(101 days)
The Medtronic Fusion Compact computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
The FUSION Compact™ system is a surgical guidance platform that supports use of special application software and associated instruments. The system reformats patient-specific CT or MR images acquired before surgery and displays them on-screen from a variety of perspectives (axial, sagittal, coronal). During surgery, the system tracks the position of specialized surgical probes in or on the patient anatomy and continuously updates the probe position on these images.
While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the FUSION Compact™ system can serve to validate this judgment as well as guide.
The FUSION Compact™ is an Electromagnetic-based navigation system, also known as an Image Guided System (IGS), which consists of clinical navigation software, a referencing system and platform/computer hardware. Navigation tracks the position of navigated instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. The FUSION Compact™ system is modular and designed for use in medical office or operating room environments to conduct ENT procedures including Endoscopic Skull Base, Lateral Skull Base, and Functional Endoscopic Sinus Surgery (FESS) procedures. The FUSION Compact™ will utilize a monitor and PC all-in-one computer and a free-standing emitter holder option. The system supports the FUSION Compact™ 1.0 software application. The FUSION Compact™ will interface with the existing Electromagnetic (EM) localization system and existing ENT instruments.
The Medtronic FUSION Compact™ Navigation System is a surgical guidance platform used for precisely locating anatomical structures in ENT procedures. The information provided outlines the system's acceptance criteria and the studies conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy | Maximum error ≤ 3.0 mm at 95% confidence and 99.5% reliability. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that accuracy testing evaluated the FUSION Compact's 3D positional accuracy. The "upper bound of the tip error data" was determined by statistical data analysis. However, it does not specify the exact sample size for the test set (e.g., number of measurements, number of instruments tested).
The data provenance is described as "a pegboard in a surgical office and OR simulated environment with all of the typical instruments and equipment seen in those environments." This indicates that the testing was conducted in simulated environments rather than with actual patient data. The country of origin of this simulated data is not specified.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
The document does not provide information on the number of experts used to establish ground truth for the accuracy testing or their qualifications. Given that the testing involved a "pegboard" and simulated environments, it's unlikely that clinical experts were directly involved in establishing ground truth for individual measurements, but rather for defining the performance requirements.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method for the test set. Since the accuracy testing involved measuring the device's performance against a known physical standard (a pegboard), an adjudication method in the context of human interpretation would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focused on the standalone performance of the device's accuracy.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The "Accuracy Testing" described directly evaluates the algorithm embedded within the FUSION Compact™ Navigation System without human intervention for the measurement itself. It states: "Accuracy Testing was conducted to ensure that the FUSION Compact met the prescribed requirement for accuracy. The FUSION Compact System demonstrates performance in 3D positional accuracy with a maximum error ≤ 3.0 mm."
7. Type of Ground Truth Used:
The type of ground truth used for the accuracy testing appears to be based on a physical standard or a precisely measured reference geometry, implied by the use of a "pegboard." This means the ground truth was a known, objective measurement rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
The document does not provide information regarding the sample size for a training set. The descriptions focus on the testing of the final device's performance. As this is a navigation system primarily relying on electromagnetic tracking and image registration rather than machine learning on large clinical datasets, a "training set" in the typical sense of AI/ML might not be applicable or explicitly documented here.
9. How the Ground Truth for the Training Set Was Established:
Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2016
Medtronic Navigation, Inc. Rishi Sinha Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K153247
Trade/Device Name: Fusion Compact Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: January 15, 2016 Received: January 19, 2016
Dear Mr. Sinha:
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 devicerelated 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.
