(318 days)
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No
The summary describes a reprocessing process for electrosurgical electrodes and does not mention any AI or ML components in the device or the reprocessing method.
No.
The device's intended use is to remove tissue and control bleeding during surgery by use of electrical current, which are surgical functions rather than therapeutic ones.
No
Explanation: The device is an electrosurgical electrode used to remove tissue and control bleeding during surgery, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states the devices are physical electrosurgical electrodes made of various materials and shapes, which are then reprocessed. This indicates 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 to "remove tissue and control bleeding during surgery by use of electrical current." This is a therapeutic and surgical function performed directly on a patient's body.
- Device Description: The description reinforces the surgical nature of the device, stating it's used "to remove tissue and control bleeding during surgery."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.
Product codes
GEI
Device Description
The devices that are the subject of this submission are used to remove tissue and control bleeding during surgery. They are made of a variety of materials and come in different shapes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning. refurbishing, testing, packaging, and sterilization. It allows the electrodes to be used several times rather than just once.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing: Comparative performance testing and clinical evaluations were not included as part of this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
The predicate device for each reprocessed electrosurgical electrode is the same product as provided by the original manufacturer.
Reference Device(s)
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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