(204 days)
No
The document describes a device that uses electrical stimulation and EMG to measure muscle response, which is a standard physiological measurement technique. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
This device is for monitoring neuromuscular transmission, not for directly treating or preventing a disease or condition. It helps assess the effect of administered neuromuscular blockade.
No
The device monitors the relaxation of a patient when neuromuscular blockade is administered by measuring nerve and muscle response to electrical stimulation, which is a monitoring function, not a diagnostic one. It assesses the effect of a treatment (neuromuscular blockade), rather than identifying a disease or condition.
No
The device description explicitly states it is a "portable, battery-operated EMG-based neuromuscular transmission monitor" and describes hardware functions like electrical stimulation and direct measurement of muscle response using electromyography. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the TetraGraph Neuromuscular Transmission (NMT) Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). The TetraGraph directly measures the electrical response of muscles within the patient's body in response to electrical stimulation of a nerve.
- The device description clearly states it uses electromyography (EMG) to measure the evoked response of muscles. This is a direct physiological measurement, not an analysis of a sample taken from the body.
- The intended use is for monitoring the relaxation of the patient when neuromuscular blockade is administered. This is a real-time monitoring function during a medical procedure, not a diagnostic test performed on a sample.
Therefore, the TetraGraph is a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.
Product codes
KOI
Device Description
The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, battery-operated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block.
Neuromuscular Transmission (NMT) is the transfer of an electrical impulse between a motor nerve and its associated muscle. The NMT is blocked by neuromuscular blocking agents ("NMBAs") which cause transient muscle paralysis preventing the patient from moving and breathing spontaneously.
Muscle relaxation is used during general anesthesia to enable endotracheal intubation and mechanical ventilation and to provide optimal surgical conditions. Muscle relaxation may also be used in critical care during mechanical ventilation. In these circumstances, TetraGraph can be used as an objective monitor of neuromuscular transmission. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG). The TetraGraph is a prescription-only medical device and is indicated for use in hospitals. TetraGraph supplements the use of clinical information/data obtained from other monitors, such as peripheral oxygen saturation (SpO2), end-tidal carbon dioxide (ETCO2), as well as clinical assessment, to determine the adequacy of ventilation.
The level of neuromuscular block is routinely measured by stimulating a peripheral nerve, usually in the forearm and by evaluating the muscle response typically in the thumb or little finger. The TetraGraph controls the level of electrical stimulation applied to the nerve and monitors the muscle response by the use of Electromyography (EMG) detected by electrodes on the muscle.
TetraGraph consists of the following main components:
TetraGraph Monitor: The TetraGraph Monitor is used to control the electrical stimulation and to measure the EMG-response. The Monitor is controlled via a touch screen and a power button. The TetraGraph Monitor is connected to the electrode via a cable (the TetraCord Cable). The battery in the TetraGraph Monitor is charged via a communication port connected to a USBsupply adapter.
TetraSens Electrode: The TetraSens Electrode is a single-use electrode array includes two stimulating electrodes (applied along the ulnar nerve at the wrist) and two recording electrodes (applied on the hand). The TetraGraph Monitor can transmit stimulation pulses to the patient and can receive EMG signals via the electrode array. The electrodes are neither supplied sterile nor intended to be sterilized by the user. The TetraSens Electrodes are sold separately from the TetraGraph monitor and are available in boxes of 20 pcs.
TetraCord Cable: The TetraCord Cable is connected to the TetraGraph Monitor via a port and is connected to the TetraSens Electrode via the cable connector at the other end of the TetraCord Cable. The TetraCord Cable is supplied in together with the TetraGraph monitor as part of the kit and can also be sold separately as a spare part.
TetraGraph Pole Clamp kit: A Pole clamp kit is available for mounting the TetraGraph on a pole stand. The kit includes a mounting device and an attachment to the TetraGraph. The Pole clamp kit is supplied separately from the TetraGraph kit.
Rechargeable lithium-polymer battery: A re-chargeable lithium-polymer battery is included in the TetraGraph, and also available as spare part. The rechargeable battery is charged using the USB power supply adapter.
USB power supply adapter and USB cable: The rechargeable battery is charged using the USB power supply adapter is configured for local power outlets and connects to the TetraGraph using a USB cable. Data can also be transferred to a PC via the USB-port by using the USB-cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral nerve, usually in the forearm; muscle response typically in the thumb or little finger. Stimulating electrodes applied along the ulnar nerve at the wrist, recording electrodes applied on the hand.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical personnel only. Used perioperative and in recovery and critical care environments, in hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Performance testing, Electrical safety, Electromagnetic compatibility, Biocompatibility testing, Thermal testing, Mechanical strength, Environmental testing, Usability testing, Shelf life testing, Battery life testing, Performance testing of electrodes (tensile testing and electrical performance).
