(41 days)
Not Found
No
The description focuses on the physical properties and coatings of electrosurgical electrodes, with no mention of AI or ML capabilities.
Yes
The device is described as an electrosurgical device "designed for cutting of soft tissue and coagulation," which are therapeutic actions performed on a patient.
No
The device is described as an electrosurgical device for cutting soft tissue and coagulation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly describes physical electrodes with coatings, 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 is "cutting of soft tissue and coagulation." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details electrosurgical electrodes used for physical manipulation of tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
These electrosurgical devices are designed for cutting of soft tissue and coagulation.
Product codes
Not Found
Device Description
The unimed Coated Laparoscopic Electrode, unimed Coated Arthroscopy Electrode and the unimed Coated Suction-Irrigation Electrode are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency.
Each coating is non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff.
The electrodes are available in a variety of diameters, lengths and tip configurations.
The electrodes are available sterile, single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OR staff
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)
Not Found
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
§ 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
Image /page/0/Picture/0 description: The image contains a sequence of characters, specifically the string "K 97 0066". The characters are written in a handwritten style, with varying stroke thicknesses. The characters are all black against a white background.
SAFETY AND EFFECTIVENESS SUMMARY
COMMON/USUAL NAME: Electrosurgical Electrodes
FEB 1 8 1997
PROPRIETARY NAME: unimed Coated Laparoscopic Electrode unimed Coated Arthroscopy Electrode unimed Coated Suction-Irrigation Electrode
CLASSIFICATION: CLASS II
MATERIALS: All materials used to manufacture the Coated Electrodes are nontoxic and have been used in other previously marketed devices.
DESCRIPTION: The unimed Coated Laparoscopic Electrode, unimed
Coated Arthroscopy Electrode and the unimed Coated Suction-Irrigation Electrode are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency.
Each coating is non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff.
These electrosurgical devices are designed for cutting of soft tissue and coagulation. The electrodes are available in a variety of diameters, lengths and tip configurations.
The electrodes are available sterile, single use only.
SUBSTANTIAL EQUIVALENCE: This 510(k) notification represents the adding of a coating that is identical to the coatings on unimed's Coated Electrode (K962935) to unimed Electrodes identified as unimed Laparoscopic Electrodes (K945030) and unimed Suction-Irrigation Electrodes (K963338).