(224 days)
No
The document describes a reprocessed electrosurgical electrode and does not mention any AI or ML capabilities.
Yes.
The device is used for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels, which are therapeutic interventions.
No
Explanation: The device is an electrosurgical electrode intended for therapeutic procedures like ablation, resection, and coagulation, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like electrodes, insulated shafts, and handles, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels" during surgical procedures. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details an electrosurgical electrode used for interacting directly with tissue during surgery. This aligns with surgical tools, not devices used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue samples, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly modify tissue during surgery.
N/A
Intended Use / Indications for 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.
Product codes
NUJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
• 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033257, K033584, K963783, K050898, K030720, K050923, K023986, K861112, K051627, K043198, K012631
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
.
:
.
:
.