(119 days)
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.
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.
The provided text describes specific acceptance criteria and the results of a study conducted to demonstrate the substantial equivalence of the Leksell® Vantage™ Stereotactic System with CT accessories to its predicate devices.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test) | Reported Device Performance and Acceptance Criteria Met |
|---|---|
| Sterilization | Test Method: Sterility validation (EtO) according to ISO 11135:2014 was performed to demonstrate that the device has a sterility assumed level (SAL) of 10-6. Tests were conducted on the predicate device (K171123). |
| Results: Results met pre-established acceptance criteria, demonstrating equivalence to the predicate device in terms of sterility. | |
| MR Testing (Safety & Compatibility) | Test Method: Device subjected to compliance testing according to ASTM F2052; ASTM F2119; ASTM F2182, ASTM F2213 and ASTM F2503, and FDA guidance regarding safety and compatibility in the MR environment. |
| Results: The device is compliant with FDA guidance and applicable consensus standards, demonstrating substantial equivalence. | |
| Accuracy | Test Method: Accuracy was tested at different levels: Total system accuracy (imaging to treatment), total mechanical accuracy, mechanical accuracy of each component, handling accuracy (e.g., repeated mounting, scale setting), and displacement from head load when fixed in the frame. |
| Results: All test cases were passed, demonstrating that the overall system accuracy of the Vantage system with CT accessories is substantially equivalent to the predicate device. The mechanical accuracy specified for both the subject and predicate devices is 0.9 mm. | |
| Design and Usability Validation | Test Method: Design and usability validation was performed by trained, competent, and professionally qualified personnel to ensure the product fulfills its intended use and user needs. The validation also aimed to ensure the effectiveness of risk control measures related to safety functions. |
| Results: No unacceptable human factor risks were identified. Residual risks were weighed against the product's benefit and deemed acceptable, demonstrating substantial equivalence to the predicate device when used with CT accessories. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state sample sizes for the test sets in the performance reports for Sterilization, MR testing, Accuracy, or Design and Usability validation. It refers to "test cases" for accuracy and "trained competent and professionally qualified personnel" for usability.
The provenance of the data (country of origin, retrospective/prospective) is not specified. However, the applicant is "Elekta Instrument AB" from Stockholm, Sweden.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document mentions "trained competent and professionally qualified personnel" for Design and Usability validation, but does not specify the number or specific qualifications (e.g., years of experience, specialty) of these experts. For Accuracy, Sterilization, and MR testing, it refers to testing methods and compliance with standards, implying technical personnel rather than clinical experts establishing ground truth in the traditional sense for medical imaging AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method (like 2+1, 3+1) for establishing ground truth, as it's not a study involving diagnostic interpretation where multiple experts would provide conflicting assessments requiring adjudication. The tests performed are engineering and usability validations against predetermined criteria and standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device is a stereotactic system, a mechanical instrument for surgical guidance, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a hardware device without AI algorithms. Performance testing was done on the device's physical and functional properties, which could be considered standalone performance for a mechanical system. For example, "Accuracy" testing assessed the system's inherent mechanical precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the various tests appears to be:
- Sterilization: The specified sterility assumed level (SAL) of 10-6 according to ISO 11135:2014.
- MR Testing: Compliance with applicable consensus safety standards (ASTM F2052, F2119, F2182, F2213, F2503) and FDA guidance.
- Accuracy: The predefined mechanical accuracy specification of 0.9 mm, determined through various measurements of the system and its components.
- Design and Usability Validation: Fulfillment of intended use and user needs, and effectiveness of risk control measures associated with safety functions, assessed by qualified personnel.
8. The sample size for the training set
This is not applicable. The device is a stereotactic system, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI model.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2019
Elekta Instrument AB Alf Laurell Regulatory Affairs Engineer Kungstensgatan 18 Stockholm, 10393 SE
Re: K190887
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: July 1, 2019 Received: July 3, 2019
Dear Alf Laurell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190887
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) |
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Dokumentnamn/Name of document Traditional 510(k)
| Issuer | Ref nr/Dok nr/Ref no/Doc no | Edition |
|---|---|---|
| Alf Laurell | -- | -- |
| Regarding | Directory | |
| CT accessories for Leksell Vantage Stereotactic System | -- |
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: 2019-07-27
2. Trade Name
Leksell® Vantage™ Stereotactic System
3. Common Name
Stereotaxic instrument
Device Classification 4.
| Trade Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Leksell® Vantage™ Stereotactic System | HAW | II | 21 CFR 882.4560 |
Classification Panel 5.
