(98 days)
The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma (J-Plasma energy) for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.
The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.
The J-Plasma Precise® Flex Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the delivery of radiofrequency ("RF") energy and/or helium gas plasma for electrosurgical cutting, coaqulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The handpiece has one configuration, model # APYX-500BF. The compatible Generators operate at an adjustable power of up to 40 W (expressed as 0-100% where 100% is 40 W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation.
The J-Plasma Precise® Flex Handpiece has an extendable electrode (blade) in the tip to generate helium plasma. The tip is controlled by the user via graspers to actuate (extend and retract) the blade. The handpiece comes with an Introducer that allows for more control of the tip when introducing and removing the distal end to and from the cannula. The handpiece has a flexible, seamless cable that can be advanced with graspers through the cannula during minimally invasive surgical procedures. The handpiece is activated by the footswitch.
The provided text describes a 510(k) premarket notification for a medical device, the J-Plasma Precise® FLEX Handpiece. The core of the submission is to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner (e.g., a specific percentage or value to be met). Instead, the studies aim to demonstrate equivalence to the predicate device. The performance is reported qualitatively as "equivalent" or that requirements were "met."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Functionality: Device must demonstrate proper mechanical operation. | "Mechanical functionality requirements were all met." |
| Tissue Thermal Effect (Plasma Activation): Tissue effects (depth and lateral spread of thermal effects) must be similar to the predicate device across different tissue types and energy settings. | "The depth and lateral spread (i.e. average length and width) of thermal tissue effects were demonstrated to be equivalent between the subject device and Predicate device across all tissue types and J-Plasma energy settings." |
| Tissue Thermal Effect (Monopolar Coagulation): Tissue effects (depth and lateral spread of thermal effects) must be similar to the predicate device across different tissue types and energy settings. | "The depth and lateral spread (i.e. average length and width) of thermal tissue effects were demonstrated to be equivalent between the subject device and Predicate device across all tissue types and Monopolar Coagulation energy settings." |
| Electrical Safety and EMC: Compliance with relevant electrical safety and electromagnetic compatibility standards. | "The handpiece complies with the ANSI/AAMI/IEC 60601-1:2005/(R)2012 and A1:2012, and AAMI/ANSI/IEC 60601-2-2:2017 standards for safety and the AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) standard for EMC. The J-Plasma Precise® Flex was determined to be in conformance with these standards." |
| Biocompatibility: Device materials must be biocompatible for indirect blood path contact of less than 24 hours. | "Biocompatibility has been established per ISO 10993 guidelines for this category. Biocompatibility verification testing was satisfactorily conducted for the subject device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that an "ex-vivo study was conducted on several tissue types (i.e., muscle, liver, kidney)" for the tissue thermal effect equivalency testing. However, the specific number of samples or replicates for each tissue type is not provided.
- Data Provenance: The study was "ex-vivo," meaning performed on tissue outside of a living organism. The country of origin for the tissue or the testing location is not specified, but the applicant is Apyx Medical Corporation, located in Clearwater, Florida, USA. The study design appears to be retrospective in the sense that it's comparing a modified device to an existing predicate, rather than a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes bench testing and ex-vivo studies. There is no mention of human experts establishing ground truth for a test set in the context of diagnostic performance or interpretation. The "ground truth" for the performance tests (e.g., tissue effect, electrical safety) would be established by the physical measurements and compliance with engineering standards by qualified technical personnel.
4. Adjudication Method for the Test Set
As there's no mention of a human expert-based assessment or diagnostic interpretation requiring adjudication, there is no adjudication method described. The tests are directly measuring physical and electrical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an electrosurgical handpiece, not an AI diagnostic tool. The performance evaluation focuses on the safety and effectiveness of the device itself and its equivalence to a predicate, not on how it assists human readers in making diagnoses.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. The J-Plasma Precise® FLEX Handpiece is a physical surgical tool, not an algorithm. Its "performance" is its ability to cut, coagulate, and ablate tissue, and to meet safety standards. The ex-vivo tissue effect studies are "standalone" in the sense that they assess the device's direct effect on tissue, independent of a human operator's skill, but it's not an algorithm's performance.
7. The Type of Ground Truth Used
The ground truth for the performance studies is based on:
- Physical Measurements and Engineering Standards: For electrical safety and mechanical functionality, the ground truth is defined by compliance with established international standards (e.g., IEC 60601 series, ISO 14971) and meeting predefined operational requirements.
- Quantitative Tissue Effect Data: For tissue thermal effect, the ground truth is derived from measurements of depth and lateral spread of thermal effects in the ex-vivo tissue samples. The "truth" is established by direct scientific measurement and comparison to the predicate device's measured effects.
- ISO Standards for Biocompatibility: For biocompatibility, the ground truth is established by demonstrating compliance with ISO 10993 guidelines.
8. The Sample Size for the Training Set
This document describes a medical device, not an AI/ML algorithm. Therefore, there is no concept of a "training set" as would be used for machine learning. The device's design, manufacturing, and testing follow established engineering and quality system procedures.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's development and verification relies on engineering specifications, risk assessments (ISO 14971), and established laboratory testing protocols in compliance with design and development procedures (21 CFR 820.30).
§ 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.