(205 days)
Not Found
No
The summary describes a standard nerve conduction study device and software for data storage and handling. There is no mention of AI/ML in the device description, intended use, or performance studies. The studies focus on agreement with traditional NCS methods, not on validating an AI/ML algorithm.
No.
The device is used for measurement and evaluation of nerve function, which aids in diagnosis. It does not treat a condition.
Yes
The device measures sensory and motor peripheral nerves to evaluate patients suspected of having focal neuropathies, and the data is reviewed and interpreted by a physician, indicating its role in diagnosis.
No
The device description explicitly states it is a "hand-held NCS Device to stimulate and record the nerve responses from patient" and includes hardware components like cables, a charger, a docking station, and a test module. While it uses software for communication and data handling, it is not solely software.
Based on the provided information, the Mediracer NCS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a patient's health.
- Mediracer NCS Function: The Mediracer NCS directly measures electrical signals from the patient's peripheral nerves. It does not analyze samples taken from the body.
- Intended Use: The intended use describes measuring nerve responses in vivo (within the living body) to evaluate focal neuropathies.
Therefore, the Mediracer NCS falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The Mediracer NCS is intended to measure sensory and motor neripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.
Product codes (comma separated list FDA assigned to the subject device)
JXE
Device Description
The Mediracer NCS is intended to measure sensory and motor nerve conduction from peripheral nerves, when there is reason to suspect nerve damage. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. Current application allows examination of Carpal Tunnel Syndrome related median nerve entrapment and ulnar nerve entrapment at the elbow. Test results can be used to determine if the findings are abnormal and in CTS, grade the severity of the nerve entrapment.
The Mediracer NCS is a hand-held NCS Device to stimulate and record the nerve responses from patient. The NCS Device is connected to the disposable surface electrodes with cables provided with the NCS Device. The NCS Device communicates via Bluetooth with a computer which is using The Mediracer Analysis Center (MAC) software. The computer uses the MAC software to store and handle the patient measurement data. With the NCS Device comes a charger and a docking station for charging the NCS Device. Also, solution includes a test module for checking the functionality of the whole test system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Peripheral nerves, median nerve, ulnar nerve
Indicated Patient Age Range
Finnish multicenter study: 17-85 years
Finnish study control volunteers: 16-80 years
Intended User / Care Setting
Mediracer NCS is used by physician or by technician on the order of physician for measuring sensory or motor nerve conductions from distal nerves.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Bench-testing:
Performed to seven people, which six was within the measurement criteria set before testing. The six results taken into account with proper placement show significantly similar nerve response action potential values. The source was human subjects. The comparison was against a conventional EMG device.
Clinical Studies:
Two separate studies; one in Finland and the other in the United Kingdom. All subjects examined had AANEM 2002 recommended set of traditional nerve conduction studies (NCS) and measurement with the Mediracer NCS done.
Finnish multicenter study:
- Sample Size: 194 recruited patients and 95 healthy control volunteers.
- Data Source: Patients and healthy volunteers
- Annotation Protocol: Participants went through a clinical examination, Mediracer NCS measurement and the traditional NCS.
- Exclusion criteria: prior surgery for CTS (the measured hand), neurological disorder that may produce numbness or paraesthesias in hand and those with diagnosed diabetes mellitus.
United Kingdom study:
- Sample Size: 63 patients.
- Data Source: Patients recruited from the normal referral stream to Leicester Carpal Tunnel Service.
- Annotation Protocol: Participants went through clinical assessment, Mediracer NCS measurement and the traditional NCS.
- Exclusion criteria: None specified beyond the selection from referral stream.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing:
- Study type: In vitro testing of Electrode conductive hydrogel.
- Sample size: Not specified.
- Key results: Assessed according to International Organization of Standardization 10993-1. Passed Cytotoxicity, Irritation, and Sensitization tests.
Electrical safety and electromagnetic compatibility (EMC):
- Study type: Bench testing.
- Sample size: Mediracer NCS device, patient stimulator, stimulation cable and recording cable.
- Key results: Complies with IEC 60601-1, IEC 60601-2-40 standards for safety and EN 60601-1-21 standard for EMC.
Software Verification and Validation Testing:
- Study type: Documentation review as recommended by FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Sample size: Not applicable.
- Key results: Software was considered "Moderate" level of concern.
Performance testing (Bench-testing):
- Study type: Bench-testing comparing Mediracer NCS to a conventional EMG device.
- Sample size: Seven people, with six results used.
- Key results: Mediracer NCS device results compared to conventional EMG device were matching inside the given deviation, demonstrating equivalence and accurate readings.
Clinical Studies:
- Study type: Comparison against traditional nerve conduction test devices in two separate studies (Finland and UK).
