The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.

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. 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).

AI/ML Overview

The provided text is a 510(k) summary for the TetraGraph Neuromuscular Transmission (NMT) Monitor. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Datex Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT).

However, the summary does not include a detailed table of acceptance criteria or the reported device performance in those terms. It generally states that "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."

Therefore, for aspects directly requesting specific acceptance criteria and reported performance values, the information is not present in the provided document. Similarly, details about a specific study proving the device meets these criteria (like sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance metrics) are not provided in the depth requested.

Here's a breakdown of the information that can be extracted or inferred based on the prompt's requirements, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Stated or Inferred)	Reported Device Performance
Overall Performance	"met all the acceptance criteria for this device, and which are the same or very similar to the predicate device's specifications" (General Statement)	"at least as safe and effective in monitoring the relaxation of the patient when neuromuscular blockade is administered as Datex-Ohmeda."
Electrical Safety	In accordance with IEC 60601-1	Met acceptance criteria (no specific performance data provided)
Electromagnetic Compatibility (EMC)	In accordance with IEC 60601-1-2 and IEC 60601-2-40	Met acceptance criteria (no specific performance data provided)
Biocompatibility	In accordance with ISO10993-1	Met acceptance criteria (no specific performance data provided)
Thermal Performance	(Not explicitly stated, but implied to be within acceptable limits)	Met acceptance criteria (no specific performance data provided)
Mechanical Strength	(Not explicitly stated, but implied to be within acceptable limits)	Met acceptance criteria (no specific performance data provided)
Environmental Testing	(Not explicitly stated, but implied to be within acceptable limits)	Met acceptance criteria (no specific performance data provided)
Usability	(Not explicitly stated, but implied to be acceptable)	Met acceptance criteria (no specific performance data provided)
Shelf Life	(Not explicitly stated, but implied)	Met acceptance criteria (no specific performance data provided)
Battery Life	(Not explicitly stated, but implied)	Met acceptance criteria (no specific performance data provided)
Electrode Performance	As specified in ANSI/AAMI EC12:2000 (including tensile and electrical performance)	Met acceptance criteria (no specific performance data provided)
Measurement Technology	Muscle response detection using Electromyography (EMG)	Functions as intended, similar to predicate's EMG/MMG methodology.
Stimulation Current Range	10-60 mA (matching device specification)	Operates within specified range and meets performance for this range.
Stimulation Pulse Width	Square wave, constant current: 200 µs or 300 µs (matching device specification)	Operates within specified parameters and meets performance for this output.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the document.
Data Provenance: Not specified. The document describes "performance testing" but does not indicate if it involved human subjects, animal subjects, or purely bench testing, nor does it specify the country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document highlights functional and safety performance testing but does not mention the use of experts for establishing ground truth, as would be common in an AI/diagnostic device context. Given that this is a hardware monitoring device, the "ground truth" might be more related to established physical measurements and electrical standards, rather than expert interpretation of medical images or data.

4. Adjudication method for the test set

Not applicable/Not specified as no expert review or human-in-the-loop diagnostic assessment is described for the performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. The document explicitly states: "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." This implies the evaluation was primarily based on technical performance and comparison to the predicate's technical specifications, not a clinical effectiveness study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "Neuromuscular Transmission Monitor" operating on electromyography (EMG) signals. Its core functionality is standalone measurement and display of physiological parameters. While it's a "monitor," meaning it presents information to a human operator, the performance testing described is of the device's ability to accurately make these measurements. The document does not describe performance tests specifically for an algorithm distinct from the device's integrated operation. Its performance is its standalone performance.

7. The type of ground truth used

The specific type of "ground truth" for the performance testing is not explicitly detailed. However, based on the types of tests listed (electrical safety, EMC, biocompatibility, thermal, mechanical, environmental, shelf life, battery, electrode performance), the ground truth would likely be established through:
- Engineering specifications and standards: Conformance to IEC, ISO, and ANSI/AAMI standards.
- Reference measurements: Using calibrated equipment to measure electrical outputs, physical properties, etc.
- Bench testing: Controlled laboratory conditions to verify functional parameters against predefined acceptable ranges.

8. The sample size for the training set

This device is not described as an AI/machine learning device that would typically have a separate "training set" in the context of learning algorithms for diagnosis or prediction. It is a measurement device. Therefore, this concept of a training set is not applicable as described in the document.

9. How the ground truth for the training set was established

As explained in point 8, the concept of a "training set" for an AI/ML algorithm does not apply to this device as described.

Summary

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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

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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

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 therelaxation of the patient when neuromuscularblockade is administered.	The Datex-Ohmeda S/5TNI E-NMT moduleis indicated for monitoring the relaxation ofthe patient and regional block stimulationfor nerve location. The device is indicatedfor 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	TetraGraphNeuromuscularTransmission Monitor	Datex-Ohmeda S/5NeuroMuscularTransmission 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 nervestimulator	Electrical peripheralnerve stimulator	Electrical peripheral nervestimulator
Regulation Number	868.2775	868.2775	868.2775
Classification Panel	Anesthesiology	Anesthesiology	Anesthesiology
Intended Use	The TetraGraphNeuromuscular (NMT)Monitor is an electricalperipheral nervestimulator(neuromuscular blockademonitor) that is used toapply an electrical currentto a patient to test thelevel of pharmacologicaleffect of anesthetic drugsand gases.	Datex-Ohmeda is anelectrical peripheral nervestimulator(neuromuscular blockademonitor) that is used toapply an electrical currentto a patient to test thelevel of pharmacologicaleffect of anesthetic drugsand gases.	TOF-Watch is an electricalperipheral nerve stimulator(neuromuscular blockademonitor) that is used toapply an electrical currentto a patient to test the levelof pharmacological effect ofanesthetic drugs and gases.
Indications for Use	The TetraGraphNeuromuscularTransmission (NMT)Monitor is indicated formonitoring the relaxationof the patient whenneuromuscular blockadeis administered.	The Datex-OhmedaS/5TNI E-NMT module isindicated for monitoringthe relaxation of thepatient and regional blockstimulation for nervelocation. The device isindicated for use byqualified medicalpersonnel only.	The TOF-Watch is aninstrument for monitoringthe neuromusculartransmission during surgeryor in the intensive care unitby means ofacceleromyography.The TOF-Watch is only to beoperated by trained medicalpersonnel.
Muscle movementdetection technology	Electromyography (EMG)	Electromyography EMGMechanomyography(MMG)	Acceleromyography (AMG)
Electrode Connection	Reusable Cable	Reusable Cable	Reusable Cable
Electrode forStimulation	Single use electrodearray (4 electrodes on anarray)	Single use standard ECGelectrodes (5 electrodes)	Single use standard ECGelectrodes (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 CurrentRange	10-60 mA	10 - 70 mA	0 - 60 mA
Stimulation Pulse Width	Square wave, constantcurrent: 200 μs or 300 μs	Square wave, constantcurrent: 100, 200 or 300μs	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.

Regulation Number and Section

§ 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).