SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES by SURETEK MEDICAL

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 Description

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.

AI/ML Overview

The SureTek Medical 510(k) summary provided does not contain the specific type of acceptance criteria and associated study details that would typically be found for a medical imaging AI device. Instead, this document describes the reprocessed electrosurgical electrodes and focuses on demonstrating substantial equivalence to predicate devices for safety and performance in a manufacturing context.

Therefore, I cannot extract the information required concerning an AI device study. The provided text outlines:

Acceptance Criteria & Device Performance: The document states that "Simulated-use testing of instruments following maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices." This is a broad statement regarding functional equivalence but lacks specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI device. The other listed testing (insulation, cleaning, packaging, sterility, biocompatibility) are related to manufacturing and safety standards, not AI performance.
Sample Size, Data Provenance: Not applicable in this context as no AI study is described. The "sample" here refers to reprocessed medical devices, not patient data.
Number of Experts, Qualifications: Not applicable.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable.
Standalone Performance: The closest analogous information is the "Simulated-use testing" which compares the reprocessed devices directly to new, unused devices. This is a standalone comparison for the physical device's function.
Type of Ground Truth: For the reprocessed electrosurgical electrodes, the "ground truth" seems to be the performance of new, unused devices as the benchmark for "substantial equivalence."
Sample Size for Training Set: Not applicable, as this is not an AI model.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided SureTek Medical 510(k) summary is for reprocessed electrosurgical electrodes and details performance testing related to manufacturing, safety, and functional equivalence to predicate devices, rather than an AI device's clinical performance study.

Summary

{0}------------------------------------------------

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.• Product insulation conforms to the relevant safety requirements of ANSI/AAMI HF18 Electrosurgical Devices.• SureTek cleaning process is validated to be effective for decontamination of grossly contaminated instruments under worst case operational conditions.• 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.• Product sterility and process validation conform to the relevant requirements of ISO 11135 Medical Devices – Validation and routine control of ethylene oxide sterilization.• 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.

and the comments of the country

113

Regulation Number and Section

§ 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.