Neurology
Predicate Device Identification 6.
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell Stereotactic System | K080355 |
| Leksell® Vantage™ Stereotactic System (Primary) | K171123 |
7. Other relevant submissions
N/A, no other relevant submissions
8. 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
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| Dokumentnamn/Name of document | Traditional 510(k) |
|---|---|
| ------------------------------- | -------------------- |
Traditional 510(k)
| Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Edition | -- |
| Regarding | CT accessories for Leksell Vantage Stereotactic System |
| Directory | -- |
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.
9. Summary of clinical testinq
Clinical testing was deemed not required to demonstrate substantial equivalence with the predicate devices.
10. 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.
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 devices.
Testing is summarized in the table below.
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Dokumentnamn/Name of document Traditional 510(k)
| Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Edition | -- |
| Regarding | CT accessories for Leksell Vantage Stereotactic System |
| Directory | -- |
| Test | Test Method Summary | Results |
|---|---|---|
| Sterilization | Sterility validation (EtO) according toISO 11135:2014 was performed todemonstrate that the device have asterility assumed level (SAL) of 10-6.The tests were performed on thepredicate device Leksell® Vantage™Stereotactic System (K171123). | Results met pre-established acceptancecriteria, demonstratingequivalence to thepredicate device in termsof sterility. |
| MR testing | The device was subjected tocompliance testing to applicableconsensus safety standards, such as:ASTM F2052; ASTM F2119; ASTMF2182, ASTM F2213 and ASTM F2503,and FDA guidance regarding safety andcompatibility in the MR environment. | The result demonstratesthat the device iscompliant to the FDAguidance and applicableconsensus standards. Thiscompliance demonstratessubstantial equivalence. |
| Accuracy | Accuracy was tested on differentlevels of the subject device:- Total system accuracy fromimaging to treatment.- Total mechanical accuracy ofthe system- Mechanical accuracy of eachcomponent- Handling accuracy of varioussteps like repeated mountingof parts to each other andscale setting accuracy.- Displacement from load ofhead when fixed in the frame. | All test cases were passed,demonstrating that theoverall system accuracy ofthe Vantage system whenused with the CTaccessories is substantialequivalent to the predicatedevice. |
| Design and Usabilityvalidation | Design and usability validation of thesystem has been performed by trainedcompetent and professionally qualifiedpersonnel to ensure that the productfulfils the intended use and userneeds. | No unacceptable humanfactor risks were identified.Residual risks havebeen weighted against thebenefit of the product andare deemed acceptabledemonstrating that theLeksell® Vantage™Stereotactic System used |
| with the CT accessories issubstantial equivalent tothe predicate device. |
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Dokumentnamn/Name of document Traditional 510/lz)
Traditional 510(k)
| Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Edition | -- |
| Regarding | CT accessories for Leksell Vantage Stereotactic System |
| Directory | -- |
11. 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.
12. Technological Characteristics
The CT accessories of Leksell® Vantage™ Stereotactic System has equivalent technological characteristics as its predicate device (K080355), for further details see the table below.
Substantial Equivalence 13.
The intended use, the basic functionality and the fundamental technological characteristics of the device Leksell® Vantage™ Stereotactic System remain unchanged with the introduction of the CT accessories and the Leksell Vantage Head Frame Holder.
Leksell® Vantage™ Stereotactic as compared to the predicate devices has:
- Same mechanical 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
- Intended for use by the same health care professionals
In addition, the risk evaluation regarding endotoxin testing in routine production for product FirmFix™ 1 -5 has been updated.
The conclusion from verification and validation is that the Leksell® Vantage™ Stereotactic System is substantial equivalent to its predicate devices.
The table below shows a comparison between the Leksell® Vantage™ Stereotactic System and the predicate devices.
