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510(k) Data Aggregation
(69 days)
The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
The Edge™ Insulated Blade Electrode (E1455G) is a sterile, single-use, monopolar electrode intended to conduct radiofrequency (RF) current. It is a coated stainless-steel electrode blade with insulation. It is compatible with electrosurgical pencils that have a 0.093" insertion diameter or commonly referred to as a standard 3/32" insertion diameter, this includes the Covidien Valleylab™ Rocker Switch Pencil Family (SEP5000, SEP5015) cleared in K182772.
The provided FDA 510(k) summary for the Edge™ Insulated Blade Electrode (K210338) describes performance testing, but it fundamentally differs from the study of an AI/ML powered device. This document is for a traditional medical device, an electrosurgical electrode, not a software or AI/ML product. Therefore, the specific questions regarding AI/ML powered devices, such as sample sizes for test/training sets, ground truth establishment for AI, number of experts, adjudication methods, and MRMC studies, are not applicable to this submission.
The "acceptance criteria" and "reported device performance" in this context refer to traditional engineering and biological testing to ensure the device is safe and effective and substantially equivalent to a predicate device, not evaluation of algorithmic accuracy.
Here's an interpretation of the available information for a traditional device:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are generally derived from recognized standards and internal specifications to demonstrate safety and effectiveness and substantial equivalence to the predicate. The performance reported here relates to meeting those standards, not to a specific quantitative metric like sensitivity or specificity.
| Acceptance Criteria Category | Specific Tests/Standards Met | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity) | The subject device complies with the relevant clauses of ISO 10993-1. (Direct tissue contacting materials: stainless steel, silicone, and polymer insulation) |
| EMC & Electrical Safety | IEC 60601-1, IEC 60601-2-2 (Electrical Safety), IEC 60601-1-2 (EMC) | The subject device complies with relevant clauses of these standards. |
| Mechanical/Functional | Related design inputs and product specifications | Mechanical, electrical, and functional testing verified that the subject device performs as expected and conforms to requirements. (Details of specific tests are not provided in this summary, but would be in the full submission). |
| Ex vivo Thermal Effect | Comparison to predicate device | Monopolar ex vivo testing evaluated thermal effect across a range of power settings and modes on different tissue types. The subject device demonstrated substantial equivalence to the predicate device. |
| Rated Accessory Voltage | (Implicitly, that it does not negatively affect electrical safety or performance compared to predicate) | Subject Device: |
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