MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799

K041409 · Inomed GmbH · GZL · Aug 20, 2004 · Neurology

Device Facts

• Record ID: K041409
• Device Name: MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
• Applicant: Inomed GmbH
• Product Code: GZL · Neurology
• Decision Date: Aug 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micro - recording and stimulation electrodes are intended to be used in the human brain for the recording of Neuro potentials of single brain cells and for electrical stimulation of small areas in the brain.

Device Story

Device consists of monopolar electrodes (Micro-recording/stimulation, Macro-recording/stimulation, or MicroMacro-electrodes) used for neurophysiological monitoring and stimulation. Micro-tips record single-cell or cell-cluster potentials and perform microstimulation; macro-tips record local field potentials and perform stimulation. Used in the human brain; operated by clinicians. Input consists of electrical neuro-potentials; output consists of electrical stimulation or recorded signals for clinical analysis. Device aids in mapping brain activity and targeting small areas for stimulation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Monopolar electrodes with micro and/or macro tips. Designed for intracranial use. Functionality includes recording of neuro potentials and electrical stimulation. Technical characteristics are equivalent to the predicate FHC microTargeting Electrode.

Indications for Use

Indicated for use in the human brain for recording neuro potentials of single brain cells and for electrical stimulation of small areas of the brain.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• FHC microTargeting Electrodes (K033173)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text 'K041409' in a handwritten style. The text appears to be a code or identifier. The characters are written in black ink on a white background.

Inomed GmbH AUG 2 0 2004
Dokumentnamn/Name of document Traditional 510(k)

| Utfärdare/Issuer | Anders Skoglund |
|-----------------------------|----------------------------------------------|
| Ref nr/Dok nr/Ref no/Doc no | Pj03 017 |
| Utgåva /Edition | 1.0 |
| Sida/Page | 12 |
| Avser/Regarding | Micro - recording and stimulation electrodes |
| | Directory |

### Section 4- 510(k) Summary

As Required by 21 CFR 807.87(k)510 (k) Summary

#### Subscribers Name & Address 1.

Inomed GmbH Tullastraße 5a D-79331 Teningen, Germany Tel: [phone] Fax: [phone] Official Correspondent: Mr Alexander Thern

Contact Person for this submission: Contact Person for this submission
Mr Anders Skoglund (Elekta Instrument AB, Tel: [phone] Fax: [phone])

#### Trade Name 2.

Micro - recording and stimulation electrodes

#### Device Classification 3.

| Common Name | Product Code | Class | Regulation Number |
|-----------------|--------------|-------|-------------------|
| Depth electrode | 84 GZL | II | 21 CFR 882.1330 |

#### Predicate Device Identification 4.

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| FHC microTargeting Electrodes | K033173 |
| -- | -- |

#### Other relevant submissions 5.

| I<br>I Devices | 510(k) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| N/A | N//<br>----------------------------------------------------------------------------------------------------------------------------- |

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Ko41409

212

## Inomed GmbH

Dokumentnamn/Name of document

| Inomed GmbH | | Traditional 510(k) | |
|-----------------------------------------------------------------|-----------------------------------------|------------------------|-----------------|
| Utfärdare/Issuer<br>Anders Skoglund | Ref nr/Dok nr/Ref no/Doc no<br>Pj03 017 | Utgåva /Edition<br>1.0 | Sida/Page<br>13 |
| Avser/Regarding<br>Micro - recording and stimulation electrodes | | Directory | |

Device Description (for detailed description see Section "Device Description") 6.

MicroMacroelectrodes are equipped with a micro tip and a MacroElectrode. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for If acca to tol sion. The macro tip is used for stimulation and recording of local field potentials.

MacroElectrodes are monopolar electrodes equipped with an active macro tip. They are used for stimulation and recording of local field potentials.

Micro Electrodes are monopolar electrodes equipped with a micro tip. They are used for recording cell potentials of single cells or cell clusters and for Microstimulation. They are similar to MicroMacroelectrodes but without the Macroelectrode.

#### 7. Intended Use:

The Micro - recording and stimulation electrodes is intended to be used in the human brain for the recording of Neuro potentials of single brain cells and for electrical stimulation of small areas in the brain.

Summary of technological characteristics of Device and Predicate Device: 8 The functionality for the Micro - recording and stimulation electrodes are equivalent to its predicate device the FHC Inc, microTargeting Electrode (K033173) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2004

Inomed Omtin c/o Mr. Anders Skoglund Regulatory Affairs Engineer Elekta Instrument AB Kungstensgatan 18. P.O. Box 7593 SE-103 93 Stockholm Sweden

Rc: K041409

Trade/Device Name: Micro-Recording and Stimulation Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: July 29, 2004 Received: August 2, 2004

Dear Mr. Skoglund:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) promote is substantially equivalent (for the indications ferenced above and nave acterimined in the enclicate devices marketed in interstate for use stated in the encrosale) to togens actment date of the Medical Device Amendments, or to conninered phor to May 20, 1778, the entordance with the provisions of the Federal Food, Drug. devices marchave been roomstiled in avere approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do not require appent to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration. Iisting of general controls provisions of tractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 abs. Existing major regulations affecting your device can may be subject to sueri addrivital combologics. Title 21. Parts 800 to 898. In addition. FDA may be found in the evas acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase oe advised that 1171 si issuants or our device complies with other requirements of the Act that I 17A has made a determinations administered by other Federal agencies. You must of any reactal statures and regalanced sainting, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CPR Part 807), adocing (21 CFR Part 820), and if and if and if and if and if any 1000, 1050 form in the quality witherns (Sections 531-542 of the Act): 21 CFR 1000-1050.

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### Page 2 - Mr. Anders Skoglund

This letter will allow you to begin marketing your device as described in your Section 510/k) I ms lefter will and wyou to begin maneting of substantial equivalence of your device to a legally prematicated predicated on "The Post mang
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please If you desire specific advice for Jour at [phone]. Also, please note the regulation entitled, Contact the Office of Compuner and (21CFR Part 807.97). You may obtain Misoranting of Icrerchee to premainentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Sincerely yours,

Hypt. Rurles

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Inomed GmbH |
|-------------|
|-------------|

| Dokumentnamn/Name of document | Traditional 510(k) |
|-------------------------------|--------------------|
|-------------------------------|--------------------|

| Utfärdare/Issuer | Anders Skoglund |
|-----------------------------|-----------------|
| Rel nr/Dok nr/Ref no/Doc no | Pj03 017 |
| Utgåva /Edition | 1.0 |
| Sida/Page | 19 |

Arse; Regulating

Micro - recording and stimulation electrodes

# Section 7- Indications for Use Statement

| 510(k) Number | To be defined<br>K041409 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Micro - recording and stimulation electrodes |
| Indications for Use | The Micro - recording and stimulation electrodes are intended to<br>be used in the human brain for the recording of Neuro potentials of<br>single brain cells and for electrical stimulation of small areas in the<br>brain. |

× Prescription Use (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 NECESSARY) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Hypt Surdus

ign-Off) (Divisio Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________