(87 days)
No
The summary describes a simple electrical stimulator controlled by external software and hardware, with no mention of AI/ML capabilities for data analysis, parameter adjustment, or any other function.
No
The device is described as a stimulator used during electroencephalography for diagnostic and study purposes, not for treating a condition, which aligns with diagnostic rather than therapeutic use.
No
This device is a stimulator, and while it is used during examinations (stereoEEG) that can be related to the diagnosis/study of nervous system diseases, it itself applies stimulation rather than directly performing a diagnostic function by analyzing data to identify a condition or disease. It is an accessory to a signal acquisition system and software, which are likely involved in the diagnostic aspects.
No
The device description explicitly states it is a "low power, constant current, bi-phasic stimulator," which is a hardware component that delivers electrical stimulation. It also mentions being an "accessory" to a signal acquisition system and software, indicating it is a physical device that works in conjunction with software.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cortical stimulation during electroencephalography examinations (i.e. stereoEEG)". This is a therapeutic or diagnostic procedure performed directly on the patient, not an in vitro test performed on biological samples outside the body.
- Device Description: The description reiterates the purpose of stimulating the brain and recording potentials, again indicating a direct interaction with the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
Therefore, the SD LTM STIM is a medical device used for stimulation during neurological examinations, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).
The stimulation is applied to the brain using third-party stimulation cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.
The SD LTM STIM itself is an accessory to the SD LTM 64 EXPRESS Signal Acquisition System and SystemPlus EVOLUTION software. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from these devices. The SD LTM STIM can operate only when so connected and with the SystemPlus EVOLUTION software; it cannot serve as a stand-alone cortical stimulator.
Product codes (comma separated list FDA assigned to the subject device)
GYC
Device Description
The SD LTM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intraccanial electrodes) and the resulting cortical or deep brain potentials third-party cortical or intracranial electrodes. The use of these types of recordings can be related to the diagnosis/study of nervous system diseases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
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)
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
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.
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
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 18, 2018
MICROMED S.P.A. % John Ziobro Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, Wisconsin 53018
Re: K180761
Trade/Device Name: SD LTM STIM Cortical Stimulator Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: March 20, 2018 Received: March 23, 2018
Dear John Ziobro:
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 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180761
Device Name SD LTM STIM Cortical Stimulator
Indications for Use (Describe)
The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).
The stimulation is applied to the brain using third-party stimulation cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.
The SD LTM STIM itself is an accessory to the SD LTM 64 EXPRESS Signal Acquisition System and SystemPlus EVOLUTION software. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from these devices. The SD LTM STIM can operate only when so connected and with the SystemPlus EVOLUTION software; it cannot serve as a stand-alone cortical stimulator.
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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K180761 SD LTM STIM Cortical Stimulator
Traditional 510(k) Summary
| Submitter Information | |
|---|---|
| Company Name: | MICROMED S.P.A. |
| Via Giotto 2 | |
| Mogliano Veneto | |
| Treviso, ITALY 31021 | |
| Contact Person: | John F. Ziobrio, Principal Consultant |
| SpectraMedEx, LLC | |
| Address: | 49 E Chase St. Pensacola, FL 32502 |
| 3215 Golf Road, 149 | |
| Delafield, WI 53018 | |
| Telephone: | (262)719-8922 |
| Date Prepared: | June 1, 2018 |
| Subject Device | |
| Trade Name: | Model SD LTM STIM |
| Common or Usual Name: | Cortical Stimulator |
| Classification: | Class II, 21 CFR 882.1310, Cortical Electrode |
| Product Code: | GYC |
| Predicate Device | |
| Predicate: | K151354 Cervello Stim |
| 21 CFR 882.1310, GYC | |
| Device Description |
The SD LTM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intraccanial electrodes) and the resulting cortical or deep brain potentials third-party cortical or intracranial electrodes. The use of these types of recordings can be related to the diagnosis/study of nervous system diseases.
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Generally, the analysis of the recorded traces is perialist off-line, who combines the readings with information coming from other sources. As such, this analysis does not provide immediate information
Intended Use
The SD LTM is a low power, constant current, bi-phasic simulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).
The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.
The SD LTM STIM itself is an accessory to the SD LTM 64 EXPRESS Signal Acquisition System and SystemPlus EVOLUTION software. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from these devices. The SD LTM STIM can operate only when so connected; it cannot serve as a stand-alone cortical stimulator.
Comparison of Technological Characteristics with Predicate
| Feature | micromed S.p.A.
