(23 days)
No
The summary describes manual surgical instruments used with a navigation system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself is mentioned, but its specific technology is not detailed as AI/ML.
No
The device is a set of navigation instruments used for precise location during spinal surgery, and it does not directly treat or prevent a disease or condition.
No
The device is described as "manual surgical instruments" used in "preparation and placement of Tiger OCT screw implants during spinal surgery to assist the surgeon in precisely locating anatomical structures." It is a surgical tool, not a device that diagnoses a condition.
No
The device description explicitly states that the CoreLink Navigation Instruments are "non-sterile, re-usable manual surgical instruments made from stainless steel," indicating they are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the CoreLink Navigation Instruments are manual surgical instruments used during spinal surgery to assist in the placement of implants. They are used in vivo (within the body) to guide the surgeon, not to analyze samples in vitro (outside the body).
- Intended Use: The intended use is to assist in precisely locating anatomical structures during surgery, not to diagnose a condition based on a biological sample.
Therefore, the CoreLink Navigation Instruments fall under the category of surgical instruments or navigation systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT screw implants 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 S8 (V1.2.20), 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
OLO
Device Description
CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer compatibility with CoreLink OCT pedicle screws.
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
Surgeon, 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)
CoreLink, LLC has conducted confirmatory positional accuracy testing per ASTM F2554 with Medtronic StealthStation® System S8 Version 1.2.0 (1.2.0-20) as well as engineering analysis including tolerance stack analysis to demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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January 19, 2022
CoreLink, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K214059
Trade/Device Name: CoreLink Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 23, 2021 Received: December 27, 2021
Dear Nathan Wright:
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.
1
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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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
2
Indications for Use
510(k) Number (if known) K214059
Device Name CoreLink Navigation Instruments
Indications for Use (Describe)
CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT screw implants 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 S8 (V1.2.20), 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter's Name: | CoreLink, LLC |
|---|---|
| Submitter's Address: | 2072 Fenton Logistics Park |
| St. Louis, Missouri 63026 | |
| Submitter's Telephone: | 888-349-7808 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Testing Corp. Logo | |
| Date Summary was Prepared: | December 23, 2021 |
| Trade or Proprietary Name: | CoreLink Navigation Instruments |
| Common or Usual Name: | Orthopedic Stereotaxic Instruments |
| Classification: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Orthopedic - Spinal Devices (DHT6B) |
K214059 510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.
The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer compatibility with CoreLink OCT pedicle screws.
INDICATIONS FOR USE
CoreLink Navigation Instruments are intended to be used in the preparation and placement of Tiger OCT Screw implants 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 S8 (V1.2.0), 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.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- . Indications for use
- Materials of manufacture ●
- . Principles of operation
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| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Predicate
Type |
|----------------|-------------------------------------------------------------|-----------------------------------|-------------------|
| K212825 | CoreLink Navigation Instruments | CoreLink, LLC | Primary |
| K181111 | Navigated INFINITY™ Instruments | Medtronic Sofamor Danek USA, Inc. | Additional |
| K200863 | Tiger Occipital-Cervical-Thoracic Spinal
Fixation System | CoreLink, LLC | Reference |
Table 5-1 Predicate Devices
PERFORMANCE DATA
In support of this Special 510(k) submission, CoreLink, LLC has conducted confirmatory positional accuracy testing per ASTM F2554 with Medtronic StealthStation® System S8 Version 1.2.0 (1.2.0-20) as well as engineering analysis including tolerance stack analysis to demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use.
CONCLUSION
The overall technology characteristics and performance data lead to the conclusion that the CoreLink Navigation Instruments are substantially equivalent to the predicate device.