(193 days)
Not Found
No
The summary explicitly states that the device "only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals". Furthermore, there is no mention of AI, ML, or related concepts in the device description or performance studies.
No
The device is described as acquiring, recording, transmitting, and displaying physiological signals; it does not claim to treat or provide therapy.
No
The device acquires, records, transmits, and displays physiological signals but explicitly states "no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability." This indicates it is a data acquisition and display system, not a device that provides a diagnosis or diagnostic analysis of the signals.
No
The device description explicitly states that the X-trodes System M "combines hardware, firmware, and software" and includes a "data acquisition unit connected to electrode arrays patches." This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the X-trodes System M is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The X-trodes System M acquires physiological signals directly from the patient's body (EEG, EOG, ECG, EMG, accelerometer, gyroscope). It does not analyze samples like blood, urine, or tissue.
- The intended use is to acquire, record, transmit, and display physiological signals. This is a function of a physiological monitoring device, not an IVD.
- No claims are made for analysis of the acquired signals with respect to accuracy, precision, and reliability. IVDs are typically used to provide diagnostic information based on the analysis of specimens. The X-trodes System M explicitly states it only acquires and displays signals.
- The device description focuses on acquiring and transmitting physiological data. It mentions converting the data to a format suitable for analysis by third-party software, but the device itself is not performing the diagnostic analysis.
In summary, the X-trodes System M is a device for physiological signal acquisition and monitoring, not for the in vitro examination of specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
The X-trodes System M is intended for prescription use only in the home or healthcare facility to acquire, record, transmit and display physiological signals from adult patients. The X-trodes System M acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer and gyroscope signals. The X-trodes System M only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.
Product codes (comma separated list FDA assigned to the subject device)
GWL, GXY, DPS, IKN
Device Description
The X-trodes System M combines hardware, firmware, and software to acquire the following physiological signals: physiologic signal amplifier (EEG), electrooculography (EOG), surface electromyography (sEMG), electrocardiography (ECG), and accelerometer and gyroscope signals. It acquires physiological data through a data acquisition unit connected to electrode arrays patches, applied by a technician or patient to the patient. The data is recorded and transmitted to a cloud where it is converted to an EDF (European Data Format) format, suitable for analysis by third party software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead/head (for EEG), undefined for EOG, ECG, EMG.
Indicated Patient Age Range
adult patients.
Intended User / Care Setting
prescription use only in the home or healthcare facility
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
X-trodes conducted a case-controlled study of 55 subjects who wore the subject and reference devices (X8) simultaneously. The test duration was approximately 20 minutes and was conducted in a clinic environment. There was a one minute preliminary screening evaluation to determine that electrode conductivity was established and then four minutes of data collection for each modality. Study subjects were adults who had been referred by either a neurologist for an electrophysiology test in the last 5 years.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
X-trodes conducted a case-controlled study of 55 subjects. The primary study endpoint was the proportion of interpretable readings of each ExG signal by the XTR that are equivalent to those of the reference device. The agreement proportion for the ECG was 89.36%, for the EEG 97.37%, for the EMG 96.15% and for the EOG 95.24%. All lower 98.75% confidence intervals are higher than 60%. Taking into consideration the high agreement proportions per signal modality and the high CI, it can be concluded that the primary end point was met successfully. For the secondary end point, each modality, the characteristic signal was quantified, and the RMS values were obtained by comparing the signals captured by the X-trodes and X8 devices. The results demonstrate the consistency and reliability of the measurements obtained from the devices and provide an indication of the level of agreement between them. The comparison between the X-trodes XTR and the predicate device demonstrates that the XTR satisfied the pre-specified performance criteria and thus can be found substantially equivalent to the X8 sleep profiler PSG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement proportion: ECG 89.36%, EEG 97.37%, EMG 96.15%, EOG 95.24%. All lower 98.75% confidence intervals are higher than 60%.
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
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
0
February 4, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety.
X-Trodes % Donna-Bea Tillman Senior Consultant Biologics Consulting Group 100 Daingerfield Rd, Suite 400 Alexandria, VA 22314
Re: K232210
Trade/Device Name: X-trodes System M Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GXY, DPS, IKN Dated: January 4, 2024 Received: January 4, 2024
Dear Donna-Bea Tillman:
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 (the 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 (QS) 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.
