The NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface.

The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation.

The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

Device Description

The NM-01/CPT neurometer is a noninvasive device intentity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

The NEUROMETER NM-01/CPT is a unique neurodiagnostic device that painlessly evaluates the functioning of small unmyelinated (C, small myelinated (A) and large myelinated (A) sensory nerve fibers at any cutaneous site by determining neuro selective sensory nerve conduction threshold. The electronic unit emits non-aversive transcutaneous electrical stimuli through a pair of special noninvasive electrodes in three fixed frequency ranges (thick myelincoated fiber 250Hz, thin myelin-coated fiber 2000Hz) with a manually adjustable current value. The emitted stimulus pulses canbe changed between 0.01 and 9.99 mA and their values qiven by the software are in CPT (Current Precipitation Threshold) values accepted in clinical practice (1CPT = 0.01mA). The test method is sensitive to both hyperesthetic abnormalities, and has more than 800 peer reviewed research publications documenting its diagnostic capabilities. The device can measure sensory nerve function at any cutaneous site including mucosal surfaces such as the bladder and the measures are not affected by skin temperature, edema or electromag-netic interference unlike traditional electro-diagnostic and biopsy procedures. The conducted tests are painless, noninvasive and non-aversive procedure is easy to perform and safe and harmless however it is only for profession clinical use. The evaluation of the tests result could only be approved by a medical doctor but the tests could be conducted by a trained assistant.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NM-01/CPT neurometer (K240189) and its substantial equivalence to predicate devices. It includes a summary of non-clinical testing performed.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a numerically quantified target, but the study implies an acceptance range for the ratio of measurements between the NM-01/CPT neurometer and the predicate device (Neurometer) to be within 10%.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence of measured result ratios within 10% for resistance.	The ratio of the measured result equivalence was above 1 for each resistance (1, 5, 30 Kohm). The confidence intervals do not include a value of 1 in any of the cases, but in all three cases, they show a difference within 10% of the confidence intervals (90%; 11%). According to the TOST tests, the two measurements can be considered within the 10% limit.
Equivalence of measured result ratios within 10% for CPT values.	For CPT breakdown, the ratios are above 1 for CPT values between 10 and 250 and below 1 for CPT values above that. The confidence intervals of the ratios for values greater than 10 CPTs are (90%; 11%). The TOST tests performed indicate that the two measurements are equivalent within the 10% limit for CPT values greater than 10. For CPT 10, the mean of the ratio is 1.109, with a 90% confidence interval of (1.0531; 1.1648), meaning the two measurements cannot be considered equivalent within the 10% limit for CPT 10. However, the document states such values are "not expected in the population under study."

Acceptance Criteria (Implied)

Reported Device Performance

Equivalence of measured result ratios within 10% for resistance.

The ratio of the measured result equivalence was above 1 for each resistance (1, 5, 30 Kohm). The confidence intervals do not include a value of 1 in any of the cases, but in all three cases, they show a difference within 10% of the confidence intervals (90%; 11%). According to the TOST tests, the two measurements can be considered within the 10% limit.

Equivalence of measured result ratios within 10% for CPT values.

For CPT breakdown, the ratios are above 1 for CPT values between 10 and 250 and below 1 for CPT values above that. The confidence intervals of the ratios for values greater than 10 CPTs are (90%; 11%). The TOST tests performed indicate that the two measurements are equivalent within the 10% limit for CPT values greater than 10. For CPT 10, the mean of the ratio is 1.109, with a 90% confidence interval of (1.0531; 1.1648), meaning the two measurements cannot be considered equivalent within the 10% limit for CPT 10. However, the document states such values are "not expected in the population under study."

Conclusion on Acceptance: The device generally met the implicit acceptance criteria of equivalence within a 10% limit, with a noted exception for CPT 10 values, which the submitter claims are not clinically relevant for the target population.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated. The text mentions "Bench testing was performed on the NM-01/CPT neurometer measured values with the results of the Neurometer used in clinical practice," but it does not specify the number of resistance measurements or CPT measurements performed for this comparison.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study is described as "Bench testing," implying it was conducted in a controlled environment as opposed to a clinical trial with human subjects.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The study described is a bench test comparing the performance of the new device against a predicate device, not involving human interpretation for establishing ground truth regarding a medical condition.

4. Adjudication Method

Not applicable for a bench test comparing device measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The study was a bench test comparing the device's measurements to a predicate device.

6. Standalone Performance Study

Yes, a standalone performance study (bench testing) was done. The NM-01/CPT neurometer's measured values were compared against the results of the legally marketed predicate device (Neurometer). This comparison assesses the algorithm/device's technical performance.

7. Type of Ground Truth Used

The "ground truth" for this bench test was the measurements obtained from the predicate device, the "Neurometer used in clinical practice." This means the new device's performance was evaluated against an established and accepted device's output.

