(106 days)
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
The TiLink-L Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to fixate the joint. There are various sacroiliac implant sizes available for implanting to accommodate a range of sacroiliac joint sizes and geometries.
This document is a 510(k) premarket notification for a medical device called the "TiLink-L SI Joint Fusion System." It establishes the substantial equivalence of this new device to previously cleared predicate devices. Therefore, the information provided focuses on demonstrating this equivalence rather than presenting an original study with acceptance criteria and device performance in the typical sense of a diagnostic or algorithmic device.
Here's an analysis based on your requested points, highlighting that this document is for a mechanical implant and not an AI or diagnostic device:
1. A table of acceptance criteria and the reported device performance:
This document does not present acceptance criteria or reported device performance in the manner expected for a device like an AI algorithm with metrics like sensitivity, specificity, or accuracy. Instead, the "performance data" listed are primarily related to general device safety and mechanical integrity, demonstrating that the new device performs comparably to the predicate devices in these aspects. The acceptance criteria implicitly refer to meeting established standards for medical implants.
| Acceptance Criteria (Implied from testing types) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility (per ISO 10993-1:2018) | Compliant with standard (essential for substantial equivalence) |
| Sterilization Validation (per ISO 17665-1:2006/(R) 2013) | Compliant with standard (essential for substantial equivalence) |
| Mechanical Static Testing (per ASTM F543) | Substantially equivalent to predicate (demonstrated through testing) |
| Mechanical Dynamic Testing (per ASTM F1264) | Substantially equivalent to predicate (demonstrated through testing) |
| V/V Mechanical and Safety Testing | Conforms to Mechanical and Safety requirements (essential for substantial equivalence) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this submission. The "test set" here refers to the physical samples of the TiLink-L device that underwent engineering and biological testing, not a dataset of patient cases. The number of physical units tested for each mechanical or biocompatibility standard would be part of the detailed test reports (which are not included in this summary).
- Data Provenance: Not applicable in the context of this submission. The tests are laboratory-based engineering and biological assessments of the device itself, not analyses of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in this context is irrelevant as the tests are for physical and biological properties against established standards, not for diagnostic accuracy or clinical outcomes assessed by experts.
4. Adjudication method for the test set:
Not applicable. This concept applies to human interpretation of data where consensus is needed. For mechanical and biological testing, the outcome is determined by adherence to predefined standards and measurement against those standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is for a physical implant, not an AI or diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a standalone physical implant, not an algorithm.
7. The type of ground truth used:
Not applicable in the AI/diagnostic sense. The "ground truth" for the performance data in this submission would be the established scientific and engineering standards (e.g., ISO 10993-1, ISO 17665-1, ASTM F543, ASTM F1264) that the device must meet or demonstrate equivalence against.
8. The sample size for the training set:
Not applicable. This device is not an AI model, so there is no training set in the machine learning sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
Summary for this specific document:
This 510(k) submission successfully demonstrates substantial equivalence for a physical medical implant (TiLink-L SI Joint Fusion System) by showing that its technological characteristics and performance (biocompatibility, sterilization, mechanical properties) are comparable to legally marketed predicate devices. The "study" here refers to the non-clinical performance data and engineering tests conducted on the device components themselves, which align with established standards for medical implants. It is crucial to understand that the requested questions about acceptance criteria, sample sizes, experts for ground truth, and MRMC studies are primarily relevant for diagnostic devices, especially those incorporating AI, and not for mechanical implants like the one described in this document.
{0}------------------------------------------------
June 7, 2023
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.
Surgentec, LLC Andrew Shoup Chief Operating Officer 911 Clint Moore Rd Boca Raton, Florida 33487
Re: K230446
Trade/Device Name: TiLink-L SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: March 10, 2023 Received: March 10, 2023
Dear Andrew Shoup:
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
{1}------------------------------------------------
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.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Eileen Cadel. The date of the signature is 2023.06.07 and the time is 08:45:23 -04'00'.
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K230446
Device Name TiLink-L SI Joint Fusion System
Indications for Use (Describe)
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| Submitter Information | |
|---|---|
| Submitter: | Surgentec, LLC911 Clint Moore RdBoca Raton, FL 33487Telephone: 561-990-7882 |
| Contact: | Andrew ShoupChief Operating OfficerTelephone: 561-990-7882Email: ashoup@surgentec.com |
| Date Prepared: | February 1, 2023 |
| Name of DeviceDevice Proprietary Name: | TiLink-L SI Joint Fusion System |
| Device Common Name: | Sacroiliac Joint Screw |
| Classification Regulation: | Class II; 21 CFR 888.3040 |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Panel: | Orthopedic |
| Product Code: | OUR |
| Legally Marketed Predicate DevicePrimary Predicate: | SI-LOK SACROILIAC JOINT FIXATION SYSTEMGLOBUS MEDICAL, INC.510(k) number: K112028 |
| Additional Predicate: | SIJFuse™ Sacroiliac Joint Fusion Device SystemSpineFrontier, Inc.510(k) number: K150017 |
Device Description
The TiLink-L Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to fixate the joint. There are various sacroiliac implant sizes available for implanting to accommodate a range of sacroiliac joint sizes and geometries.
Indication for Use
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
{4}------------------------------------------------
Technological Characteristics and Substantial Equivalence
The subject TiLink-L Joint Fusion System is substantially equivalent to the predicate SIJFuse™ Sacroiliac Joint Fusion Device System previously cleared in 510k K150017 and the SI-LOK SACROILIAC JOINT FIXATION SYSTEM previously cleared in 510k K112028. Both devices are contained in a device tray containing the required components to action the device, not provided sterile but can be sterilized via steam sterilization prior to use and are intended for surgical treatment of the sacroiliac joint. All characteristics and indications between the TiLink-L Joint Fusion System and the predicates are the same, therefore the subject device is substantially equivalent to the predicate devices.
Performance Data
The following non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicates.
- Biocompatibility per ISO 10993-1:2018 ●
- Sterilization validation per ISO 17665-1:2006/(R) 2013
- Mechanical static and dynamic testing per ASTM F543 and ASTM F1264 ●
- V/V Mechanical and Safety Testing .
Conclusion
The design characteristics of the TiLink-L Joint Fusion System does not raise different questions of safety and effectiveness. Non-clinical study data supports that the device is substantially equivalent to predicate devices. This data supports that the TiLink-L Joint Fusion System is substantially equivalent to the predicate device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.