(445 days)
Not Found
No
The summary describes a mechanical stereotactic system and fixation screws, with no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
No.
The device is used for localization and diagnosis, and for guiding surgical treatment, but it does not directly treat a disease or condition itself.
Yes
The "Intended Use / Indications for Use" states that the system is "intended for localization and diagnosis of intracranial disorders."
No
The device description explicitly states it includes "Reusable Fixation Screws," which are hardware components used to affix a frame to the patient's skull. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy." This describes a device used directly on or in the patient for surgical and therapeutic purposes, not for testing samples in vitro (outside the body).
- Device Description: The description states the screws are used to "affix the Leksell® Coordinate Frame G firmly to the patient's skull." This is a physical fixation device used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components of an in vitro diagnostic test.
Therefore, the Leksell Stereotactic System® with Reusable Fixation Screws is a medical device used for surgical and therapeutic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Leksell Stereotactic System® with Reusable Fixation Screws is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Reusable Fixation Screws are a part of the Leksell Stereotactic System® and are used to affix the Leksell® Coordinate Frame G firmly to the patient's skull with minimal inconvenience to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial
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
§ 882.4560 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
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ELEKTA INSTRUMENT AB
Dokumentnamn/Nama of document Traditional 510/k)
| Utfärdare//ssuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva ¡Edition |
|---|---|---|
| Anders Skoglund | -- | -- |
| Avser/Regarding | ||
| Leksell Stereotactic System® with Reusable Fixation Screws | 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.
Leksell Stereotactic System® with Reusable Fixation Screws
3. Device Classification
| 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) # |
|---|---|
| Leksell Stereotactic System ® | K031999 |
5. Other relevant submissions
| 10.0.000 00
10.000 0
AVICAS
| . | 1 |
|---|---|
| SUSTEM | |
| 9000 | VA21000 |
| --------------------------------------------------------------------------------------------------------------------------- |
Company Company Control Concession Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come
· AVCAL.
AVERTAIN
. A . A considered a do . C . C . C . C . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments .
Comments of the Research Annual Comments of the callers and consisted annual consistences and the controlled to the controlled to the controlled to the controlled to the cont
And Accessories
A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - - A - - - - - - - - - - - - - - - - - - - - - - - - - - - | AND AND AND A
170500 |
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00
MAY - 1 2009
1
K040 355
S
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document
F-Utl-1 (5.12.1)
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Anders Skoglund | -- | -- |
| Avser/Regarding | Directory | |
| Leksell Stereotactic System® with Reusable Fixation Screws |
- Device Description (for detailed description see Section "Device Description")
The Reusable Fixation Screws are a part of the Leksell Stereotactic System® and are used to affix the Leksell® Coordinate Frame G firmly to the patient's skull with minimal inconvenience to the patient.
7. Intended Use
The Leksell Stereotactic System® with Reusable Fixation Screws is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy.
Substantial Equivalence 8
The functionality for the Leksell Stereotactic System® with Reusable Fixation Screws is equivalent to its predicate device the Leksell Stereotactic System® (K031999) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.
· Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 255 00
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elekta Instrument AB % Mr. Anders Skoglung Director Regulatory Affairs P.O. Box 7593. SE-103 93 Stockholm Sweden
MAY - 1 2009
Re: K080355
Trade/Device Name: Leksell Stereotactic System® with Reusable fixation Screws Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 27, 2009 Received: April 29, 2009
Dear Mr. Skoglung:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Anders Skoglung
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A Millman
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K.050355
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document Traditional 510/k)
| Utfärdare/Issuer | Rel. nr/Dok. nr/Ref. no/Doc. no | Utgåva /Edition |
|---|---|---|
| Anders Skoglund | -- | -- |
| Avser/Regarding | Directory | |
| Leksell Stereotactic System® with Reusable Fixation Screws |
Section 7- Indications for Use Statement
| 510(k) Number | To be defined |
|---|---|
| Device Name | Leksell Stereotactic System® with Reusable Fixation Screws |
| Indications for Use | The Leksell Stereotactic System® with Reusable Fixation Screws is |
| a system intended for localization and diagnosis of intracranial | |
| disorders and their surgical treatment, including radiotherapy | |
| and stereotactic radiaton therapy |
Prescription X 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Oslen forman
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K040355
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tei +46 8 587 254 00 Fax +46 8 587 255 00