(174 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of the electrode in an MRI environment. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as being for recording neurological activity (EEG, EP), not for providing therapy.
Yes
Explanation: The device is intended for use in "recording the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording," which are diagnostic procedures used to assess neurological activity.
No
The device description clearly outlines physical components including a disk-shaped electrode, micro needles, and leadwires. The performance studies also describe physical testing and simulations related to the hardware's interaction with the MRI environment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for recording the Electroencephalogram (EEG) and evoked potential (EP), and as a ground and reference for these recordings. These are procedures that measure electrical activity within the body, not tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is an electrode designed to be placed on the skin to pick up electrical signals. This is consistent with in-vivo (within the living body) measurement, not in-vitro (in glass, or outside the body) testing.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological samples, which are hallmarks of IVD devices.
Therefore, the MR Conditional PressOn™ Electrode is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MR Conditional PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is provided sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.
Product codes
GXZ
Device Description
The design of the Rhythmlink Disposable MR Conditional PressOn electrode is identical to the existing PressOn electrodes used to record neurological activity during electroencephalograph (EEG) and evoked potential (EP) procedures.
The device consists of a disk shaped electrode with three sets of flat tyne or micro needles made from Nitinol. The Electrode is permanently attached to a leadwire which is 10cm (100mm) in length. An accessory cable is supplied to attach to the 10cm electrode leadwire to create a 1.0, 1.5, 2.0 or 2.5 meter traditional lengths during the Monitoring procedure. This accessory cable is labeled "MR Unsafe" and is NOT intended to be in the MR environment at any time. A significantly shorter lead wire of 10cm is permanently attached to the electrode and reduces the effects of matching the electrode leadwire length to the wave length of the RF component. This condition reduces the probability of matching the RF wave length to the leadwire length and reduces the likely hood of an increase in the heating effect. This will enable users to leave the electrodes in place during magnetic resonance imaging (MRI) procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Tests:
- Study type: Bench testing
- Sample size: Not specified
- Key results: "Pull Tests of the leadwire to the electrodes' connection." and "Resistance testing of the completed assembly". "Bench Testing did not raise any additional questions of safety and efficacy."
Clinical Tests:
- Study type: Simulation testing (Phase one) and physical MRI testing (Phase two)
- Sample size: Not specified, three different electrode types (Cup, WEBB, PressOn™ Electrode) were simulated.
- Key results: "The simulation testing showed the PressOn™ electrode to be the worst case configuration of the three types." "The second phase was to perform actual MRI physical testing for real world application. The physical testing also included Torque and Artifact testing and measuring." "Our test results were then compared to the IEC 60601-1-1 §11.1.2 - Temperature for Applied Parts, stated that the maximum temperature is not to exceed 43C° at any time. The temperatures in both the simulations and the real time tests only indicated a raise of 0.4C° at the area the electrodes are attached to the skin as measured directly under the electrode."
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
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
5. Traditional 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR§807.92(a).
| 807.92(a)(1)
Submitter Information: | Rhythmlink International, LLC
1140 First Street South
Columbia, SC 29209
Phone: 803-252-1222
FDA Registration #: 1067162
Owner Operator #: 9052354 |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | James M. Mewborne
Manager of Regulatory Affairs
Rhythmlink International, LLC
1140 First Street South
Columbia, SC 29209
Phone: 803-252-1222 ext. 101
Email: jmewborne@rhythmlink.com |
| Summary Date: | January 22, 2013 |
| 807.92(a)(2)
Device Identification: | Proprietary Device Name:
MR Conditional PressOn™ Electrode
(Trade name has not been finalized at this time)
Generic Device Name: MR Conditional PressOn Electrode
Regulatory Class: Class II
Classification Name: 21 CFR §882.1350, Neurological Electrode
Product Code: GXZ |
| 807.92(a)(3)
Predicate Device(s): | K103103
Persyst PressOn™ Electrodes
K121347
Rhythmlink PressOn™ Electrode |
| 807.92 (a)(4)
Device Description: | The design of the Rhythmlink Disposable MR Conditional PressOn
electrode is identical to the existing PressOn electrodes used to record
neurological activity during electroencephalograph (EEG) and evoked
potential (EP) procedures.
The device consists of a disk shaped electrode with three sets of flat tyne
or micro needles made from Nitinol. The Electrode is permanently
attached to a leadwire which is 10cm (100mm) in length. An accessory
cable is supplied to attach to the 10cm electrode leadwire to create a 1.0,
1.5, 2.0 or 2.5 meter traditional lengths during the Monitoring procedure.
