Cranial Reducing Tubes

K162604 · Medtronic Navigation, Inc. · HAW · Dec 30, 2016 · Neurology

Device Facts

• Record ID: K162604
• Device Name: Cranial Reducing Tubes
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Dec 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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.

Device Story

Cranial Reducing Tubes (CRT) are metallic, reusable accessories for neurosurgical procedures; used in operating rooms by surgeons. CRTs insert into the Precision Aiming Device of the Medtronic StealthStation System. Input: navigational trajectories determined by StealthStation using preoperative MR/CT scans. Function: maintains position of instruments/devices (e.g., for biopsies, catheter/electrode introduction) during surgery. Output: physical guidance/stabilization of surgical tools. Benefit: provides accurate delivery of instruments to target sites; ensures navigational accuracy during neurological procedures.

Clinical Evidence

Bench testing only. Evaluated system accuracy (mean positional error <2mm, mean trajectory error <2 degrees), useful life, repeated drilling exposure, and usability. Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation), and ISO 10993-11 (acute systemic toxicity) confirmed non-cytotoxic, non-sensitizing, non-irritant, and non-toxic status.

Technological Characteristics

Material: Stainless steel. Form factor: Reusable tubes with inner diameters of 1.7mm, 3.2mm, and 4.0mm. Sterilization: Steam sterilization. Connectivity: Interfaces with Medtronic StealthStation System via optical tracking. Sensing/Actuation: Mechanical guidance/stabilization. No software/algorithm.

Indications for Use

Indicated for patients undergoing neurological procedures requiring stereotactic guidance for instrument or device placement, performed in conjunction with the Medtronic StealthStation System. Not intended for use in an MRI environment.

Regulatory Classification

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.

Predicate Devices

• Navigus Trajectory Guide (K992304)
• Navigus II Trajectory Guide (K012366)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) Summary

#### I. SUBMITTER

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

Telephone: [phone] Fax: [phone]

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

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.

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#### V. INDICATIONS FOR USE

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.

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| | Cranial Reducing Tubes<br>(Subject Device) | Navigus II Trajectory Guide<br>(Predicate Device) | Navigus Manual Trajectory Guide<br>(Predicate Device) |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | | | |
| 510k Number | K162604 | K012366 | K992304 |
| Indications for Use | The Cranial Reducing Tubes are<br>intended to maintain the position<br>of instruments or devices placed<br>using stereotactic guidance during<br>planning and operation of<br>neurological procedures<br>performed in conjunction with the<br>use of the Medtronic<br>StealthStation System Image<br>Guided Workstation. The devices<br>were not tested for MR<br>compatibility, and are not<br>intended for use in an MRI<br>environment. | The Navigus II Trajectory Guide is<br>intended to provide stereotactic<br>guidance for the placement and<br>operation of instruments or devices<br>during planning and operation of<br>neurological procedures within the<br>MRI/CT environment and in<br>conjunction with the use of an Image<br>Guided Workstation System using<br>preoperative MR and/or CT imaging.<br>These procedures include biopsies,<br>catheter and electrode introduction. The<br>device is ETO sterilized and for one<br>time use. | The Trajectory Guide is intended to provide<br>stereotactic guidance for the placement and<br>operation of instruments or devices during<br>planning and operation of neurological<br>procedures within the MRI/CT environment<br>and in conjunction with MR/CT-imaging. The<br>Trajectory Guide is intended as an integral part<br>of procedures that have traditionally used<br>stereotactic methodology. These procedures<br>include biopsies, catheter and electrode<br>introduction. The device will provide accurate<br>delivery of devices or instruments to target<br>sites 3mm and larger. |
| Sterility | Provided non-sterile<br>Steam Sterilization<br>Reusable | Provided sterile<br>ETO Sterilization<br>Single Use | Provided sterile<br>ETO Sterilization<br>Single 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-Contacting<br>Material | Stainless Steel | SABIC ValoxTM Resin | Polycarbonate |
| Guide for instruments<br>and devices | Yes | Yes | Yes |
| Trajectory aligned by<br>Image Guided<br>Workstations (IGW) | Yes | Yes | No |
| Able to interface<br>stereotactic navigation<br>tool for guidance | Yes, optical tracking | Yes, optical tracking | No |
| Navigational<br>Performance | Mean Error ≤2.00 mm and ≤2.00° | Value not available | Delivery of devices or instruments to target<br>sites ≥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 accessories<br>and the StealthStation system have demonstrated<br>accuracy with a mean positional error of <2mm<br>and mean trajectory error of <2 degrees. | The CRTs are accurate for their<br>intended use. |
| Useful Life | The CRTs maintain acceptable use when exposed<br>to cleaning, sterilization, and use conditions over<br>the useful life of the device. | The CRTs meet the intended use<br>throughout the useful life of the<br>device. |
| Repeated Drilling<br>Exposure | The CRTs maintain acceptable use and are<br>functional when repeatedly drilled through over<br>the useful life of the device. | The CRTs meet the intended use<br>when repeated drilled through<br>over the useful life of the device. |
| Usability | The CRTs satisfy the user's needs and product<br>usability. | The instruments can be used<br>correctly by the defined users. |
| Biocompatibility | | |
| Cytotoxicity – MEM<br>Elution<br>ISO 10993-5 | Cell culture treated with test sample exhibited no<br>reactivity (Grade 0) | Non-cytotoxic |
| Maximization<br>Sensitization –<br>ISO 10993-10 | Intradermal injection of representative material<br>test sample showed no evidence of sensitization. | Non-sensitizer |
| Intracutaneous Irritation-<br>ISO 10993-10 | Intracutaneous injection of representative material<br>test sample showed no evidence of irritation. | Non-irritant |
| Acute Systemic<br>Toxicity-ISO 10993-11 | Systemic injection of representative material test<br>sample 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.