(87 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the SD LTM STIM Cortical Stimulator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K180761) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than establishing new performance criteria through a de novo clinical trial. Therefore, explicit "acceptance criteria" related to a new clinical performance study, in terms of specific sensitivity, specificity, or other outcome measures, are not defined in the document.
Instead, the acceptance is based on demonstrating that the new device (SD LTM STIM) is as safe and effective as a legally marketed predicate device (Cervello Stim K151354). The "performance" reported is primarily a comparison of its technological characteristics to the predicate.
Here's a table summarizing the comparative technical performance, which serves as the basis for acceptance in this 510(k) submission:
| Feature | Acceptance Criteria (Predicate Device K151354) | Reported Device Performance (SD LTM STIM K180761) |
|---|---|---|
| Basic Function | Cortical stimulator, not standalone | Cortical stimulator, not standalone |
| Switching Unit | Yes | Yes |
| Max Stimulation Charge | 20 µC | 20 µC |
| Current Stimulation Range | 0-15 mA (peak), 0.1 mA steps | 0-15 mA (peak), 0.1 mA steps |
| Stimulation Frequency | Single pulse; 0.1 Hz to 100 Hz, 0.1 Hz steps | Single pulse; 0.1 Hz to 100 Hz, 0.1 Hz steps |
| Stimulation Pulse Width | 50 µs to 1000 µs, 1 µs steps | 50 µs to 1000 µs, 1 µs steps |
| Stimulation Train Length | User specified 1-15 seconds | User specified 1-15 seconds |
| Output Trigger | Single pulse up to 20 Hz, train start for higher | Single pulse up to 20 Hz, train start for higher |
| Pulse Shape | Rectangular | Rectangular |
| Stimulation Mode | Biphasic (independently controllable phases) | Biphasic (independently controllable phases) |
| Number of Channels | 1 electrical stimulator, any of 64 output channels | 1 electrical stimulator, any of 64 output channels |
| Dimensions | 9cm x 10cm x 4cm | 9cm x 10cm x 4cm |
| Weight | 263 gm | 263 gm |
| Patient Contact / Interface | Does not contact patient; third-party electrodes make contact | Does not contact patient; third-party electrodes make contact |
| User Input Mechanism | All settings controlled by acquisition system software; electrode switching array | All settings controlled by acquisition system software; electrode switching array |
| Software Version | SystemPlusEvolution ver.1.04.0186 (rebranded Cervello software) | SystemPlusEvolution ver.1.04.0198 |
| Display | Real-time displaying, processing, storage of traces; control on current; import electrode names | Real-time displaying, processing, storage of traces; control on current; import electrode names |
| Alarms / Safety Features | Electrically connected only during stimulus supply; unselected electrodes bypassed; selected electrodes switched by isolation section | Electrically connected only during stimulus supply; unselected electrodes bypassed; selected electrodes switched by isolation section |
| Standards Compliance | UL 60601-1, CAN/CSA-C22.2, IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-40, 60601-1-4, 60601-2-26, CE Mark, IP20 | IEC 60601-1:2005 +A1:2012 (ed.3.1), IEC 60601-2-26:2012, IEC 60601-1-2 (4th ed.), IEC 60601-2-40:2016, IEC 62304:2006, cMETus mark, CE Mark, IP20 |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
Therefore, there was no test set of clinical data used in this submission. The evaluation was based on a comparison of technological characteristics and compliance with recognized voluntary consensus standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set was used, no experts were involved in establishing ground truth for a test set.
4. Adjudication Method for the Test Set
As there was no clinical test set, no adjudication method was employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done as the submission did not rely on clinical performance data. The device is a stimulator, not an diagnostic imaging AI, so this type of study would not typically be applicable for a 510(k) of this nature.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a hardware cortical stimulator that works as an accessory to an EEG system and software. It is explicitly stated that "it cannot serve as a stand-alone cortical stimulator." Therefore, there was no standalone performance evaluation in the context of an algorithm. Its performance is always in conjunction with the controlling system.
7. The Type of Ground Truth Used
Given that no clinical performance data was used, no traditional "ground truth" (like pathology, expert consensus, or outcomes data) was established or utilized for comparison in this submission. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety profile of the predicate device and compliance with relevant safety standards.