This accessory cable is labeled "MR Unsafe" and is NOT intended to be in
the MR environment at any time. A significantly shorter lead wire of
10cm is permanently attached to the electrode and reduces the effects of
matching the electrode leadwire length to the wave length of the RF
component. This condition reduces the probability of matching the RF
wave length to the leadwire length and reduces the likely hood of an
increase in the heating effect. This will enable users to leave the
electrodes in place during magnetic resonance imaging (MRI) procedures. |
| 807.92(a)(5)
Intended Use /
Indications for Use: | The MR Conditional PressOn™ Electrode is intended for use in the
recording of the Electroencephalogram (EEG), the evoked potential
(EP), or as a ground and reference in an EEG or EP recording. This
device is provided sterile for Single Patient Use Only and may
remain on the patient in a MRI environment under specific
conditions. |
| 807.92(a)(6)
Technological
Characteristics | The main source of heating within the magnetic resonant imaging comes
from the matching of the RF (radio frequency) wave length to the length
of the electrode's leadwire. The reduction of the proposed device's
leadwire length permanently attached to the electrode is the only
physical change from the predicate device. This reduction in the cable
length is to reduce the likely hood of heating effect from the RF
component. The other issue is the torque produced by the magnetic field
in the MR environment. The materials used in the PressOn EEG Electrode
are minimally affected by the magnetic field and the reduced lead length
has shown a minimal heating effect from the radio frequency "E" field.
The manufacturing processes, materials and the sterility process are
identical to the predicate device {K121347 and K103103}, the Persyst
PressOn Electrodes. |
| 807.92(b)(1) | In summary even though the manufacturing processes are identical to |
| Summary of Non-Clinical Tests | validate no changes had occurred and the performance remained the
same as the predicate devices.. There have been no design changes to th
MR Conditional PressOn Electrodes other than the length of the leadwire
permanently connected to the electrode. These tests consisted of the
following tests;
➤ Pull Tests of the leadwire to the electrodes' connection.
➤ Resistance testing of the completed assembly
Bench Testing did not raise any additional questions of safety and
efficacy. |
| 807.92(b)(2)
Clinical Tests | In summary the clinical testing was conducted in two phases. Phase one
was to determine which electrode and modality would be the worst case
configuration. This was completed by using the SIMCAD X validated
software with FDTD (Finite-Difference Time-Domain) modeling. The
simulation plan consisted of three different electrode types;
➤ Cup Electrodes
➤ WEBB Electrodes
➤ PressOn™ Electrode
The simulation testing showed the PressOn™ electrode to be the worst
case configuration of the three types. All the simulation data was taken
and then compared to the actual MRI testing using the same field
strengths of 1.5T and 3.0T and 68 MHZ and 128MHZ respectfully. The
second phase was to perform actual MRI physical testing for real world
application. The physical testing also included Torque and Artifact testing
and measuring. |
| 807.92(b)(3)
Clinical Summary | Once both the bench testing and simulation testing were completed the
MR Conditional PressOn electrodes were subjected to real time MRI
testing. These physical testing was completed using the known worst
case configuration from the three types. (Cups, WEBBs and PressOn) The
PressOn Electrode was found to be the worst case electrode.
The bench testing confirmed that the materials used and the current
manufacturing processes being used are the same and did not raise any
additional questions of safety or efficacy.
The simulation testing and the real time MRI testing were shown to be
the same. Our test results were then compared to the IEC 60601-1-1
§11.1.2 - Temperature for Applied Parts, stated that the maximum
temperature is not to exceed 43C° at any time. The temperatures in both
the simulations and the real time tests only indicated a raise of 0.4C° at
the area the electrodes are attached to the skin as measured directly
under the electrode. The simulation indicated that the "Z" axis with two |
JUL 2 2 2 2013
200
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| and temperature. Additional simulations and testing were completed to show the results of the complete leadwire (10cm) within the E filed. |
|---|
| In summary all testing indicated that the proposed MR Conditional PressOn Electrodes performed as expected and did not raise any |
| additional questions of safety or efficacy. |
. .
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4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
July 22, 2013
Rhythmlink International, LLC c/o Mr. James M. Mewborne 1140 First Street, South Columbia, SC 29209
Re: K130220
Trade/Device Name: MR Conditional PressOn Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: June 3, 2013 Received: June 5, 2013
Dear Mr. Mewborne
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
5
Page 2 - Mr. James M. Mewborne
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
hup://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
hup://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: MR Conditional PressOn™ Electrode
Indications For Use:
The MR Conditional PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is provided sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Victor Krauthamer -S 2013.07.22 15:58:30 -04'00'
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K130220
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