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 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,
Patrick Antkowiak -S for Jay Gupta Assistant Director
2
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
510(k) Number (if known) K232210/S001
Device Name X-trodes System M
Indications for Use (Describe)
The X-trodes System M is intended for prescription use only in the home or healthcare facility to acquire, record, transmit and display physiological signals from adult patients. The X-trodes System M acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer and gyroscope signals. The X-trodes System M only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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1. SUBMITTER INFORMATION
| Applicant: | X-trodes |
|---|---|
| Contact: | Ziv Peremen, Ph.D |
| Phone: | +972 54 2244811 |
| Email: | Ziv@xtrodes.com |
| Address | 4 Maskit St. |
| Herzliya, Israel |
2. CORRESPONDENT INFORMATION
| Contact: | Donna-Bea Tillman, Ph.D. |
|---|---|
| Title: | Senior Consultant |
| Firm: | Biologics Consulting Group |
3. -DATE PREPARED: FEBRUARY 2, 2024
4. DEVICE INFORMATION
| Device Name: | X-trodes System M |
|---|---|
| Common Name: | Reduced-Montage Standard |
| Electroencephalograph | |
| Regulation Number: | 21 CFR 882.1835 |
| Regulation Name: | Physiological signal amplifier |
|---|---|
| Primary Product Code: | GWL |
| Secondary Product: | |
| Codes | GXY, DPS, IKN |
| Regulatory Class: | Class II |
5. PREDICATE DEVICE INFORMATION
| Primary EEG/EOG Predicate Device Name: | Quick-20m |
|---|---|
| 510(k) Number: | K203331 |
| Manufacturer: | CGX, LLC |
5
| ECG Predicate Device Name: | Electrocardiograph (SE-1200 Pro, SE-1201 Pro) |
|---|---|
| 510(k) Number: | K222902 |
| Manufacturer: | Edan Instruments, Inc. |
| EMG Predicate Device Name: | Focus EMG |
| 510(k) Number: | K102610 |
| Manufacturer: | TeleEMG, LLC |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION 6.
The X-trodes System M combines hardware, firmware, and software to acquire the following physiological signals: physiologic signal amplifier (EEG), electrooculography (EOG), surface electromyography (sEMG), electrocardiography (ECG), and accelerometer and gyroscope signals. It acquires physiological data through a data acquisition unit connected to electrode arrays patches, applied by a technician or patient to the patient. The data is recorded and transmitted to a cloud where it is converted to an EDF (European Data Format) format, suitable for analysis by third party software.
7. INDICATIONS FOR USE
The X-trodes System M is intended for prescription use only in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X-trodes System M acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer and gyroscope signals. The X-trodes system M only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL 8. CHARACTERISTICS WITH THE PREDICATE DEVICE
The table below compares the intended use and the technological characteristics of the subject device and predicate device.
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| | Subject Device | Primary Predicate
EEG/EOG | Predicate ECG | Predicate EMG | Comments |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K232210 | K203331 | K222902 | K102610 | |
| Applicant | Xtrodes Ltd. | CGX, LLC | Edan Instruments, Inc. | TeleEMG, LLC | |
| Device Name | X-trodes System M | Quick-20m | Electrocardiograph (SE-
1200 Pro, SE-1201 Pro) | Focus EMG | |
| Classification
Regulation | 21 CFR 882.1835
Physiological signal | 21 CFR 882.1835
Physiological signal | 21 CFR 870.2340
Electrocardiograph | 21 CFR 890.1375
Diagnostic | |
| | amplifier
21 CFR 882.1320
Cutaneous Electrode
21 CFR 870.2340
Electrocardiograph
21 CFR 890.1375
Diagnostic
Electromyograph | amplifier
21 CFR 882.1320
Cutaneous Electrode | | Electromyograph | |
| Product Code | GWL, GXY, DPS, IKN | GWL, GXY | DPS | IKN | |
| Intended Use | The X-trodes System M is
intended for prescription
use only in the home,
healthcare facility, or
clinical research
environment to acquire,
record, transmit and
display physiological
signals from adult patients.
