(44 days)
Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument. Do not exceed a maximum output of 6250 Vp of your generator.
Bissinger monopolar cables are non-sterile, reusable Monopolar Cables fitting Bovie Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.
This document is a 510(k) summary for Bissinger Monopolar Cables, seeking clearance from the FDA. It declares substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on describing the device and comparing it to predicates, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically expected for AI/software-as-a-medical-device (SaMD) clearances.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this document, as they are not typically required for a mechanical device like electrosurgical cables that are seeking substantial equivalence based on material, design, and performance conformity to existing standards, rather than a clinical effectiveness study.
However, I can extract the relevant information that is available:
1. A table of acceptance criteria and the reported device performance
The document frames compliance with recognized standards as the performance criteria. The "new device" (Bissinger Monopolar Cables) is compared to predicate devices across several technological characteristics, with the "RE-SULT" column consistently indicating "Substantial Equivlent".
| Characteristic | New Device Acceptance Criteria (implied by standards conformity and predicate equivalence) | Reported Device Performance (as demonstrated by testing and comparison) |
|---|---|---|
| Primary Safety Standards Met | Conformance to IEC 60601-2-2: 2009 (Electrical Safety Standard for Electrosurgery) | Conforms to IEC 60601-2-2: 2009. Electrical safety testing performed. (Section 7.1) |
| Sterilization Process | Sterilizable to a sufficient sterility assurance level using standard parameters. Validated according to recognized standards. | Sterilization process validated under recognized standards. Products can be steam sterilized with sufficient sterility assurance level. (Section 7.2) |
| Reprocessability | Reprocessable according to recognized standards. | Reprocessability tested and validated under recognized standards. (Section 7.3) |
| Manual Cleaning | Cleaning validated according to recognized standards. | Manual cleaning validation performed under recognized standards. (Section 7.4) |
| Biocompatibility | Meets all biocompatibility requirements for clinical use, materials with established safe use history (ISO 10993-1). | All biocompatibility requirements met through material composition and established safe use history in other medical devices. (Section 8) |
| Maximum Output Voltage | Not to exceed 6250 Vp of the generator. | Power maxima 6.250 Vp (consistent with predicate and reference device). (Section 6) |
| Intended Use | Designed to conduct electrical power from high-frequency electrosurgical generator to instrument. | Matches the stated intended use. (Section 5, Section 6) |
| Materials | Silicon (consistent with predicate devices). | Material: Silicon. (Section 6) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for tests. The testing performed is related to electrical safety, sterilization validation, reprocessing, and manual cleaning. These are typically bench tests or validation studies for manufacturing processes, not clinical studies with patient data. Therefore, concepts like data provenance (country of origin, retrospective/prospective) are not applicable in the usual sense for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "ground truth" for this device's clearance is conformity to engineering standards (e.g., IEC 60601) and validated manufacturing processes (e.g., sterilization). Expert consensus of clinical data is not a part of this submission type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically for clinical outcome assessments where there might be disagreement in interpretation. For engineering and process validation, the conformity to standards is typically assessed by engineers and quality control personnel.
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 is not applicable. This is not an AI/SaMD device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device (monopolar cables), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the recognized consensus standards (e.g., IEC 60601-2-2:2009 for electrical safety, and other "recognized standards" for sterilization, reprocessing, and biocompatibility). The device performance is assessed against the specifications and requirements outlined in these standards.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this device.
§ 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.