(59 days)
Not Found
Not Found
No
The device description focuses on the physical characteristics and functions of a standard electrosurgical device (suction/irrigation, cutting, coagulating) and does not mention any computational or algorithmic features indicative of AI/ML. There are no mentions of AI, DNN, ML, image processing, or data sets for training/testing.
No
The device is described as an electrosurgical device for cutting and coagulating soft tissue, which are surgical functions, not therapeutic ones in the typical sense of treating a disease or disorder.
No
Explanation: The device description states its purpose is for "suction/irrigation as well as cutting and coagulating of soft tissue," which are therapeutic and surgical functions, not diagnostic ones.
No
The device description clearly describes physical hardware components (electrodes, sheath, shaft, tip configurations) designed for surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Description: The description clearly states the device is an "electrosurgical device designed for suction/irrigation as well as cutting and coagulating of soft tissue." This describes a device used on the body during a surgical procedure, not for testing specimens outside the body.
- Intended Use/Indications for Use: While "Not Found" is listed, the device description provides enough information to understand its function, which is surgical intervention, not diagnostic testing of specimens.
Therefore, the unimed Surgical Products unimed Suction-Irrigation Electrode and unimed Sliding Sheath are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The unimed Surgical Products unimed Suction-Irrigation Electrode and unimed Sliding Sheath are electrosurgical devices designed for suction/irrigation as well as cutting and coagulating of soft tissue.
unimed Surgical Products intends to market the unimed Suction-Irrigation Electrode with five tip configurations. The tip configurations are the Spatula, J-Hook, L-Hook, Coagulator and Needle. The electrodes are available with a shaft diameter of 5mm and a working length of 28cm or 32 cm. The unimed Sliding Sheath will be marketed in one configuration in 28cm and 32cm lengths. The proximal end is designed to fit a standard monopolar cord.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
§ 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
96333
OCT 21 1996
SAFETY AND EFFECTIVENESS SUMMARY
COMMON/USUAL NAME: Electrosurgical Electrodes
PROPRIETARY NAME: unimed Suction-Irrigation Electrode and unimed " Sliding Sheath
CLASSIFICATION: CLASS II
MATERIALS: All materials used to manufacture the unimed Suction-Irrigation Electrode and unimed Sliding Sheath are non-toxic and have been used in other previously marketed devices.
DESCRIPTION: The unimed Surgical Products unimed Suction-Irrigation Electrode and unimed Sliding Sheath are electrosurgical devices designed for suction/irrigation as well as cutting and coagulating of soft tissue.
unimed Surgical Products intends to market the unimed Suction-Irrigation Electrode with five tip configurations. The tip configurations are the Spatula, J-Hook, L-Hook, Coagulator and Needle. The electrodes are available with a shaft diameter of 5mm and a working length of 28cm or 32 cm. The unimed Sliding Sheath will be marketed in one configuration in 28cm and 32cm lengths. The proximal end is designed to fit a standard monopolar cord.
SUBSTANTIAL EQUIVALENCE: The unimed Suction-Irrigation Electrodes and unimed Sliding Sheath are similar to other Suction-Irrigation Electrodes currently commercially available. Numerous electrodes with a variety of tip configurations are marketed by Cabot Medical and American Hydro-Surgical Instruments.