(117 days)
MB8010 Electrosurgical generator is indicated for monopolar cutting and coagulation and bipolar coagulation in surgical procedures and is intended to be used with monopolar handpieces and ground pad or bipolar handpieces and footswitches.
Medrange MB 8010 ESU is an electrosurgical generator with monopolar pure cut; blend cut, coagulation and bipolar coagulation functions which meet surgical demands. Those functions are achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show status of self-test and monitoring. The final output power control is made through foot or hand switches. Both monopolar and bipolar electrodes are provided. It is designed to comply with international safety standards.
This document is a 510(k) summary for the Medrange MB8010 Electrosurgical Unit (ESU). It describes the device, its intended use, and claims substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Medrange MB8010 ESU are primarily based on its conformance to various international safety and performance standards. The "reported device performance" in this context refers to the device being found to meet these standards and thus demonstrating substantial equivalence to its predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Conformance to ANSI/AAMI HF-18 (American National Standard for Electrosurgical Devices) | The device "conforms to" this standard. |
| Conformance to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | The device "conforms to" this standard. |
| Conformance to IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests) | The device "conforms to" this standard. |
| Conformance to IEC 60601-1-4 (Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems) | The device "conforms to" this standard. |
| Conformance to IEC 60601-1-8 (Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) | The device "conforms to" this standard. |
| Conformance to IEC 60601-2-2 (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) | The device "conforms to" this standard. |
| Conformance to ISO 14971 (Medical devices – Application of risk management to medical devices) | The device "conforms to" this standard (risk management). |
| Substantial Equivalence to Predicate Devices (ConMed Excalibur Plus PC K953007 and Valleylab FX™ K944602) | "Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." |
| Functions as Intended | "Performance testing was performed to ensure that MB 8010 electrosurgical generator functions as intended..." |
| Meets Design Specifications | "...and meets design specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for performance testing or study (e.g., number of units tested, number of simulated procedures, or patient data). It only mentions "Performance testing was performed to ensure that MB 8010 electrosurgical generator functions as intended, and meets design specifications."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for an electrosurgical unit, the testing would typically involve laboratory benches tests and potentially animal or cadaveric studies rather than human patient data in the same way a diagnostic AI device might.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. For electrosurgical units, ground truth is typically established through engineering specifications, regulatory standards, and objective physical measurements rather than expert consensus on clinical findings.
4. Adjudication Method
An adjudication method is not applicable or mentioned in this context. Adjudication typically applies to assessments of subjective clinical findings, which are not detailed here for an electrosurgical generator.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. MRMC studies are primarily relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can be evaluated for improving their performance. This device is an electrosurgical unit, not a diagnostic imaging AI.
6. Standalone Performance Study (Algorithm Only)
The concept of "standalone performance (algorithm only without human-in-the-loop performance)" is not directly applicable to this device. The MB8010 ESU is a hardware device with embedded control systems. Its "performance" refers to its electrical output characteristics, safety features, and functional behavior as designed, not an AI algorithm that operates independently. The performance testing evaluated the device's ability to meet its technical specifications and regulatory standards.
7. Type of Ground Truth Used
The ground truth used for this device's performance evaluation would primarily be:
- Engineering Specifications and Design Requirements: The device's output power levels, waveform characteristics, safety interlocks, and other functional parameters must adhere to predefined engineering designs.
- Regulatory Standards: Conformance to standards like ANSI/AAMI HF-18, IEC 60601-1 series, and ISO 14971 establishes the ground truth for safety and essential performance. This is the explicit ground truth mentioned in the document.
- Predicate Device Performance: Implicitly, the performance of the predicate devices (ConMed Excalibur Plus PC and Valleylab FX™) serves as a benchmark for "substantial equivalence."
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here. This device is an electrosurgical unit, not an AI/ML-based diagnostic or predictive algorithm that requires a training set of data. Its functionality is based on established electrical engineering principles and control systems, not machine learning from data.
9. How Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
§ 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.