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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Leksell® Vantage™ Stereotactic System:

The document (K171123) describes the Leksell® Vantage™ Stereotactic System, a device used for stereotactic neurosurgical procedures. The primary focus of the regulatory submission is to demonstrate substantial equivalence to a previously cleared predicate device (Leksell Stereotactic System, K080355). This means the study design focuses on proving the new device performs as well as the existing one, rather than establishing absolute performance thresholds.

Important Note: The provided text does not include acceptance criteria in a quantitative, pre-defined manner for all performance tests. Instead, it generally states that "Results met pre-established acceptance criteria" or "All test cases were passed." For the "Accuracy" test, it specifically mentions an equivalence to the predicate device's mechanical accuracy of 0.9 mm.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (As Implied/Stated in Document)	Reported Device Performance
Biocompatibility	Pass respective biocompatibility requirements (according to ISO 10993-1, -5, -7, -10).	All tests reported to pass, judged substantially equivalent to predicate device.
Sterilization - devices sold as sterile	Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ (according to ISO 11135:2014).	Results met pre-established acceptance criteria, demonstrating substantial equivalence.
Sterilization - reusable parts	Achieve a Sterility Assurance Level (SAL) of at least 10⁻⁶ when steam sterilized in 134°C-3 min or 132°C-4 min.	Results met pre-established acceptance criteria, demonstrating substantial equivalence.
Cleaning - reusable parts	Be clean when using methods described in IFU, with artificial blood and detection of protein residues after cleaning (according to EN ISO 15883).	All parts passed final validation and met all pre-established acceptance criteria, demonstrating substantial equivalence.
Shelf life and packaging/shipping testing	Maintain sterility after transport and exhibit a shelf life of three years for pre-sterilized parts (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 tests were passed, demonstrating sterility after transport and shelf life of three years, showing substantial equivalence.
MR Testing	Compliance to applicable consensus safety standards (ASTM F2052, F2119, F2182, F2213, F2503) and FDA guidance for safety and compatibility in MR environment.	The result demonstrates compliance to FDA guidance and applicable consensus standards, demonstrating substantial equivalence.
Accuracy	Overall system accuracy substantially equivalent to the predicate device, which has a mechanical accuracy of 0.9 mm.	All test cases were passed, demonstrating that the overall system accuracy of the Vantage system is substantially equivalent to the predicate device. Mechanical accuracy (subject device): 0.9 mm.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each non-clinical performance test (e.g., number of devices or components tested for biocompatibility, sterility, cleaning, or accuracy tests). The testing is described as occurring "on the subject device" or "on different levels of the subject device components."
Data Provenance: The studies are non-clinical, performed by the manufacturer (Elekta Instrument AB). No country of origin for data is specified beyond the manufacturer's location in Stockholm, Sweden. These are prospective tests performed on the new device (Leksell® Vantage™ Stereotactic System).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This device is a medical instrument, not an AI or diagnostic imaging device that requires interpretation of results by human experts to establish ground truth for a test set.
The "ground truth" for the non-clinical tests (e.g., whether a device is sterile, biocompatible, or accurate) is established by objective measurements against scientific and engineering standards, not by expert consensus or interpretation in the way it would be for an AI diagnostic tool.
The document states that "Design and usability validation of the system has been performed by competent and professionally qualified personnel." No specific number or qualifications (e.g., "radiologist with 10 years of experience") are provided as they are not relevant for this type of device testing.

4. Adjudication Method for the Test Set

None applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies evaluating subjective interpretations (e.g., reading medical images) where multiple experts produce differing opinions that need to be resolved. For non-clinical, objective performance testing, results are determined by compliance to pre-defined, measurable standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned because this is a physical medical device (stereotactic system), not an AI or imaging software that assists human readers in interpreting cases. The comparison is between the new device's engineering performance and validated standards/predicate device performance, not human diagnostic ability.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

N/A. This question is also not applicable. The device is a physical instrument for neurosurgery, not an algorithm. Its "standalone" performance would be its inherent mechanical accuracy and compliance with various standards, which are evaluated in the non-clinical tests described.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests is based on objective measurements against established engineering, biocompatibility, sterilization, and safety standards (e.g., ISO, ASTM, FDA guidance). For accuracy, the ground truth is a precisely measured distance (0.9 mm Mechanical Accuracy).

8. Sample Size for the Training Set

N/A. This device does not use an "AI algorithm" that requires a training set. The term "training set" is relevant for machine learning models, not for traditional medical devices undergoing performance verification.

