(151 days)
No
The summary describes a mechanical stereotactic system for guiding instruments based on a physical principle, with no mention of AI or ML in the device description, intended use, or performance testing.
Yes
The device is used to perform various neurosurgical procedures such as deep brain stimulation, biopsies, targeted injections, and lesioning, which are all therapeutic interventions.
No
This device is used for target localization and fixation of the patient head to perform stereotactic neurosurgical procedures, such as deep brain stimulation, lesioning, and biopsies. It is an interventional device, not a diagnostic one.
No
The device description explicitly states the system consists of a head frame, accessories for frame application and imaging, a stereotactic arc, and operating room accessories, all of which are hardware components.
Based on the provided information, the Leksell® Vantage™ Stereotactic System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for target localization and fixation of the patient's head for neurosurgical procedures performed directly on the patient (in vivo). This includes procedures like deep brain stimulation, lesioning, biopsies, and injections.
- Device Description: The device is a mechanical system used to physically position and guide instruments during surgery. It involves a head frame, stereotactic arc, and accessories for surgical procedures.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Leksell® Vantage™ system does not perform any analysis or testing of biological samples in vitro.
The system is a surgical tool used for precise targeting and intervention within the patient's brain, which is an in vivo application, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
The Intended Purpose of Leksell® Vantage™ Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
Product codes
HAW
Device Description
The Leksell® Vantage™ Stereotactic System is a device used for minimally invasive neurosurgical procedures. It enables coordinate referencing and fixation of the patient's skull and brain during image acquisition and treatment. The coordinate referencing enables target localization and accurate stereotactic treatment of brain targets; for example for aspirations and biopsies, electrode placements, injections of cells & drugs, heamatoma evacuations as well as lesioning using a number of methodologies.
The system consists of a head frame that is fixated to the patient skull by minimally invasive disposable fixation pins and a number of accessories for frame application and imaging as well as a stereotactic arc and operating room accessories for the sterile surgical procedure.
The system is based on the established Leksell center-of-arc principle, which allows guidance of compatible interventional instruments at any trajectory angle to the brain target. Compatible interventional instruments are based on the Leksell principle of an active working length of 190 mm (as the arc radius) and use the correct mechanical interfacing of the Arc instrument stop and guide holders. Various instruments, such as biopsy needles, cannulas, and electrodes can be used with the system to perform biopsies, hematoma evacuation and injections of radioactive nuclides and cytostatic agents, puncture of cysts, positioning electrodes for stimulation/ recording or lesioning and stereotactic endoscope guidance.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient head, brain, intracranial anatomical targets
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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
The verification activities have covered requirements at system and subsystem level to show that the design output meet the design input.
Design and usability validation of the system has been performed by competent and professionally qualified personnel to ensure that the product fulfils the intended use and user needs. The design and usability validation was also made to ensure that the risk control measures associated with functions related to safety (FRS) was effective.
-
Study Type: Biocompatibility
- Test Method Summary: Biocompatibility testing were performed for those materials that come in contact with the patient. The tests were performed on the subject device according to ISO 10993-1, ISO 10993-5, ISO 10993-7 and ISO 10993-10.
- Results: All biocompatibility tests are reported to pass the respective biocompatibility requirements. Based on the results, knowledge of the material, exposure time and area and indication, the device is judged to be substantial equivalent to the predicate device from a biocompatibility perspective.
-
Study Type: Sterilization - devices sold as sterile
- Test Method Summary: Sterility validation (EtO) according to ISO 11135:2014 was performed to demonstrate that the devices have a sterility assurance level (SAL) of 10$^{-6}$. The tests were performed on the subject device.
- Results: Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of sterility.
-
Study Type: Sterilization - reusable parts
- Test Method Summary: Reusable parts were validated for steam sterilization. The validation was performed with the intent to prove that the Leksell Vantage™ Arc System can obtain a sterility assurance level (SAL) of at least 10$^{-6}$ when steam sterilized in 134°C-3 min or 132°C-4 min. The tests were performed on the subject device.
- Results: Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of sterility for reusable parts.
-
Study Type: Cleaning - reusable parts
- Test Method Summary: Reusable parts were validated for manual cleaning and cleaning with a washer-disinfector according to EN ISO 15883. The validation was performed with the intent to prove that the Leksell® Vantage™™ System will be clean when using the methods described in the IFU. The tests were performed on the subject device by using artificial blood and detection of protein residues after cleaning.
