SD LTM STIM Cortical Stimulator

K180761 · Micromed S.P.A. · GYC · Jun 18, 2018 · Neurology

Device Facts

• Record ID: K180761
• Device Name: SD LTM STIM Cortical Stimulator
• Applicant: Micromed S.P.A.
• Product Code: GYC · Neurology
• Decision Date: Jun 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1310
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Low-power, constant-current, bi-phasic cortical stimulator; accessory to SD LTM 64 EXPRESS Signal Acquisition System and SystemPlus EVOLUTION software. Inputs: stimulation parameters set via software. Operation: interfaces with third-party cortical/intracranial electrodes to deliver stimulation and record potentials. Used in clinical settings for brain mapping; operated by clinicians. Output: electrical stimulation pulses (0-15 mA, 0.1-100 Hz, 50-1000 µs pulse width). Device acts as a switching unit; electrodes not selected for stimulation remain connected to EEG amplifier inputs. Benefits: enables rapid switching between stimulated areas during mapping, shortening evaluation procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety and electromagnetic compatibility testing per IEC 60601-1, 60601-1-2, 60601-2-26, and 60601-2-40.

Technological Characteristics

Constant current, bi-phasic stimulator. Materials: Gray ABS plastic. Power: External (from amplifier) or 3x AAA batteries. Connectivity: Wired/Bluetooth to acquisition system. Isolation: Optical coupling, relay/photoMOS switching. Standards: IEC 60601-1:2005+A1:2012, IEC 60601-1-2 (2014), IEC 60601-2-26:2012, IEC 60601-2-40:2016, EN 62304:2006. IP20 rating.

Indications for Use

Indicated for cortical stimulation during electroencephalography (stereoEEG) examinations in patients undergoing brain mapping procedures to determine cortical functionality.

Regulatory Classification

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.

Predicate Devices

• Cervello Stim (K151354)

