(79 days)
The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.
The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.
The provided text is a summary of safety and effectiveness for a Bipolar Suction Coagulator. It details various safety and performance standards met by the device. However, it does not contain the specific information requested about acceptance criteria, device performance metrics (sensitivity, specificity, accuracy, etc.), details of a study (sample size, data provenance, ground truth establishment, expert qualifications), or comparative effectiveness studies with AI or standalone algorithm performance.
The document primarily focuses on:
- Intended Use: Soft tissue surgical procedures requiring fluid evacuation and low-energy coagulation.
- Biological Safety: Materials tested according to ISO 10993-1.
- Sterilization Safety: Validated to a SAL of 10-6 using EtO sterilization.
- Performance Testing: Compliance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18.
- Substantial Equivalence: To Bipolar Suction Coagulator, K960455.
Therefore, I cannot populate the requested table or answer the specific questions because the necessary data is not present in the provided input. This document describes regulatory compliance and testing for a physical medical device, not the performance metrics of a diagnostic or AI-driven system.
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K 9652 41
SUMMARY OF SAFETY AND EFFECTIVENESS
The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.
Biological safety has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The materials have been tested in accordance with ISO Standard 10993-1, Biological Evaluation of Medical Devices, Part 1 (external communicating device, blood path indirect, contact duration category "A").
Sterilization safety has been assured to a sterility assurance level (SAL) of 106. Sterility has been validated in accordance with and complies with the requirements of the applicable sections of the following standards:
100% Ethylene Oxide (EtO) sterilization: EtO Sterilization of Medical Devices (ST27- 1988).
The Bipolar Suction Coagulator (Angled) has been performance tested in accordance with and complies with the requirements of the applicable sections of the following standards:
IEC 601-1-2 (1988). Medical Electrical Equipment Part 1; General Requirements for the Safety.
IEC 601-2-2 (1991), Medical Electrical Equipment Part 2; Particular Requirements for the Safety of High Frequency Surgical Equipment.
ANSI/AAMI HF 18 (1993), Electrosurgical Devices
The Bipolar Suction Coagulator (Angled) is substantially equivalent in function and intended use to the Bipolar Suction Coagulator, 510(k) K960455.
§ 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.