Alphatec Navigation Instruments

K153603 · Alphatec Spine, Inc. · OLO · Apr 29, 2016 · Neurology

Device Facts

• Record ID: K153603
• Device Name: Alphatec Navigation Instruments
• Applicant: Alphatec Spine, Inc.
• Product Code: OLO · Neurology
• Decision Date: Apr 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which 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 a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Story

Alphatec Navigation Instruments are manual, reusable surgical tools designed for use with Medtronic StealthStation System; instruments assist surgeons in locating anatomical structures during spinal surgery for pedicle screw placement. Device inputs include real-time 3D/2D imaging data (CT, MR, or fluoroscopy) processed by the StealthStation navigation system. Instruments function as tracked surgical probes/drivers; navigation system tracks instrument position relative to patient anatomy. Used in OR by surgeons for open or minimally invasive procedures. Output is visual confirmation of instrument position relative to anatomical landmarks on navigation display. Benefits include improved accuracy for hardware placement in complex spinal procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including dimensional measurements, interface compatibility, and functionality verification. Validation testing performed using 1:1 accuracy and performance testing of subject and predicate devices in a simulated surgical navigation environment.

Technological Characteristics

Manual, reusable surgical instruments. Designed for compatibility with Medtronic StealthStation System and NavLock Tracker. Materials and design features are equivalent to predicate navigation instruments. No electronic components or software algorithms contained within the instruments themselves; they function as passive tracked components within the navigation system ecosystem.

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of Alphatec screws, where stereotactic navigation is appropriate for locating anatomical structures in open or minimally invasive procedures.

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

• Navigated CD Horizon Solera Screwdrivers and Taps (K140454)

Reference Devices

• Arsenal Spinal Fixation System (K133221, K143149, K152968)
• Illico MIS Posterior Fixation System (K123623)

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

April 29, 2016

Alphatec Spine, Incorporated Ms. Renée Murphy Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K153603

Trade/Device Name: Alphatec Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 15, 2015 Received: December 17, 2015

Dear Ms. Murphy:

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,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K153603

Device Name Alphatec Navigation Surgical Instruments

### Indications for Use (Describe)

Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which 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 a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for 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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

#### I. SUBMITTER

Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Phone: [phone] Fax: [phone]

Contact Person: Renée L. Murphy Date Prepared: March 24, 2016

#### II. DEVICE

Name of Device: Alphatec Spine Navigation Instruments Common or Usual Name: Stereotaxic instruments Classification Name: Stereotaxic instruments (21 CFR 882.4560) Regulatory Class: II Product Code: OLO

#### III. PREDICATE DEVICE

K140454, Medtronic Navigation, Inc., Navigated CD Horizon Solera Screwdrivers and Taps

#### IV. DEVICE DESCRIPTION

The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

The purpose of this Traditional 510(k) Premarket Notification is to clear for market Alphatec NAV Instruments which are additions to the Arsenal™ Spinal Fixation System (K133221, K143149, K152968) and the Illico MIS® Posterior Fixation System (K123623) for use with the Medronic StealthStation System.

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#### V. INDICATIONS FOR USE

Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which 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 a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

#### TECHNOLOGICAL COMPARISON TO PREDICATES VI.

The technological design features of the subject Alphatec Spine Navigation Instruments were compared to the predicate in indications for use, intended use, design, technology, materials, function, and performance. It was demonstrated that the subject Alphatec NAV Instrument technology is substantially equivalent to the predicate.

#### VII. PERFORMANCE DATA

Engineering analysis and performance data demonstrate that the subject Alphatec Spine Navigation Instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance. Engineering analysis includes dimensional measurements of both predicate and subject devices. Verification testing includes interface compatibility and functionality of the subject device. Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.

Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject Alphatec NAV Instruments are substantially equivalent to the predicate Medtronic navigation instruments when used with the StealthStation System and NavLock Tracker.

## VIII. CONCLUSION

Based upon the information provided in this Traditional 510(k) submission, it has been demonstrated that the subject Alphatec Spine Navigation Instruments are substantially equivalent to legally marketed predicate devices in regards to indications for use, intended use, design, technology, functionality, and performance.