8. The Sample Size for the Training Set
There was no training set in the context of a machine learning or AI algorithm, as this is a hardware device submission.
9. How the Ground Truth for the Training Set Was Established
Since there was no training set, this question is not applicable.
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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);
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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 STIMK180761 | CERVELLO® STIMK151354 | Comments |
|---|---|---|---|
| Comparison of Technological Characteristics | |||
| Picture | Image: SD LTM STIM | Image: CERVELLO® STIM | The subject device an updated version of the predicate and branded underits 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 corticalstimulator. |
| Switching Unit | Yes | Yes | Both devices are designed to function as separate switching units. |
| GeneralDescription | The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation duringelectroencephalography examinations (i.e. stereoEEG). | The Cervello® STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation duringelectroencephalography examinations (i.e. stereoEEG). | Both devices are used during brain mapping procedures to determine thefunctionality of the stimulated cortex and except for branding issues andcolor issues (SD LTM STIM vs Cervello® STIM aka the SD LTM STIM)are identical. |
| Product Code | GYC (cortical electrodes) | GYC (cortical electrodes) | Identical |
| Indication forUse | The SD LTM STIM is a low power, constant current,bi-phasic stimulator intended for cortical stimulationduring electroencephalography examinations (i.e.stereoEEG). | The Cervello® STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation duringelectroencephalography examinations (i.e. stereoEEG).The stimulation is applied to the brain using third-partystimulation probes (including cortical or intracranial | Identical |
| Feature | micromed S.p.A.SD LTM STIMK180761 | CERVELLO® STIMK151354 | 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-LevelComponents(Included) | Stimulator (STIM)Cable (CB LTM) | Stimulator (STIM)Cable (CB LTM) | Identical system components.Identical |
| AdditionalComponentsRequired for Useof the SubjectDevice(supplied by theapplicable 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. | ||
| AdditionalComponentsRequired forUse of theSubject Device(supplied by 3rdparties) | 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 STIMK180761 | CERVELLO® STIMK151354 | Comments |
| ELECTRICAL SPECIFICATIONS | |||
| Power Source | External (From the SD LTM 64 EXPRESS Amplifier) orfrom Three (3) batteries AAA ,1.5V | External (From the Cervello® Amplifier) or fromThree (3) batteries AAA ,1.5V | Identical |
| StimulationOutput Method | Constant Current | Constant Current | Identical |
| MaximumStimulationCharge | 20μC | 20μC | Identical |
| CurrentStimulationRange | 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 |
| StimulationFrequency | Single pulse; continuous: from 0.1 Hz to 100 Hz in stepsof 0.1 Hz | Single pulse; continuous: from 0.1 Hz to 100 Hz in stepsof 0.1 Hz | Identical |
| StimulationPulse WidthDuration | 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 |
| StimulationTrain 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 |
| StimulationMode | Biphasic (with independently controllable main & reversephases) | Biphasic (with independently controllable main & reversephases) | Identical |
| Number ofChannels | 1 electrical stimulator, positive and negative electrode canbe switched to any of the 64 available output channels | 1 electrical stimulator, positive and negative electrode canbe 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 SDLTM 64 EXPRESS EEG Signal Acquisition System and the JB LTM 64Express Jackbox. The predicate device uses white PVC plastic. Neitherdevice is implanted, and only has momentary contact with skin of theclinician, and not the patient. The material has been approved as alternatecomponent in MET safety certification. |
| micromed S.p.A.SD LTM STIMK180761 | CERVELLO® STIMK151354 | ||
| Feature | USER INTERFACE SPECIFICATIONS | Comments | |
| Patient Contact /InterfaceMaterials | The Stimulator does not contact the patient.The third-party electrodes (strip, grid, depth and/orstimulation probes) make patient contact | The Stimulator does not contact the patient.The third-party electrodes (strip, grid, depth and/orstimulation probes) make patient contact | Identical |