- Sample size: Finnish study: 194 patients and 95 healthy control volunteers. UK study: 63 patients.
- Key results:
- Positive per cent agreement between the traditional and the Mediracer NCS devices was around 90 %.
- Negative per cent agreement was 99-100 %.
- The new device study missed abnormalities mainly in cases with very mild conduction slowing and due to technical or biological causes.
- High concordance between the used latency difference parameters between the traditional and the new device study were obtained.
- These parameters were not dependent on skin temperature.
- The method is non-invasive and safe, no adverse effects or complications were reported.
- Mediracer NCS measurement device seems to reliably detect the median nerve lesion in CTS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive per cent agreement: around 90 %
Negative per cent agreement: 99-100 %
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.
NeuroMetrix ADVANCE K070109
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Mediracer Ov Lassi Laitinen Product Specialist R&D Rantakatu 4 Oulu, 90100 FI
Re: K190536
Trade/Device Name: Mediracer NCS Regulation Number: 21 CFR 882.1550 Regulation Name: Nerve Conduction Velocity Measurement Device Regulatory Class: Class II Product Code: JXE Dated: August 26, 2019 Received: August 30, 2019
Dear Lassi Laitinen:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 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-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,
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
510(k) Number (if known) K190536
Device Name Mediracer NCS
Indications for Use (Describe)
The Mediracer NCS is intended to measure sensory and motor neripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.
| 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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Image /page/3/Picture/0 description: The image is a logo for a company called "mediracer". The logo consists of a pink abstract shape on the left, followed by the word "mediracer" in black and gray letters. Below the word "mediracer" is the phrase "POINT OF CARE DIAGNOSTIC TESTING" in smaller, gray letters. The logo is simple and modern, and the colors are eye-catching.
510(K) SUMMARY
| Submission type: | Traditional 510(k) |
|---|---|
| Basis for submission: | New device introduced |
| Submitter information | |
| Sponsor: | Mediracer Oy (Ltd.) |
| Address: | Rantakatu 4 |
| 90100 Oulu | |
| Finland | |
| Contact person: | Georg Meissner, CEO |
| Phone: | +358 40 517 0182 |
| Submission date: | 19/09/2019 |
Device information
| Trade name: | Mediracer NCS |
|---|---|
| Common name: | Nerve Conduction Testing System |
| Classification name: | Nerve Conduction Study Measuring |
| Device Class: | Device Class II (21 CFR 882.1550) |
| Product Code: | JXE |
| Predicate device: | |
| NeuroMetrix ADVANCE | K070109 |
1 Device Description
The Mediracer NCS is intended to measure sensory and motor nerve conduction from peripheral nerves, when there is reason to suspect nerve damage. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. Current application allows examination of Carpal Tunnel Syndrome related median nerve entrapment and ulnar nerve entrapment at the elbow. Test results can be used to determine if the findings are abnormal and in CTS, grade the severity of the nerve entrapment.
The Mediracer NCS is a hand-held NCS Device to stimulate and record the nerve responses from patient. The NCS Device is connected to the disposable surface electrodes with cables provided with the NCS Device. The NCS Device communicates via Bluetooth with a computer which is using The Mediracer Analysis Center (MAC) software. The computer
4
uses the MAC software to store and handle the patient measurement data. With the NCS Device comes a charger and a docking station for charging the NCS Device. Also, solution includes a test module for checking the functionality of the whole test system.
Mediracer NCS is used by physician or by technician on the order of physician for measuring sensory or motor nerve conductions from distal nerves. The measured data is transferred during the measurement to a computer via Bluetooth connection. The data measured is reviewed and interpreted by a specially trained physician or specialist in neurophysiology.
2 Intended Use
The Mediracer NCS is intended to measure sensory and motor nerve conduction from peripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.
3 Comparison of technological characteristics with the predicate device
Mediracer NCS which is the subject of this Premarket Notification is substantially equivalent in sensory nerve conduction studies to the predicate device. NeuroMetrix ADVANCE. All the other functions of the predicate device are ignored in the comparison. Neuromuscular signal measurement is the technological principle for both the subject and predicate devices. It is based on stimulating the nerve with electric stimulus on skin above the nerve and the activated nerve response is measured on skin from the same nerve at some distance of the stimulus.
Difference between the devices are mainly in the design and the technological specifications due to the design. None of the different features of Mediracer NCS compared to predicate device have altered the basic performance, operation or intended use. At high level, the subject and predicate devices are based on the following same technological elements:
- stimulating and recording electrodes
- stimulation and recording cables
- hand-held, point-of-care, device that performs the measurement
- . Bluetooth for data transfer
The following technological differences exist between the subject and predicate devices:
- Electrodes differ in design and placement. ●
- The cables differ in design, the predicate uses the Proximal adapter in which the stimulation cable and recording cable are connected whereas the subject device has two separate cables which are connected straight to the device.
