(103 days)
K01286, K031980
No
The summary does not mention AI, ML, or related terms, and the description focuses on image-based planning software without indicating advanced algorithmic capabilities beyond standard image processing.
No
The device is described as neurosurgical planning software intended for use in planning surgical procedures, not for directly treating a condition or disease.
No
The device is described as neurosurgical planning software used for planning surgical procedures, not for diagnosing conditions or diseases.
Yes
The device description explicitly states it is "an advanced image-based neurosurgical planning software" and does not mention any associated hardware components included with the device itself. While it is designed for use with the Leksell Stereotactic System, the 510(k) summary describes the device as the software component.
Based on the provided information, Leksell SurgiPlan® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "planning invasive intracranial stereotactic surgical procedures." This describes a software used for surgical planning on a patient, not for testing samples in vitro (outside the body).
- Device Description: It's described as "image-based neurosurgical planning software." This reinforces its role in processing medical images for surgical purposes.
- Anatomical Site: The anatomical site is "intracranial," referring to the inside of the skull, which is part of the patient's body.
IVD devices are used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. Leksell SurgiPlan®'s function is clearly related to surgical planning based on imaging of the patient's anatomy, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
Leksell SurgiPlan® is intended for use in planning invasive intracranial stereotactic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
Leksell SurgiPlan® is an advanced image-based neurosurgical planning software, specifically designed for Leksell Stereotactic System®.
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.
K01286, K031980
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
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document
Special 510(k)
| Utfärdare/Issuer | Anders Skoglund |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Utgåva /Edition | -- |
| Avser/Regarding | Leksell SurgiPlan® |
| Directory |
K080250
Section 4- 510(k) Summary
MAY 1 3 2008
2
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 SurgiPlan®
3. Device Classification
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Stereotaxic instrument | HAW | II | 21 CFR 882.4560 |
4. Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell SurgiPlan® | K033340 |
-
- 2
5. Other relevant submissions
| Devices | And Archive of the state of the state of the comments of the comments of the comments of the with the with the with the with and the with the with and the world to the with a
510(k) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 100
PICAL
1118111 | ---------------
KO1286 |
| eksel
Stereotactic System | K031980
ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤ |
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 08
1
Dokumentnamn/Name of document Conciol E10/L)
ELEKTA INSTRUMENT AB
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition |
|---|---|---|
| Anders Skoglund | -- | -- |
| Avser/Regarding | Directory | |
| Leksell SurgiPlan® |
Device Description (for detailed description see Section "Device Description") 6.
Leksell SurgiPlan® is an advanced image-based neurosurgical planning software, specifically designed for Leksell Stereotactic System®.
7. Intended Use
100 100 100
Leksell SurgiPlan® is intended for use in planning invasive intracranial stereotactic surgical procedures.
Substantial Equivalence 8
The functionality for the Leksell SurgiPlan® is equivalent to its predicate device the Leksell SurgiPlan® (K033340) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device.
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized stripes forming its wing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 13 2008
Elekta Instrument AB % Mr. Anders Skoglund Regulatory Affairs P.O. Box 7593 SE-103 93 Stockholm, Sweden
Re: K080250
Trade/Device Name: Leksell SurgiPlan® Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 24, 2008 Received: April 28, 2008
Dear Mr. Skoglund:
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, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 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); 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document
| Utfärdare/issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Special 510(k) |
|---|---|---|---|
| Anders Skoglund | -- | -- | |
| Avser/Regarding | Directory | ||
| Leksell SurgiPlan® |
Section 7- Indications for Use Statement
| 510(k) Number | To be defined K080250 |
|---|---|
| Device Name | Leksell SurgiPlan® |
| Indications for Use | Leksell SurgiPlan® is intended for use in planning invasive intra- |
| cranial stereotactic surgical procedures. |
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)
Nil Re dgl formxm
(Division Sign-Off (Division of General, Restorative, and Neurological Devices
510(k) Number K 080250
Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel +46 8 587 254 00 Fax +46 8 587 255 00