(135 days)
PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
This document is a 510(k) Premarket Notification from the FDA regarding the Plasma IQ device. It primarily focuses on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a performance study for a novel AI or diagnostic device.
Therefore, many of the requested elements for describing the acceptance criteria and study that proves a device meets acceptance criteria (especially those related to AI algorithm performance, human reader studies, and ground truth establishment for image analysis) are not applicable to this document. This document describes a device for direct physical interaction (removal and destruction of skin lesions, coagulation of tissue) using electrosurgery, not an AI or diagnostic tool.
However, I can extract information relevant to the device's technical specifications and the basis for its clearance.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (as inferred from Substantial Equivalence)
For a device like Plasma IQ, "acceptance criteria" for FDA clearance through the 510(k) pathway are primarily demonstrating substantial equivalence to a previously cleared predicate device. This means the new device is as safe and effective as the predicate. The "study" proving this largely involves comparing technical specifications and intended use.
Inferred Acceptance Criteria for Substantial Equivalence:
- Identical Intended Use: The device must have the same indications for use as the predicate.
- Similar Technological Characteristics: Key physical and operational characteristics must be substantially similar.
- No New Questions of Safety/Effectiveness: Any differences must not raise new safety or effectiveness concerns.
Table of Acceptance Criteria (as demonstrated by comparison to predicates) and Reported Device Performance:
| Feature/Characteristic | Acceptance Criteria (from Predicate K192813 and K201738) | Reported Device Performance (Plasma IQ K212329) |
|---|---|---|
| Indications for Use | Used in the removal and destruction of skin lesions and coagulation of tissue. | Used in the removal and destruction of skin lesions and coagulation of tissue. |
| Mode of Operation | Plasma | Plasma |
| Output | Monopolar | Monopolar |
| Power Supply | 110 – 250 VAC, 50/60 Hz | 110 – 250 VAC, 50/60 Hz |
| Frequency | 40 kHz | 40 kHz |
| Max Output Power | 5 W | 5 W |
| Output Impedance | 54,000 | 54,000 |
| System Components | Handpiece with electrosurgical generator, Charging Station, two active electrode designs. | Handpiece with electrosurgical generator, Charging Station, two active electrode designs. |
| Electrical Safety Standards Compliance | EN60601-1, EN60601-1-2, EN60601-2-2 | Complies with EN60601-1, EN60601-1-2, EN60601-2-2 |
Study Details (as related to Substantial Equivalence for this type of device)
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Sample sizes used for the test set and the data provenance:
- N/A. This submission is for an electrosurgical device cleared via the 510(k) pathway, primarily demonstrating "substantial equivalence" to predicate devices. It states: "No performance testing data was provided in this submission other than what was provided in the predicate (K192813) to establish substantial equivalence."
- The "study" here is a comparison of technical specifications, safety standards compliance, and intended use to predicate devices. The data provenance is implied to be existing documentation and specifications of the predicate devices.
- The intent of this specific K212329 submission was to amend labeling to remove a contraindication, which was supported by clinical evidence (though not detailed here beyond this statement).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is not an AI/diagnostic device where expert "ground truth" for image data or clinical outcomes is established for a test set in the conventional sense. The "ground truth" for demonstrating substantial equivalence is the existing safety and effectiveness profiles of the cleared predicate devices, confirmed by technical comparisons.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for this type of 510(k) submission.
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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:
- No. This is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device for direct physical treatment, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the predicate devices (K192813 and K201738) based on their prior FDA clearances and compliance with recognized standards (EN60601-1, EN60601-1-2, EN60601-2-2). The clinical evidence mentioned for the contraindication removal would refer to outcomes data from relevant studies, but these are not presented in this summary document.
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The sample size for the training set:
- N/A. This is not an AI/machine learning device that uses a "training set."
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How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this device type.
Conclusion stated in the document: "The Plasma IQ that is subject to this submission is the same device that was cleared in K192813. No changes have been made to this device. The Plasma IQ is substantially equivalent to the predicate device. The intent of this submission is to amend the labeling to remove a contraindication. This removal of the contradiction is supported by clinical evidence. There are no new questions regarding safety or effectiveness raised by the change in the labeling."
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.