(57 days)
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No
The device description explicitly states "There is no software utilized in the operation of the Controller." and there are no mentions of AI, ML, or related concepts in the document.
Yes
The device is intended for use in "arthroscopic surgical procedures... for soft tissue resection and hemostasis," which are therapeutic interventions.
No
The device is intended for soft tissue resection and hemostasis during arthroscopic surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device is a physical electrosurgical system comprised of a probe, probe cable, and a generator (Controller). It explicitly states "There is no software utilized in the operation of the Controller."
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The ArthroCare Arthroscopic Electrosurgery System 980 is used during surgical procedures (arthroscopy) to directly interact with tissue within the body for resection and hemostasis. It is an active surgical device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "for use in arthroscopic surgical procedures... for soft tissue resection and hemostasis." This describes a surgical intervention, not a diagnostic test.
The device operates directly on tissue within the patient's body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The ArthroCare Arthroscopic Electrosurgery System 980 is intended for use in arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, hip and wrist for soft tissue resection and hemostasis.
Product codes
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Device Description
The ArthroCare Arthroscopic Electrosurgery System 980 is comprised of three components: the Probe, the Probe Cable, and an electrosurgical generator called the Controller. The Probe Cable connects the Controller to the Probe. The Probe is provided in a variety of models, ranging in diameters from 1.5 mm to 4.5 mm with the distal tip of the probe as straight or bent at angles up to 90 degrees. The distal tip may be configured with multi-electrodes or loop electrodes. The Probe is supplied sterile and intended for single patient use. The Probe Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller. The ArthroCare Arthroscopic Electrosurgery System 980 is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
knee, shoulder, ankle, elbow, hip and wrist
Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
ArthroCare Corporation Sunnyvale, California Premarket Notification August 9, 1996
OCT - 8 1996
X. 510(k) Summary
K96 3/23
Name of Device A.
| Trade name: | ArthroCare Arthroscopic Electrosurgery System
980 |
|-------------------------|-------------------------------------------------------------------------------------|
| Common name: | Electrosurgical Generator |
| Classification
name: | Electrosurgical Cutting and Coagulation Device
and Accessories (21 CFR 878.4400) |
Accessory to an Arthroscope (21 CFR 888.1100
B. Predicate devices
| Device | Premarket
Notification |
|-------------------------------------------------------------------------------------|---------------------------|
| ArthroCare Arthroscopic Electrosurgery System 970 | K943450 |
| ArthroCare Arthroscopic Electrosurgery System 970
(Addition of Hip Indication) | K961747 |
| ArthroCare Arthroscopic Electrosurgery System 970
(Addition of Wrist Indication) | K962321 |
C. Device description
The ArthroCare Arthroscopic Electrosurgery System 980 is comprised of three components: the Probe, the Probe Cable, and an electrosurgical generator called the Controller. The Probe Cable connects the Controller to the Probe. The Probe is provided in a variety of models, ranging in diameters from 1.5 mm to 4.5 mm with the distal tip of the probe as straight or bent at angles up to 90 degrees. The distal tip may be configured with multi-electrodes or loop electrodes. The Probe is supplied sterile and intended for single patient use. The Probe Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
1
ArthroCare Corporation Sunnyvale, California Premarket Notification August 9, 1996
The ArthroCare Arthroscopic Electrosurgery System 980 is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
D. Intended use
The ArthroCare Arthroscopic Electrosurgery System 980 is intended for use in arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, hip and wrist for soft tissue resection and hemostasis.
E. Technological characteristics
The technological characteristics of the ArthroCare Arthroscopic Electrosurgery System 980 are the same as those of the ArthroCare Arthroscopic Electrosurgery System 970. The devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization.
F. Summary
By virtue of design, materials, function and intended use, the ArthroCare Arthroscopic Electrosurgery System 980 is substantially equivalent to the ArthroCare Arthroscopic Electrosurgery System 970 which is currently marketed in the United States.