(71 days)
No
The description focuses on standard electrosurgical technology and makes no mention of AI or ML capabilities. The predicate devices are also standard electrosurgical systems.
Yes
The device is intended to resect soft tissue and provide hemostasis in general urological surgery, which are therapeutic actions.
No
Explanation: The device is described as an electrosurgical system intended for "resecting soft tissue and providing hemostasis" in urological surgery, which indicates a therapeutic rather than a diagnostic function. There is no mention of it being used to detect, diagnose, or monitor a disease or condition.
No
The device description explicitly lists hardware components: the UroWand, UroWand Cable, and the Controller. It also describes the physical design and function of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to resect soft tissue and provide hemostasis" in general urological surgery. This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is an "electrosurgical device" used for cutting and controlling bleeding during surgery. This is a therapeutic and surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely surgical and therapeutic.
N/A
Intended Use / Indications for Use
The ArthroCare Urologic Multi-electrode Electrosurgery System is a high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide hemostasis.
Product codes
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Device Description
The ArthroCare Urologic Multi-electrode Electrosurgery System is a high frequency electrosurgical device. The System is comprised of three components: the UroWand, the UroWand Cable, and the Controller. The UroWand, UroWand Cable and the Controller are virtually identical to the ArthroCare Probe, Probe Cable and Controller determined substantially equivalent in K943450 for the ArthroCare Arthroscopic Electrosurgery System. The bipolar design of the ArthroCare UroWand incorporates the return electrode into the shaft of the device, eliminating the need for a patient ground pad. The device is designed to be operated in a physiological saline environment. The materials used in the system are identical to those used in the ArthroCare Arthroscopic Electrosurgery System (K943450) and the ArthroCare Bipolar Loop Electrode System (K955531). Predicate devices use either stainless or titanium for the wire material of their electrosurgical electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
soft tissue (in general urological surgery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing has demonstrated equivalent performance characteristics between the ArthroCare UroWand and the ACMI Circon and Olympus America electrosurgical devices. In vivo arthroscopic animal studies have demonstrated that the depth of soft tissue alteration with the ArthroCare Arthroscopy System (which is virtually identical to the ArthroCare Urological Multi-electrode Electrosurgery System), is similar to that of a standard monopolar electrosurgery device.
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
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
MAY 28 1996
ArthroCare Corporation Sunnyvale, California March 15, 1996
Summary of Safety and Effectiveness x
The ArthroCare Urologic Multi-electrode Electrosurgery System is a high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide hemostasis. The System is comprised of three components: the UroWand, the UroWand Cable, and the Controller. The UroWand, UroWand Cable and the Controller are virtually identical to the ArthroCare Probe, Probe Cable and Controller determined substantially equivalent in K943450 for the ArthroCare Arthroscopic Electrosurgery System. The technology is also substantially equivalent to that of the ArthroCare Bipolar Loop Electrode System (K955531).
Predicate electrode products and electrosurgical generators have been marketed since the 1950's by several different manufacturers such as Circon ACMI and Karl Storz. Other monopolar and bipolar electrosurgery devices have been cleared for market via 510/k)'s, such as the electrosurgery devices manufactured by Olympus America and Karl Storz-America, Inc. These products have been demonstrated to be safe and effective in resecting soft tissue during urological surgical procedures.
The ArthroCare Urologic Multi-electrode Electrosurgery System raises no new issues of safety or efficacy. The bipolar design of the ArthroCare UroWand incorporates the return electrode into the shaft of the device. This means that a patient ground pad is not required as with monopolar electrodes. The energy flows back to the Controller via the integral return electrode rather than through the patient's body to the grounding pad. In addition, the ArthroCare UroWand is designed to be operated in a physiological saline environment while the predicate products must be operated in a non-conductive environment, such as sterile water or glycine. This allows ArthroCare to achieve equivalent efficacy in tissue resection with less power requirements.
The materials used in the ArthroCare Urologic Multi-electrode Electrosurgery System are identical to those used in the ArthroCare Arthroscopic Electrosurgery System (K943450) and the ArthroCare Bipolar Loop Electrode System (K955531). Predicate devices use either stainless or titanium for the wire material of their electrosurgical electrodes. The materials used in the UroWand Cable are identical to those used in the Probe Cable (K943450 and K955531).
Bench testing has demonstrated equivalent performance characteristics between the ArthroCare UroWand and the ACMI Circon and Olympus America electrosurgical devices. In vivo arthroscopic animal studies have demonstrated that the depth of soft tissue alteration with the ArthroCare Arthroscopy System (which is
025
1
ArthroCare Corporation Sunnyvale, California Premarket Notification March 15, 1996
virtually identical to the ArthroCare Urological Multi-electrode Electrosurgery System), is similar to that of a standard monopolar electrosurgery device. In addition, the ArthroCare System meets applicable domestic and international safety requirements and standards.
By virtue of design, materials and function, the ArthroCare Urologic Multi-electrode Electrosurgery System is substantially equivalent to the predicate devices currently marketed in the United States.