- Results: All parts passed the final validation and met all pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of cleaning.
-
Study Type: Shelf life and packaging/shipping testing
- Test Method Summary: Shelf life and transport testing was performed on 3 years accelerated aged products according to ASTM F1980-07, ASTM F1886-09, ASTM F1929-15, ASTM F88-15, ISO 11607-1:2006/A1:2014, ASTM D4169-14, ISO 11737-2
- Results: All test were passed, demonstrating sterility after transport and shelf life of three years for the pre-sterilized parts, showing substantial equivalence to the predicate device.
-
Study Type: MR testing
- Test Method Summary: The device was subjected to compliance testing to applicable consensus safety standards, such as: ASTM F2052; ASTM F2119; ASTM F2182, ASTM F2213 and ASTM F2503, and FDA guidance regarding safety and compatibility in the MR environment.
- Results: The result demonstrates that the device is compliant to the FDA guidance and applicable consensus standard. This compliance demonstrates substantial equivalence.
-
Study Type: Accuracy
- Test Method Summary: Accuracy was tested on different levels of the subject device:
- Total system accuracy from imaging to treatment.
- Total mechanical accuracy of the system
- Mechanical accuracy of each component
- Handling accuracy of various steps like repeated mounting of parts to each other and scale setting accuracy.
- Displacement from load of head when fixed in the frame
- Results: All test cases were passed, demonstrating that the overall system accuracy of the Vantage system is substantial equivalent to the predicate device.
- Test Method Summary: Accuracy was tested on different levels of the subject device:
Key Metrics
Mechanical accuracy 0,9 mm
Predicate Device(s)
Reference Device(s)
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
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2017
Elekta Instrument AB Matilda Forsberg Regulatory Affairs Engineer Kungstensgatan 18 Stockholm, 10393 SE
Re: K171123
Trade/Device Name: Leksell Vantage Stereotactic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 9, 2017 Received: June 19, 2017
Dear Ms. Forsberg:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171123
Device Name
Leksell® Vantage™ Stereotactic System
Indications for Use (Describe)
The Intended Purpose of Leksell® Vantage™ Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 4- 510(k) Summary
As Required by 21 CFR 807.92(c) 510 (k) Summary
1. Subscribers Name & Address
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 Official Correspondent: Mats Premfors, QA Manager
Date summary prepared: 2017-09-14
2. Trade Name
Leksell® Vantage™ Stereotactic System
Common Name 3.
Stereotaxic instrument
4. Device Classification
| Trade Name | Product
Code | Regulation
Number | Class | Classification Panel |
|------------------------------------------|-----------------|----------------------|-------|----------------------|
| Leksell® Vantage™ Stereotactic
System | HAW | 21 CFR 882.4560 | II | Neurology |
5. Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell Stereotactic System | K080355 |
Other relevant submissions 6.
| Device | 510(k) # |
|---|---|
| Leksell Stereotactic System, Injection/ Aspiration Needle Kit | K152558 |
| Leksell Stereotactic System, Biopsy Needle Kit | K031980 |
| Leksell Stereotactic System | K972324 |
4
7. Device Description
The Leksell® Vantage™ Stereotactic System is a device used for minimally invasive neurosurgical procedures. It enables coordinate referencing and fixation of the patient's skull and brain during image acquisition and treatment. The coordinate referencing enables target localization and accurate stereotactic treatment of brain targets; for example for aspirations and biopsies, electrode placements, injections of cells & drugs, heamatoma evacuations as well as lesioning using a number of methodologies.
The system consists of a head frame that is fixated to the patient skull by minimally invasive disposable fixation pins and a number of accessories for frame application and imaging as well as a stereotactic arc and operating room accessories for the sterile surgical procedure.
The system is based on the established Leksell center-of-arc principle, which allows guidance of compatible interventional instruments at any trajectory angle to the brain target. Compatible interventional instruments are based on the Leksell principle of an active working length of 190 mm (as the arc radius) and use the correct mechanical interfacing of the Arc instrument stop and guide holders. Various instruments, such as biopsy needles, cannulas, and electrodes can be used with the system to perform biopsies, hematoma evacuation and injections of radioactive nuclides and cytostatic agents, puncture of cysts, positioning electrodes for stimulation/ recording or lesioning and stereotactic endoscope guidance.