Sample Size: Not specified.
AUC: Not Found.
MRMC: Not Found.
Standalone Performance: Not Found.
Key Results: The performance testing showed that TetraGraph met all of the acceptance criteria for this device, which are the same or very similar to the predicate device's specifications. The test data demonstrate that TetraGraph is at least as safe and effective in monitoring the relaxation of the patient when neuromuscular blockade is administered as the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
Not Found
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).
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October 18, 2019
Senzime AB % Elisa Maldonado-Holmertz RA/OA Consultant Obleix Consulting LLC 12416 Fairfax Ridge Place Austin, Texas 78738
Re: K190795
Trade/Device Name: Tetragraph Neuromuscular Transmission Monitor Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: KOI Dated: September 11, 2019 Received: September 12, 2019
Dear Elisa Maldonado-Holmertz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190795
Device Name
TetraGraph Neuromuscular Transmission Monitor
Indications for Use (Describe)
The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 005 - 510(k) Summary
1. Submission Sponsor
Senzime AB Ulls väg 29B 756 51 Uppsala Sweden Johanna Faris, QA/RA Director Email: johanna.faris@senzime.com Tel number: +46 (0)705286330
2. Submission Correspondent
Obelix Consulting, LLC 12416 Fairfax Ridge Place Austin, TX 78738 USA Elisa Maldonado-Holmertz, RA/QA Consultant Email: elisamh@obelixconsult.com Cellphone number: +1 512 431 6069
3. Date Prepared
15 October 2019
4. Device Identification
| Type of 510(k) Submission: | Traditional |
|---|---|
| Trade or Proprietary Name: | TetraGraph Neuromuscular Transmission (NMT) |
| Monitor (TetraGraph) | |
| Common or Usual Name: | TetraGraph |
| Product Code: | KOI |
| Regulation Nr: | 868.2775 |
| Regulation Name: | Electrical peripheral nerve stimulator |
| Class of Device: | Class II |
| Panel: | Anesthesiology |
| Reason for Submission: | New device |
| Multiple Devices: | No; this is the only device in the submission |
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5. Legally Marketed Predicate and Reference Devices
Predicate Device- K051635, Datex Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT (from GE Healthcare) Reference Device - K992598, TOF-Watch SX (from Merck & Co, Inc. (Organon Teknika Corp.))
6. Device Description
The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, battery-operated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block.
Neuromuscular Transmission (NMT) is the transfer of an electrical impulse between a motor nerve and its associated muscle. The NMT is blocked by neuromuscular blocking agents ("NMBAs") which cause transient muscle paralysis preventing the patient from moving and breathing spontaneously.
Muscle relaxation is used during general anesthesia to enable endotracheal intubation and mechanical ventilation and to provide optimal surgical conditions. Muscle relaxation may also be used in critical care during mechanical ventilation. In these circumstances, TetraGraph can be used as an objective monitor of neuromuscular transmission. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG). The TetraGraph is a prescription-only medical device and is indicated for use in hospitals. TetraGraph supplements the use of clinical information/data obtained from other monitors, such as peripheral oxygen saturation (SpO2), end-tidal carbon dioxide (ETCO2), as well as clinical assessment, to determine the adequacy of ventilation.
The level of neuromuscular block is routinely measured by stimulating a peripheral nerve, usually in the forearm and by evaluating the muscle response typically in the thumb or little finger. The TetraGraph controls the level of electrical stimulation applied to the nerve and monitors the muscle response by the use of Electromyography (EMG) detected by electrodes on the muscle.
TetraGraph consists of the following main components:
TetraGraph Monitor
The TetraGraph Monitor is used to control the electrical stimulation and to measure the EMG-response. The Monitor is controlled via a touch screen and a power button. The
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TetraGraph Monitor is connected to the electrode via a cable (the TetraCord Cable). The battery in the TetraGraph Monitor is charged via a communication port connected to a USBsupply adapter.
TetraSens Electrode
The TetraSens Electrode is a single-use electrode array includes two stimulating electrodes (applied along the ulnar nerve at the wrist) and two recording electrodes (applied on the hand). The TetraGraph Monitor can transmit stimulation pulses to the patient and can receive EMG signals via the electrode array. The electrodes are neither supplied sterile nor intended to be sterilized by the user.