SD LTM STIM
K180761 | CERVELLO® STIM
K151354 | Comments |
|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of Technological Characteristics | | | |
| Picture | Image: SD LTM STIM | Image: CERVELLO® STIM | The subject device an updated version of the predicate and branded under
its own name. |
| Basic Function | Cortical stimulator that interfaces with an EEG system.
Cannot be used as a standalone device | Cortical stimulator that interfaces with an EEG system.
Cannot be used as a standalone device | Both devices have the same design and are intended to serve as a cortical
stimulator. |
| Switching Unit | Yes | Yes | Both devices are designed to function as separate switching units. |
| General
Description | The SD LTM STIM is a low power, constant current, bi-
phasic stimulator intended for cortical stimulation during
electroencephalography examinations (i.e. stereoEEG). | The Cervello® STIM is a low power, constant current, bi-
phasic stimulator intended for cortical stimulation during
electroencephalography examinations (i.e. stereoEEG). | Both devices are used during brain mapping procedures to determine the
functionality of the stimulated cortex and except for branding issues and
color issues (SD LTM STIM vs Cervello® STIM aka the SD LTM STIM)
are identical. |
| Product Code | GYC (cortical electrodes) | GYC (cortical electrodes) | Identical |
| Indication for
Use | The SD LTM STIM is a low power, constant current,
bi-phasic stimulator intended for cortical stimulation
during electroencephalography examinations (i.e.
stereoEEG). | The Cervello® STIM is a low power, constant current, bi-
phasic stimulator intended for cortical stimulation during
electroencephalography examinations (i.e. stereoEEG).
The stimulation is applied to the brain using third-party
stimulation probes (including cortical or intracranial | Identical |
| Feature | micromed S.p.A.
SD LTM STIM
K180761 | CERVELLO® STIM
K151354 | Comments |
| | The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.
The SD LTM STIM itself is an accessory to the SD LTM 64 EXPRESS Signal Acquisition System and SystemPlus EVOLUTION software. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from these devices. The SD LTM STIM can operate only when so connected; it cannot serve as a stand-alone cortical stimulator. | electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.
The Cervello® STIM itself is an accessory to the Cervello® Basic Biopotential Signal Acquisition System. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from it. The Cervello® STIM can operate only when so connected; it cannot serve as a stand-alone cortical stimulator. | |
| DEVICE CONFIGURATIONS & INTERFACE WITH OTHER DEVICES & COMPONENTS | | | |
| System-Level
Components
(Included) | Stimulator (STIM)
Cable (CB LTM) | Stimulator (STIM)
Cable (CB LTM) | Identical system components.
Identical |
| Additional
Components
Required for Use
of the Subject
Device
(supplied by the
applicable 510(k)
holder) | Image: SD LTM STIM | Image: CERVELLO STIM | The proposed SD LTM STIM devices requires/interfaces with the EEG system in an identical manner as the predicate. |
| | The SD LTM STIM operates with the model SD LTM 64 EXPRESS EEG Signal Acquisition System and Jackbox, shown with the SD LTM STIM sandwiched in between these two components. These components were included as part of the MORPHEUS system, cleared under K071782, and in the BRAIN QUICK system, cleared under K171384. | The CERVELLO® STIM operates with the CERVELLO® Amplifier and Jackbox, shown with the CERVELLO STIM sandwiched in between these two components. The CERVELLO® was cleared under K122196 citing the MORPHEUS K071782 as the predicate. | |
| Additional
Components
Required for
Use of the
Subject Device
(supplied by 3rd
parties) | The clinical use of the device requires the use of a bipolar probe and/or intracranial electrodes | The clinical use of the device requires the use of a bipolar probe and/or intracranial electrodes | Identical; Both devices require the use of third-party electrodes. |
| Feature | micromed S.p.A.
