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VLFT10GEN: The Valleylab FT10 energy platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN): The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN): The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

Valleylab™ FT10 Energy Platform (VLFT10GEN): The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. The generator provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications (LigaSure/vessel sealing function) and cardiac applications. It is a combination of a full-featured general surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure/Bipolar section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN): The Valleylab™ FT10 Electrosurgical Generator is a high frequency electrosurgical only version of the VLFT10GEN Energy Platform. It is intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN): The Valleylab™ FT10 Vessel Sealing Generator is the vessel sealing only version of the VLFT10GEN Energy Platform. It is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurqical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The Valleylab™ SM Smoke Management Pencils are monopolar electrosurgical smoke evacuation pencils intended for cutting and coagulation of tissue while simultaneously removing surgical smoke. The pencils are designed to capture surgical smoke and improve visibility to target tissues, while reducing staff and patient exposure to the hazards of surgical plume. The Valleylab™ SM Smoke Management Extended Nozzle accessories are for use with longer electrodes for deeper access procedures. The predicate device is the Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772. The proposed devices are compatible with Covidien electrosurgical generators at a maximum peak voltage 4500 Vpk having a 3-prong connector and smoke evacuators having a 3/8" port. Electrode compatibility includes use with standard 3/32" diameter hex and non-hex electrodes. The pencils are available in 10' and 15' tubing/cable lengths models.

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for oral or nasal intubation of the trachea. The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management.

The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.

The BISTM Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility. For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall. For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoffurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BIS™ Index in pediatric patients, when used with sevothurane anesthesia, has demonstrated a reduction in primary anesthetic use.

The BIS™ Advance Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS value, which correlates with the patient's level of hypnosis. The BIS™ Advance Monitoring system is comprised of the following components: BIS™ Advance Monitor, BIS™ Advance Docking Station, BIS™ Advance Adapter Cable, GCX Mounting Accessory, BISx/BISx4 Module, Patient Interface Cable (PIC) and Monitor Interface Cable (MIC). The BIS™ Advance Monitor displays: - The current BIS™ number . - . Raw EEG waveforms in real time - . Various signal quality indicators (EMG. SQI) - 트 Trend graphs of processed EEG parameters (including various options) - I Processed EEG variables: - . Electromyography (EMG) - Signal Quality Index (SQI) - . Suppression Ratio (SR) - . Burst Count (BURST) (for Extend Sensor and four-channel monitoring only) - . Suppression Time (ST) - I Spectral Edge Frequency (SEF) - Median Frequency (MF) - EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only) - I Alarm Indicator and Messages The BIS™ Advance Monitor displays 2 channels of EEG when connected to the BISx module and a unilateral BIS sensor (BIS™ Extend Sensor, BIS™ Pediatric Sensor and BIS™ Quatro Sensor) and displays 4 channels of EEG, two from each side of the brain, when connected to the BISx4 module and BIS™ Bilateral Sensor. For both the 2-channel and the 4-channel systems, BIS monitoring is implemented as follows: A sensor placed on the patient's head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.

The Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esoplagus, in patients from five years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The subject Endoflip™ 300 System is equivalent to the predicate Endoflip™ 300 System (K223705) except for an update to the Endoflip™ 300 System software to remove the analysis episode feature of the predicate device. Other software updates include minor feature enhancements and bug fixes. Changes to device labeling rrom the software updates and other minor changes for clarification purposes were also addressed. The Endoflip™ 300 System software is supplied pre-installed in the Endoflip™ 300 Display System. It is also the software used for the Endoflip™ 300 Reader in reader mode only. There is no change to the display system hardware or to how the reader is supplied (USB stick). No changes were made to any of the other components that comprise the Endoflip™ 300 System when compared to the predicate.

The Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from 5 years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The Endoflip™ 300 System is the next generation of the predicate Endoflip™ System consisting of design changes to the device hardware and software components. The design changes improve device usability when compared to the predicate. Changes were made to the platform components only; no design changes were made to the system catheters (Endoflip™ or Esoflip™) except for labeling changes (not related to indications for use). The system is comprised of a pump, display, cart and accessories, including pre-use tube and balloon catheters.

The Microstream™ CO2 NanoPod, when connected to the host monitor, is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2-based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines. The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/ hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up. IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SPO2 data to the NanoPod in order to calculate these parameters. The Microstream™ CO2 NanoPod is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.