The TetraSens Electrodes are sold separately from the TetraGraph monitor and are available in boxes of 20 pcs.
TetraCord Cable
The TetraCord Cable is connected to the TetraGraph Monitor via a port and is connected to the TetraSens Electrode via the cable connector at the other end of the TetraCord Cable. The TetraCord Cable is supplied in together with the TetraGraph monitor as part of the kit and can also be sold separately as a spare part.
TetraGraph Pole Clamp kit
A Pole clamp kit is available for mounting the TetraGraph on a pole stand. The kit includes a mounting device and an attachment to the TetraGraph. The Pole clamp kit is supplied separately from the TetraGraph kit.
Rechargeable lithium-polymer battery
A re-chargeable lithium-polymer battery is included in the TetraGraph, and also available as spare part. The rechargeable battery is charged using the USB power supply adapter.
USB power supply adapter and USB cable
The rechargeable battery is charged using the USB power supply adapter is configured for local power outlets and connects to the TetraGraph using a USB cable. Data can also be transferred to a PC via the USB-port by using the USB-cable.
7. Indication for Use Statement
Indications for Use: The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.
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8. Substantial Equivalence Discussion
A device comparison is made for the TetraGraph compared to the predicate device Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT from GE Healthcare ("Datex-Ohmeda"). Datex-Ohmeda's existing 510(k) clearance (K051635) means it is legally marketed.
Intended use and indications for use, substantial equivalence discussion
The intended use for the predicate device (Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT) is the same since the Regulation 868.2775 applies for both:
An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.
| | TetraGraph Neuromuscular Transmission
(NMT) Monitor | Datex-Ohmeda S/5TNI E-NMT module |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The TetraGraph Neuromuscular Transmission
(NMT) Monitor is indicated for monitoring the
relaxation of the patient when neuromuscular
blockade is administered. | The Datex-Ohmeda S/5TNI E-NMT module
is indicated for monitoring the relaxation of
the patient and regional block stimulation
for nerve location. The device is indicated
for use by qualified medical personnel only. |
Both devices are indicated for monitoring the muscle relaxation of the patient, which is TetraGraph's sole indication. Datex-Ohmeda also has a second indication: nerve location. However, TetraGraph has only one of the predicate device's two indications meaning that the subject device is compared to its predicate device with respect to their mutual indication only.
The predicate device states that it is indicated for use by qualified medical professionals only in its indications. However, TetraGraph is a prescription device, and thus, it is also limited to use by medical professionals. TetraGraph's indications for use statement and its device's labeling identify it as a prescription device. Thus, both devices have the same population of intended users. Senzime believes that TetraGraph's Rx designation in its indications for use statement and on its labeling conveys that limitation and that it would be redundant to identify its intended user population in the device's indications.
To summarize, the indications for use statement for the TetraGraph and its predicate device are not identical, but their mutual indication and common user population mean that they have the same intended use.
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Technological Characteristics
Both TetraGraph and the predicate device measure muscle response using electromyography (EMG) and have reusable cables for the electrode connection. The electrode used for the stimulation are single-use. There are minor technological differences in number of electrodes and stimulation settings. Performance testing show that TetraGraph met all the acceptance criteria for this device, and which are the same or very similar to the predicate device's specifications. Thus, the test data demonstrate that TetraGraph is at least as safe and effective in monitoring the relaxation of the patient when neuromuscular blockade is administered as Datex-Ohmeda.