8. Sample Size for the Training Set

Not applicable. This document describes a performance evaluation of a device, not the development of a machine learning algorithm that typically involves a training set. The device appears to be an electrodiagnostic tool that directly measures nerve conduction thresholds, rather than an AI/ML diagnostic system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set or machine learning algorithm.

Summary

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March 26, 2025

MDE Orvosbiológiai Kutató, Fejleszto, Aba Tomjanovich CEO Gyártó Korlátolt Felelosségu Társaság Podmaniczky u. 87 Budapest, 1064 Hungary

Re: K240189

Trade/Device Name: NM-01/CPT neurometer (NM-01/CPT) Regulation Number: 21 CFR 21 CFR 882.1550 Regulation Name: Nerve Conduction Velocity Measurement Device Regulatory Class: Class II Product Code: JXE Dated: February 24, 2025 Received: February 24, 2025

Dear Aba Tomjanovich:

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 (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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

Image /page/2/Picture/3 description: The image shows the FDA logo on the left and the name "Patrick Antkowiak -S" on the right. The FDA logo is in a light blue color. The name is in black and is written in a simple, sans-serif font.

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240189

Device Name

NM-01/CPT neurometer (NM-01/CPT)

Indications for Use (Describe)

The NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface.

The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation.

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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510(k) #:	K240189	510(k) Summary	Prepared on:	2025-02-23
-----------	---------	----------------	--------------	------------

Contact Details		21 CFR 807.92(a)(1)
Applicant Name	MDE Orvosbiológiai Kutató, Fejlesztő, Gyártó Korlátolt Felelősségű Társaság
Applicant Address	Podmaniczky u. 87 Budapest 1064 Hungary
Applicant Contact Telephone	+36305968065
Applicant Contact	Mr. Aba Tomjanovich
Applicant Contact Email	qara@mdegmbh.eu

Device Name		21 CFR 807.92(a)(2)
Device Trade Name	NM-01/CPT neurometer (NM-01/CPT)
Common Name	Nerve conduction velocity measurement device
Classification Name	Device, Nerve Conduction Velocity Measurement
Regulation Number	882.1550
Product Code(s)	JXE

Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
------------------------------------	--	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K843924	Digital Electroneurometer S-100	JXE
K190536	Mediracer	JXE

Device Description Summary		21 CFR 807.92(a)(4)
----------------------------	--	---------------------

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Intended Use/Indications for Use

The NM-01/CPT neurometer is a noninyasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface.

The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation.

The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the patient information and must be reviewed and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

Indications for Use Comparison

21 CFR 807.92(a)(5)

Neurometer CPT - K843924

"electrodiagnostic devices perform automated neuroselective sensory Nerve Conduction Threshold(sNCT) evaluations by determining Current Perception Threshold (CPT) measures"

NM-01 CPT - K240189

"electrodiagnostic devices perform automated neuroselection Threshold (sNCT) evaluations by determining Current Perception Threshold (CPT) measures"

The two devices are substantially equivalent.

Technological Comparison

The Neurometer CPT (K843924) and NM-01 CPT (K240189) are highly similar in their technological approach. Both are electrodiagnostic devices designed for automated nerve testing and evaluating peripheral neuropathy. They utilize a nusoidal waveform stimulus and detect nerve responses using verbal and remote-based methods. Additionally, both devices are powered by a rechargeable internal battery, making them portable and convenient for clinical use. Due to these similarities, NM-01 CPT is considered substantially equivalent to the Neurometer CPT.

ln contrast, the Mediracer (K190536), while also used for evaluating peripheral neuropathy, employs a different technological approach. Instead of a sinusoidal waveform stimulus, it uses a dual-phase, rectangular waveform.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Bench testing was performed on the NM-01/CPT neurometer measured values with the results of the Neurometer used in clinical practice. For the comparative analysis, we calculated the ratio of the two measurements. We examined the equivalence of the ratios per resistor and per CPT value. For the analysis, we used two-sample TOST tests to check whether the (90%; 111%) interval included the 90% confidence interval of the quotient.

The ratio of the measured result equivalence was above 1 for each resistance (1, 5, 30 Kohm). The confidence intervals do not include a value of 1 in any of the cases, however in all three cases they show a difference within 10% of the confidence intervals (90%; 11%), According to the TOST tests performed the two measurements can be considered within the 10% limit.

For the CPT breakdown, the ratios are above 1 for CPT values between 10 and 250 and below 1 for CPT values above that . The confidence intervals of the ratios for values greater than 10 CPTs are (90%; 1 1%), and t he TOST tests performed indicate that the two measurements are equivalent within the 10% limit.

