(112 days)
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories.
They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in:
- Transurethral resection of prostate (TURP) for benign prostatic hypertrophy
- Transurethral incision of the prostate (TUIP) or bladder neck
- Transurethral resection of bladder tumors (TURBT)
- Cystodiathermy
- Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. (MVVS models only)
The Plasma Edge system is a manual surgical device, consisting of a single-use electrode, an active and passive working element reusable and an adaptor or only socket with memory (fixed cable) to connect them to an HF generator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip.
It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
The provided text describes the PLASMA EDGE System, an endoscopic electrosurgical unit and accessories, and its substantial equivalence to a predicate device (K213135: Plasme EDGE System - manufactured by LAMIDEY NOURY MEDICAL).
Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device. It addresses performance through various validation and testing activities rather than specific numerical acceptance criteria. The underlying acceptance criteria for each test are implicitly the successful fulfillment of the standards mentioned.
| Acceptance Criteria Category | Reported Device Performance (Study) |
|---|---|
| Risk Analysis | Carried out in accordance with established in-house acceptance criteria based on ISO-14971:2019. Performance tests were conducted to ensure the system functions as intended and meets design specifications. |
| Biocompatibility | Evaluated in accordance with ISO 10993-1:2018. Specific tests performed due to a change in cleaning solution and process (DDM 0723-04): |
- Acute systemic toxicity test (ISO 10993-11:2018) - Reported as successfully completed.
- Pyrogen detection assay (European Pharmacopeia chapter 2.6.8 and ISO 10993-11:2018) - Reported as successfully completed.
- Acute skin irritation test (ISO 10993-23:2021) - Reported as successfully completed.
- Skin sensitization test on Guinea pig (ISO 10993-10:2021) - Reported as successfully completed.
- ISO MTS cytotoxicity test (ISO 10993-5:2009) - "Nettoyage X3_Cytotoxicité_QP2" & "Nettoyage X3 Cytotoxicité QP3" - Reported as successfully completed. Previous biocompatibility tests were also available. |
| Electrical Safety | Tested by an independent laboratory according to IEC 60601-1: 2012 and IEC 60601-2-2:2009. - Implied successful completion to meet substantial equivalence. |
| Electromagnetic Compatibility (EMC) | Tested by an independent laboratory according to IEC 60601-1-2:2007. Electrode Plasma Edge was tested on the HF generator Gyrus, and a comparison was realized with the assembly Electrode Gyrus on the HF generator Gyrus. - Implied successful completion to meet substantial equivalence. |
| Cleaning & Sterilization Validation (Reusable Working Element) | Tested by an independent laboratory following ISO 17664 and AAMI TIR Nº30 (manual cleaning). Steam sterilization validation tested following AAMI TIR Nº12, ISO 17664, and ISO 17665 (132ºC for 4 min). - Implied successful completion. |
| Sterilization Validation & Shelf-Life (Single-Use Electrode) | Validated sterilization method: ethylene oxide. Product has a shelf life of four (4) years. - Implied successful validation. |
| Bench Top Validation Testing | End of life simulation report, breakdown simulation report, working element compatibility report, and test on ex vivo tissues. These were tested on the Plasma Edge System to demonstrate product safety and efficiency on Gyrus Superpulse electrosurgical unit and MCB electrosurgical unit. - Implied successful demonstration of safety and efficiency, performing as well as or better than the predicate. |
The document states: "Comparative performance testing demonstrate that the device performed as well as, or better than, the predicate device." This is the ultimate reported performance outcome relative to acceptance (substantial equivalence).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the performance tests. For biocompatibility, tests are typically conducted on a small number of samples to represent the device materials. For electrical/EMC, typically one or a few devices are tested. For cleaning/sterilization, a specified number of cycles/samples are used based on the standard, but the exact number isn't provided here. For bench top validation, no specific sample size is mentioned.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal or contracted out to independent laboratories, as indicated by phrases like "established in-house acceptance criteria" and "tested by an independent laboratory." The document mentions European Pharmacopeia, suggesting some European standard compliance. The submission itself is from France. The studies are essentially retrospective in the context of the device's development and marketing submission.
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 technical performance validations against established standards, not clinical studies requiring expert ground truth for interpretation (e.g., imaging diagnostic devices).
4. Adjudication method for the test set:
This information is not applicable and therefore not provided, as the studies are not clinical trials that would typically involve adjudication of endpoints or diagnoses by multiple experts. The validation is against technical specifications and standard requirements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. The PLASMA EDGE System is a surgical tool, and its efficacy is evaluated through bench testing, biocompatibility, and electrical safety, not by human reader interpretation. No effect size improvement with AI assistance for human readers is mentioned as it's not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an electrosurgical system, not an AI algorithm. Its performance is inherently "standalone" in mechanical and electrical testing, but it requires a human surgeon for operation (human-in-the-loop for its clinical use, but not in the context of AI performance evaluation).
7. The type of ground truth used:
- For Risk Analysis, Electrical Safety, EMC, Cleaning, Sterilization, and Bench Top Validation: The "ground truth" is defined by the requirements of the specified international and national standards (e.g., ISO 14971, IEC 60601 series, ISO 10993 series, AAMI TIRs) and internal design specifications. Successful adherence to these standards constitutes the "ground truth" for compliance and performance.
- For Biocompatibility: The "ground truth" is established by the biological response observed in standardized in vitro and in vivo tests as per ISO 10993 series, with criteria for acceptable biological reactions.
8. The sample size for the training set:
Not applicable. This device is a medical instrument (hardware with integrated controls), not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an AI/ML model is involved.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).