(116 days)
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No
The description focuses on the mechanical function of introducing argon gas and does not mention any computational or learning capabilities.
Yes
The device is intended for use in open surgical procedures where argon-enhanced monopolar electrosurgery is desired, indicating its role in a medical treatment.
No
The device is described as an accessory for electrosurgery, used in open surgical procedures to introduce argon gas. Its function is to enhance electrosurgery, not to diagnose conditions or diseases.
No
The device description explicitly states it is a sterile, single-use, fixed electrode device, indicating it is a physical hardware accessory.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "open surgical procedures where argon-enhanced monopolar electrosurqery is desired." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as an accessory for electrosurgical pencils used in surgery. It facilitates the use of argon gas during electrosurgery. This is a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the E2590-B & E2590-N Argon Accessories are surgical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The E2590-B & E2590-N Argon Accessories are intended for use in open surgical procedures where argon-enhanced monopolar electrosurqery is desired.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The E2590-B & E2590-N Argon Accessories are sterile, single use, fixed electrode devices which allow for the introduction of argon gas around the electrosurgical electrode of an electrosurgical pencil. The Argon Accessories are designed for use with the following Valleylab Handswitching Pencils: E2515 & E2516, E2525, E2550 & E2555.
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)
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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.
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SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE E2590-B & E2590-N ARGON ACCESSORIES
The E2590-B & E2590-N Argon Accessories are intended for use in open surgical procedures where argon-enhanced monopolar electrosurqery is desired.
The E2590-B & E2590-N Argon Accessories are sterile, single use, fixed electrode devices which allow for the introduction of argon gas around the electrosurgical electrode of an electrosurgical pencil. The Argon Accessories are designed for use with the following Valleylab Handswitching Pencils: E2515 & E2516, E2525, E2550 & E2555.
The biological safety of the E2590-B & E2590-N Argon Accessories has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility.
The E2590-B & E2590-N Argon Accessories have been designed to conform with the applicable sections of, IEC 601-1 (1988), Medical Electrical Equipment Part 1: General Requirements for Safety, IEC 601-2-2 (1991), Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment, and ANSI/AAMI HF18 (1993), Electrosurqical Devices.