The Cranial Reducing Tubes are intended to maintain the position of instruments or devices placed using stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation System Image Guided Workstation. The devices were not tested for MR compatibility, and are not intended for use in an MRI environment.

Device Description

The Medtronic Cranial Reducing Tubes (CRT) are metallic, reusable accessories that maintain the position of instruments or devices placed using stereotactic guidance during neurosurgical procedures. The CRTs have differing inner diameters (4.0 mm, 3.2 mm, and 1.7mm). The CRT inserts into the Precision Aiming Device accessory of the Medtronic StealthStation System. This is conducted in an operating room environment where navigational trajectories are determined by the StealthStation System using preoperative MR/CT scans of the patient.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Cranial Reducing Tubes, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Navigational Performance (Mean Positional Error)	≤ 2.00 mm
Navigational Performance (Mean Trajectory Error)	≤ 2.00°
Useful Life	Maintains acceptable use when exposed to cleaning, sterilization, and use conditions over the useful life of the device.
Repeated Drilling Exposure	Maintains acceptable use and is functional when repeatedly drilled through over the useful life of the device.
Usability	Satisfies the user's needs and product usability.
Biocompatibility (Cytotoxicity)	No reactivity (Grade 0)
Biocompatibility (Sensitization)	No evidence of sensitization.
Biocompatibility (Intracutaneous Irritation)	No evidence of irritation.
Biocompatibility (Acute Systemic Toxicity)	No mortality or toxicity.

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

The document does not specify the sample size for the test set used for the "System Accuracy" testing. It broadly states, "The CRTs when used with compatible accessories and the StealthStation system have demonstrated accuracy..." The document also does not mention the country of origin of the data or whether the study was retrospective or prospective.

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 or their qualifications. The system accuracy testing appears to be based on physical measurements ("bench testing") rather than expert review of images or clinical outcomes.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method. The accuracy testing appears to be a direct measurement rather than involving multiple reviewers.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device, Cranial Reducing Tubes, is a physical instrument for maintaining the position of other instruments, rather than an AI-powered diagnostic tool that would typically involve human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable in this context.

6. Standalone Performance Study (Algorithm Only)

The device is a physical instrument, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable. The listed "System Accuracy" test is essentially the standalone performance of the physical device in conjunction with the StealthStation system for its intended purpose.

7. Type of Ground Truth Used

The ground truth used for the "System Accuracy" testing appears to be objective physical measurement derived from "bench testing." This is implied by the direct measurement of positional and trajectory error. The biocompatibility tests also rely on standardized laboratory test results.

8. Sample Size for the Training Set

No information is provided regarding a training set. The device is a physical instrument for which performance is evaluated through bench testing and biocompatibility assessments, not through machine learning, which typically involves training sets.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set for an algorithm, the method for establishing its ground truth is not applicable/provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 30, 2016

Medtronic Navigation, Inc. Christopher Perman Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K162604

Trade/Device Name: Cranial Reducing Tubes Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 8, 2016 Received: December 9, 2016

Dear Mr. Perman:

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,

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) K162604

Device Name Cranial Reducing Tubes

Indications for Use (Describe)

The Cranial Reducing Tubes are intended to maintain the position of instruments or devices placed using stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation System Image Guided Workstation. The devices were not tested for MR compaibility, and are not intended for use in an MRI environment.

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

I. SUBMITTER

Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA

Telephone: 720-890-3200 Fax: 720-890-3500

Contact Person: Christopher Perman Date Prepared: September 16, 2016

II. DEVICE

Name of Device: Cranial Reducing Tubes Common Name: Stereotaxic Instrument Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Regulatory Class: Class II (21 CFR 882.4560) Product Code: HAW

III. PREDICATE DEVICE

Navigus Trajectory Guide. K992304 (Medtronic Neuromodulation) Navigus II Trajectory Guide, K012366 (Medtronic Neuromodulation)