Reference Devices

• MORPHEUS system (K071782)
• BRAIN QUICK system (K171384)
• CERVELLO Basic Biopotential Signal Acquisition System (K122196)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: | [phone] |
| 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.<br>SD LTM STIM<br>K180761 | CERVELLO® STIM<br>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<br>its own name. |
| Basic Function | Cortical stimulator that interfaces with an EEG system.<br>Cannot be used as a standalone device | Cortical stimulator that interfaces with an EEG system.<br>Cannot be used as a standalone device | Both devices have the same design and are intended to serve as a cortical<br>stimulator. |
| Switching Unit | Yes | Yes | Both devices are designed to function as separate switching units. |
| General<br>Description | The SD LTM STIM is a low power, constant current, bi-<br>phasic stimulator intended for cortical stimulation during<br>electroencephalography examinations (i.e. stereoEEG). | The Cervello® STIM is a low power, constant current, bi-<br>phasic stimulator intended for cortical stimulation during<br>electroencephalography examinations (i.e. stereoEEG). | Both devices are used during brain mapping procedures to determine the<br>functionality of the stimulated cortex and except for branding issues and<br>color issues (SD LTM STIM vs Cervello® STIM aka the SD LTM STIM)<br>are identical. |
| Product Code | GYC (cortical electrodes) | GYC (cortical electrodes) | Identical |
| Indication for<br>Use | The SD LTM STIM is a low power, constant current,<br>bi-phasic stimulator intended for cortical stimulation<br>during electroencephalography examinations (i.e.<br>stereoEEG). | The Cervello® STIM is a low power, constant current, bi-<br>phasic stimulator intended for cortical stimulation during<br>electroencephalography examinations (i.e. stereoEEG).<br>The stimulation is applied to the brain using third-party<br>stimulation probes (including cortical or intracranial | Identical |
| Feature | micromed S.p.A.<br>SD LTM STIM<br>K180761 | CERVELLO® STIM<br>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.<br>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.<br>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<br>Components<br>(Included) | Stimulator (STIM)<br>Cable (CB LTM) | Stimulator (STIM)<br>Cable (CB LTM) | Identical system components.<br>Identical |
| Additional<br>Components<br>Required for Use<br>of the Subject<br>Device<br>(supplied by the<br>applicable 510(k)<br>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<br>Components<br>Required for<br>Use of the<br>Subject Device<br>(supplied by 3rd<br>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.<br>SD LTM STIM<br>K180761 | CERVELLO® STIM<br>K151354 | Comments |
| ELECTRICAL SPECIFICATIONS | | | |
| Power Source | External (From the SD LTM 64 EXPRESS Amplifier) or<br>from Three (3) batteries AAA ,1.5V | External (From the Cervello® Amplifier) or from<br>Three (3) batteries AAA ,1.5V | Identical |
| Stimulation<br>Output Method | Constant Current | Constant Current | Identical |
| Maximum<br>Stimulation<br>Charge | 20μC | 20μC | Identical |
| Current<br>Stimulation<br>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<br>Frequency | Single pulse; continuous: from 0.1 Hz to 100 Hz in steps<br>of 0.1 Hz | Single pulse; continuous: from 0.1 Hz to 100 Hz in steps<br>of 0.1 Hz | Identical |
| Stimulation<br>Pulse Width<br>Duration | 50 µs to 1000 µs in steps of 1 µs<br>(Equivalent to 0.1 to 1.0 msec) | 50 µs to 1000 µs in steps of 1 µs<br>(Equivalent to 0.1 to 1.0 msec) | Identical |
| Stimulation<br>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,<br>trigger on train start for higher stimulation rates | Trigger on single pulse for stimulation rate up to 20 Hz,<br>trigger on train start for higher stimulation rates | Identical |
| Pulse shape | Rectangular | Rectangular | Identical |
| Stimulation<br>Mode | Biphasic (with independently controllable main & reverse<br>phases) | Biphasic (with independently controllable main & reverse<br>phases) | Identical |
| Number of<br>Channels | 1 electrical stimulator, positive and negative electrode can<br>be switched to any of the 64 available output channels | 1 electrical stimulator, positive and negative electrode can<br>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<br>LTM 64 EXPRESS EEG Signal Acquisition System and the JB LTM 64<br>Express Jackbox. The predicate device uses white PVC plastic. Neither<br>device is implanted, and only has momentary contact with skin of the<br>clinician, and not the patient. The material has been approved as alternate<br>component in MET safety certification. |
| | micromed S.p.A.<br>SD LTM STIM<br>K180761 | CERVELLO® STIM<br>K151354 | |
| Feature | USER INTERFACE SPECIFICATIONS | | Comments |
| Patient Contact /<br>Interface<br>Materials | The Stimulator does not contact the patient.<br>The third-party electrodes (strip, grid, depth and/or<br>stimulation probes) make patient contact | The Stimulator does not contact the patient.<br>The third-party electrodes (strip, grid, depth and/or<br>stimulation probes) make patient contact | Identical |
| User Input<br>Mechanism | • All settings are controlled by the acquisition system<br>software (stimulus parameters, electrode selection, device<br>status) via the acquisition amplifier, connected via cable<br>or Bluetooth® connection<br>• The device includes an electrode switching array<br>allowing quick change of the stimulated area, shortening<br>the evaluation procedures | • All settings are controlled by the acquisition system<br>software (stimulus parameters, electrode selection, device<br>status) via the acquisition amplifier, connected via cable<br>or Bluetooth® connection<br>• The device includes an electrode switching array<br>allowing quick change of the stimulated area, shortening<br>the evaluation procedures | Identical |
| Software<br>Version | The proposed device uses the SystemPlusEvolution<br>software ver.1.04.0198 | The CERVELLO® Basic System was cleared using the<br>Cervello software, which was a relabeling of<br>SystemPlusEvolution software ver.1.04.0186 | The upgrade from version 1.04.0186 to 1.04.0198 does not include any<br>change related to the management of the cortical stimulator in the update<br>history submitted in the 510(k). |
| Display | Both the amplifier and the stimulator are entirely<br>managed by the acquisition software in the PC allowing<br>real-time displaying, processing and storage of the<br>acquired traces<br>• Control on actual current delivered<br>• Import electrode names from recording montages | Both the amplifier and the stimulator are entirely<br>managed by the acquisition software in the PC allowing<br>real-time displaying, processing and storage of the<br>acquired traces<br>• Control on actual current delivered<br>• Import electrode names from recording montages | Identical |
| Alarms /<br>Safety Features | • The stimulator is electrically connected to the patient<br>only during the stimulus supply.<br>• Electrodes not selected for the stimulation are connected<br>to the amplifiers input by default (the device acts as a<br>bypass<br>• Selected electrodes are automatically switched to the<br>simulator output by an isolation section made up with<br>relays and photoMOS powered by the amplifier | • The stimulator is electrically connected to the patient<br>only during the stimulus supply.<br>• Electrodes not selected for the stimulation are connected<br>to the amplifiers input by default (the device acts as a<br>bypass<br>• Selected electrodes are automatically switched to the<br>simulator output by an isolation section made up with<br>relays and photoMOS powered by the amplifier | Identical |
| Standards<br>Compliance | • IEC 60601-1:2005 +A1:2012 (ed.3.1)<br>• IEC 60601-1-2 (CEI EN 60601-1-2 fourth ed. - 2014)<br>• IEC 60601-2-26:2012<br>• IEC 60601-2-40* where applicable<br>• EN 62304:2006-10<br>• cMETus mark<br>• European Community (CE Mark): Class 2B Medical<br>Device Directive (MDD) product certified by IMQ,<br>Milano, Italy. Notified Body (ID No. 0051)<br>IP20 (Protected against the penetration of solid external<br>objects of 12.5 mm Ø and higher; not protected against<br>the penetration of liquids). | • UL 60601-1 Medical Electrical Safety Standard (USA)<br>• CAN/CSA-C22.2 no. 601.1-M90<br>• IEC 60601-1 (CEI EN 60601-1) ed. 2.0 '92+ variants<br>(A1+A11+A12 e A2:1997)<br>• IEC 60601-1:2005 (ed.3.0)<br>• IEC 60601-1-1 (CEI EN 60601-1-1 second ed. 2003-<br>06)<br>• IEC 60601-1-2 (CEI EN 60601-1-2 third ed. - 2007)<br>• IEC 60601-2-40* partially applied.<br>• IEC 60601-1-4 (CEI EN 60601-1-4 first ed .: 1996<br>+A1:1999)<br>• IEC 60601-2-26 (CEI EN 60601-2-26 second ed. 2004-<br>04) | Collectively, the proposed device complies with the same "basic set" of<br>standards as the predicate (IEC 60601-1, 60601-1-2, 60601-2-26, 60601-<br>2-40, EN 62304, CE Marking and IP20). As applicable, the proposed<br>device complies with the most recent/current versions. |
| Feature | micromed S.p.A.<br>SD LTM STIM<br>K180761 | CERVELLO® STIM<br>K151354 | Comments…