CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) 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 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

CoreLink Navigation Instruments are non-sterile, reusable manual surgical instruments made of surgical stainless steel. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

AI/ML Overview

The provided text describes the CoreLink Navigation Instruments, but it does not contain the specific information requested about acceptance criteria and the detailed study that proves the device meets those criteria.

The document is a 510(k) Premarket Notification from the FDA, which primarily focuses on establishing substantial equivalence to a legally marketed predicate device. While it mentions "Performance Data" and "Testing to ASTM F2554-10," it does not elaborate on the specific acceptance criteria, reported performance values, study design details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance), or training set information.

Therefore, I cannot fulfill your request as the necessary details are not present in the provided text.

Summary

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December 13, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. The words "U.S. FOOD & DRUG" are in a larger font than the word "ADMINISTRATION".

Corelink LLC Meredith May Vice President 4628 Northpark Dr. Colorado Springs, Colorado 80918

Re: K182731

Trade/Device Name: Corelink Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 12, 2019 Received: November 13, 2019

Dear Meredith May:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182731

Device Name CoreLink Navigation Instruments

Indications for Use (Describe)

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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CoreLink Navigation Instruments 510K Traditional 510(k) Premarket Notification

510(k) Summary: CoreLink's Navigation Instruments

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular, 21 CFR Part 807.92, the following summary of information is provided:

Submitter:	CoreLink LLC2072 Fenton Logistics Park Blvd.St. Louis, MO 63026
Contact Person	Steven D. Mounts(888) 349-7808 x2205
Date Prepared	December 13, 2019
Trade Name	CoreLink Navigation Instruments
Class	Class II
Classification Nameand Number	Orthopedic Stereotaxic Instrument, 21 CFR 882.4560
Common Name	Navigation Instruments
Product Code / Panel	OLO, Orthopedic
Predicate Device	Medtronic Navigated Reusable Instruments, K161210 (Primary)Globus Navigation Instruments, K153203Alphatec Navigation Instruments, K153603SI-BONE iFuse Navigation, K172268
Special Controls	N/A
Device Description	CoreLink Navigation Instruments are non-sterile, reusable manual surgical instruments made of surgical stainless steel. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.
Indications for Use	CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) 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 Medtronic StealthStation® System, which is indicated for any medical condition in which the use of
		stereotactic surgery may be appropriate, and wherereference to a rigid anatomical structure, such asvertebra, can be identified relative to a CT or MR basedmodel, fluoroscopy images, or digitized landmarks of theanatomy.
Summary of the	TechnologicalCharacteristics	The CoreLink Navigation Instruments are designed tointerface with the already-cleared MedtronicStealthStation® Navigation System. CoreLink NavigationInstruments have similar designs as the predicateinstruments and incorporate all necessary designfeatures to enable navigation and use with theStealthStation®. Like the predicate devices, the subjectCoreLink Navigation Instruments are made of surgicalstainless steel.
Performance Data		Testing to ASTM F2554-10 was performed as well astesting to ensure CoreLink's Navigation Instruments areacceptable for their intended use, functionality andcompatibility with the Medtronic StealthStation® Systemand to ensure substantial equivalence to the predicateinstruments.
Conclusion		Based on the indications for use, technologicalcharacteristics, required performance testing andcomparison to the predicate device, CoreLink'sNavigation Instruments have been shown to besubstantially equivalent to legally marketed predicatedevice and is safe and effective for its intended use

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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).