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510(k) Data Aggregation
K Number
K242852Device Name
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
Manufacturer
inomed Medizintechnik GmbH
Date Cleared
2025-06-13
(266 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALM Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative neuromonitoring by recording the EMG activity of the laryngeal musculature when connected to an appropriate neuromonitoring device.
This device must be used in connection with the C2 Xplore® or any approved IEC 60601-1, compatible EMG monitoring system with 42802 DIN compatible connectors.
Device Description
The ALM Tube is an endotracheal intubation tube which combines the function of airway ventilation and intraoperative neuromonitoring purposes regarding recording of electrophysiological signals. It combines the recording of EMG signals from the vocal cords to monitor the recurrent laryngeal nerve or the vagal nerve function during surgical procedures. The product is used intraoperatively and is connected to an appropriate neuromonitoring device for signal recording outside of the sterile field via a connection cable. The connection cable is not part of the delivered package.
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K Number
K233001Device Name
Bioscope Neuromonitor Device
Manufacturer
Biosys Biyomedikal Muhendislik San. Ve Tic. A.S.
Date Cleared
2024-12-13
(448 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.
Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.
Device Description
Bioscope Neuromonitor Device is a nerve locator and monitor. The device has 3 infrastructure;
- Electronic
- Mechanic
- Software
These infrastructures are integrated with each other and work with the principle of stimulating current at 0.01-10 mA levels, conceiving EMG signals from related muscles groups. Collected signals are interpreted by the device and auditory and visual notifications will be given.
The device basically consists of stimulation and EMG subsystems. Both stimulation and EMG lines can send and collect signals from 2 channels. Depending on the operation, an EMG Endotracheal Tube or needle electrode is inserted into the muscles innervated by the relevant nerves for EMG reading. The electrode parts of the EMG tube are placed in contact with the muscles attached to the vocal cords. Needle electrodes are also inserted into the relevant muscle. Appropriate current is sent with the stimulation probe. The electrical changes in the muscles in the region and are transmitted to the device as a signal. The device gives audible and visual warnings.
Channels works on the principle of potentially stimulating the critical region through monopolar or bipolar probe connection and completing the circuit, allowing the device to make a nerve-tissue separation audibly and visually. It allows the detection of nerves such as the recurrent laryngeal nerve, which are connected to the vocal cords. The doctor brings the probe into contact with the area of potential nerve risk. The current sent to the patient through the probe causes a change in the electrical activity of the nerves and the muscles to which the nerves are connected, and this change can be detected by the device. Based on the collected data, the device gives clear audible alerts for nerve-tissue separation. The EMG signal collected from the patient is displayed as a both voltage value and latency times on the output. These values can be recorded and the interface can be used to select specific details, such as the right and left sides of the vagus, and recurrent laryngeal nerves.
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K Number
K241917Device Name
EARP Nerve Cuff Electrode
Manufacturer
Retropsoas Technologies, LLC
Date Cleared
2024-07-31
(30 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K232888Device Name
Disposable Laryngeal Electrodes
Manufacturer
Suzhou Haishen Medical Device Associates Co., Ltd
Date Cleared
2023-12-21
(94 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable laryngeal electrodes are intended to be used as a disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.
Device Description
The Disposable Laryngeal Electrodes are single used electrodes constructed from an medical-grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor.
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K Number
K230320Device Name
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
Manufacturer
Medtronic Xomed, Inc.
Date Cleared
2023-10-26
(262 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EMG tube is indicated for use where continuous monitoring of the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.
Device Description
Medtronic Xomed, Inc.'s NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are flexible, reinforced endotracheal tubes with inflatable cuffs. The NIM EMG ET Tubes are made from silicone elastomer. Each tube is fitted with electrodes on the main shaft, which are exposed only for a short distance, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and cuff are manufactured from material that allows the tube to conform readily to the shape of the patient's trachea with minimal trauma to tissues.
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K Number
K230853Device Name
EARP Nerve Cuff Electrode
Manufacturer
Nvision Biomedical Technologies, Inc.
Date Cleared
2023-10-06
(192 days)
Product Code
ETN, CLA
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
Device Description
The EARP Nerve Cuff Electrode conducts electrical signal as a component of intraoperative neuromonitoring. The EARP Nerve Cuff Electrode is used with commercially available neuromonitoring systems and does not stimulate or record signal itself. The standard connectors at the proximal end of the EARP Nerve Cuff Electrode interface with the neuromonitoring equipment and the distal cuff contacts the target tissue. The EARP Nerve Cuff Electrode is provided sterile packaged and is for single use only.
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K Number
K231580Device Name
NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
Manufacturer
Medtronic Xomed, Inc.
Date Cleared
2023-08-30
(91 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.
Device Description
The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.
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K Number
K223254Device Name
C2 Xplore
Manufacturer
Inomed Medizintechnik GmbH
Date Cleared
2023-01-27
(98 days)
Product Code
ETN, GWF
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C2 Xplore is designed for use in the operating room to measure and display the neurophysiological signals. The system supports the application of Electromyography (EMG) for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The system is not intended for monitoring life-sustaining functions.
Device Description
The C2 Xplore is an electromyography (EMG) monitor for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The C2 Xplore assists the surgeon in nerve identification, helping to locate and identify nerves at risk in the surgical field. The device records the EMG activity from the innervated nerves and provides visual and audible feedback for the surgeon, helping to preserve the nerve structures throughout the procedure. The device is equipped with 8 differential amplifier channels and with two independent stimulators. The C2 Xplore is operated via mechanical turning knobs and a touchscreen on the front. The audio feedback is generated by an integrated loudspeaker. The nerve monitoring provides information about the amplitude and latency of the EMG responses.
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K Number
K212164Device Name
Mapping Suction Probe
Manufacturer
inomed Medizintechnik GmbH
Date Cleared
2022-11-11
(487 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.
Device Description
The Mapping Suction Probe is a surgical instrument which combines surgical suction instrument and a monopolar stimulation probe in one instrument. The stimulation function of the Mapping Suction Probe is used for monopolar stimulation during intraoperative surgical interventions and is connected to electrical stimulators of neuromonitoring devices outside the sterile field via an appropriate integrated connection cable. To ensure a correct monopolar stimulation, a counter electrode is also included in the sterile package which must be placed at the resection marqin. The suction function of the Mapping Suction Probe is used for aspiration during tumor resection and is connected to suction devices via a tube, which is not part of the delivered package.
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K Number
K213246Device Name
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
Manufacturer
Medtronic Xomed, Inc.
Date Cleared
2022-03-21
(172 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Product Code :
ETN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NIM™ Surgeon Control Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Device Description
The NIMTM surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.
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