9. How the Ground Truth for the Training Set Was Established

N/A. As there is no AI algorithm, there is no training set and therefore no ground truth establishment for a training set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K171123

Device Name

Leksell® Vantage™ Stereotactic System

Indications for Use (Describe)

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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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	ProductCode	RegulationNumber	Class	Classification Panel
Leksell® Vantage™ StereotacticSystem	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

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7. Device Description

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:

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Test	Test Method Summary	Results
Biocompatibility	Biocompatibility testing wereperformed for those materials thatcome in contact with the patient.The tests were performed on thesubject device according to ISO 10993-1, ISO 10993-5, ISO 10993-7 and ISO10993-10.	All biocompatibility testsare reported to pass therespective biocompatibilityrequirements. Based on theresults, knowledge of thematerial, exposure timeand area and indication, thedevice is judged to besubstantial equivalent tothe predicate device from abiocompatibilityperspective.
Sterilization - devicessold as sterile	Sterility validation (EtO) according toISO 11135:2014 was performed todemonstrate that the devices have asterility assurance level (SAL) of 10 $^{-6}$ .The tests were performed on thesubject device.	Results met pre-establishedacceptance criteria,demonstrating substantialequivalence to thepredicate device in terms ofsterility.
Sterilization -reusable parts	Reusable parts were validated forsteam sterilization. The validation wasperformed with the intent to prove thatthe Leksell Vantage™ Arc System canobtain a sterility assurance level (SAL)of at least 10 $^{-6}$ when steam sterilized in134°C-3 min or 132°C-4 min.The tests were performed on thesubject device.	Results met pre-establishedacceptance criteria,demonstrating substantialequivalence to thepredicate device in terms ofsterility for reusable parts.
Cleaning - reusableparts	Reusable parts were validated formanual cleaning and cleaning with awasher-disinfector according to EN ISO15883. The validation was performedwith the intent to prove that theLeksell® Vantage™™ System will be cleanwhen using the methods described inthe IFU. The tests were performed onthe subject device by using artificialblood and detection of protein residuesafter cleaning.	All parts passed the finalvalidation and met all pre-established acceptancecriteria, demonstratingsubstantial equivalence tothe predicate device interms of cleaning.
Shelf life andpackaging/shippingtesting	Shelf life and transport testing wasperformed on 3 years accelerated agedproducts according to ASTM F1980-07,ASTM F1886-09, ASTM F1929-15,ASTM F88-15, ISO 11607-1:2006/A1:2014, ASTM D4169-14, ISO11737-2	All test were passed,demonstrating sterilityafter transport and shelf lifeof three years for the pre-sterilized parts, showingsubstantial equivalence tothe predicate device.
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 is compliantto the FDA guidance andapplicable consensusstandard. This compliancedemonstrates substantialequivalence.
Accuracy	Accuracy was tested on different levelsof the subject device:- Total system accuracy fromimaging to treatment.- Total mechanical accuracy ofthe system- Mechanical accuracy of eachcomponent- Handling accuracy of varioussteps like repeated mounting ofparts to each other and scalesetting accuracy.- Displacement from load of headwhen fixed in the frame	All test cases were passed,demonstrating that theoverall system accuracy ofthe Vantage system issubstantial equivalent tothe predicate device.

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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.

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10. Intended Use

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.

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	Subject Device	Predicate Device
Device Name	Leksell® Vantage™ StereotacticSystem	Leksell Stereotactic System®(K080355)
RegulationNumber	21 CFR 882.4560	21 CFR 882.4560
Product Code	HAW	HAW
Product Class	II	II
Description	Head Frame and semi-circular arcsystem used for the coordinatereferencing of targets in the brainand the guidance of neurosurgicalinstruments to these brain targets.	Head Frame and semi-circular arcsystem used for the coordinatereferencing of targets in the brainand the guidance of neurosurgicalinstruments to these brain targets.
TechnicalFeatures	Coordinate System:Leksell Coordinate System usingCartesian coordinatesFixation:Head Frame applied to patientskull with four fixation pins.Fixation Pins:Single use Fixation Pins andInserts that secures the Vantagehead frame to the patient skullusing Leksell Vantage Keys	Coordinate System:Leksell Coordinate System usingCartesian coordinatesFixation:Head Frame applied to patientskull with four fixation pins.Fixation Pins:Titanium Fixation Pins, ReusableFixation Pins and DisposableInserts that secures the LeksellCoordinate Frame G to thepatient skull using InstrumentScrew Drivers
Principles ofUse	Center of the arc principle usingan arc radius of 190 mm.Cartesian coordinates applied tothe brain of the patient by the useof a head frame fixated to theskull.• comprises a headframe and arc;• is target centered• uses Cartesian (x,y,z)coordinates to triangulate targetposition in frame• utilizes fiducial markers that canbe registered to a stereotacticbrain atlas and/or intracranialimage;• provides support andaccessories for surgicalinstruments to the target;	Center of the arc principle usingan arc radius of 190 mm.Cartesian coordinates applied tothe brain of the patient by the useof a head frame fixated to theskull.• comprises a headframe and arc;• is target centered• uses Cartesian (x,y,z)coordinates to triangulate targetposition in frame• utilizes fiducial markers that canbe registered to a stereotacticbrain atlas and/or intracranialimage;• provides support andaccessories for surgicalinstruments 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 forinsulation in MRI)
	Arc:Aluminum	Arc:Aluminum
Accuracy	Mechanical accuracy 0,9 mm	Mechanical accuracy 0,9 mm
Accessories	Neurosurgical Instruments withworking length of 190 mm	Neurosurgical Instruments withworking length of 190 mm

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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.

Regulation Number and Section

§ 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).