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510(k) Data Aggregation
(64 days)
OWL RF PROBES
The OWL Sterile Single Use Disposable R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.
The Diros OWL RF Probe/Temperature Sensor is a modification of the previously 510(k) cleared OWL Reusable RF Probes. The modification includes the change of the device from reusable to sterile and single use as well as the option to include a thermocouple in place of a thermistor for temperature measurement.
The provided 510(k) summary for the Diros OWL Sterile Single Use RF Probes describes a device that is a modification of a previously cleared reusable RF probe. The acceptance criteria and the study proving the device meets these criteria are primarily focused on demonstrating substantial equivalence to the predicate device, K010202.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device are established through direct comparison to the predicate device (OWL Reusable RF Probes, K010202) and verifying that the modifications (single-use nature and inclusion of thermocouple option) do not adversely affect its safety or efficacy. The "reported device performance" is essentially the demonstrated equivalence.
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Diros Disposable Probes) | Conclusion (Device Meets Criteria) |
|---|---|---|---|
| Intended Use | The OWL R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain. | The OWL Sterile Single use R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain. | Meets: Intended use is identical with the exception of the "single use" characteristic, which is addressed by the safety and performance evaluation. |
| Diameter | 25AWG | 25AWG and 27 AWG | Meets: The new device offers 25AWG (matching predicate) and an additional 27AWG, which is an expansion, not a deviation that would negatively impact performance. The document implies this difference is acceptable and does not raise new questions of safety/efficacy. |
| Lengths Available (Cannulae length to be used with) | 65.8mm (5cm), 116.5mm (10cm), 161mm (15cm) | 65.8mm (5cm), 116.5mm (10cm), 161mm (15cm), 194mm (20cm) | Meets: The new device offers all lengths of the predicate and an additional 194mm (20cm). This expansion is acceptable, as probe length is "determined by length of cannula to ensure probe measures temperature at lesion site." |
| Temperature Measurement Devices Available | Thermistor only | Thermistor, Thermocouple | Meets: The new device includes the thermistor (matching predicate) and adds a thermocouple. The document states that "Temperature accuracy of thermocouple has been demonstrated through comparison testing with predicate to be as accurate as Thermistor type." |
| Single Use | Reusable | Yes (Single Use) | Meets: This is the primary modification. "Single use characteristic does not affect safety and efficacy. Sterilization and packaging validation confirm that single use device can be used safely out of package." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document describes comparison testing between the cleared reusable probes and the disposable probes.
- Sample Size: The exact sample size for this testing is not specified in the summary. It mentions "comparison testing has been done" but doesn't quantify how many probes were tested or how many test cycles were performed.
- Data Provenance: The data provenance is prospective bench testing conducted by the manufacturer, Diros Technology Inc. The country of origin is implied to be Canada, where the company is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: This type of study (demonstrating substantial equivalence through bench testing) does not typically involve external human experts establishing ground truth in the same way clinical studies do. The "ground truth" for the performance characteristics (e.g., temperature accuracy, dimensions) would be established by validated measurement equipment and established engineering standards/specifications that define the acceptable performance range.
- Qualifications of Experts: Not applicable in the context of expert consensus for ground truth as this was a technical comparison study. The "experts" would be the engineers and quality control personnel at Diros Technology Inc. responsible for performing and verifying the comparison testing, whose qualifications are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This was a technical comparison study, not a clinical study involving subjective assessments that require adjudication. The performance metrics are objective and measurable (e.g., temperature readings, dimensions).
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a radiofrequency probe for heat lesion procedures. It is a medical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This device is a physical medical probe, not an algorithm or software requiring a standalone performance evaluation in that sense. Its "standalone" performance is assessed by its physical and electrical characteristics as described in the comparison table (e.g., temperature accuracy, dimensions, mechanical integrity). The comparison testing served this purpose.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this substantial equivalence submission is based on:
- Predicate Device Specifications: The established and cleared specifications and performance of the Diros OWL Reusable RF Probes (K010202) serve as the primary ground truth or benchmark.
- Bench Test Measurements: Measurements taken during comparison testing for dimensions, temperature accuracy, and other physical characteristics of both the new and predicate devices, verified against engineering standards and internal specifications.
- Validated Sterilization and Packaging: For the single-use characteristic, the ground truth is established through validated sterilization and packaging protocols, ensuring the device meets sterility assurance levels and maintains integrity.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware product, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant to this device.
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