(88 days)
Nissha Medical Technologies Neutral Electrodes - SWAROPLATE:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A²s in a 60 s period occur.
Nissha Medical Technologies Neutral Electrodes - Boston Scientific:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices "Boston Scientific G4TM and 1A/1B Radiofrequency Generators".
A neutral electrode is a non-sterile non-active dispersive conductor intended to be fastened to a patient and connected to an electrosurgical diathermy generator, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. It is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This medical device is intended for single-use.
This document describes the premarket notification for Nissha Medical Technologies Neutral Electrodes. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data in the context of clinical efficacy or diagnostic accuracy.
Therefore, many of the requested data points (such as acceptance criteria for specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and detailed ground truth establishment) are typically associated with performance studies for diagnostic or AI-driven medical devices, which are not detailed in this submission for a neutral electrode.
However, based on the provided text, I can extract information related to non-clinical performance and substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance results in the format typically seen for diagnostic device studies. Instead, it states that the device "passed all the testing in accordance with internal requirements, and international standards." The performance is reported in terms of compliance with these standards.
| Standard/Test | Description of Acceptance | Reported Device Performance |
|---|---|---|
| IEC 60601-2-2:2017 (relevant requirements) | Compliance with "Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories" | Passed tests for Thermal performance, Contact impedance, Adhesion, Shelf-life, Cord attachment, Cord connector, and Cord insulation. |
| IEC 60601-1 (relevant requirements) | Compliance with general requirements for basic safety and essential performance of medical electrical equipment. | Passed. |
| ISO 10993-1 (Biocompatibility) | Confirmation that finished devices are biocompatible and do not induce new risks. | Confirmed biocompatible. |
| ISO 10993-5 (Cytotoxicity) | Acceptable level of cytotoxicity. | Showed a slight reactivity (implies within acceptable limits for clearance). |
| ISO 10993-10 (Skin Irritation and Sensitization) | No adverse results for skin irritation and sensitization. | Showed no adverse results. |
| Shelf-Life Testing (per IEC 60601-2-2, subclause 201.15.101.8) | Demonstrated shelf-life based on accelerated aging and subsequent electrical safety testing. | Demonstrated a shelf-life of 24 months. |
2. Sample Sizes used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this is a non-clinical performance testing submission for an accessory device, not a diagnostic or AI-driven device with a traditional "test set" from patient data. The testing would have involved a sufficient number of device samples to demonstrate compliance with standards.
- Data Provenance: The data is from non-clinical laboratory testing conducted by Nissha Medical Technologies Ltd. (United Kingdom).
3. Number of Experts used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a non-clinical engineering and safety compliance submission for an electrosurgical accessory. The "ground truth" for these tests are the established parameters and thresholds within the cited international standards (e.g., maximum temperature rise, impedance limits). No human experts were involved in establishing a "ground truth" for interpretation of data in the way radiologists or pathologists would for imaging-based devices.
4. Adjudication Method for the Test Set
Not applicable, for the reasons stated above. Compliance with engineering standards is typically determined by measurement against predefined limits, not human adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a neutral electrode accessory for electrosurgery, not a diagnostic or AI-assisted interpretation device. Therefore, there is no human-in-the-loop performance improvement to measure with AI.
6. Standalone Performance Study
Yes, the non-clinical performance testing described (thermal performance, contact impedance, adhesion, shelf-life, cord attachment, cord connector, cord insulation, biocompatibility) represents standalone performance without human input beyond operating the test equipment. The purpose was to demonstrate the device's inherent safety and performance characteristics against established engineering and biological standards.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical performance testing is based on:
- International Standards: Specific criteria and limits defined in IEC 60601-2-2:2017, IEC 60601-1, ISO 10993-1, ISO 10993-5, and ISO 10993-10. These standards provide the established benchmarks for safety and performance of such devices.
- Internal Requirements and Specifications: The manufacturer's own design inputs and specifications, which are expected to align with the international standards.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
§ 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.