Brainlab Compatible K2M Navigation Instruments

K181890 · K2m · OLO · Nov 9, 2018 · Neurology

Device Facts

• Record ID: K181890
• Device Name: Brainlab Compatible K2M Navigation Instruments
• Applicant: K2m
• Product Code: OLO · Neurology
• Decision Date: Nov 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws.

Device Story

Brainlab Compatible K2M Navigation Instruments consist of surgical tools (inserters, taps, probes, awls) used during spinal surgery. Instruments interface with Brainlab Navigation System to assist surgeons in locating anatomical structures for pedicle screw placement. System uses CT/MR models, fluoroscopy, or digitized landmarks to provide stereotactic guidance. Used in OR by surgeons; provides real-time navigation feedback to improve precision of screw placement. Benefits include enhanced accuracy in spinal instrumentation procedures.

Clinical Evidence

Bench testing only. Dimensional comparisons and simulated use testing performed to verify functionality and compatibility with the Brainlab Navigation System.

Technological Characteristics

Navigation instruments including inserters, taps, probes, and awls. Designed for mechanical interface with Brainlab Navigation System. Materials and design features are similar to previously cleared K2M navigation instruments.

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) in open or minimally invasive procedures. Contraindicated for navigation of occipital screws.

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

• K2M Navigation Instruments (K171556)
• Brainlab Spine and Trauma (K083310)
• Aesculap AIS S4 Spinal System (K130887)

Submission Summary (Full Text)

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K2M Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175

November 9, 2018

Re: K181890

Trade/Device Name: Brainlab Compatible K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 10, 2018 Received: August 13, 2018

Dear Nancy Giezen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Figure/5 description: The image shows a digital signature from Jesse Muir -S. The signature includes the date 2018.11.09 and the time 13:48:41 -05'00'. The signature is displayed in a clear, sans-serif font, making it easily readable. The text is arranged in a way that emphasizes the name and the date of the signature.

Date: 2018.11.09 13:48:41 -05'00'

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

Enclosure

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| Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br>Indications for Use |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number ( <i>if known</i> ) | K181890 |
| Device Name | Brainlab Compatible K2M Navigation Instruments |
| Indications for Use ( <i>Describe</i> ) | Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws. |
| Type of Use (Select one or both, as applicable) | <p><span style="text-decoration: underline;"><b>Prescription Use</b></span> (Part 21 CFR 801 Subpart D)</p> <p>Over-The-Counter Use (21 CFR 801 Subpart C)</p> |

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# 510(k) SUMMARY Brainlab Compatible K2M Navigation Instruments

#### Submitter

K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: [phone] Date Prepared: 11/09/2018

# Classification

Brainlab Compatible K2M Navigation Instruments Trade Name: Common Name: Navigation Instrument Regulatory Class: Class II

Classification Name(s): Stereotaxic instrument (21 CFR 882.4560, Product Code OLO)

## Predicate Device(s)

Primary Predicate: K2M Navigation Instruments (K171556) Additional Predicates: Brainlab Spine and Trauma (K083310) Aesculap AIS S4 Spinal System (K130887)

## Device Description

Brainlab Compatible K2M Navigation Instruments include inserters, taps, probes and awls intended be used when implanting previously cleared components of MESA, DENALI, EVEREST and YUKON Spinal Systems.

Function: These instruments are designed to interface with the Brainlab Navigation System when used for navigation during spinal surgery.

## Indications for Use

Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws.

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#### Technological Comparison to Predicate(s)

Brainlab Compatible K2M Navigation Instruments were compared to predicate devices and the design features, materials and indications were the same or similar to the previously cleared devices.

#### Non-clinical Performance Evaluation

Dimensional comparisons and simulated use testing was performed to ensure functionality and compatibility with the Brainlab Navigation System. In addition, testing met the acceptance criteria established by Brainlab for these devices. The results of these evaluations confirmed that the Brainlab Compatible K2M Navigation Instruments are equivalent to predicate devices.

#### Conclusion

There are no significant differences between the Brainlab Compatible K2M Navigation Instruments and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.