(441 days)
Not Found
No
The summary describes manual surgical instruments that interface with a navigation system, but there is no mention of AI or ML being incorporated into the instruments themselves or the navigation system's function as described here.
No
These instruments are used to assist during surgery and are not directly used for the treatment of a disease or condition.
No
The CoreLink Navigation Instruments are surgical tools designed to assist surgeons in precisely locating anatomical structures during spinal surgery. They are used in conjunction with the Medtronic StealthStation® System, which is for stereotactic surgery, not for diagnosing a medical condition.
No
The device description explicitly states that the CoreLink Navigation Instruments are "non-sterile, reusable manual surgical instruments made of surgical stainless steel," indicating they are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical navigation during spinal surgery to assist in the placement of screws. This is a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The device is described as "non-sterile, reusable manual surgical instruments made of surgical stainless steel." This aligns with surgical tools, not diagnostic tests performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used to guide a procedure.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing to ASTM F2554-10 was performed as well as testing to ensure CoreLink's Navigation Instruments are acceptable for their intended use, functionality and compatibility with the Medtronic StealthStation® System and to ensure substantial equivalence to the predicate instruments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medtronic Navigated Reusable Instruments, K161210, Globus Navigation Instruments, K153203, Alphatec Navigation Instruments, K153603, SI-BONE iFuse Navigation, K172268
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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)
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.
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 LLC
2072 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 Name
and 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, K153203
Alphatec Navigation Instruments, K153603
SI-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 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. |
| Summary of the | Technological
Characteristics | The CoreLink Navigation Instruments are designed to
interface with the already-cleared Medtronic
StealthStation® Navigation System. CoreLink Navigation
Instruments have similar designs as the predicate
instruments and incorporate all necessary design
features to enable navigation and use with the
StealthStation®. Like the predicate devices, the subject
CoreLink Navigation Instruments are made of surgical
stainless steel. |
| Performance Data | | Testing to ASTM F2554-10 was performed as well as
testing to ensure CoreLink's Navigation Instruments are
acceptable for their intended use, functionality and
compatibility with the Medtronic StealthStation® System
and to ensure substantial equivalence to the predicate
instruments. |
| Conclusion | | Based on the indications for use, technological
characteristics, required performance testing and
comparison to the predicate device, CoreLink's
Navigation Instruments have been shown to be
substantially equivalent to legally marketed predicate
device and is safe and effective for its intended use |
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