The Microstream™ CO2 NanoPod is a finished medical device that when connected to a host monitor is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, including End-tidal CO2 (EtCO2), Fractional Concentration of Inspired CO2 (FiCO2), and CO2 based respiration rate, for adult, pediatric, and neonatal patients utilizing Microstream™CO2 or Microstream™ Advance CO2 sampling lines. The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr), and oxygen desaturation index (ODI) values. The IPI measurement is intended for use in pediatric and adult patients only, and A/hr and ODI measurements are intended for age 22 and up. Both IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SpO2 data to the NanoPod to calculate these parameters. The Microstream™ CO2 NanoPod encloses a NanoMediCO2 capnography module, which measures inspired/expired carbon dioxide and respiration rate. The NanoPod is powered by the host monitor on a DC supply. The Microstream™ CO2 NanoPod system includes the following sub-systems: - . NanoPod is the medical device enclosure that encloses the NanoMediCO2 module. The NanoPod has a connected active cable that has a LEMO connector end, which connects to a host monitoring system. - . NanoMediCO2 capnography module is enclosed in the NanoPod. The NanoMediCO2 module measures inspired and expired carbon dioxide and respiration rate. The active cable is what provides bidirectional communication between the Host monitor and the NanoMediCO2 module enclosed inside the NanoPod. - . Interface Board is enclosed inside NanoPod which consists of an LED exposed on the outside of the NanoPod to provide the functional status of the subject device to the user. - l Cradle is a plastic holder used to connect the NanoPod with a GCX clamp or other mounting solution, which can then be used to mount the NanoPod on a pole or bedrail. There are no sharp edges on the Microstream™ CO2 NanoPod, which enables the medical device to be held in the hand at times when it is removed from its mounting cradle. The Microstream™ and or Microstream™ Advance CO2 sampling lines can attach to the NanoPod CO2 port on the NanoPod enclosure. Microstream™ Capnography parameters are displayed the Microstream™ and or Microstream™ Advance CO2 sampling line is connected to the NanoPod CO2 Port and the Microstream™ CO2 NanoPod is connected via LEMO connector to a host monitoring system. Please note that the Microstream™ and Microstream™ Advance sampling lines have been cleared in their own respective 510K submissions.

ProdiGI Traction Wire: The Medtronic ProdiGI Traction Wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure. ProdiGI Traction Magnet: The Medtronic ProdiGI Traction Magnet is indicated to grasp tissue within the stomach and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.

The ProdiGI Traction System includes the Traction Wire and Traction Magnet devices. The Traction Wire and Traction Magnet are not intended to be used together. Both devices are used in adults only and are used to provide improved visualization of the submucosal space during an endoscopic submucosal dissection (ESD) procedure. ProdiGI Traction Wire Device: The Traction Wire consists of two graspers: a primary tissue grasper with traction wire attached (ERD-TW20 and ERD-TW35), and a secondary tissue grasper (ERD-TWSG) without a wire. The secondary tissue grasper is used to secure the distal end of the traction wire. The traction wire is a nitinol shape-memory loop (2.0 cm or 3.5 cm in length) that provides tension to the attached tissue after deployment. The nitinol wire is attached to the grasper with a stainless-steel crimp. ProdiGI Traction Magnet Device: The traction magnet (ERD-TMST and ERD-TMLG) consists of two identical tissue graspers with a permanent neodymium magnet attached to the grasper via a suture. The sutured magnet provides tension to the attached tissue after deployment.

The Nellcor™ OxySoftN single patient use sensor is indicated for use with neonatal, infant, pediatric and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospit, mobile emergency medical applications including both ground and air transport and home environments. Transport environments include intra-hospital transport and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The Nellcor™ OxySoft SpO2 Sensor works in conjunction with monitoring systems that use OxiMax™ and Nellcor compatible pulse oximetry systems to facilitate spot checking or continuous monitoring of a patient's arterial hemoglobin (SpO2) and pulse rate via topical application of the sensor over a pulsating arteriolar vascular bed, such as a finger, foot or hand. This device is for prescription use only.

The Nellcor™ OxySoft™ Neonatal/Adult SpO2 Sensor, OxySoftNHC monitors the amount of oxygen in the patient's blood (oxygen saturation) or SpO2 and pulse rate after applying the sensor on the finger, foot, or hand. The sensor utilizes a pair of light emitting diodes (LEDs) employing light at two wavelengths, and the time varying absorbance of the tissue due to the pulsatile blood signal is obtained, amplified from a photodiode to determine functional arterial oxygen saturation. A clinician will prescribe the sensor for use as spot check or continuous use in hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport and home environments. The OxySoftNHC sensor can be used with all Nellcor™ compatible systems. The sensor consists of a sensor assembly and cable assembly and is provided sterile (EtO) and is meant for single use.

The CARESCAPE™* CO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2 based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines. The CARESCAPE™* CO2 - Microstream™ parameter is intended for use in hospital-type facilities, during intra-hospital transport between and within areas of care.

The GE CARESCAPE™* CO2 -Microstream™ parameter is a module utilizing Microstream™ Capnography technology designed for use with specific GE Host monitors (CARESCAPE™* ONE. CARESCAPE™* B450 [K213234]. CARESCAPE™* B650 [K213181]. or CARESCAPE™* B850 [K213336]). The GE CARESCAPE™* CO2 -Microstream™ parameter comprised of two main sub-systems: - Microstream™ NanoMediCO2 is a Capnography module in its plastic enclosure called . the NanoPod, responsible for measuring the inspired carbon dioxide and respiration rate of adults, pediatric patients, and neonatal patients, - . U-MCO2-active cable module in its enclosure (called "Active cable" or "Bridge" or "Common block") responsible for enabling the bidirectional communication between the Host monitor and the NanoMediCo2 module, using the specific GE communication protocol (Taq-Length-Data). The Active Cable also acts as a power supply to the NanoPod, transferring power from the host to the pod and provides the user with an indication of the Pod's functional status. The NanoPod mates on one side with the Microstream™ Advance Filter Lines. On the other side the NanoPod attaches to GE patient monitoring system via the U-MCO2- active cable, allowing them to display the Microstream™ Capnography parameters. The U-MCO2 active cable module, is connected to an interface board located inside the active device (NanoPod), while on the other side of the U-MCO2 active cable, there is a proprietary GE (Amphenol) connector, designed to connect solely with GE Healthcare monitors. The NanoPod is activated by Microstream™ Advance Filter Lines that are connected through the blue door located on the upper side of the NanoPod.