(72 days)
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No
The device description and intended use focus on a simple electrical switch and cord for activating an electrosurgical generator, with no mention of AI or ML capabilities.
No
The device is an accessory (switch and cord) for electrosurgical procedures, delivering current to instruments, and does not directly provide a therapeutic effect itself.
No
The device description states it delivers monopolar RF current for electrosurgical procedures and activates coagulation output. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly details physical components (switch, cord, connectors, adhesive) and their function in delivering electrical current, indicating it is 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 clearly states the device is for "monopolar laparoscopic and thoracoscopic electrosurgical procedures." This involves surgical intervention on the body.
- Device Description: The description details how the device delivers "monopolar RF current from a standard electrosurgical generator to a laparoscopic or thoracoscopic instrument." This is a surgical tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, urine, etc.) taken from the body. IVDs are designed for diagnostic purposes performed in vitro (outside the living organism).
This device is an accessory for electrosurgical equipment used in surgical procedures.
N/A
Intended Use / Indications for Use
The Trigger Switch and Cord accessories are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic or thoracoscopic instruments, such as scissors and graspers, is desired.
Product codes
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Device Description
The Trigger laparoscopic switch system consists of a sterile, single use switch and a sterile single use cord that is used to deliver monopolar RF current from a standard electrosurgical generator to a laparoscopic or thoracoscopic instrument.
The switch contains a female electrical connector that mates with the electrosurgical connector post on a laparoscopic or thoracoscopic instrument and a male connector that mates with the power cord. The adhesive on the switch button allows it to be placed on the instrument in a user-selected location. When the switch assembly is connected via the power cord to an electrosurgical generator, depression of the switch button results in the activation of the coagulation output of the generator .
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
The Trigger Switch and Cord have been tested in accordance with 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
- ANSI/AAMI HF18 (1993), Electrosurgical Devices
Key Metrics
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Predicate Device(s)
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
SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE TRIGGER SWITCH AND CORD
K 970/40
MAR 28 1997
The Trigger Switch and Cord accessories are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic or thoracoscopic instruments, such as scissors and graspers, is desired.
The Trigger laparoscopic switch system consists of a sterile, single use switch and a sterile single use cord that is used to deliver monopolar RF current from a standard electrosurgical generator to a laparoscopic or thoracoscopic instrument.
The switch contains a female electrical connector that mates with the electrosurgical connector post on a laparoscopic or thoracoscopic instrument and a male connector that mates with the power cord. The adhesive on the switch button allows it to be placed on the instrument in a user-selected location. When the switch assembly is connected via the power cord to an electrosurgical generator, depression of the switch button results in the activation of the coagulation output of the generator .
Trigger Switch and Cord are non-patient contact accessories, thus. The biocompatibility testing is not pertinent.
The Trigger Switch and Cord have been tested in accordance with 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
- · ANSI/AAMI HF18 (1993), Electrosurgical Devices
The Trigger Switch and Cord accessories are substantially equivalent in function and intended use to the following legally marketed devices: E2750, Laparoscopic Pencil Grip Handset (K904560); E2751, Laparoscopic Pistol Grip Handset (K925647); and E0510 Laparoscopic Cord (Preamendments Device).
The Trigger Switch and Cord are substantially equivalent to the above devices in that all of the devices are accessories which are used to deliver RF current from a standard electrosurgical generator to the surgical site during laparoscopic or thoracoscopic procedures. Both the trigger switch and the laparoscopic handsets provide a switching mechanism for output control.