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510(k) Data Aggregation
(121 days)
Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.
Thixo-Gel Ultrasound Spray® is a colorless, thisotropic gel contained in a dispenser that allows it to be dispersed as a thin layer on external, intact skin.
Acceptance Criteria and Study for Thixo-Gel Ultrasound Spray®
This device, Thixo-Gel Ultrasound Spray®, is classified as a Diagnostic Ultrasound Transducer Accessory. The FDA has not established special controls or performance standards for this device. Therefore, the acceptance criteria are primarily based on demonstrating substantial equivalence to a predicate device (Aquasonic 100®) through comparison of technological characteristics and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Top Testing) | Reported Device Performance (Thixo-Gel Ultrasound Spray®) |
|---|---|
| Biocompatibility (in accordance with ISO-10993) | Safe as Predicate Device, passed ISO-10993 testing |
| Bacterial contamination (shelf life retests) | Performed, results not explicitly detailed but implied compliance |
| Physical property comparison to predicate (Acoustic Impedance, Density, Attenuation @ 10 MHz, Sound Velocity) | Substantially equivalent (values provided below) |
| Same Intended Use as predicate device | Substantially equivalent |
Detailed Physical Property Comparison:
| Feature | Thixo-Gel Ultrasound Spray® (Reported Performance) | Aquasonic 100® (Predicate) | Acceptance Criteria Met? |
|---|---|---|---|
| Acoustic Impedance | 0.166 gm/cm² | 0.163 gm/cm² | Yes |
| Density | 1056 km/m³ | 1012 km/m³ | Yes |
| Attenuation @ 10 MHz | 1-2 dB/mm | 1-2 dB/mm | Yes |
| Sound Velocity | 1566 m/sec | 1588 m/sec | Yes |
| Device Description (Couplant) | Ultrasound Couplant | Ultrasound Couplant | Yes |
| Dispenser | 250 ml nozzle spray bottle (single use) | 250 ml squeeze bottle (refillable) | Considered substantially equivalent despite difference in dispenser type/refillability due to functional equivalence as a coupling medium. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" in the context of clinical trials or human subject testing for this device. The evaluation primarily relies on bench-top testing and comparison to the predicate device.
- For Biocompatibility: Tests were performed in accordance with ISO-10993. The sample size for biocompatibility testing (e.g., number of samples tested for cytotoxicity, sensitization, irritation) is not explicitly stated but is implicitly governed by the ISO-10993 standard.
- For Bacterial Contamination: Retests were performed for shelf life. The sample size is not explicitly stated.
- For Physical Property Comparison: The values provided (Acoustic Impedance, Density, etc.) are intrinsic properties of the material. The sample size would refer to the number of batches or samples evaluated to ensure these properties are consistent. This information is not detailed in the summary.
- Data Provenance: The origin of the data is from bench-top laboratory tests conducted by the submitter (Cloverline International Pharma Services GmbH). Both the biocompatibility and physical property comparison tests are inherently retrospective in the sense that they are conducted on manufactured samples to characterize the device properties.
3. Number of Experts and Qualifications for Ground Truth
Not applicable for this type of device and study. The ground truth for this device (an ultrasound coupling medium) is established through standardized laboratory testing and material characterization, not expert clinical interpretation of results.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical imagery or diagnostic output requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is an ultrasound coupling medium, not an AI-assisted diagnostic tool. Its performance is evaluated based on its physical properties and biocompatibility, not its impact on human reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical product (ultrasound gel), not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for this device is based on:
- Standardized Laboratory Measurements: For physical properties like acoustic impedance, density, attenuation, and sound velocity, using appropriate laboratory equipment and methods.
- International Standards Compliance: For biocompatibility, adherence to ISO-10993 standards constitutes the ground truth for safety in biological interaction.
- Predicate Device Data: The physical properties of the predicate device (Aquasonic 100®) serve as a comparative ground truth for demonstrating substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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