(77 days)
3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESUs) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY etc.). 3M™ Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended applications could lead to an unsafe condition.
3M™ Universal Electrosurgical Pads, 9135 & 9165 have a green shaded coating technology that more uniformly distributes electrosurgical RF current over the whole conductive surface of the pad. The more uniform distribution rechnology and square shape permits universal orientation of the pad at a suitable placement site. The pad has a maximum temperature rise that is similar to pads up to 33% larger in conductor surface area. The entire surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive surface area to isolate the conductive area from surgical fluids. These pads include a disposable pre-attached cord.
The 3M™ Universal Electrosurgical Pads (9135 & 9165) demonstrate compliance with relevant performance standards through safety and efficacy testing, specifically focusing on biocompatibility and adherence to ANSI/AAMI HF18-1993 Voluntary Standard for Electrosurgical Devices.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI HF18-1993) | Device Performance |
|---|---|
| For 9165 (Split with cord): | Meets criteria. |
| 5.2.3.1 Maximum Safe Temperature Rise | Meets criteria. |
| 5.2.3.2 Electrode Contact Impedance | Meets criteria. |
| 5.2.8.2.2 Contact Quality Monitor | Meets criteria. |
| For 9135 (Solid with cord): | Meets criteria. |
| 5.2.3.1 Maximum Safe Temperature Rise | Meets criteria. |
| 5.2.3.2 Electrode Contact Impedance | Meets criteria. |
| 5.2.3.3 Electrode Adherence Test | Meets criteria. |
| For 9135 (Solid with cord): | |
| 5.2.5.1 Dielectric Withstand 60 Hz | Meets criteria. |
| 5.2.5.2 High Frequency Leakage Current | The biological safety of selected components has been assured through material selection demonstrating appropriate biocompatibility levels, based on ISO 10993-1, "Biological Evaluation of Medical Devices," Part 1 tests. Additionally, the device meets specific performance standards as listed above. |
| Biocompatibility |
2. Sample Size and Data Provenance for Test Set:
- The document does not specify the exact sample sizes used for each individual test conducted under the ANSI/AAMI standard.
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the tests were conducted by the device manufacturer, 3M, to demonstrate compliance with a US national standard (ANSI/AAMI).
3. Number of Experts and Qualifications for Ground Truth:
- This information is not applicable. The testing described involves objective physical and electrical measurements against a predefined standard (ANSI/AAMI HF18-1993), not a subjective assessment requiring expert consensus for ground truth.
4. Adjudication Method:
- This is not applicable as the testing involves objective measurements against a standard, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- This is not applicable to the evaluation of an electrosurgical pad, which does not involve human readers interpreting cases or AI assistance in a diagnostic context.
6. Standalone (Algorithm Only) Performance:
- This is not applicable as the device is a physical electrosurgical pad, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for the performance evaluation is the established technical specifications and thresholds outlined in the ANSI/AAMI HF18-1993 Voluntary Standard for Electrosurgical Devices. For biocompatibility, it's compliance with ISO 10993-1, "Biological Evaluation of Medical Devices" Part 1 tests.
8. Sample Size for Training Set:
- This is not applicable as the device is a physical electrosurgical pad and does not involve AI/machine learning requiring a training set.
9. How Ground Truth for Training Set was Established:
- This is not applicable for the reasons stated above.
§ 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.