(406 days)
Not Found
No
The summary describes a standard electrosurgical device and does not mention any AI or ML components or functionalities.
Yes
The device is used for the removal/vaporization/ablation of soft tissue and for coagulation, which are therapeutic interventions.
No
The device is used for removing/vaporization/ablation of soft tissue and coagulation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is an electrosurgical device made of physical materials (stainless steel, teflon, etc.) and includes electrodes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "electrosurgical device" used for "removing/vaporization/ablation of soft tissue" and "coagulation" on anatomical sites like the prostate or myomas. This is a surgical procedure performed directly on the patient's body, not a test on a sample outside the body.
The information provided describes a surgical tool, not a diagnostic test.
N/A
Intended Use / Indications for Use
The EVAP roller electrodes can be used for removing/vaporization/ablation of soft tissue. For example; on the prostate or on myomas. The electrodes may also be used for coagulation.
Product codes
Not Found
Device Description
The EVAP electrode is an electrosurgical device made of medical grade stainless steel, teflon, new silver and Hytrel tubing. Some EVAP versions have gold plated rollers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate or on myomas
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)
Devices were tested to meet the appropriate sections of the ANSI/AAMI standard on High Frequency Devices.
Using Canine Models, it has been shown that coagulation depth increases with higher wattage but does not exceed 2-3mm. Irrigation reduces the risk of heat damage. Long term morbidity and healing were not known.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Richard Wolf Medical Instruments Corporation
OCT - 2 1996
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
510(k) Summary of Safety and Effectiveness
-
1.0 Classification Name:
Electrode, Electrosurgical -
2.0 Common Name:
Roller electrode, Coagulation electrode, Electrosurgical Electrode -
Trade Name: 3.0
Electrosurgical Vaporization (EVAP) electrode -
4.0 Equivalence:
The EVAP electrodes are substantially equivalent to electrodes currently sold by Richard Wolf, as well as electrodes sold by ProSurg (K946377) and ACMI/Circon (no 510(k) available). -
5.0 Description:
electrode is an electrosurgical device made of The EVAP medical grade stainless steel, teflon, new silver and Hytrel tubing. Some EVAP versions have gold plated rollers. -
6.0 Intended Use:
used for EVAP roller electrodes can be be The removing/vaporization/ablation of soft tissue. For example; on the prostate or on myomas. The electrodes may also be used for coagulation. -
7.0 Technological Characteristics:
The only variation from the existing electrodes is the addition of grooves and gold plating on various versions of The insulating material has been changed to the roller. Hytrel 8236 thermoplastic polyester elastomer. -
8.0 Performance Data:
Devices were tested to meet the appropriate sections of the ANSI/AAMI standard on High Frequency Devices.
1
Richard Wolf Medical Instruments Corporation
Clinical Tests: 9.0
Using Canine Models, it has been shown that coagulation depth increases with higher wattage but does not exceed 2-3mm. Irrigation reduces the risk of heat damage. Long term morbidity and healing were not known.
10.0 Data Conclusion:
The Richard Wolf EVAP Electrode is equivalent to existing electrodes particularly those sold by ProSurg and ACMI/Circon.
By: Robert J. Casassa
Date: July 16, 96