clinical study requiring adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is not mentioned as it is not relevant for demonstrating the safety and effectiveness of an ultrasound gel pad, which is a coupling agent and not a diagnostic algorithm.

6. Standalone (Algorithm Only) Performance Study

• No. This is not an algorithm-based device. The device itself (the gel pad) is the product being evaluated.

7. Type of Ground Truth Used

• Not applicable in the typical sense of diagnostic ground truth. For biocompatibility, the "ground truth" is adherence to standard biological responses (e.g., absence of cytotoxicity). For physical properties, the "ground truth" is the measured values against established physical standards.

8. Sample Size for the Training Set

• Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, no training set is involved.

Summary of the Study (Based on Provided Text):

The submission describes a series of non-clinical performance tests conducted on the SOLID GEL PAD. The "study" for this device is not a traditional clinical trial or an AI/ML performance study, but rather a set of laboratory tests designed to demonstrate that the device meets safety (biocompatibility) and basic functional (physical properties) standards, and is therefore substantially equivalent to legally marketed predicate devices.

The tests performed were:

• Biocompatibility:
  • Tests for In Vitro Cytotoxicity (based on ISO 10993-5:2009)
  • Tests for Irritation and Skin Sensitization (based on ISO 10993-10:2010)
• Physical Properties:
  • Determination of density (based on ISO 12185:2003)
  • Testing methods for kinematic viscosity and calculating method for viscosity index (based on KS M 2014:2004)

The results of these tests "supported that the subject device is substantially equivalent to the predicate device in safety and effectiveness." The conclusion drawn is that the SOLID GEL PAD is safe and effective and substantially equivalent to the identified predicate devices (Sheathes Ultrasound Gel and Thixo-Gel Ultrasound Spray). The primary acceptance criterion appears to be meeting the standards outlined in the referenced ISO and KS documents, thereby demonstrating equivalence to the predicates.

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