(94 days)
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No
The summary describes a physical electrosurgical electrode with a non-stick coating and its performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as an electrosurgical electrode used for cutting and coagulation, which are surgical procedures, not therapeutic ones in the context of device classification.
No
Explanation: The device is an electrosurgical electrode used for cutting and coagulation, not for diagnosing medical conditions. It is a surgical tool.
No
The device description clearly states it is a physical electrode with a coating, intended for use with electrosurgical accessories. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for "use in conventional monopolar electrosurgical accessories" for "monopolar electrosurgical cutting and coagulation." This describes a surgical tool used on a patient during a procedure.
- Device Description: The description reinforces this by explaining the coating provides a "non-stick surface for easier cleaning of eschar during electrosurgery." This is a feature related to the surgical process itself.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The description of the Valleylab Coated Electrodes does not involve any of these activities.
The device is a surgical instrument used directly on the patient during an electrosurgical procedure, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
Valleylab Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Valleylab Coated Electrodes are modifications of Valleylab's line of singleuse electrodes that includes various tip configurations. The coating provides a non-stick surface for easier cleaning of eschar during electrosurgery.
The electrodes are intended for use with monopolar electrosurgical accessories, and will be packaged separately as well as in combination with Valleylab electrosurgical pencils. The Coated Electrodes will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
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 was performed on prototype Valley|ab Coated Electrodes (blade configuration). This configuration is representative of the range of electrodes which will be available in a coated form.
Electrode Cleanability and Durability: The Valleylab Coated Blade Electrode retained its easy to clean properties for a longer period of use than other coated electrodes or standard uncoated stainless steel electrodes tested.
Electrode Cut Performance: The Valleylab Coated Blade Electrode initiates cutting immediately and continues to cut more readily and consistently than "non-stick" coated blades at both lower and higher power settings.
Electrode Bendability Test: The Valleylab Coated Blade Electrode was bent to a maximum of 90 degrees ten times or until failure of the steel blade, without visible cracking of the coating.
Pre-Clinical Performance: In pre-clinical trials involving a variety of surgical procedures in swine, surgeons rated the performance of the Valleylab Coated Blade equal or superior to other coated blades tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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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
AUG 30 1996 K962044
SUMMARY OF SAFETY AND EFFECTIVENESS VALLEYLAB COATED ELECTRODES
Intended Use
Valleylab Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.
Product Description
The Valleylab Coated Electrodes are modifications of Valleylab's line of singleuse electrodes that includes various tip configurations. The coating provides a non-stick surface for easier cleaning of eschar during electrosurgery.
The electrodes are intended for use with monopolar electrosurgical accessories, and will be packaged separately as well as in combination with Valleylab electrosurgical pencils. The Coated Electrodes will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
Safety and Performance
1. Biocompatibility Testing
The biological safety of the Valleylab Coated Electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The components of the Coated Electrodes have incidental short term contact with patient tissues at the surgical site.
2. Performance Testing
Performance testing was performed on prototype Valley|ab Coated Electrodes (blade configuration). This configuration is representative of the range of electrodes which will be available in a coated form.
1
Electrode Cleanability and Durability
The Valleylab Coated Blade Electrode retained its easy to clean properties for a longer period of use than other coated electrodes or standard uncoated stainless steel electrodes tested.
Electrode Cut Performance
The Valleylab Coated Blade Electrode initiates cutting immediately and continues to cut more readily and consistently than "non-stick" coated blades at both lower and higher power settings.
Electrode Bendability Test
The Valleylab Coated Blade Electrode was bent to a maximum of 90 degrees ten times or until failure of the steel blade, without visible cracking of the coating.
Pre-Clinical Performance
In pre-clinical trials involving a variety of surgical procedures in swine, surgeons rated the performance of the Valleylab Coated Blade equal or superior to other coated blades tested.