(112 days)
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No
The description focuses on controlled gas flow, electrosurgical modes, and pressure monitoring, with no mention of AI or ML technologies.
Yes
The device is used to perform argon-enhanced electrosurgery (cutting and coagulation) during surgical procedures, which directly treats tissues.
No
The device is described as an electrosurgical system intended for cutting and coagulation during surgical procedures, not for diagnosing conditions.
No
The device description explicitly details hardware components such as the Force Argon™ II unit, electrosurgical handsets, and tank holders, and the performance studies mention hardware validation and testing.
Based on the provided information, the Force Argon™ II Argon Enhanced Electrosurgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical procedures (open, laparoscopic, and thoracoscopic) where electrosurgery is used. This involves direct interaction with the patient's tissue during surgery.
- Device Description: The device delivers argon gas to enhance electrosurgical cutting and coagulation. It also monitors peritoneal pressure during laparoscopic procedures. These are all actions performed on or within the patient's body during a surgical procedure.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The Force Argon™ II does not perform any such analysis of specimens.
Therefore, the Force Argon™ II Argon Enhanced Electrosurgical System is a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Force Argon™ II Argon Enhanced Electrosurgical System is intended for use in both open, laparoscopic, and thoracoscopic surgical procedures (general. neurosurgical, gynecologic) where monopolar electrosurgery (cutting and coagulation) is normally used. The Force Argon™ II Argon Enhanced Electrosurgical System provides a controlled flow of argon to electrosurgical handsets during cutting and coagulation. When the handset is activated in the gas enhanced modes, an argon gas plasma is created between the electrode and the tissue.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Force Argon™ II Argon Enhanced Electrosurgical System is designed to provide a controlled flow of argon (an inert, non-reactive gas) to custom designed electrosurgical handsets powered by Valleylab electrosurgical generators. The handsets allows the surgeon to perform argon enhanced electrosurgery in open and laparoscopic procedures. Depending on the handpiece, the system can function in the following argon enhanced modes:
- Argon Shrouded Cut Argon gas is delivered through the handset . while the attached electrosurgical generator is activated in the cut mode.
- Argon Enhanced Coag Argon gas is delivered through the handset while . the generator is activated in the coag mode.
The Force Argon™ II Argon Enhanced Electrosurgical System has two gas flow modes; one for laparoscopic procedures (Low Flow Mode, 0.5 - 4.0 SLPM) and one for open procedures (Standard Flow Mode, 0.5-12 SLPM).
In addition, the system monitors the peritoneal pressure during laparoscopic procedures. The physician can set the desired pressure on the Force Argon™ II Argon Enhanced Electrosurgical System. When the peritoneal pressure approaches a predefined percentage of the set pressure, an alarm is activated to alert the user. A second alarm sounds when the actual peritoneal pressure reaches the set point. The physician can then vent the peritoneal cavity to relieve the pressure. The Force Argon™ Argon Enhanced Electrosurgical System is designed to allow the physician to continue to use argon enhanced electrosurgery when the peritoneal pressure set limit is reached.
The Force Argon™ II unit is designed to fit on a table top or a cart. Tank holders will be offered for use with the Valleylab Gas Delivery System carts which will accommodate argon tank sizes ranging from 14 to 42 cubic feet.
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)
Safety and performance of the Force Argon™ II Argon Enhanced Electrosurgical System were verified through preclinical testing, hardware validation and testing, and software validation.
A. Hardware Validation
The Force Argon™ II Argon Ènhanced Electrosurgical System has been tested in accordance with applicable sections of the following standards:
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
EN 60601-1-2 (1993) Medical Electrical Equipment, Part 1 General Requirements for Safety, 2, Collateral Standard: Electromagnetic Compatibility- Requirements and Tests
IEC 801-3 (1984), Radiated Electromagnetic Field Requirements
ANSI/AAMI HF18 (1993), Electrosurgical Devices
B. Software Validation
The software for the Force Argon™ II unit has been designed and is being validated in accordance with accepted industry standards.
C. Biocompatibility Testing
The biological safety of the peritoneal pressure tubing has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The materials have been tested in accordance with USP Class V.
D. Preclinical and Laboratory Bench Testing
Preclinical and laboratory bench testing were performed on the Force Argon™ II Argon Enhanced Electrosurgical System in conjunction with a Valleylab electrosurgical generator and associated accessories using laparoscopic procedures in a swine model and a simulated laparoscopic model, respectively. This testing showed the Force Argon™ II Argon Enhanced Electrosurgical System functioned according to specification and monitored peritoneal pressure as designed.
