(108 days)
The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.
The Plasma Pen utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the disposable tip and the skin is created by a radio frequency generator housed in an electrosurqical unit (handpiece) that ionizes the gas particles in the air. A straight disposable tip is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
The system components include the following:
- Plasma Pen (Plasma MD (with 2 level switch) and Plasma+ (without switch)
- Docking station for Plasma Pen
- Cable for Plasma Pen
- Power bank battery
- Cable for power bank battery
- Charging Block
The provided text describes a 510(k) premarket notification for the Plasma Pen (Plasma MD and Plasma +) device. It details the device's characteristics, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not contain the specific information requested regarding acceptance criteria, a study that proves the device meets those criteria, or details about test sets, ground truth establishment, or expert involvement.
The document focuses on demonstrating substantial equivalence to an existing predicate device (SubNovii Advanced Plasma Technology, K201738) based on similar indications for use, mode of operation, and performance characteristics. The "performance data" mentioned refers to non-clinical bench testing, not a clinical study involving human patients or complex AI-driven analysis.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format of a clinical study with metrics like sensitivity, specificity, or AUC. Instead, it compares characteristics and performance benchmarks against a predicate device to claim substantial equivalence. The closest to "acceptance criteria" are the "SAME" or "DIFFERENT" conclusions for various characteristics and the damage depth for thermal effects.
| Characteristic | Acceptance Criteria (from Predicate) | Reported Device Performance (Plasma Pen) | Met Criteria? (Substantial Equivalence) |
|---|---|---|---|
| Indications for Use | Intended for the removal and destruction of skin lesions and coagulation of tissue. | Intended for the removal and destruction of skin lesions and coagulation of tissue. | SAME |
| Prescription or OTC | Prescription | Prescription | SAME |
| Mode of Operation | Plasma; Radiofrequency energy ionizes the air creating a plasma stream | Plasma; Radiofrequency energy ionizes the air creating a plasma stream | SAME |
| Output | Monopolar | Monopolar | SAME |
| Power Supply | 110-250 VAC 50/60 Hz | 110-250 VAC 50/60 Hz | SAME |
| Frequency | 40 kHz | 40 kHz | SAME |
| Max Power Output | 5W | 2W | DIFFERENT (Lower max power output, with intended effect still achievable) |
| System Components | Handpiece, electrosurgical generator unit, docking station, active electrode. | Handpiece, electrosurgical generator unit, docking station, active electrode. | SAME |
| Thermal Effects on 4 porcine tissues (liver, kidney, muscle and skin) per FDA Guidance "Premarket Notification (510(K)) Submission for Electrosurgical Devices for General Surgery" (Damage Depth) | Damage depth of |
§ 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.