(48 days)
No
The summary describes a standard electrosurgical device with irrigation and suction capabilities, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for delivering electrosurgical current for cutting or coagulation, which is a therapeutic purpose during laparoscopic surgical procedures.
No
The device is described as surgical equipment for delivering electrosurgical current, irrigation, and suction during laparoscopic procedures, not for diagnostic purposes.
No
The device description clearly states that the device consists of sterile, disposable hardware components (handsets and electrodes) used for delivering electrosurgical current, irrigation, and suction. There is no mention of software being the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable." This describes a surgical tool used on the patient during a procedure.
- Device Description: The description reinforces this by detailing a "sterile, disposable device, capable of delivering either electrosurgical cutting or coagulation currents, as well as irrigation and suction." This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to analyze samples like blood, urine, tissue, etc., to provide diagnostic information. This device is used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The Valleylab Laparoscopic Handsets (models E2750, E2750T, E2751 and E2751T) and the Electrodes (models E2770 series, E2780 series, E2780R series and E2780R-ASP) are intended for use in those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable.
The device is not intended to be used in endoscopic surgical procedures.
Product codes
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Device Description
The Valleylab Laparoscopic Handsets referenced above are sterile, disposable devices, capable of delivering either electrosurgical cutting or coagulation currents, as well as irrigation and suction. They are for single use only, and are not to be resterilized.
The Valleylab Laparoscopic Electrodes referenced above are sterile, disposable electrodes. The Electrodes are offered in two lengths, 28 cm and 36 cm., and are designed for use with a 5 mm trocar cannula, or larger trocar cannulas with appropriate 5 mm adapters. The Electrodes are for single use only, and are not to be resterilized.
Mentions image processing
Not Found
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Valleylab Laparoscopic Handsets and Laparoscopic Electrodes
Intended Use
The Valleylab Laparoscopic Handsets (models E2750, E2750T, E2751 and E2751T) and the Electrodes (models E2770 series, E2780 series, E2780R series and E2780R-ASP) are intended for use in those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable.
The device is not intended to be used in endoscopic surgical procedures.
Product Description
The Valleylab Laparoscopic Handsets referenced above are sterile, disposable devices, capable of delivering either electrosurgical cutting or coagulation currents, as well as irrigation and suction. They are for single use only, and are not to be resterilized.
The Valleylab Laparoscopic Electrodes referenced above are sterile, disposable electrodes. The Electrodes are offered in two lengths, 28 cm and 36 cm., and are designed for use with a 5 mm trocar cannula, or larger trocar cannulas with appropriate 5 mm adapters. The Electrodes are for single use only, and are not to be resterilized.
Safety and Performance
Published studies indicate that laparoscopic and thoracoscopic electrosurgery is safe and effective in a variety of surgical procedures.
BIOCOMPATABILITY TESTING
The biological safety of the Valleylab Laparoscopic Handsets and Electrodes referenced above has been assured through the selection of materials which demonstrate appropriate levels of biocompatability. Patient contact components of the devices have been tested in accordance with USP Class V or ISO Standard 10993-1, Biological Evaluation of Medical Devices, Part 1.
ELECTRICAL TESTING
Electrical testing was performed on handsets and electrodes, with the following results:
- High voltage breakdown testing was conducted on handsets and electrodes . at a minimum of 5200 volts RMS (60 Hz) for 60 seconds. All of the devices
1
passed this test. This testing exceeds AAMI HF18-1986 for dielectric withstand (hipot) which requires testing at 3000 volts RMS (60 Hz) for 60 seconds.
- High Frequency Leakage Current testing was conducted on the electrodes . and confirmed to be well below the acceptable limit of 150mA (reference IEC Standard 601-2-2).
- The product has been designed to meet the requirements for High Frequency . Breakdown testing according to IEC Standard 601-2-2, and this was confirmed during product qualification.