(427 days)
Not Found
No
The description focuses on the device's ability to emit electrical stimuli and measure nerve conduction thresholds. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The performance studies are based on comparing measurements to a predicate device, not on evaluating the performance of an AI/ML model.
No.
The device is described as a "noninvasive electrodiagnostic device intended for verifying nerve integrity" and a "neurodiagnostic device" used for "evaluating patients suspected of having neuropathies." Its purpose is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for verifying nerve integrity" and "The population of subject for whom this device may be used for diagnostic purposes". It also mentions that "The measured data can be utilized in evaluating patients suspected of having neuropathies." The "Device Description" further reinforces this by calling it a "unique neurodiagnostic device."
No
The device description explicitly states it is an "electronic unit" that emits "transcutaneous electrical stimuli through a pair of special noninvasive electrodes." This indicates the device includes hardware components beyond just software.
Based on the provided information, the NM-01/CPT neurometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- NM-01/CPT Neurometer Function: The description clearly states that the NM-01/CPT neurometer is a noninvasive electrodiagnostic device. It applies electrical stimuli to the skin surface and measures the patient's perception of sensation. This is a test performed on the body (in vivo), not on a specimen taken from the body.
Therefore, the NM-01/CPT neurometer falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JXE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
any cutaneous site including mucosal surfaces such as the bladder
Indicated Patient Age Range
adult patients
Intended User / Care Setting
The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of 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, sample size, AUC, MRMC, standalone performance, key results)
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%; 11%) 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%; 11%), and the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
§ 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).
0
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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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
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.
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.
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) | |
|---|---|---|
| ---------------------------- | -- | --------------------- |
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.
5
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))
| | Substantially
equivalent? | 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 automated
neuroselective sensory Nerve
Conduction Threshold
(sNCT) evaluations by determining
Current Perception Threshold
(CPT) measures | Performs automated
neuroselective sensory Nerve
Conduction Threshold
(sNCT) evaluations by determining
Current Perception Threshold
(CPT) measures | Device for stimulate and
measure neuromuscular
that are useful in signals
that are useful in
diagnosing and evaluating
systemic and entrapment
neuropathies. | 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 by
electronical measurement | No |
| Stimulus Type | Yes | Sinusoid | Sinusoid | Dual phase, rectangular
wave | 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 displacement
detection built in testing protocol
for the checking the patient cable
damages | NA | No |
| Controlling the device | Yes | Manual control by buttons of the
device | Software based controlling the
device that could run on different
operating system (Win, los,
Android) | Software based controlling
the device that could run
on different operating
system (Win) | Yes |
| Nerves Tested | Yes | small unmylenated (C), small
myelinated (Aδ) and large
myelinated (Aβ) sensory nerve
fibers | small unmylenated (C), small
myelinated (Aδ) and large
myelinated (Aβ) sensory nerve
fibers | Median and ulnar nerves | No |
| Normative values | Yes | Normative values established for
more
than 30 multiple testing sites | Normative values included to the
software evaluation for more than
30 multiple testing sites | NA | No |
| Assessment time | Yes | 10 - 20 minutes depending on the
number of the analyzed arrea | 10 - 18 minutes depending on the
number of the analyzed arrea | 15 minutes | Yes |
| Access to test data adjustment | Yes | Using the device remote to export
the stored measurement values
from memory | Cursor placing adjustment | Cursor placing adjustment | Yes |
| Patient Data Handling and Storage | Neurometer does
not have patient
handling system. | The device has a built in memory
for saving the measured CPT
values, data could be saved to a
disk for export but it does not
have patient management
systemvsince it is an analog device | On the software included part of
the system. All patient and test
data could be stored on the device. | On the software included
part of the system. All
patient and test data could
be stored on the device. | Yes |
| Operator Skill Requirements | Yes | Trained technician supervised by a
physician or a physician | Trained technician supervised by a
physician or a physician | Trained technician
supervised by a physician
or a physician | Yes |
| Interpretation of the Test Results | Yes | Physician or specialist locally | Physician or specialist locally | Physician or specialist
locally | Yes |
| Examination areas | Yes | Examination of all skin/mucous
membrane areas | Examination of all skin areas | forarm and foot | Yes |
| Alternative measurement protocols | Yes | Suitable to measure a patient's
Pain Tolerance Threshold (PTT) | Suitable to measure a patient's
Pain Tolerance Threshold (PTT) | NA | No |
| Regulations | NM CPT is under
FDA Approval | FDA and CE mark | CE - marked | FDA and CE mark | Yes |
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