SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES

K052692 · Suretek Medical · NUJ · May 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052692
• Device Name: SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
• Applicant: Suretek Medical
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels.

Device Story

SureTek Reprocessed Electrosurgical Electrodes are monopolar and bipolar instruments used for soft tissue ablation, resection, coagulation, and hemostasis. Devices feature distal electrodes, insulated shafts, and proximal handles connecting to compatible electrosurgical units. Some models include suction tubing for site cooling and fluid/debris aspiration. Used in general, arthroscopic, and endoscopic surgical settings by physicians. Reprocessing restores used devices to original design, dimensions, and energy delivery specifications. Shaft insulation may be replaced with comparable heat shrink material. Devices function by delivering RF energy to target tissue; monopolar versions require a separate return electrode. Reprocessing ensures performance equivalence to new devices, maintaining clinical utility for tissue management.

Clinical Evidence

Bench testing only. Simulated-use testing confirmed performance equivalence to new devices after maximum use and reprocessing cycles. Cleaning process validated for decontamination. Packaging validated per ISO 11607, EN868-1, and ASTM standards. Sterilization validated per ISO 11135. Biocompatibility and ethylene oxide residuals confirmed per ISO 10993.

Technological Characteristics

Monopolar/bipolar electrosurgical electrodes. Materials identical to original devices; shaft insulation may use comparable heat shrink. Energy source: external electrosurgical unit. Dimensions/configurations vary by model. Sterilization: ethylene oxide (ISO 11135). Safety standards: ANSI/AAMI HF18. Packaging standards: ISO 11607, EN868-1, ASTM F88-00, F2906-04, D4169-04a, F1980-02. Biocompatibility: ISO 10993.

Indications for Use

Indicated for patients undergoing general, arthroscopic, or endoscopic surgery requiring RF ablation, resection, coagulation of soft tissue, or hemostasis of blood vessels.

Regulatory Classification

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.

Predicate Devices

• ArthroWand (K033257)
• PlasmaWand (K033584)
• VAPR (K963783)
• Vulcan (K050898)
• Saphyre (K050898)
• UltrAblator (K030720)
• Lightwave (K050923)
• OPES (K023986)
• Electrosurgical Device (K861112)
• Electrosurgical Device (K051627)
• Reprocessed Arthroscopic Wands (K043198)
• Reprocessed Soft Tissue Ablators (K012631)

Submission Summary (Full Text)

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## SureTek Medical 510(k) Summary

| Submitter | SureTek Medical 25-B Maple Creek Circle Greenville, SC 29607 | | |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------|
| Contact | Mike Sammon, Ph.D. 864-299-9743 | | |
| Date | 9/25/05 | | |
| Product | SureTek Reprocessed Electrosurgical Electrodes | | |
| Classification | Code: NUJ Regulation: 21 CFR 878.4400 Name: Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed. | | |
| Predicate Devices | Manufacturer/Reprocessor | Device/System Tradenames | 510(k) |
| | Arthrocare | ArthroWand*, PlasmaWand* | K033257, K033584 |
| | Mitek | VAPR* | K963783 |
| | Smith & Nephew | Vulcan*, Saphyre* | K050898 |
| | Linvatec | UltrAblator, Lightwave* | K030720, K050923 |
| | Arthrex | OPES* | K023986 |
| | ValleyLab | Electrosurgical Device | K861112, K051627 |
| | Vanguard Medical Concepts | Reprocessed Arthroscopic Wands | K043198 |
| | Alliance Medical | Reprocessed Soft Tissue Ablators | K012631 |
| Device Description and Technological Features | Devices are monopolar and bipolar electrosurgical electrodes designed for ablation, resection and coagulation of soft tissue. Instruments consist of one or more distal electrodes, an insulated shaft, and a proximal handle with electrical connections to a compatible electrosurgical unit. Monopolar instruments require concurrent use of a compatible return electrode. Models have varying electrode configurations and tip angles. Some models are equipped with suction tubing for continuous cooling of the ablation site and aspiration of fluids/debris during use. Reprocessed electrodes have equivalent technological characteristics as the predicate devices, i.e. device design, dimensions, energy delivery and system compatibility are unchanged during reprocessing. Device materials are identical with the exception of shaft insulation, which may be replaced with a comparable heat shrink material. | | |
| Intended Use | SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels. | | |
| Testing and Standards | • Simulated-use testing of instruments following maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices.<br>• Product insulation conforms to the relevant safety requirements of ANSI/AAMI HF18 Electrosurgical Devices.<br>• SureTek cleaning process is validated to be effective for decontamination of grossly contaminated instruments under worst case operational conditions.<br>• Product packaging conforms to all relevant requirements of ISO 11607 Packaging for terminally sterilized medical devices, with performance qualifications tested according to EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02.<br>• Product sterility and process validation conform to the relevant requirements of ISO 11135 Medical Devices – Validation and routine control of ethylene oxide sterilization.<br>• Products conform to the relevant requirements of ISO 10993 Biological Evaluation of Medical Devices for ethylene oxide residuals and biocompatibility of device materials | | |
| Substantial Equivalence | Product testing and comparisons of specifications demonstrate that SureTek Reprocessed Electrodes are substantially equivalent to their predicate devices with respect to device design, technological characteristics, intended use and performance, as well as product packaging, labeling, sterility and safety. | | |

^* Product tradenames are registered trademarks of their respective manufacturers.

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