8. Summary of clinical testing
Clinical testing was deemed not required to demonstrate substantial equivalence.
9. Summary of Non Clinical and Performance testing
The verification activities have covered requirements at system and subsystem level to show that the design output meet the design input.
Design and usability validation of the system has been performed by competent and professionally qualified personnel to ensure that the product fulfils the intended use and user needs. The design and usability validation was also made to ensure that the risk control measures associated with functions related to safety (FRS) was effective.
The table below summarize the performance testing performed, test method summary and result:
5
| Test | Test Method Summary | Results |
|---|---|---|
| Biocompatibility | Biocompatibility testing were | |
| performed for those materials that | ||
| come in contact with the patient. |
The tests were performed on the
subject device according to ISO 10993-
1, ISO 10993-5, ISO 10993-7 and ISO
10993-10. | All biocompatibility tests
are reported to pass the
respective biocompatibility
requirements. Based on the
results, knowledge of the
material, exposure time
and area and indication, the
device is judged to be
substantial equivalent to
the predicate device from a
biocompatibility
perspective. |
| Sterilization - devices
sold as sterile | Sterility validation (EtO) according to
ISO 11135:2014 was performed to
demonstrate that the devices have a
sterility assurance level (SAL) of 10 $^{-6}$ .
The tests were performed on the
subject device. | Results met pre-established
acceptance criteria,
demonstrating substantial
equivalence to the
predicate device in terms of
sterility. |
| Sterilization -
reusable parts | Reusable parts were validated for
steam sterilization. The validation was
performed with the intent to prove that
the Leksell Vantage™ Arc System can
obtain a sterility assurance level (SAL)
of at least 10 $^{-6}$ when steam sterilized in
134°C-3 min or 132°C-4 min.
The tests were performed on the
subject device. | Results met pre-established
acceptance criteria,
demonstrating substantial
equivalence to the
predicate device in terms of
sterility for reusable parts. |
| Cleaning - reusable
parts | Reusable parts were validated for
manual cleaning and cleaning with a
washer-disinfector according to EN ISO
15883. The validation was performed
with the intent to prove that the
Leksell® Vantage™™ System will be clean
when using the methods described in
the IFU. The tests were performed on
the subject device by using artificial
blood and detection of protein residues
after cleaning. | All parts passed the final
validation and met all pre-
established acceptance
criteria, demonstrating
substantial equivalence to
the predicate device in
terms of cleaning. |
| Shelf life and
packaging/shipping
testing | Shelf life and transport testing was
performed on 3 years accelerated aged
products according to ASTM F1980-07,
ASTM F1886-09, ASTM F1929-15,
ASTM F88-15, ISO 11607-
1:2006/A1:2014, ASTM D4169-14, ISO
11737-2 | All test were passed,
demonstrating sterility
after transport and shelf life
of three years for the pre-
sterilized parts, showing
substantial equivalence to
the predicate device. |
| MR testing | The device was subjected to
compliance testing to applicable
consensus safety standards, such as:
ASTM F2052; ASTM F2119; ASTM
F2182, ASTM F2213 and ASTM F2503,
and FDA guidance regarding safety and
compatibility in the MR environment. | The result demonstrates
that the device is compliant
to the FDA guidance and
applicable consensus
standard. This compliance
demonstrates substantial
equivalence. |
| Accuracy | Accuracy was tested on different levels
of the subject device:
- Total system accuracy from
imaging to treatment. - Total mechanical accuracy of
the system - Mechanical accuracy of each
component - Handling accuracy of various
steps like repeated mounting of
parts to each other and scale
setting accuracy. - Displacement from load of head
when fixed in the frame | All test cases were passed,
demonstrating that the
overall system accuracy of
the Vantage system is
substantial equivalent to
the predicate device. |
6
Summary:
The components have been subjected to compliance testing to applicable consensus safety standards in order to support the MR conditional and MR safety claims. Testing has also been done to meet applicable biocompatibility and sterilization standards.
Results from verification and validation testing demonstrates that conformance to applicable technical requirement specifications and user needs have been met showing that the system is safe to use and is substantially equivalent to the predicate device.
