(30 days)
Not Found
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
This device is a navigation instrument used in surgery to assist in precisely locating anatomical structures, not to treat or cure a disease or condition itself.
No
Explanation: The device is described as "manual surgical instruments" and "navigation instruments" used to assist surgeons in "precisely locating anatomical structures" during spinal surgery. It is designed to be used with a navigation system to guide placement of implants, rather than to diagnose medical conditions or diseases.
No
The device description explicitly states that the CoreLink Navigation Instruments are "non-sterile, re-usable manual surgical instruments made from stainless steel," indicating a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The CoreLink Navigation Instruments are described as "non-sterile, re-usable manual surgical instruments" used during surgery to assist in precisely locating anatomical structures. They interface with a navigation system that uses imaging data.
- Intended Use: The intended use is to assist surgeons in placing implants during spinal surgery by providing navigational guidance based on imaging. This is a surgical aid, not a diagnostic test performed on a specimen.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CoreLink Navigation Instruments is indicated for use during the preparation and placement of Siber Ti Sacroiliac Joint Fusion System implants and Entasis Dual-Lead Sacroiliac Implant System 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 S8 System (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 a 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, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. 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 offer compatibility of the previously cleared CoreLink Navigation Instruments for sacroiliac fusion implants with additional CoreLink Sacroiliac Screws and to update the sacroiliac navigation instrument set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
rigid anatomical structure, such as a vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / spinal surgery
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)
Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments as submitted under previous submissions of the CoreLink Navigation Instruments (K212825). An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject 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.
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).
0
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August 16, 2023
CoreLink, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K232116
Trade/Device Name: CoreLink Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 14, 2023 Received: July 17, 2023
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.
Teien D. Soni -S
For
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232116
Device Name CoreLink Navigation Instruments
Indications for Use (Describe)
CoreLink Navigation Instruments is indicated for use during the preparation and placement of Siber Ti Sacroiliac Joint Fusion System implants and Entasis Dual-Lead Sacroiliac Implant System 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 S8 System (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 a 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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K232116 510(K) SUMMARY
| 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, RAC |
| Empirical Technologies | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Technologies Logo | |
| Date Summary was Prepared: | August 16, 2023 |
| Trade or Proprietary Name: | CoreLink Navigation Instruments |
| Common Name: | Orthopedic Stereotaxic Instruments |
| Device Classification Name: | Stereotaxic Instrument |
| Classification & Regulation #: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Orthopedic - Stereotaxic, Trauma, and Restorative Devices (DHT6C) |
Description of the Device Subject to Premarket Notification:
CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. 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 offer compatibility of the previously cleared CoreLink Navigation Instruments for sacroiliac fusion implants with additional CoreLink Sacroiliac Screws and to update the sacroiliac navigation instrument set.
INDICATIONS FOR USE
CoreLink Navigation Instruments is indicated for use during the preparation and placement of CoreLink 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 Medronic StealthStation S8 System (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 a 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 similar between the subject and predicates:
- Indications for use
- Materials of manufacture
- Principles of operation ●
- Sizes ●
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K232116 510(K) SUMMARY
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K212825 | CoreLink Navigation Instruments | CoreLink, LLC | Primary |
| K161210 | Medtronic Navigated Manual Reusable Instruments | Medtronic Sofamor Danek | Additional |
Performance Data
Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments as submitted under previous submissions of the CoreLink Navigation Instruments (K212825). An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the CoreLink Navigation Instruments are substantially equivalent to the predicate device.