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510(k) Data Aggregation
(551 days)
The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode. The NEW POTENZA consists of the following components: Electrosurgical Unit - Main body, handpieces (Predicate Device have Motor, AC handpieces), electrode tips for the handpiece – Add three non-invasive tips connect to S handpiece, Neutral electrode pad and neutral electrode pad cable, cleared under K201685, Handpiece stand, Foot switch, Power cord.
This 510(k) summary describes a device (POTENZA) that is substantially equivalent to a previously cleared predicate device. The key changes are the addition of a new S handpiece and three new non-invasive electrode tips. The provided text primarily focuses on demonstrating the safety and effectiveness of these additions through non-clinical testing rather than complex AI performance studies. As such, many of the requested points regarding AI acceptance criteria, MRMC studies, and large-scale data sets are not directly applicable or available in this specific document.
However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets them as they relate to the changes in the device.
1. Table of Acceptance Criteria and Reported Device Performance
For the specific changes (new S handpiece and non-invasive tips), the acceptance criteria are generally focused on safety and functionality demonstrating equivalence to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance (as stated or inferred) |
|---|---|---|
| Biocompatibility | All four newly added electrode tips must pass biocompatibility tests (Cytotoxicity, Sensitization, Skin Irritation) as per ISO 10993 standards for devices with limited skin contact (<24 hours). | Pass: All specified tests (Cytotoxicity, Sensitization: Guinea Pig Maximization Test, Skin Irritation Test) were passed for the non-invasive electrode tips as per ISO 10993-05:2009 and ISO 10993-10:2010. |
| Electrical Safety & EMC | The POTENZA system (including new components) must conform to recognized consensus standards for electrical safety and electromagnetic compatibility (EMC), specifically IEC 60601-2-2:2017 and IEC 60601-1-2:2014. | Conformity: Electrical safety, EMC, device-related electrical safety for high frequency, and usability were conducted according to IEC 60601-2-2:2017 and IEC 60601-1-2:2014. Implies successful conformance. |
| Bench Testing / Performance | The device (with new handpiece and tips) must operate safely and within predefined design specifications, including accurate output power (monopolar/bipolar, 1MHz/2MHz), correct frequency, stable power fluctuation, negative output protection, accurate impedance measurement, HO count accuracy, motor speed, and safe failure mechanisms. | Conformity: Bench testing was conducted to assure safe operation and conformance to design specifications. Tested parameters included (and implicitly passed): Output accuracy (Monopolar/Bipolar at 1MHz and 2MHz), Frequency, Power fluctuation, Negative output protection, Impedance measurement accuracy/range, HO count accuracy, Safety test of various warnings/failsafe mechanisms, Motor speed level. |
| Ex Vivo Testing | Must demonstrate appropriate electrocoagulation and hemostasis characteristics on various tissue types (Liver, Kidney, Muscle) under GLP, and thermal testing in accordance with FDA guidance. | Conformity: Ex Vivo testing was conducted on three types of tissue (Liver, Kidney and Muscle) under GLP. Thermal testing was done in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", August 15, 2014. Implies successful outcomes for these tests. |
| Impact on Safety & Effectiveness | The addition of new S handpiece with three electrode tips must not introduce new or different questions of safety or effectiveness. | No New Questions: Verification and validation activities confirmed that the additions do not introduce new or different questions of safety or effectiveness. The new tip is explicitly stated as being "safer than the invasive type" due to being non-invasive. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify numerical sample sizes for most performance tests (e.g., number of units tested for electrical safety, number of times functions were tested). For biocompatibility, it refers to standard ISO test protocols, which imply specific sample sizes for each test type (e.g., Guinea Pig Maximization Test typically involves a certain number of animals). For Ex Vivo testing, it mentions "three types of tissue (Liver, Kidney and Muscle)," but not the quantity of each.
- Data Provenance: The tests are described as non-clinical (bench and ex vivo) and conducted by Jeisys. There is no information regarding country of origin for data samples (as it's not a clinical study involving patients), or if the testing was retrospective or prospective. It is implied to be prospective testing specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document as it pertains to AI/clinical ground truth establishment, which is not the focus of this 510(k) submission for an electrosurgical device modification. The "ground truth" here is based on engineering specifications and recognized consensus standards (e.g., ISO, IEC).
4. Adjudication Method for the Test Set
This information is not applicable/provided as it relates to expert review of data (e.g., medical images for AI), which is not detailed for this type of device submission. Performance is based on objective measurements against engineering specifications and standard test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was performed." MRMC studies are typically for evaluating the impact of AI on human reader performance, which is not relevant here as there is no AI component or clinical reader assessment being evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is an electrosurgical unit, not an algorithm. There is no standalone algorithm performance described.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance validation is based on:
- Engineering Specifications: Predefined design parameters for power output, frequency, impedance, motor speed, etc.
- Recognized Consensus Standards: International standards like ISO 10993 (biocompatibility) and IEC 60601 series (electrical safety, EMC).
- FDA Guidance Documents: Bench and thermal testing were conducted in accordance with FDA guidance for electrosurgical devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. 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, there is no ground truth establishment for it.
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