For CPT 10, the mean of the ratio is 1.109, with a 90% confidence interval of (1.0531; 1.1648), i.e. in this case the two measurements cannot be considered equivalent within the 10% limit. Note that such values are not expected in the population under study.

To summarise the above, since the measurements were equivalent in all cases except for the 10 CPT values not used in clinical practice, the results of the two instruments can be considered equivalent in the measurement domain to be applied.

21 CFR 807.92(a)(6)

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Table 1 - Technological Comparison (21 CFR 807.92(a)(6))

	Substantiallyequivalent?	Nerometer CPT - K843924	NM-01 CPT - K240189	Mediracer - K190536	Substantially equivalent?
Diseases to be Diagnosed	Yes	Peripheral Neuropathy	Peripheral Neuropathy	Peripheral Neuropathy	Yes
Intended use	Yes	Performs automatedneuroselective sensory NerveConduction Threshold(sNCT) evaluations by determiningCurrent Perception Threshold(CPT) measures	Performs automatedneuroselective sensory NerveConduction Threshold(sNCT) evaluations by determiningCurrent Perception Threshold(CPT) measures	Device for stimulate andmeasure neuromuscularthat are useful in signalsthat are useful indiagnosing and evaluatingsystemic and entrapmentneuropathies.	Yes
Power supply	Yes	Rechargeable Internal Battery	Rechargeable Internal Battery	Rechargeable Internal Batter	Yes
Simulation detection	Yes	Verbal and remote based	Verbal and remote based	Muscle response byelectronical measurement	No
Stimulus Type	Yes	Sinusoid	Sinusoid	Dual phase, rectangularwave	No
Resolution	Yes	0.001 mA	0.001 mA	10 bits	No
Output Current	Yes	0-10 mA Constant AC	0-10 mA Constant AC	NA	No
Stimulation Frequency	Yes	5Hz, 250Hz, 2000Hz	5Hz, 250Hz, 2000Hz	2 Hz	No
Recording Channels	Yes	1 channel	1 channel	1 channel	Yes
Connectivity	No	Wire connection	Bluetooth connection	Bluetooth connection	Yes
Dimensions	Yes	11,43 x 8,89 x 6,35 cm	30 x 12 x 25,5 cm	18.99x6.971	Yes
Electrodes	Yes	Disposable Goldtrode (golden)	Permanent gold coated electrodes	Stimulation Ring Electrode	Yes
Electrode safety	Yes	Cabel chack before each usage	automatic sensor displacementdetection built in testing protocolfor the checking the patient cabledamages	NA	No
Controlling the device	Yes	Manual control by buttons of thedevice	Software based controlling thedevice that could run on differentoperating system (Win, los,Android)	Software based controllingthe device that could runon different operatingsystem (Win)	Yes
Nerves Tested	Yes	small unmylenated (C), smallmyelinated (Aδ) and largemyelinated (Aβ) sensory nervefibers	small unmylenated (C), smallmyelinated (Aδ) and largemyelinated (Aβ) sensory nervefibers	Median and ulnar nerves	No
Normative values	Yes	Normative values established formorethan 30 multiple testing sites	Normative values included to thesoftware evaluation for more than30 multiple testing sites	NA	No
Assessment time	Yes	10 - 20 minutes depending on thenumber of the analyzed arrea	10 - 18 minutes depending on thenumber of the analyzed arrea	15 minutes	Yes
Access to test data adjustment	Yes	Using the device remote to exportthe stored measurement valuesfrom memory	Cursor placing adjustment	Cursor placing adjustment	Yes
Patient Data Handling and Storage	Neurometer doesnot have patienthandling system.	The device has a built in memoryfor saving the measured CPTvalues, data could be saved to adisk for export but it does nothave patient managementsystemvsince it is an analog device	On the software included part ofthe system. All patient and testdata could be stored on the device.	On the software includedpart of the system. Allpatient and test data couldbe stored on the device.	Yes
Operator Skill Requirements	Yes	Trained technician supervised by aphysician or a physician	Trained technician supervised by aphysician or a physician	Trained techniciansupervised by a physicianor a physician	Yes
Interpretation of the Test Results	Yes	Physician or specialist locally	Physician or specialist locally	Physician or specialistlocally	Yes
Examination areas	Yes	Examination of all skin/mucousmembrane areas	Examination of all skin areas	forarm and foot	Yes
Alternative measurement protocols	Yes	Suitable to measure a patient'sPain Tolerance Threshold (PTT)	Suitable to measure a patient'sPain Tolerance Threshold (PTT)	NA	No
Regulations	NM CPT is underFDA Approval	FDA and CE mark	CE - marked	FDA and CE mark	Yes

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Regulation Number and Section

§ 882.1550 Nerve conduction velocity measurement device.

(a)
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.(b)
Classification. Class II (performance standards).