7
10. Intended Use
The Intended Purpose of Leksell® Vantage™ Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
11. Technological Characteristics
The Leksell® Vantage™ Stereotactic System has equivalent technological characteristics as its predicate device (K080355). It uses the same coordinate system and center-of-arc principle, which allows guidance of compatible interventional instruments at any trajectory angle to the brain target. Neurosurgical Instruments from Elekta (needles and cannulas) with a working length of 190 mm, previously cleared in the predicate devices K080355, K152558 and K031980, are also fully compatible with Leksell Vantage Stereotactic System.
12. Substantial Equivalence
The Leksell® Vantage™ Stereotactic System is built on the same technique as its predicate device Leksell Stereotactic System (K080355). It utilizes the same Center-of-Arc Principle with a 190 mm Arc radius for the introduction of neurosurgical instruments.
Leksell® Vantage™ Stereotactic System and the previously cleared Leksell Stereotactic System has/is:
- . Same system accuracy
- . Same coordinate system
- . Same Center of Arc Principle
- . Intended for localizing the same intracranial anatomical targets
- . Used for the same clinical interventions and/or treatments i.e.
- . Intended for use by the same health care professionals
The table below shows a comparison between the Leksell® Vantage™ Stereotactic System and the predicate device.
8
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Leksell® Vantage™ Stereotactic | |
| System | Leksell Stereotactic System® | |
| (K080355) | ||
| Regulation | ||
| Number | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | HAW | HAW |
| Product Class | II | II |
| Description | Head Frame and semi-circular arc | |
| system used for the coordinate | ||
| referencing of targets in the brain | ||
| and the guidance of neurosurgical | ||
| instruments to these brain targets. | Head Frame and semi-circular arc | |
| system used for the coordinate | ||
| referencing of targets in the brain | ||
| and the guidance of neurosurgical | ||
| instruments to these brain targets. | ||
| Technical | ||
| Features | Coordinate System: | |
| Leksell Coordinate System using | ||
| Cartesian coordinates |
Fixation:
Head Frame applied to patient
skull with four fixation pins.
Fixation Pins:
Single use Fixation Pins and
Inserts that secures the Vantage
head frame to the patient skull
using Leksell Vantage Keys | Coordinate System:
Leksell Coordinate System using
Cartesian coordinates
Fixation:
Head Frame applied to patient
skull with four fixation pins.
Fixation Pins:
Titanium Fixation Pins, Reusable
Fixation Pins and Disposable
Inserts that secures the Leksell
Coordinate Frame G to the
patient skull using Instrument
Screw Drivers |
| Principles of
Use | Center of the arc principle using
an arc radius of 190 mm.
Cartesian coordinates applied to
the brain of the patient by the use
of a head frame fixated to the
skull.
• comprises a headframe and arc;
• is target centered
• uses Cartesian (x,y,z)
coordinates to triangulate target
position in frame
• utilizes fiducial markers that can
be registered to a stereotactic
brain atlas and/or intracranial
image;
• provides support and
accessories for surgical
instruments to the target; | Center of the arc principle using
an arc radius of 190 mm.
Cartesian coordinates applied to
the brain of the patient by the use
of a head frame fixated to the
skull.
• comprises a headframe and arc;
• is target centered
• uses Cartesian (x,y,z)
coordinates to triangulate target
position in frame
• utilizes fiducial markers that can
be registered to a stereotactic
brain atlas and/or intracranial
image;
• provides support and
accessories for surgical
instruments to the target; |
| | Subject Device | Predicate Device |
| | | |
| Material | Invasive components:
PEEK with Aluminum tip. | Invasive components:
Aluminum or Titanium. |
| | Head Frame:
Glass fiber reinforced Epoxy | Head Frame:
Aluminum (with glued joints for
insulation in MRI) |
| | Arc:
Aluminum | Arc:
Aluminum |
| Accuracy | Mechanical accuracy 0,9 mm | Mechanical accuracy 0,9 mm |
| Accessories | Neurosurgical Instruments with
working length of 190 mm | Neurosurgical Instruments with
working length of 190 mm |
9
Conclusion:
The main differences to the predicate device is the frame material, made in a composite material, making it more suitable for MR imaging. Other improvements made are easier fixation and handling due to fewer components. The similarities are significant and the conclusion is that the device is substantial equivalent with the predicate device.