| User InputMechanism | • All settings are controlled by the acquisition systemsoftware (stimulus parameters, electrode selection, devicestatus) via the acquisition amplifier, connected via cableor Bluetooth® connection• The device includes an electrode switching arrayallowing quick change of the stimulated area, shorteningthe evaluation procedures | • All settings are controlled by the acquisition systemsoftware (stimulus parameters, electrode selection, devicestatus) via the acquisition amplifier, connected via cableor Bluetooth® connection• The device includes an electrode switching arrayallowing quick change of the stimulated area, shorteningthe evaluation procedures | Identical |
| SoftwareVersion | The proposed device uses the SystemPlusEvolutionsoftware ver.1.04.0198 | The CERVELLO® Basic System was cleared using theCervello software, which was a relabeling ofSystemPlusEvolution software ver.1.04.0186 | The upgrade from version 1.04.0186 to 1.04.0198 does not include anychange related to the management of the cortical stimulator in the updatehistory submitted in the 510(k). |
| Display | Both the amplifier and the stimulator are entirelymanaged by the acquisition software in the PC allowingreal-time displaying, processing and storage of theacquired traces• Control on actual current delivered• Import electrode names from recording montages | Both the amplifier and the stimulator are entirelymanaged by the acquisition software in the PC allowingreal-time displaying, processing and storage of theacquired traces• Control on actual current delivered• Import electrode names from recording montages | Identical |
| Alarms /Safety Features | • The stimulator is electrically connected to the patientonly during the stimulus supply.• Electrodes not selected for the stimulation are connectedto the amplifiers input by default (the device acts as abypass• Selected electrodes are automatically switched to thesimulator output by an isolation section made up withrelays and photoMOS powered by the amplifier | • The stimulator is electrically connected to the patientonly during the stimulus supply.• Electrodes not selected for the stimulation are connectedto the amplifiers input by default (the device acts as abypass• Selected electrodes are automatically switched to thesimulator output by an isolation section made up withrelays and photoMOS powered by the amplifier | Identical |
| StandardsCompliance | • 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 MedicalDevice Directive (MDD) product certified by IMQ,Milano, Italy. Notified Body (ID No. 0051)IP20 (Protected against the penetration of solid externalobjects of 12.5 mm Ø and higher; not protected againstthe 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" ofstandards as the predicate (IEC 60601-1, 60601-1-2, 60601-2-26, 60601-2-40, EN 62304, CE Marking and IP20). As applicable, the proposeddevice complies with the most recent/current versions. |
| Feature | micromed S.p.A.SD LTM STIMK180761 | CERVELLO® STIMK151354 | Comments |
| Towards PC greater than 3000V; optical coupling oncommunication line towards SD LTM 64 EXPRESS.Isolated in/out trigger line. | • European Community (CE Mark) class 2B MedicalDevice Directive (MDD) product certified by IMQ,Milano, Italy Notified Body (ID No. 0051) | ||
| According IEC 60601-1:2005: class II / internallypowered device, BF type. To comply with the standardfor this type of classification, the stimulator must be usedwith SD LTM 64 EXPRESS amplifier and according tothe prescription for the use of this device. | IP20 (Protected against the penetration of solid externalobjects of 12.5 mm Ø and higher; not protected againstthe penetration of liquids) | ||
| Towards PC greater than 3000V; optical coupling oncommunication line towards CERVELLO. Isolatedin/out trigger line | |||
| According IEC 60601-1:2005: class II / internallypowered device, BF type. To comply with the standardfor this type of classification, the stimulator must be used | |||
| with CERVELLO amplifier and according to theprescription for the use of this device. |
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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: GeneralRequirements for Safety |
| IEC | 60601-2-26:2012, third edition | Medical Electrical Equipment – Particularrequirements for the basic safety and essentialperformance of electroencephalographs |
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| Body | Standard ID | Standard Title |
|---|---|---|
| IEC | 60601-1-2 (EN 60601-1-2 fourthed. - 2014) | Medical electrical equipment. General requirements forbasic safety and essential performance. Collateralstandard. Electromagnetic compatibility. Requirementsand tests |
| IEC | 60601-2-40:2016 | Medical electrical equipment - Part 2-40: Particularrequirements for the safety of electromyographs andevoked response equipment |
| IEC | 62304:2006 | Medical device software - Software life-cycleprocesses |
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.
§ 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).