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Dokumentnamn/Name of document Traditional 510(k)
| Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Edition | -- |
| Regarding | CT accessories for Leksell Vantage Stereotactic System |
| Directory | -- |
| Subject Device | Predicate Device (K080355) | Predicate Device (K171123) | |
|---|---|---|---|
| Device Name | Leksell® Vantage™ Stereotactic System | Leksell Stereotactic System® (K080355) | Leksell® Vantage™ Stereotactic System (K171123) |
| Regulation Number | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 |
| Product Code | HAW | HAW | HAW |
| Product Class | II | 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. | 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 | Coordinate System: Leksell Coordinate System using Cartesian coordinates | Coordinate System: Leksell Coordinate System using Cartesian coordinates |
| Fixation: Head Frame applied to patient skull with four fixation pins. | Fixation: Head Frame applied to patient skull with four fixation pins. | 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 | 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 | Fixation Pins: Single use Fixation Pins and Inserts that secures the Vantage head frame to the patient skull using Leksell Vantage Keys | |
| Imaging modality | CT and MR | CT and MR | MR |
| Technical characteristics | CT accessories: The Leksell Vantage CT Fiducial Box is used for referencing of the stereotactic coordinate system on the patient's anatomical CT images. | CT accessories: The Open CT Indicator Box is used for referencing of the stereotactic coordinate system on the patient's anatomical CT images. | CT accessories: N/A |
| Leksell® Vantage™ Head Frame interface: | Leksell® Vantage™ Head Frame interface: | Leksell® Vantage™ Head Frame interface: | |
| Subject Device | Predicate Device(K080355) | Predicate Device(K171123) | |
| Leksell® Vantage™ FrameHolder is a modified ORadapter. In addition toholding the Leksell®Vantage™ Head Frame inthe operating room, theFrame Holder is alsointerfacing the CT Fiducialbox via one hole on eachside. | N/A | Leksell® Vantage™ ORadapter | |
| Principles of Use | Center of the arcprinciple using an arcradius of 190 mm.Cartesian coordinatesapplied to the brain ofthe patient by the use ofa head frame fixated tothe skull.• comprises a headframeand arc;• is target centered• uses Cartesian (x,y,z)coordinates totriangulate targetposition in frame• utilizes fiducial markersthat can be registeredto a stereotactic brainatlas and/orintracranial image;• provides support andaccessories for surgicalinstruments to thetarget; | Center of the arcprinciple using an arcradius of 190 mm.Cartesian coordinatesapplied to the brain ofthe patient by the useof a head frame fixatedto the skull.• comprises aheadframe and arc;• is target centered• uses Cartesian (x,y,z)coordinates totriangulate targetposition in frame• utilizes fiducialmarkers that can beregistered to astereotactic brainatlas and/orintracranial image;• provides support andaccessories forsurgical instrumentsto the target; | Center of the arcprinciple using an arcradius of 190 mm.Cartesian coordinatesapplied to the brain ofthe patient by the useof a head frame fixatedto the skull.• comprises aheadframe and arc;• is target centered• uses Cartesian (x,y,z)coordinates totriangulate targetposition in frame• utilizes fiducialmarkers that can beregistered to astereotactic brainatlas and/orintracranial image;• provides support andaccessories forsurgical instrumentsto the target; |
| Material | Invasive components:PEEK with Aluminum tip. | Invasive components:Aluminum or Titanium. | Invasive components:PEEK with Aluminum tip. |
| Head Frame:Glass fiber reinforcedEpoxy | Head Frame:Aluminum (with gluedjoints for insulation inMRI) | Head Frame:Glass fiber reinforcedEpoxy | |
| Subject Device | Predicate Device(K080355) | Predicate Device(K171123) | |
| Arc:Aluminum | Arc:Aluminum | Arc:Aluminum | |
| Accuracy | Mechanical accuracy 0,9 mm | Mechanical accuracy 0,9 mm | Mechanical accuracy 0,9 mm |
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Dokumentnamn/Name of document Traditional 510(k)
| Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Edition | -- |
| Regarding | CT accessories for Leksell Vantage Stereotactic System |
| Directory | -- |
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Dokumentnamn/Name of document Traditional 510/k)
Traditional 510(k)
| Issuer | Alf Laurell |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Edition | -- |
| Regarding | CT accessories for Leksell Vantage Stereotactic System |
| Directory | -- |
Conclusion:
The conclusion is that the subject device is substantial equivalent to its predicate devices.
§ 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).