- . Hand-held device differs from the display of data, the predicate uses touch screen for display of data whereas the subject device uses small LCD screen.
- . The subject device must be used in conjunction with the Mediracer Analysis Center (MAC) whereas predicate device can be used without any external software.
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Table 1. Device Comparison
| Advance NCS | Mediracer NCS | |
|---|---|---|
| Intended use | Device for measuring | |
| neuromuscular signals that | ||
| are useful as an aid in | ||
| diagnosing and evaluating | ||
| patients suspected of | ||
| having focal or systemic | ||
| neuropathies. | Device for stimulate and | |
| measure neuromuscular | ||
| signals that are useful in | ||
| diagnosing and evaluating | ||
| systemic and entrapment | ||
| neuropathies. | ||
| Power supply | High Capacity Lithium Ion | |
| Battery | Battery: Nickel Metal | |
| Hybrid NiHM battery 6V, | ||
| 730 mAh | ||
| Common Mode Rejection | ||
| Ratio | 90 dB min | 95...100 dB at 1 kHz |
| Noise | 4 The European version (60601-1-2:2015) of the standard and the IEC-version (60601-1-2:2014) are equivalent to each other. In the European version the differences to its IEC counterpart are the exception of references of the 61000-4-x series and the addition of an Essential Requirements annex. The technical content of the IEC version is identical to the EN version. |
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Performance testing
Performance testing as a bench-testing, was conducted to the subject device to show equivalence to a previously approved device and to verify Mediracer NCS device accuracy. The performed test was same for both devices and the testing was performed by a trained operator.
The testing was performed to seven people, which six was within the measurement criteria set before testing. The six results taken into account with proper placement show significantly similar nerve response action potential values. The results show that the Mediracer NCS device results compared to conventional EMG device were matching inside the given deviation. Based on this comparison test it can be said that Mediracer NCS device is equivalent to a conventional EMG device and shows accurate readings.
Clinical Studies
The clinical validation was made against traditional nerve conduction test devices in two separate studies; one in Finland and the other in the United Kingdom. All the subjects examined in these tests had AANEM 2002 recommended set of traditional nerve conduction studies (NCS) and measurement with the Mediracer NCS done.
In the Finnish multicenter study, there were 194 recruited patients and 95 healthy control volunteers tested. The participants went through a clinical examination, Mediracer NCS measurement and the traditional NCS. In the United Kingdom study, the devices were compared only in the patient population, total of 63 patients participated in the study. The participants went through clinical assessment, Mediracer NCS measurement and the traditional NCS.
In the Finnish multicenter study, the number of patients studied were 194, aged 17-85. mean 49 years. Of these patients 147 (75.77 %) were female. Exclusion criteria for the study were prior surgery for CTS (the measured hand), neurological disorder that may produce numbness or paraesthesias in hand and those with diagnosed diabetes mellitus. For the study control values of 95 healthy volunteers aged from 16-80, mean 41 years, were examined. Of these volunteers 52 (54.73 %) were female. In the United Kingdom the patients were recruited from the normal referral stream to Leicester Carpal Tunnel Service, total of 104 referrals were selected and invited to a clinical study. No other exclusion criteria. Of the invited patients 65 fulfilled the clinical CTS diagnosis after symptom inquiry and clinical assessment. On the day of the study two participants cancelled their involvement, thus the total participation number were 63 patients. Of these patients 47 (74.60 %) were female.
Safety and effectiveness
In both studies positive per cent agreement between the traditional and the Mediracer NCS devices was around 90 % and negative per cent agreement 99-100 %. The new device study missed abnormalities mainly in cases with very mild conduction slowing and due to technical (one broken cable) or biological causes (patient was unable to relax). A high concordance between the used latency difference parameters between the traditional and the new device study were obtained. Moreover, these parameters were not dependent on skin temperature as absolute conduction velocities clearly are. The method is non-invasive and is safe to preform for the patients, no adverse effects or complications were reported during these studies.
Summary
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Based on the two studies performed, the Mediracer NCS measurement device seems to reliably detect the median nerve lesion in CTS. In the studies were found high degree of agreement between the systems compared, the new and traditional methods of NCS testing.
5 Conclusions
The non-clinical data support the safety of the device and the Mediracer NCS and MAC software verification and validation demonstrate that the Mediracer NCS device should perform as intended in the normal use conditions. The clinical data and bench-testing demonstrates that nerve conduction measurements obtained using the Mediracer NCS are comparable to those obtained using conventional nerve conduction measurement equipment.