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

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	Cranial Reducing Tubes(Subject Device)	Navigus II Trajectory Guide(Predicate Device)	Navigus Manual Trajectory Guide(Predicate Device)
Device Name
510k Number	K162604	K012366	K992304
Indications for Use	The Cranial Reducing Tubes areintended to maintain the positionof instruments or devices placedusing stereotactic guidance duringplanning and operation ofneurological proceduresperformed in conjunction with theuse of the MedtronicStealthStation System ImageGuided Workstation. The deviceswere not tested for MRcompatibility, and are notintended for use in an MRIenvironment.	The Navigus II Trajectory Guide isintended to provide stereotacticguidance for the placement andoperation of instruments or devicesduring planning and operation ofneurological procedures within theMRI/CT environment and inconjunction with the use of an ImageGuided Workstation System usingpreoperative MR and/or CT imaging.These procedures include biopsies,catheter and electrode introduction. Thedevice is ETO sterilized and for onetime use.	The Trajectory Guide is intended to providestereotactic guidance for the placement andoperation of instruments or devices duringplanning and operation of neurologicalprocedures within the MRI/CT environmentand in conjunction with MR/CT-imaging. TheTrajectory Guide is intended as an integral partof procedures that have traditionally usedstereotactic methodology. These proceduresinclude biopsies, catheter and electrodeintroduction. The device will provide accuratedelivery of devices or instruments to targetsites 3mm and larger.
Sterility	Provided non-sterileSteam SterilizationReusable	Provided sterileETO SterilizationSingle Use	Provided sterileETO SterilizationSingle Use
Number of Lumens	1	5	1
Lumen Diameter	1.7mm, 3.2mm, 4.0mm	2.2mm	1mm, 2mm, 3mm, 5mm
MR Compatibility	No	Yes	Yes
Patient-ContactingMaterial	Stainless Steel	SABIC ValoxTM Resin	Polycarbonate
Guide for instrumentsand devices	Yes	Yes	Yes
Trajectory aligned byImage GuidedWorkstations (IGW)	Yes	Yes	No
Able to interfacestereotactic navigationtool for guidance	Yes, optical tracking	Yes, optical tracking	No
NavigationalPerformance	Mean Error ≤2.00 mm and ≤2.00°	Value not available	Delivery of devices or instruments to targetsites ≥3mm

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

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For comparison of the technological characteristics between the subject and predicate devices, the attribute of navigational performance for the subject device value was presented as mean navigational error and the predicate device presented as a minimum target size. Although these values cannot be directly compared, the safety and efficacy for navigational accuracy of the subject device was demonstrated in bench testing.

PERFORMANCE DATA VII.

Testing was completed to ensure the functionality and compatibility with the identified Medtronic navigation systems and instruments. The following table summarizes the performance testing completed:

Test	Results	Conclusions
System Accuracy	The CRTs when used with compatible accessoriesand the StealthStation system have demonstratedaccuracy with a mean positional error of <2mmand mean trajectory error of <2 degrees.	The CRTs are accurate for theirintended use.
Useful Life	The CRTs maintain acceptable use when exposedto cleaning, sterilization, and use conditions overthe useful life of the device.	The CRTs meet the intended usethroughout the useful life of thedevice.
Repeated DrillingExposure	The CRTs maintain acceptable use and arefunctional when repeatedly drilled through overthe useful life of the device.	The CRTs meet the intended usewhen repeated drilled throughover the useful life of the device.
Usability	The CRTs satisfy the user's needs and productusability.	The instruments can be usedcorrectly by the defined users.
Biocompatibility
Cytotoxicity – MEMElutionISO 10993-5	Cell culture treated with test sample exhibited noreactivity (Grade 0)	Non-cytotoxic
MaximizationSensitization –ISO 10993-10	Intradermal injection of representative materialtest sample showed no evidence of sensitization.	Non-sensitizer
Intracutaneous Irritation-ISO 10993-10	Intracutaneous injection of representative materialtest sample showed no evidence of irritation.	Non-irritant
Acute SystemicToxicity-ISO 10993-11	Systemic injection of representative material testsample showed no mortality or toxicity.	Non-toxic

VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the Cranial Reducing Tubes should perform as intended in the specified use conditions. The non-clinical data demonstrate that the Cranial Reducing Tubes perform comparably to the predicate device that is currently marketed for the same intended use.

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).