SD LTM STIM
K180761 | CERVELLO® STIM
K151354 | Comments |
| ELECTRICAL SPECIFICATIONS | | | |
| Power Source | External (From the SD LTM 64 EXPRESS Amplifier) or
from Three (3) batteries AAA ,1.5V | External (From the Cervello® Amplifier) or from
Three (3) batteries AAA ,1.5V | Identical |
| Stimulation
Output Method | Constant Current | Constant Current | Identical |
| Maximum
Stimulation
Charge | 20μC | 20μC | Identical |
| Current
Stimulation
Range | 0 to 15 mA (peak; up to 2KΩ load) in steps of 0.1 mA | 0 to 15 mA (peak; up to 2KΩ load) in steps of 0.1 mA | Identical |
| Stimulation
Frequency | Single pulse; continuous: from 0.1 Hz to 100 Hz in steps
of 0.1 Hz | Single pulse; continuous: from 0.1 Hz to 100 Hz in steps
of 0.1 Hz | Identical |
| Stimulation
Pulse Width
Duration | 50 µs to 1000 µs in steps of 1 µs
(Equivalent to 0.1 to 1.0 msec) | 50 µs to 1000 µs in steps of 1 µs
(Equivalent to 0.1 to 1.0 msec) | Identical |
| Stimulation
Train Length | User specified 1-15 seconds | User specified 1-15 seconds | Identical |
| Output Trigger | Trigger on single pulse for stimulation rate up to 20 Hz,
trigger on train start for higher stimulation rates | Trigger on single pulse for stimulation rate up to 20 Hz,
trigger on train start for higher stimulation rates | Identical |
| Pulse shape | Rectangular | Rectangular | Identical |
| Stimulation
Mode | Biphasic (with independently controllable main & reverse
phases) | Biphasic (with independently controllable main & reverse
phases) | Identical |
| Number of
Channels | 1 electrical stimulator, positive and negative electrode can
be switched to any of the 64 available output channels | 1 electrical stimulator, positive and negative electrode can
be switched to any of the 64 available output channels | Identical |
| MECHANICAL SPECIFICATIONS | | | |
| Dimensions | 9cm x 10cm x 4cm | 9cm x 10cm x 4cm | Identical |
| Weight | 263 gm | 263 gm | Identical |
| Material | Gray ABS type GRAFLUX2 (MZ Italia) plastic | White PVC (Boianoflon) plastic. | The proposed device uses gray ABS plastic to match the color of SD
LTM 64 EXPRESS EEG Signal Acquisition System and the JB LTM 64
Express Jackbox. The predicate device uses white PVC plastic. Neither
device is implanted, and only has momentary contact with skin of the
clinician, and not the patient. The material has been approved as alternate
component in MET safety certification. |
| | micromed S.p.A.
SD LTM STIM
K180761 | CERVELLO® STIM
K151354 | |
| Feature | USER INTERFACE SPECIFICATIONS | | Comments |
| Patient Contact /
Interface
Materials | The Stimulator does not contact the patient.
The third-party electrodes (strip, grid, depth and/or
stimulation probes) make patient contact | The Stimulator does not contact the patient.
The third-party electrodes (strip, grid, depth and/or
stimulation probes) make patient contact | Identical |
| User Input
Mechanism | • All settings are controlled by the acquisition system
software (stimulus parameters, electrode selection, device
status) via the acquisition amplifier, connected via cable
or Bluetooth® connection
• The device includes an electrode switching array
allowing quick change of the stimulated area, shortening
the evaluation procedures | • All settings are controlled by the acquisition system
software (stimulus parameters, electrode selection, device
status) via the acquisition amplifier, connected via cable
or Bluetooth® connection
• The device includes an electrode switching array
allowing quick change of the stimulated area, shortening
the evaluation procedures | Identical |
| Software
Version | The proposed device uses the SystemPlusEvolution
software ver.1.04.0198 | The CERVELLO® Basic System was cleared using the
Cervello software, which was a relabeling of
SystemPlusEvolution software ver.1.04.0186 | The upgrade from version 1.04.0186 to 1.04.0198 does not include any
change related to the management of the cortical stimulator in the update
history submitted in the 510(k). |
| Display | Both the amplifier and the stimulator are entirely
managed by the acquisition software in the PC allowing
real-time displaying, processing and storage of the
acquired traces
• Control on actual current delivered
• Import electrode names from recording montages | Both the amplifier and the stimulator are entirely
managed by the acquisition software in the PC allowing
real-time displaying, processing and storage of the
acquired traces
• Control on actual current delivered
• Import electrode names from recording montages | Identical |
| Alarms /
Safety Features | • The stimulator is electrically connected to the patient
only during the stimulus supply.
• Electrodes not selected for the stimulation are connected
to the amplifiers input by default (the device acts as a
bypass
• Selected electrodes are automatically switched to the
simulator output by an isolation section made up with
relays and photoMOS powered by the amplifier | • The stimulator is electrically connected to the patient
only during the stimulus supply.
