(63 days)
The Bipolar Forceps is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated. The submitted Bipolar Forceps are indicated for both GYN and general laparoscopic procedures.
The submitted Bipolar forceps are forceps that grasps, coagulate, and transects tissue, utilizing electrical current. The Bipolar forceps are compatible with all standard bipolar generators that have a bipolar outlet.
This document describes a 510(k) premarket notification for Bipolar Forceps by Richard Wolf Medical Instruments Corporation. The submission claims substantial equivalence to a previously cleared device (K012279).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Implied for medical devices) | "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (Section 7.0 Conclusions Drawn) |
| Material Equivalence | The submitted devices are "the same devices cleared in 510(k) K012279, April 30, 2002." (Section 3.0, 4.0, 5.0) |
| Intended Use Equivalence | The submitted device's intended use ("open and laparoscopic surgery where grasping, coagulating, and transecting is indicated") is implicitly equivalent to the predicate device, as confirmed by the substantial equivalence finding. (Section 2.0 & Indications for Use) |
| Technological Characteristics Equivalence | The submitted devices have "the same technological characteristics" as the predicate device (K012279). (Section 3.0) |
| Performance Equivalence | The submitted devices "perform the same as the devices cleared in 510(k) K012279." (Section 5.0) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission explicitly states "No clinical tests performed." The basis for substantial equivalence is direct comparison to an identical, previously cleared device.
- Data Provenance: Not applicable. No new test data generated for this specific submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No clinical tests were performed, and thus no expert-established ground truth was required for a new test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No new test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical tests performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable. This device is Bipolar Forceps, a surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of new performance testing. The "ground truth" for this 510(k) submission relies on the established safety and effectiveness of the predicate device (Patton Tripol Bipolar Forceps, K012279), to which the current device is claimed to be identical.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/ML device where a training set would be used. The device is a surgical instrument.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As per point 8, there is no training set for this type of 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.