Substantial Equivalence Table:
The following Comparison of Characteristics Table compares the TetraGraph to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
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Senzime AB Traditional 510(k) Premarket Submission TetraGraph
| Table – Comparison of Characteristics | |||
|---|---|---|---|
| Trade Name | TetraGraph | ||
| Neuromuscular | |||
| Transmission Monitor | Datex-Ohmeda S/5 | ||
| NeuroMuscular | |||
| Transmission Module, E-NMT | TOF-Watch SX | ||
| Device | SUBJECT | PREDICATE (K051635) | REFERENCE (K992598) |
| Product Code | KOI | KOI | KOI |
| Device Class | Class II | Class II | Class II |
| Classification name | Electrical peripheral nerve | ||
| stimulator | Electrical peripheral | ||
| nerve stimulator | Electrical peripheral nerve | ||
| stimulator | |||
| Regulation Number | 868.2775 | 868.2775 | 868.2775 |
| Classification Panel | Anesthesiology | Anesthesiology | Anesthesiology |
| Intended Use | The TetraGraph | ||
| Neuromuscular (NMT) | |||
| Monitor is an electrical | |||
| peripheral nerve | |||
| stimulator | |||
| (neuromuscular blockade | |||
| monitor) that is used to | |||
| apply an electrical current | |||
| to a patient to test the | |||
| level of pharmacological | |||
| effect of anesthetic drugs | |||
| and gases. | Datex-Ohmeda is an | ||
| electrical peripheral nerve | |||
| stimulator | |||
| (neuromuscular blockade | |||
| monitor) that is used to | |||
| apply an electrical current | |||
| to a patient to test the | |||
| level of pharmacological | |||
| effect of anesthetic drugs | |||
| and gases. | TOF-Watch is an electrical | ||
| peripheral nerve stimulator | |||
| (neuromuscular blockade | |||
| monitor) that is used to | |||
| apply an electrical current | |||
| to a patient to test the level | |||
| of pharmacological effect of | |||
| anesthetic drugs and gases. | |||
| Indications for Use | The TetraGraph | ||
| Neuromuscular | |||
| Transmission (NMT) | |||
| Monitor is indicated for | |||
| monitoring the relaxation | |||
| of the patient when | |||
| neuromuscular blockade | |||
| is administered. | The Datex-Ohmeda | ||
| S/5TNI E-NMT module is | |||
| indicated for monitoring | |||
| the relaxation of the | |||
| patient and regional block | |||
| stimulation for nerve | |||
| location. The device is | |||
| indicated for use by | |||
| qualified medical | |||
| personnel only. | The TOF-Watch is an | ||
| instrument for monitoring | |||
| the neuromuscular | |||
| transmission during surgery | |||
| or in the intensive care unit | |||
| by means of | |||
| acceleromyography. | |||
| The TOF-Watch is only to be | |||
| operated by trained medical | |||
| personnel. | |||
| Muscle movement | |||
| detection technology | Electromyography (EMG) | Electromyography EMG | |
| Mechanomyography | |||
| (MMG) | Acceleromyography (AMG) | ||
| Electrode Connection | Reusable Cable | Reusable Cable | Reusable Cable |
| Electrode for | |||
| Stimulation | Single use electrode | ||
| array (4 electrodes on an | |||
| array) | Single use standard ECG | ||
| electrodes (5 electrodes) | Single use standard ECG | ||
| electrodes (3 electrodes) | |||
| Stimulation Patterns | Single Twitch (ST), Train- | ||
| of-Four (TOF), Post- | |||
| tetanic Count (PTC) | ST, TOF, PTC, DBS | TOF, PTC, DBS, 1Hz, 0,1 Hz, | |
| TET | |||
| Stimulation Current | |||
| Range | 10-60 mA | 10 - 70 mA | 0 - 60 mA |
| Stimulation Pulse Width | Square wave, constant | ||
| current: 200 μs or 300 μs | Square wave, constant | ||
| current: 100, 200 or 300 | |||
| μs | 200 μs or 300 μs |
Comparison of Characteristics Tahle
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9. Performance Testing
Performance testing has been made for the TetraGraph which supports substantial equivalence between the TetraGraph and the predicate device.
The performance testing made for the device is summarized below:
- Software performance testing
- Electrical safety (in accordance with IEC 60601-1)
- Electromagnetic compatibility (in accordance with IEC 60601-1-2 and IEC 60601-2-40)
- Biocompatibility testing (in accordance with ISO10993-1)
- Thermal testing
- Mechanical strength
- Environmental testing
- Usability testing
- Shelf life testing ●
- . Battery life testing
- Performance testing of electrodes; including tensile testing as well as electrical ● performance (as specified in the ANSI/AAMI EC12:2000 standard)
The performance testing show that TetraGraph met all of the acceptance criteria for this device, and which are the same or very similar to the predicate device's specifications. Thus, the test data demonstrate that TetraGraph is at least as safe and effective in monitoring the relaxation of the patient when neuromuscular blockade is administered as the predicate
10. Clinical Performance Data
There was no clinical testing required to demonstrate that TetraGraph is substantial equivalent to the Datex-Ohmeda Device, as the predicate has similar technological characteristics.
11. Statement of Substantial Equivalence
In summary, TetraGraph, compared to its predicate device, has the same intended use, one of the same indications for use, very similar technological characteristics, where the technological differences do not raise different questions of safety or effectiveness. Test data demonstrates that TetraGraph is at least as safe and effective as its predicate device for the same indications. Thus, TetraGraph is substantially equivalent to its predicate device.