• Electrodes not selected for the stimulation are connected
to the amplifiers input by default (the device acts as a
bypass
• Selected electrodes are automatically switched to the
simulator output by an isolation section made up with
relays and photoMOS powered by the amplifier | Identical |
| Standards
Compliance | • IEC 60601-1:2005 +A1:2012 (ed.3.1)
• IEC 60601-1-2 (CEI EN 60601-1-2 fourth ed. - 2014)
• IEC 60601-2-26:2012
• IEC 60601-2-40* where applicable
• EN 62304:2006-10
• cMETus mark
• European Community (CE Mark): Class 2B Medical
Device Directive (MDD) product certified by IMQ,
Milano, Italy. Notified Body (ID No. 0051)
IP20 (Protected against the penetration of solid external
objects of 12.5 mm Ø and higher; not protected against
the penetration of liquids). | • UL 60601-1 Medical Electrical Safety Standard (USA)
• CAN/CSA-C22.2 no. 601.1-M90
• IEC 60601-1 (CEI EN 60601-1) ed. 2.0 '92+ variants
(A1+A11+A12 e A2:1997)
• IEC 60601-1:2005 (ed.3.0)
• IEC 60601-1-1 (CEI EN 60601-1-1 second ed. 2003-
06)
• IEC 60601-1-2 (CEI EN 60601-1-2 third ed. - 2007)
• IEC 60601-2-40* partially applied.
• IEC 60601-1-4 (CEI EN 60601-1-4 first ed .: 1996
+A1:1999)
• IEC 60601-2-26 (CEI EN 60601-2-26 second ed. 2004-
04) | Collectively, the proposed device complies with the same "basic set" of
standards as the predicate (IEC 60601-1, 60601-1-2, 60601-2-26, 60601-
2-40, EN 62304, CE Marking and IP20). As applicable, the proposed
device complies with the most recent/current versions. |
| Feature | micromed S.p.A.
SD LTM STIM
K180761 | CERVELLO® STIM
K151354 | Comments |
| | Towards PC greater than 3000V; optical coupling on
communication line towards SD LTM 64 EXPRESS.
Isolated in/out trigger line. | • European Community (CE Mark) class 2B Medical
Device Directive (MDD) product certified by IMQ,
Milano, Italy Notified Body (ID No. 0051) | |
| | According IEC 60601-1:2005: class II / internally
powered device, BF type. To comply with the standard
for this type of classification, the stimulator must be used
with SD LTM 64 EXPRESS amplifier and according to
the prescription for the use of this device. | IP20 (Protected against the penetration of solid external
objects of 12.5 mm Ø and higher; not protected against
the penetration of liquids) | |
| | | Towards PC greater than 3000V; optical coupling on
communication line towards CERVELLO. Isolated
in/out trigger line | |
| | | According IEC 60601-1:2005: class II / internally
powered device, BF type. To comply with the standard
for this type of classification, the stimulator must be used | |
| | | with CERVELLO amplifier and according to the
prescription for the use of this device. | |
5
6
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Technological and Performance Characteristics
The differences between the SD LTM STIM and the CERVELLO® STIM predicate device are as follows:
- · The proposed device is interface with micromed S.p.A. devices cleared under their own 510(k)s instead of versions of the same devices cleared by Blackrock and/or micromed.
- · The proposed device uses a different color plastic material (gray versus white).
- · The proposed device has updated software (version 1.04.0198 versus version 1.04.0186).
- · The proposed device complies with the updated IEC 60601-related standards.
These differences do not raise different questions of safety and effectiveness.
Conformance to Recognized Voluntary Consensus (Non-Clinical Testing in Support of Substantial Equivalence and Device Performance)
Standards to which the subject device conforms are outlined below:
| Body | Standard ID | Standard Title |
|---|---|---|
| IEC | 60601-1:2005 +A1:2012 (ed.3.1) | Medical Electrical Equipment, Part 1: General |
| Requirements for Safety | ||
| IEC | 60601-2-26:2012, third edition | Medical Electrical Equipment – Particular |
| requirements for the basic safety and essential | ||
| performance of electroencephalographs |
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| Body | Standard ID | Standard Title |
|---|---|---|
| IEC | 60601-1-2 (EN 60601-1-2 fourth | |
| ed. - 2014) | Medical electrical equipment. General requirements for | |
| basic safety and essential performance. Collateral | ||
| standard. Electromagnetic compatibility. Requirements | ||
| and tests | ||
| IEC | 60601-2-40:2016 | Medical electrical equipment - Part 2-40: Particular |
| requirements for the safety of electromyographs and | ||
| evoked response equipment | ||
| IEC | 62304:2006 | Medical device software - Software life-cycle |
| processes |
Clinical Testing
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusion
Through the comparison of technological and performance characteristics, the subject device is determined to the predicate device.