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
K96+636
MAR i i 1997
VALLEYLAB FORCE ARGON™ II ARGON ENHANCED ELECTROSURGICAL SYSTEM SUMMARY OF SAFETY AND EFFECTIVENESS
I. Product Description:
The Force Argon™ II Argon Enhanced Electrosurgical System is designed to provide a controlled flow of argon (an inert, non-reactive gas) to custom designed electrosurgical handsets powered by Valleylab electrosurgical generators. The handsets allows the surgeon to perform argon enhanced electrosurgery in open and laparoscopic procedures. Depending on the handpiece, the system can function in the following argon enhanced modes:
- Argon Shrouded Cut Argon gas is delivered through the handset . while the attached electrosurgical generator is activated in the cut mode.
- Argon Enhanced Coag Argon gas is delivered through the handset while . the generator is activated in the coag mode.
The Force Argon™ II Argon Enhanced Electrosurgical System has two gas flow modes; one for laparoscopic procedures (Low Flow Mode, 0.5 - 4.0 SLPM) and one for open procedures (Standard Flow Mode, 0.5-12 SLPM).
In addition, the system monitors the peritoneal pressure during laparoscopic procedures. The physician can set the desired pressure on the Force Argon™ II Argon Enhanced Electrosurgical System. When the peritoneal pressure approaches a predefined percentage of the set pressure, an alarm is activated to alert the user. A second alarm sounds when the actual peritoneal pressure reaches the set point. The physician can then vent the peritoneal cavity to relieve the pressure. The Force Argon™ Argon Enhanced Electrosurgical System is designed to allow the physician to continue to use argon enhanced electrosurgery when the peritoneal pressure set limit is reached.
The Force Argon™ II unit is designed to fit on a table top or a cart. Tank holders will be offered for use with the Valleylab Gas Delivery System carts which will accommodate argon tank sizes ranging from 14 to 42 cubic feet.
II. Intended Use
The Force Argon™ II Argon Enhanced Electrosurgical System is intended for use in both open, laparoscopic, and thoracoscopic surgical procedures (general. neurosurgical, gynecologic) where monopolar electrosurgery (cutting and
1
coagulation) is normally used. The Force Argon™ II Argon Enhanced Electrosurgical System provides a controlled flow of argon to electrosurgical handsets during cutting and coagulation. When the handset is activated in the gas enhanced modes, an argon gas plasma is created between the electrode and the tissue.
III. Safety and Performance Data
Safety and performance of the Force Argon™ II Argon Enhanced Electrosurgical System were verified through preclinical testing, hardware validation and testing, and software validation.
A. Hardware Validation
The Force Argon™ II Argon Ènhanced Electrosurgical System has been tested in accordance with applicable sections of the following standards:
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 EN 60601-1-2 (1993) Medical Electrical Equipment, Part 1 General Requirements for Safety, 2, Collateral Standard: Electromagnetic Compatibility- Requirements and Tests IEC 801-3 (1984), Radiated Electromagnetic Field Requirements ANSI/AAMI HF18 (1993), Electrosurgical Devices
B. Software Validation
:
The software for the Force Argon™ II unit has been designed and is being validated in accordance with accepted industry standards.
C. Biocompatibility Testing
The biological safety of the peritoneal pressure tubing has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The materials have been tested in accordance with USP Class V.
D. Preclinical and Laboratory Bench Testing
Preclinical and laboratory bench testing were performed on the Force Argon™ II Argon Enhanced Electrosurgical System in conjunction with a Valleylab electrosurgical generator and associated accessories using laparoscopic procedures in a swine model and a simulated laparoscopic model, respectively. This testing
2
showed the Force Argon™ II Argon Enhanced Electrosurgical System functioned according to specification and monitored peritoneal pressure as designed.
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Summary of Substantial Equivalence IV.
The Force Argon™ II Argon Enhanced Electrosurgical System is substantially equivalent in function and intended use to the following legally marketed devices: -
· Valleylab Force GSU® Argon Enhanced Electrosurgical System.
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· Valleylab Force GSU® System with Laparoscopic option.
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· Valleylab Force GSU® SLPM System.
The peritoneal pressure monitoring function of the Force Argon™ II Argon Enhanced Electrosurgical System is comparable to similar systems in currently marketed insufflators.