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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 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 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 yours,
Eric A. Mann -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) N/A
Device Name Fusion Compact Navigation System
Indications for Use (Describe)
The Medtronic Fusion Compact computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
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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510(k) Summary
| Submitter: | Medtronic Navigation, Inc.826 Coal Creek CircleLouisville, CO 80027 |
|---|---|
| Contact Person: | Rishi Sinha (Primary)Principal Regulatory Affairs SpecialistPhone: (269) 903-4373Fax: (720) 890-3500E-mail: rishi.k.sinha@medtronic.com |
| Michael Blasco (Alternate)Senior Regulatory Affairs ManagerPhone: (720)890-3391Fax: (720) 890-3500E-mail: michael.blasco@medtronic.com | |
| Date Summary Prepared: | January 15, 2016 |
| Device Trade Name: | Medtronic FUSION Compact™ Navigation System |
| Common Name: | Ear Nose and Throat Stereotaxic Instrument |
| Device Classification: | Class II |
| Product Code: | PGW |
| Classification Name: | 882.4560 - Stereotaxic Instrument |
| Predicate Device: | K001284 - StealthStation System GoldenEye Micro-MagneticTracking System Option |
| Device Description: | The FUSION Compact™ system is a surgical guidance platformthat supports use of special application software and associatedinstruments. The system reformats patient-specific CT or MRimages acquired before surgery and displays them on-screen froma variety of perspectives (axial, sagittal, coronal). During surgery,the system tracks the position of specialized surgical probes in oron the patient anatomy and continuously updates the probeposition on these images. |
| While the surgeon's judgment remains the ultimate authority,real-time positional information obtained through the FUSIONCompact™ system can serve to validate this judgment as well asguide. | |
| The FUSION Compact™ is an Electromagnetic-based navigationsystem, also known as an Image Guided System (IGS), whichconsists of clinical navigation software, a referencing system and | |
| platform/computer hardware. Navigation tracks the position ofnavigated instruments in relation to the surgical anatomy andidentifies this position on diagnostic or intraoperative images ofthe patient. The FUSION Compact™ system is modular anddesigned for use in medical office or operating room environmentsto conduct ENT procedures including Endoscopic Skull Base,Lateral Skull Base, and Functional Endoscopic Sinus Surgery(FESS) procedures. The FUSION Compact™ will utilize a monitorand PC all-in-one computer and a free-standing emitter holderoption. The system supports the FUSION Compact™ 1.0software application. The FUSION Compact™ will interface withthe existing Electromagnetic (EM) localization system and existingENT instruments. | |
| Indications for Use: | The Medtronic FUSION Compact™ computer-assisted surgerysystem and its associated applications are intended as an aid forprecisely locating anatomical structures in either open orpercutaneous ENT procedures. Their use is indicated for anymedical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure,such as the skull, can be identified relative to images of theanatomy. |
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| Substantial Equivalence: | The FUSION Compact™ Navigation System is substantially equivalent to the following device: |
|---|---|
| --------------------------------- | -------------------------------------------------------------------------------------------- |
- K001284 StealthStation System GoldenEye Micro-. Magnetic Tracking System Option
| Subject Device | Predicate | |
|---|---|---|
| FUSION Compact™Navigation System | StealthStation GoldenEye(K001284) | |
| Classification | Class II | Class II |
| Product Code | PGW; 882.4560 - StereotaxicInstrument | HAW; 882.4560 - StereotaxicInstrument |
| Indications forUse | The Medtronic FUSIONCompact™ computer-assistedsurgery system and itsassociated applications areintended as an aid for preciselylocating anatomical structures ineither open or percutaneousENT procedures. Their use isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and where | The StealthStation®GoldenEye System is intendedas an aid for precisely locatinganatomical structures in eitheropen or percutaneousprocedures. TheStealthStation® System isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and wherereference to a rigid anatomical |
| Subject Device | Predicate | |
| FUSION Compact™Navigation System | StealthStation GoldenEye(K001284) | |
| reference to a rigid anatomicalstructure, such as the skull, canbe identified relative to a CT- orMR-based model or digitizedlandmarks of the anatomy. | structure, such as the skull, along bone, or vertebra, can beidentified relative to a CT-based or MR-based model,fluoroscopy images, ordigitized landmarks of theanatomy. | |
| Example procedures includebut are not limited to: | ||
| Cranial procedures:■ Cranial biopsies■ Tumor resections■ Craniotomies/craniectomies■ Skull base proceduresThalamotomies/pallidotomies | ||
| Spinal implant procedures,such as pedicle screwplacement | ||
| ENT procedures:■ Transphenoidal procedures■ Intranasal procedures■ Orbital nerve decompressionproceduresSinus procedures, such asmaxillary antrostomies,ethmoidectomies,sphenoidotomies/sphenoidexplorations, turbinateresections, and frontalsinusotomies | ||