The X-trodes System M
acquires, records,
transmits, and displays
electroencephalogram
(EEG), electrooculogram
(EOG), electrocardiogram
(ECG), and/or
electromyogram (EMG),
and accelerometer and
gyroscope signals. The X-
trodes System M only | The Quick-20m is
intended to be used to
acquire
electroencephalograph
(EEG) and transmit it
wirelessly to a computer. | The SE-1200 Pro&SE-
1201 Pro 12-lead
electrocardiographs are
intended to acquire ECG
signals from adult and
pediatric patients through
body surface ECG
electrodes. The
electrocardiographs are
only intended to be used
in hospitals or healthcare
facilities by doctors and
trained healthcare
professionals. The
cardiogram recorded by
the electrocardiograph can
help users to analyze and
diagnose heart disease.
However, the interpreted
ECG with measurements | The Focus is intended for
use by a healthcare
provider to perform nerve
conductions and EMG
studies as an aid in the
evaluation of patients
with diseases of muscle
and nerves. The machine
can also use electrical
stimulus or sound
stimulus for evoked
potentials (EP) studies. | |
| | Subject Device | Primary Predicate
EEG/EOG | Predicate ECG | Predicate EMG | Comments |
| | acquires and displays
physiological signals, no
claims are being made for
analysis of the acquired
signals with respect to the
accuracy, precision, and
reliability. | | and interpretive
statements is offered to
clinicians on an advisory
basis only. | | |
| Patient
Population | Adults | Adults | Adult and pediatric
patients | Adults | Same |
| Environment of
Use | Home, Healthcare
facility, | Home or healthcare
facility setting | Hospitals or healthcare
facilities | Clinical environment. | The subject device and the
primary predicate device are
intended for use in either
healthcare facility or home
settings |
| Signals Acquired | Forehead/head EEG, EOG,
EMG, ECG, Microphone,
Accelerometer, Gyroscope | EEG/EOG | ECG | EMG | The subject device is a
combination of the features
of the predicate devices |
| Full scale Input
Range | ± 12.5 mV | ± 300 mV | No information in the
predicate 510(k)
Summary | No information in the
predicate 510(k)
Summary | See Discussion item 1 |
| A/D conversion | 16 bits | 24 bits | 24 bits | 16 Bits | Same for EMG
See Discussion item 2 |
| Sampling
Frequency (Rate) | 4000 Hz/Channel | 500 Hz/channel | 64,000 Hz | 200-80000 Hz | See Discussion item 3 |
| Frequency
Response | 0.35 Hz ~ 700 Hz (-3 dB) | Linear between 0.1
and 100 Hz | 0.01 Hz ~ 350 Hz (-3 dB) | No information in the
predicate 510(k) | XTR frequency range
supersedes the predicates,
thus constitutes SE. |
| Input Impedance | ≥10 MΩ | >100 MOhm (125 Hz) | ≥100 MΩ(10 Hz) | ≥100 MOhm
95 dB at 60 Hz/50Hz | >90 dB at 60 Hz | ≥140 dB (AC filter on)
≥123 dB (AC filter off) | >100 dB | For EEG - Similar to
predicates
For ECG and EMG
See Discussion item 7 |
| Connection | Bluetooth Low Energy | Wireless to receiver, USB
to computer | WIFI, 4G, Bluetooth | USB to computer | Similar to predicates |
| Number Of
Possible
Electrodes | 16 | 20 Channels in
standard 10-20 head
map | 10 | 2 | Similar to predicates range.
Differ for each predicate for
the different
electrophysiological signal
application |
| Type of
Electrodes | Dry | Dry | Body surface ECG
electrodes | Stainless steel electrodes.
No additional information
is supplied in the
predicate 510(k) summary | Similar to the EEG/EOG
predicate.
FDA has found dry
electrodes to be
substantially equivalent to
gel electrodes. |
| Type Of Applied
Part | CF | BF | CF | No information in the
predicate 510(k) | Similar to predicates |
Table 1: Comparison of Technological Features
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9. PREDICATE DEVICE DISCUSSION ITEMS
1. Full Scale Input Range
A typical adult human EEG signal is about 10 µV to 100 µV in, so even if we consider 10-fold increase to this range (1mV), it is well covered within the X-trodes device's inputs range of 12.5 mV. Any input range larger than that is unnecessary.
