(85 days)
Not Found
No
The summary describes electrodes for recording and stimulating brain activity, but there is no mention of AI or ML being used for data analysis, interpretation, or device control.
Yes
The device is described as being used for "electrical stimulation of small areas in the brain" and "stimulation and recording of local field potentials," which indicates a therapeutic (interventional) purpose in addition to diagnostic (recording) functions.
Yes
Explanation: The device is used for "recording Neuro potentials of single brain cells" and "recording cell potentials of single cells or of cell clusters", which are diagnostic activities aimed at understanding the brain's electrical activity. While it also performs stimulation, the recording function indicates a diagnostic purpose.
No
The device description explicitly details physical electrodes (micro tip, macro tip, monopolar electrodes) intended for insertion into the human brain, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside the body (in vitro).
- Device Intended Use: The intended use of this device is for recording and stimulating electrical activity within the human brain. This is an in vivo (within the living body) procedure.
- Device Description: The description details electrodes designed for direct insertion into the brain for electrical recording and stimulation.
Therefore, since the device operates directly within the body and does not involve the analysis of specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
84 GZL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
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: (011) 49 7641 9414-0 Fax: (011) 49 7641 9414-94 Official Correspondent: Mr Alexander Thern
Contact Person for this submission: Contact Person for this submission
Mr Anders Skoglund (Elekta Instrument AB, Tel: (011) 46 8 587 254 00 Fax: (011) 46 8 587 255 00)
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
| I Devices | 510(k) |
|---|---|
| N/A | N// |
| ----------------------------------------------------------------------------------------------------------------------------- |
1
Ko41409
212
Inomed GmbH
Dokumentnamn/Name of document
| Inomed GmbH | Traditional 510(k) | ||
|---|---|---|---|
| Utfärdare/Issuer | |||
| Anders Skoglund | Ref nr/Dok nr/Ref no/Doc no | ||
| Pj03 017 | Utgåva /Edition | ||
| 1.0 | Sida/Page | ||
| 13 | |||
| Avser/Regarding | |||
| 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.
2
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.
3
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
4
| 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
K041409 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Micro - recording and stimulation electrodes |
| Indications for 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. |
× 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Hypt Surdus
ign-Off) (Divisio Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________