Device Information

The FlexTip Bipolar Electrodes are single-use, sterile instruments with stainless steel tips and PEBAX tubing insulation. They are compatible with RF generators from Arthrex Inc. (AR-S9800 Synergy) and Sutter Medizintechnik GmbH (K171869 CURIS® RF Generator). Two models are available, both with 2 mm tips, with working lengths of 280 mm and 350 mm. The handpiece includes a front part, cable, and plug.

Indications

The device is used for tissue and vessel coagulation through radiofrequency current in surgeries such as endoscopic, orthopedic, and neurosurgical procedures.

Intended Use

The FlexTip Bipolar Electrodes are intended for endoscopically performed or supported surgeries, specifically for coagulating tissue and vessels during procedures. It is to be used by trained medical professionals in surgical settings.

Availability

Prescription device, not available for over-the-counter use.

Study Results

• Non-clinical Testing: The device passed all safety and performance tests, including the IEC 60601 standards for electrical safety. It was also tested for electrical safety, mechanical strength, and thermal effects on tissue.

Regulatory Information

• Regulation Number: 21 CFR 878.4400
• Regulatory Class: II
• Product Code: GEI
• 510(k) Number: K233425

The device complies with several ISO standards, including ISO 10993-1 for biocompatibility, ISO 11135 for sterilization, and ISO 11607-1 for packaging and shelf life testing.

Manufacturer Information

• Name: Sutter Medizintechnik GmbH
• Address: Alfred-Walz-Str. 22, 79312 Emmendingen, Germany
• Contact Person: Simone Peschl

Predicate Device Information

• Primary Predicate Device: TipControl RF Instrument, Bipo (K170377)
• The FlexTip Bipolar Electrodes are similar to the predicate device, with both devices being single-use and used for coagulation. The key difference is the design of the handpiece, but this does not impact the function or safety of the device.

Implications

This device provides an option for coagulation in endoscopic, orthopedic, and neurosurgical procedures. It offers compatibility with established RF generators and meets rigorous safety standards.

References

1. FlexTip Bipolar Electrodes Single-use. K233425. Sutter Medizintechnik GmbH: FDA Summary: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233425
2. https://www.sutter-med.com