For ECG, there is no information about the predicate device's input range. Therefore, we aim to establish that the X-trodes device has an input range suitable for ECG. "Normal ECG signals are time-varying signals with a small amplitude ranging from 10 µV to 5 mV" (cited from PubMed PMC7664289). The X-trodes device's input range of 12.5 mV is more than double this range.
For EMG, there is no information about the predicate device's input range. Therefore, we aim to establish that the X-trodes device has an input range suitable for EMG. "The amplitude range of EMG signal is 0-10 mV (+5 to -5) prior to amplification" (cited from PubMed PMC1455479). X-trodes device's input range of 12.5 mV is more than double this range.
Lastly, the results of the clinical study presented in Section 20 of the Original 510(k) submission demonstrate that the quality of the EEG/ECG/EOG/EMG waveforms is sufficient for clinical purposes. Taken together, these considerations are sufficient to demonstrate that the X-trodes device is substantially equivalent to the predicates in this aspect.
2. A/D conversion
For EEG, a typical adult human EEG signal is about 10 µV to 100 µV. If we consider 10fold this signal, it takes constitutes a portion of about 1000µV (1/300) of the predicate device's input range.
For ECG, there is no information about the predicate devices input range. However, based on the DC offset of the predicate device, we assume it to be 960mV, to cater for handling this DC offset. Since the X-Trodes device is AC coupled, it has no need to digitize all this vast DC range and ADC conversion is applied only on the AC signal.
A typical adult human ECG signal, which is about 5mV amplitude. It constitutes a portion of about 5mV/960mV (0.0166) of the assumed input range. This portion practically utilizes only 17 bits out of its 24-bit resolution, according to the following calculation:
Quantization step is 960,000μV/(2^24-1)= 0.057μV.
Digital representation of 5mV would be 5000uV/0.057μV=87,381 (binary 1 0101 0101 0101 0101) which is 17 bits.
FDA has also cleared many ECG devices that have a 16-bit resolution.
Lastly, the results of the clinical study presented in Section 20 of the Original 510(k) submission demonstrate that the quality of the EEG/ECG/EOG/EMG waveforms is sufficient for clinical purposes. Taken together, these considerations are sufficient to demonstrate that the X-trodes device is substantially equivalent to the predicates in this aspect.
3. Sampling frequency (Rate)
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Sampling rate should be considered in conjunction with the frequency response and should be at least 220% of the max sampled frequency to practically comply with Nyquist's law of digitation.
Therefore, the discussion should be whether the device has sufficient sampling rate to cover its frequency range. The X-Trodes device has a frequency range of 750Hz, which is broader than the predicate device's (350Hz). This frequency range can be accommodated by a sampling rate of 1.650Hz. Therefore, the X-Trodes device's sampling rate of 4KHz exceeds the required sampling rate and qualifies as substantially equivalent in this aspect.
In addition, the results of the clinical study presented in Section 20 of the Original 510(k) submission demonstrate that the quality of the EEG/ECG/EOG/EMG waveforms is sufficient for clinical purposes. Taken together, these considerations are sufficient to demonstrate that the Xtrodes device is substantially equivalent to the predicates in this aspect.
4. Input impedance
The input impedance of the X-Trodes device complies with clause 201.12.4.103 of the IEC60601-2-25 ECG standard which states that "The input impedance shall be at least 2,5 MS2 within a d.c. offset voltage range of ±300 mV".
In addition, FDA has cleared EEG devices such as the Digital NeuroPort Biopotential Signal Processing System(K202174) that also have an input impedance of ≥10 MΩ.
Lastly, the results of the clinical study presented in Section 20 of the Original 510(k) submission demonstrate that the quality of the EEG/ECG/EOG/EMG waveforms is sufficient for clinical purposes. Taken together, these considerations are sufficient to demonstrate that the X-trodes device is substantially equivalent to the predicates in this aspect.
5. DC offset
The X-Trodes device is AC coupled, thus its DC offset limits are derived from the OV/UV protection devices which are set at +3.0v and -1 V. This DC offset range is broader than the predicate's DC offset range, rendering the XTR system more tolerant to DC offset, thus the Xtrodes device is substantially equivalent in this aspect.
6. Noise
For ECG, the X-trodes device's noise is smaller than the predicate device's, thus constitutes substantial equivalence.
