(214 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard neurophysiological recording and stimulation techniques.
No
The device is used for recording and stimulating brain neurons to aid in electrode placement and deep brain stimulation during neurosurgery. While it involves stimulation, its primary purpose described is diagnostic/guidance for surgical placement rather than direct therapy for a medical condition.
Yes
The device is used to record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes. This process involves gathering information about the brain's activity to guide a medical procedure, which is a diagnostic function.
No
The device description explicitly states the system "operates the integrated neurostimulator that delivers impulses" and allows for "Recording and stimulation of up to five channels are possible simultaneously." This indicates the system includes hardware components for stimulation and recording, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes" during neurosurgery. This is a procedure performed directly on a living patient, not on samples taken from the body.
- Device Description: The description confirms the use "during neurosurgical interventions" for "extra cellular recording and deep brain stimulation." Again, this is an in-vivo application.
- 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.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the patient's brain during surgery.
N/A
Intended Use / Indications for Use
The ISIS MER System / Elekta MER System is intended to be used during neurosurgery to record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.
Product codes
84 GZL
Device Description
During neurosurgical interventions the ISIS MER System / Elekta MER System is used for optimal During nearbsargrear extra cellular recording and deep brain stimulation.
The system operates the integrated neurostimulator that delivers impulses similar to the inte system operates the megrates the simulate the later effect of an implanted impulses of the DDS Clectrouslition of up to five channels are possible simultaneously. A sixth chectrouc. Recording and sensor. Free channels may be used for EMG recording for optimal patient surveillance.
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
neurosurgery
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Dokumentnamn/Name of document 1...
Inomed GmbH
Traditional 510(k)
| Utfärdare/Issuer | Saschka Busch |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | Pj01 079 |
| Utgåva /Edition | 1.2 |
| Avser/Regarding | ISIS MER System / Elekta MER System |
| Directory |
Section 4- 510(k) Summary
As Required by 21 CFR 807.87(k)510 (k) Summary
Subscribers Name & Address 1.
Inomed Medizintechnik GmbH Tullastrasse 5a D-79331 Teningen, Germany Tel: (011) 49 7641 9414-0 Fax: (011) 49 7641 9414-94 Official Correspondent: Mr Saschka Busch
Mr Anders Skoglund (Elekta Instrument AB, Tel: (011) 46 8 587 254 00 Fax: (011) 46 8 587 255 00)
Trade Names 2.
ISIS MER System / Elekta MER System
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) # |
|---|---|
| Axon Guideline System 3000A | K970943 |
| Keypoint / Leadpoint system | K944574 |
Other relevant submissions 5.
| PVICES
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COMPANY CONFIDENTIAL
1
Dokumentnamn/Name of document
| Inomed GmbH | Traditional 510(k) | |
|---|---|---|
| Utfärdare/Issuer | ||
| Saschka Busch | Ref nr/Dok nr/Ref no/Doc no | |
| Pj01 079 | Utgåva /Edition | |
| 1.2 | ||
| Avser/Regarding | ||
| ISIS MER System / Elekta MER System | Directory |
Device Description (for detailed description see Section "Device Description") 6.
During neurosurgical interventions the ISIS MER System / Elekta MER System is used for optimal During nearbsargrear extra cellular recording and deep brain stimulation.
The system operates the integrated neurostimulator that delivers impulses similar to the inte system operates the megrates the simulate the later effect of an implanted impulses of the DDS Clectrouslition of up to five channels are possible simultaneously. A sixth chectrouc. Recording and sensor. Free channels may be used for EMG recording for optimal patient surveillance.
7. Intended Use:
The ISIS MER System / Elekta MER System is intended to be used during neurosurgery to record rne 1515 MER 3)>tem>> and sensory neurons to aid in the placement of depth electrodes.
Summary of technological characteristics of Device and Predicate Device: 8
The functionality for the ISIS MER System / Elekta MER System are equivalent to its predicate devices the Axon Guideline System 3000A (K970943) and the Dantec / Medtronic Keypoint / ue recom (K944547) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison charts provided in this 510 k submission.
COMPANY CONFIDENTIAL
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes representing its wings. The eagle is facing to the right.
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inomed Medizintechnik GmbH c/o Mr. Anders Skoglund Elekta Instrument AB Kungstensgatan 18, P.O Box 7593 Stockholm Germany SE-103 93
Rc: K042208
Trade/Device Name: NeuroTrek System Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: II Product Code: GZL Dated: February 24, 2005 Received: February 28, 2005
Dear Mr. Skoglund:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premained insubstantially equivalent (for the indications
referenced above and have determined the device is substantials in interstate referenced anove and nave decemblied the devices marketed precises marketed in interstate for use stated in the enclosure) to legally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Eaderal Food. Drug commerce prior to May 20, 1970, the chaethere and the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMA) devices that have been recialssified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previoing of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, lightyy of You may, merelore, market the devreet, basyeer to the gents for annual registration, listing of
general controls provisions of the Act include requirements for any may and general controls provisions of the Frechners requires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it c If your device is classified (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional connous. Title 21, Parts 800 to 898. In addition. FDA may be found in the Code of Peachar Ingerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualies of a substaints with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decemmation administered by other Federal agencies. You must or any Federal statutes and regulations administered of not limited to: registration and listing (21 comply with an the Act s requirements, moraling practice requirements as school as se CFR Part 807), labemig (21 CFR Part 807), good manari 820); and if applicable . the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (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) This letter will anow you to begin harketing of substantial equivalence of your device to a legally premarket nothication. The PDA midnig of substantial equive 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 80 ), please If you desire specific advice for your de not of the Also, please note the regulation entitled. contact the Office of Complance at (210FR Part 807.97). You may obtain " Misoranding by reletence to premanectionities under the Act from the Division of Small
other general information on your responsibilities under the Act from the 6000 628.00 other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Assistanto and concertaindustry/support/index.html.
Sincerely yours,
Ehk
Miriam C. Provost, Ph.D. Acting 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 | Saschka Busch |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | Pj01 079 |
| Utgåva /Edition | 1.2 |
| Avser/Regarding | ISIS MER System / Elekta MER System |
| Directory |
Section 7- Indications for Use Statement
| 510(k) Number | To be defined K042208 |
|---|---|
| Device Name | ISIS MER System / Elekta MER System |
| Indications for Use | The ISIS MER System / Elekta MER System is intended to be used during neurosurgery to record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes. |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BEŁOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
100 Sion-1 It Perforative
04 2208
COMPANY CONFIDENTIAL
Inomed GmbH Tullastr.5a D-79331 Teningen Tel +49 7641 9414-0 Fax +49 7641 9414 9414 941