(211 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 consists of the following components: Electrosurgical Unit - Main body, Two different handpieces ( motor and AC), Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products, Neutral electrode pad and neutral electrode pad cable, cleared under K092761, Handpiece stand, Foot switch, Power cord. 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 provided text describes the 510(k) premarket notification for the POTENZA device, specifically for the addition of four new electrode tips. The document details the performance data collected to demonstrate that the expanded device meets acceptance criteria and is substantially equivalent to its predicate.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides tables of acceptance criteria and results for biocompatibility and sterilization residual testing. Other tests mention conformance to specified standards as their acceptance criteria.
| Test Type / Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing (for new electrode tips) | ||
| Extractables (ISO 10993-12:2012): | Property - per standard | Pass |
| pH | pH ≤ 1.5 | Pass |
| Potassium permanganate reducing substances | ≤ 2.0 mL | Pass |
| Residue after evaporation | ≤ 1.0 mg | Pass |
| UV spectrum (250 nm - 350 nm) | ≤ 0.1 | Pass |
| Heavy Metals | per standard | Pass |
| Cytotoxicity (ISO 10993-05:2009, USP 41:2018 ) | Meet requirements of standard | Pass |
| Sensitization (Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010) | Meet requirements of standard | Pass |
| Irritation or Intracutaneous Reactivity (Animal Intracutaneous (Intradermal) Reactivity Test: ISO 10993-10:2010) | Meet requirements of standard | Pass |
| Acute Systemic Toxicity (ISO10993-11:2017) | Meet requirements of standard | Pass |
| Hemolysis (ISO 10993-4, ASTM F756) | Meet requirements of standard | Pass |
| USP Rabbit Pyrogen (ISO 10993-11, USP, General Chapter ) | Meet requirements of standard / USP | Pass |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1, IEC 60101-2-2, IEC 60601-1-2, IEC 60601-1-6 | Confirmed |
| Software Verification and Validation Testing | In accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern | Conducted |
| Bench Testing (for new electrode tips): | Operate safely and within predefined design specifications | Assured |
| Output accuracy (Monopolar at 1MHz and 2 MHz) | (Implicitly safe and within spec) | Tested |
| Output accuracy (Bipolar at 1MHz and 2MHz) | (Implicitly safe and within spec) | Tested |
| Frequency: manual and standard | (Implicitly safe and within spec) | Tested |
| Power fluctuation characteristics | (Implicitly safe and within spec) | Tested |
| Negative output protection | (Implicitly safe and within spec) | Tested |
| Impedance measurement accuracy and range | (Implicitly safe and within spec) | Tested |
| HP count accuracy | (Implicitly safe and within spec) | Tested |
| Safety test of various warnings / failsafe mechanisms | (Implicitly safe and within spec) | Tested |
| Needle depth | Within range of predicate device (0.5~2.5 mm) | Tested |
| Motor speed level | (Implicitly safe and within spec) | Tested |
| Thermal testing | 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 | Tested |
| Sterilization (Ethylene Oxide (EO) residuals) | According to ISO 10993-7:2008 | Pass |
| Sterility Assurance Level (SAL) | 10^-6 (per ISO 11135:2014) | Assured |
| Shelf-life (Accelerated Aging) | 2-year shelf-life based on 65-days accelerated aging per ASTM F1980-16, USP , ASTM F1929-15 | Established |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state sample sizes for specific tests with numerical values like "N=X". For biocompatibility testing, it mentions "the electrode tips were tested as shown in Table 1," implying a sufficient sample was used for each test type according to the standard. Similarly, for bench testing, it states "Jeisys conducted bench testing to assure that the four new electrode pins operate safely and within the predefined design specifications," suggesting testing was performed on the new electrode tips.
The data provenance is from Jeisys Medical, Inc. (South Korea), as the submitter is based in Seoul, Korea. The studies are retrospective in the sense that they are conducted by the manufacturer for the specific purpose of demonstrating substantial equivalence to a predicate device, rather than actively collecting new clinical data on human patients in a prospective manner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies described are primarily in vitro (biocompatibility, sterilization), in silico (software), and benchtop engineering tests, not studies that require expert-established ground truth from clinical images or patient data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving expert review of data (e.g., medical images). The tests described here are technical performance tests, not clinical evaluations requiring adjudication.
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
This information is not provided and not applicable. The device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The POTENZA is a hardware device with associated software, not a standalone algorithm/AI for diagnostic interpretation. Its performance is evaluated through its physical and electrical characteristics as well as its software's functionality. The bench testing and electrical safety tests demonstrate the device's standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the various tests is based on recognized consensus standards and predefined design specifications. For example:
- Biocompatibility: Standards like ISO 10993 and USP provide the "ground truth" for acceptable biological response.
- Electrical Safety & EMC: IEC 60601 series standards define the ground truth for safe electrical operation and electromagnetic compatibility.
- Software Verification: FDA guidance provides the framework for acceptable software validation.
- Bench Testing: The device's own predefined design specifications, safety mechanisms, and performance ranges (e.g., needle depth range of the predicate device) serve as the ground truth.
- Sterilization & Shelf-life: ISO standards (e.g., 10993-7, 11135), ASTM standards (e.g., F1980-16, F1929-15), and USP standards provide the ground truth for acceptable sterilization residuals, sterility assurance level, and packaging integrity.
8. The Sample Size for the Training Set
This information is not provided and not applicable. The described tests are for device validation and verification, not for training an AI or machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not provided and not applicable. No training set for an AI/ML model is mentioned or relevant to this device's submission.
§ 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.