For EEG, the X-trodes device's noise is slightly higher than the predicate device, however it relates to only a portion of the EEG spectrum. Furthermore, the overall noise performance over the full EEG spectrum of the X-trodes device, complies with the IEC60601-2-26 EEG standard as shown in the Bench Test Report.
For EMG, the X-trodes device's noise is slightly higher than the predicate device's, however, it was demonstrated in the clinical trial that the measured EMG signal was of the required signal quality. Moreover, since there is no standard noise requirement for EMG, and since EMG signal's dynamic input range is similar to ECG, compliance with ECG noise standard can fulfill this requirement. The X-Trodes device complies with ECG noise requirement of 30 µ V peak-tovalley referred to the input (IEC60601-2-25). Therefore, the X-Trodes device is substantially equivalent in this aspect.
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7. CMRR
The X-Trodes device CMRR complies with the applicable provisions for both- IEC60601-2-26 EEG and IEC60601-2-25 ECG standards of CMRR > 90db, which constitutes adequate performance.
Conclusion
In conclusion, the subject X-trodes device has the same intended use as the proposed predicate devices, that is to acquire and display electrophysiological data. While there are technological differences, these differences do not raise different questions of safety and effectiveness, and therefore the predicate devices can serve as predicate devices for the X-trodes 510(k).
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10. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
Biocompatibility Testing
The only patient-contacting component of the X-trodes System M is the XTR Electrode patches. The Xtrodes System M is classified as a surface medical device, in contact with intact skin for less than 24 hours. The following biocompatibility testing was conducted:
- Sensitization, ISO 10993-10:2021
- Irritation, ISO 10993-23:2021
- Cytotoxicity, ISO 10993-5:2009
Electrical Safety
The following tests were conducted:
IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012, Medical electrical equipment: Part 1: General requirements for basic safety and essential performance, including US deviations
IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems
IEC 60601-2-25:2011, Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
ISO/IEC 80601-2-26:2019, Particular requirements for the basic safety and essential performance of electroencephalographs
IEC 60601-2-40:2016, Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Electromagnetic Compatibility (EMC)
The following tests were conducted:
AAMI TIR69:2017, Risk management of radio-frequency wireless coexistence for medical devices and systems
ANSI/IEEE C63.27:2017, Evaluation of Wireless Coexistence
IEC 60601-1-2:2014+A1:2020/Ed. 4.1, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests
Software
Software was evaluated for a moderate level of concern as recommended in the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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Performance Testing
Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:
IEC 60601-1-6:2020. Medical electrical equipment - Part I-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Human factors testing in accordance with the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices.
SUMMARY OF CLINICAL TESTING 11.
X-trodes conducted a study to evaluate the accuracy and consistency of the X-trodes System M compared to an FDA-cleared clinical electrophysiology device.
Methods: X-trodes conducted a case-controlled study of 55 subjects who wore the subject and reference devices (X8) simultaneously. The test duration was approximately 20 minutes and was conducted in a clinic environment. There was a one minute preliminary screening evaluation to determine that electrode conductivity was established and then four minutes of data collection for each modality. Study subjects were adults who had been referred by either a neurologist for an electrophysiology test in the last 5 years.
Results: The primary study endpoint was the proportion of interpretable readings of each ExG signal by the XTR that are equivalent to those of the reference device. The agreement proportion for the ECG was 89.36%, for the EEG 97.37%, for the EMG 96.15% and for the EOG 95.24%. All lower 98.75% confidence intervals are higher than 60%. Taking into consideration the high agreement proportions per signal modality and the high CI, it can be concluded that the primary end point was met successfully.
For the secondary end point, each modality, the characteristic signal was quantified, and the RMS values were obtained by comparing the signals captured by the X-trodes and X8 devices. The results demonstrate the consistency and reliability of the measurements obtained from the devices and provide an indication of the level of agreement between them.
Conclusions: The comparison between the X-trodes XTR and the predicate device demonstrates that the XTR satisfied the pre-specified performance criteria and thus can be found substantially equivalent to the X8 sleep profiler PSG.
12. CONCLUSION
The results of the performance testing described above demonstrate that the X-trodes System is as safe and effective as the predicate device and supports a determination of substantial equivalence.