(99 days)
Not Found
No
The description focuses on mechanical components and manual operation for electrode positioning, with no mention of AI/ML terms or functionalities.
No
The device is used for accurate positioning of electrodes or other devices during neurosurgery, facilitating a procedure, but not directly treating a condition itself.
No
Explanation: The device is described as being used for "accurate positioning of electrodes or other devices during stereotactic neurosurgery" and for advancing "electrodes through the guide tubes into the brain." This indicates a therapeutic or interventional function (positioning and advancing tools), not a diagnostic one (identifying a disease or condition).
No
The device description explicitly details physical components like a drive, MicroGun, electrode holder, guide tubes, and a sledge with a fine-pitch screw, indicating it is a hardware device.
Based on the provided information, the ELEKTA Microdrive is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "accurate positioning of electrodes or other devices during stereotactic neurosurgery." This describes a surgical tool used in vivo (within a living organism) for a procedural purpose.
- Device Description: The description details a mechanical system for manipulating electrodes within the brain. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnostic, monitoring, or screening purposes. The ELEKTA Microdrive's function is purely mechanical positioning during surgery.
N/A
Intended Use / Indications for Use
The ELEKTA Microdrive is intended to be used for accurate positioning of electrodes or other devices during stereotactic neurosurgery.
Product codes
HAW
Device Description
The ELEKTA Microdrive consists of a drive which is connected to the instrument holder of the stereotactic system, the MicroGun that holds the guide tubes and the Electrode holder where the electrodes are fixed. The guide tubes are inserted into the MicroGun and fixed with the lower end of the guidetubes 11 or 21 mm (two different lengths of guide tubes exist) in front of the target point. By moving a sledge with a fine-pitch screw the electrodes are advanced through the guide tubes into the brain. It is possible to position up to five electrodes simultaneously.
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
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
| JUL | 2 |
|---|---|
| 3 | 2004 |
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document Traditional 5101k1
| Utfärdare/Issuer | Anders Skoglund |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | Pd106 OEM MER MICRODRIVE FDA |
| Utgåva /Edition | 1 |
| Avser/Regarding | ELEKTA Microdrive |
| Directory |
Section 4- 510(k) Summary
As Required by 21 CFR 807.87(k)510 (k) Summary
Subscribers Name & Address 1.
Elekta Instrument AB Kungstensgatan 18, P:O Box 7593 SE-103 93 Stockholm, Sweden Tel: (011) 46 8 587 254 00 Fax: (011) 46 8 587 255 00 Contact Person for this submission: Mr Anders Skoglund Official Correspondent: Mr Peter Löwendahl
Trade Name 2.
ELEKTA Microdrive
Device Classification 3.
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Stereotaxic instrument | HAW | II | 21 CFR 882.4560 |
Predicate Device Identification 4.
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| FHC Inc, MicroTargeting® Drive System | K011775 |
| -- | -- |
Other relevant submissions ર .
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AA A - A 400 AM A
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K0409/9
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document Traditional 510lk)
| Utfärdare/Issuer | Anders Skoglund |
|---|---|
| Avser/Regarding | ELEKTA Microdrive |
| Ref nr/Dok nr/Ref no/Doc no | Pd106 OEM MER MICRODRIVE FDA |
| Utgåva /Edition | 1 |
| Directory |
Device Description (for detailed description see Section "Device Description") 6.
The ELEKTA Microdrive consists of a drive which is connected to the instrument holder of the stereotactic system, the MicroGun that holds the guide tubes and the Electrode holder where the electrodes are fixed. The guide tubes are inserted into the MicroGun and fixed with the lower end of the guidetubes 11 or 21 mm (two different lengths of guide tubes exist) in front of the target point. By moving a sledge with a fine-pitch screw the electrodes are advanced through the guide tubes into the brain. It is possible to position up to five electrodes simultaneously.
Intended Use 7.
The ELEKTA Microdrive is intended to be used for accurate positioning of electrodes or other devices during stereotactic neurosurgery.
Substantial Equivalence 8
The functionality for the ELEKTA Microdrive is equivalent to its predicate device the FHC Inc, MicroTargeting® Drive System (K011775) 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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above two wavy lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Mr. Anders Skoglund Regulatory Affairs Engineer Elekta Instrument AB Kungstensgatan 18 P.O. Box 7593 SE-103 93 Stockholm Sweden
Re: K040979
Trade/Device Name: ELEKTA Microdrive Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 24, 2004 Received: June 30, 2004
Dear Mr. Skoglund:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been i that do not require approval of a premarket approval application (PMA). and Cosmetter For (110) that the device, subject to the general controls provisions of the Act. The r ou may, merelore, marrov of the Act include requirements for annual registration, listing of general obtitled provision practice, 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 rr your device is classified to corrols. Existing major regulations affecting your device can may oe subject to Sach additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any i with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) I mis letter with and in Journe FDA finding of substantial equivalence of your device to a legally premarket notification: " 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 deem's specific as Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Economic 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,
Mark H. Millican
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
| Utfärdare/Issuer | Anders Skoglund |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | Pd106 OEM MER MICRODRIVE FDA |
| Avser/Regarding | ELEKTA Microdrive |
| Dokumentnamn/Name of document |
|---|
| Traditional 510(k) |
| Utgåva / Edition |
|---|
| 1 |
| Directory |
|---|
| ----------- |
ELEKTA INSTRUMENT AB
Section 7- Indications for Use Statement
| 510(k) Number | To be defined K040979 |
|---|---|
| Device Name | ELEKTA Microdrive |
| Indications for Use | The ELEKTA Microdrive is intended to be used for accurate positioning of electrodes or other devices during stereotactic neurosurgery. |
X 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)
Mark A. Milburn
Division of General, Restorative, and Neurological Devices
510(k) Number K040974