| OperatingPrinciple | The electromagnetic systemcollects measurements,determines position andorientation from each coilindependently. The systemtransmits multiple magneticfields within which the receivecoils can be measured. Ameasurement for each coil withineach transmitted field is used to | The electromagnetic systemcollects measurements,determines position andorientation from each coilindependently. The systemtransmits multiple magneticfields within which the receivecoils can be measured. Ameasurement for each coilwithin each transmitted field is |
| Subject Device | Predicate | |
| FUSION Compact™Navigation System | StealthStation GoldenEye(K001284) | |
| determine the position andorientation of the coil.Measurement position andcombined to determine theinstrument position andorientation. Two measuredpositions, one from each coil,are utilized to determine positionand orientation of a two coiledinstrument. Three measuredpositions, one from each coil,are utilized to determine positionand orientation of a three coiledinstrument. | used to determine the positionand orientation of the coil.Measurement position andorientation for the coils arecombined to determine theinstrument position andorientation. Two measuredpositions, one from each coil,are utilized to determine positionand orientation of a two coiledinstrument. | |
| System Accuracy | Maximum error less than 3.0 mmat 95% confidence and 99.5%reliability. | Mean error is less than 2.0 mmwith 99% confidence level of4.0 mm |
| Computer and Software Technology | ||
| Computer | Intel-Based PCComputer/Monitor all-in-one | Intel-Based PC |
| OperatingSystem | Linux-Based: Ubuntu | Linux-based IRIX |
| ProgrammingLanguage | C++ | C++ |
| Clinical SoftwareFeatures | Imaging modalities, registrationfeatures, views (axial, coronal,sagittal) | Imaging modalities, registrationfeatures, views (axial, coronal,sagittal) |
| Electromagnetic Technology | ||
| ElectromagneticLocalizationSystem | Medtronic Navigation AxiEM IIIntegrated | Medtronic Navigation AxiEM IIntegrated |
| EM Configuration | EM field transmitter creates anEM field that is used to trackand triangulate on the receivecoils | EM field transmitter creates anEM field that is used to trackand triangulate on the receivecoils |
| Communication | USB 1.1 and 2.0 | Serial Line (RS-232) Connection |
| AmplifierTechnology | Class D | Class AB |
| Digitizer Box | CAC and NPI integrated into asingle unit, portable andmountable | CAC and NPI provided inseparate components as cart onwheels |
| Instrument ports | 4-coils per port, 8 ports in total | 2-coils per port, 6 ports in total |
| Subject Device | Predicate | |
| FUSION Compact™Navigation System | StealthStation GoldenEye(K001284) | |
| Mobile Emitter | Emitter generates a low-intensity magnetic field to locatecoils mounted within the tracker | Emitter generates a low-intensity magnetic field to locatecoils mounted within the tracker |
| EM Mountingapparatus | Emitter Stand or Emitter Clamp | No mounting capability as thisunit is incorporated into the cartand mounting is not needed. |
| Interfacing | Navigation Probe Interface (NPI)is configured for up to 4 coils perconnection port. Theinstruments used are designedwith 2 or 3 receive coils perinstrument. Each of the receivecoils is connected via theinstrument cable to theinstrument. | Navigation Probe Interface (NPI)is configured for up to 2 coils perconnection port. Theinstruments used are designedwith 2 receive coils perinstrument. Each of the receivecoils is connected via theinstrument cable to theinstrument connector, which isthen connected to the NPIthrough a connection port. |
Table 1: FUSION Compact™ Predicate Device Comparison Table
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Performance Testing: Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the FUSION Compact™ Navigation System to establish substantial equivalence of the system and verify that the device will perform as intended meeting all of the design inputs:
- AAMI/ANSI ES 60601-1:2012 Medical Electrical ● Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- . IEC 60601-1-2:2014 - Medical Electrical Equipment -Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests (2/2014)
- Software Verification and Validation testing verifying the . software requirements are met and software performs as intended
- . Hardware Verification testing ensuring the hardware requirements identified for the system are met and hardware performs as intended
- Accuracy Testing was conducted to ensure that the ● FUSION Compact met the prescribed requirement for accuracy. The FUSION Compact System demonstrates performance in 3D positional accuracy with a maximum error ≤ 3.0 mm. This performance was determined using a peqboard in a surqical office and OR simulated environment with all of the typical instruments and equipment seen in those environments. The upper bound
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of the tip error data for both the surgical office and OR simulated environments was determined by statistical data analysis.
- Usability Testing was conducted in accordance to IEC . 62366 demonstrating that the usability and human factors requirements were adequately met.
Conclusion: The FUSION Compact™ Navigation System is similar in technological characteristics, imaging performance and indications for use as the predicate devices listed. These aspects, along with the functional testing conducted to the FDA recognized standards, demonstrate that FUSION Compact™ Navigation System does not raise new risks of safety and effectiveness when compared to the predicates.
§ 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).