(82 days)
The Outlet Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Outlet Sacroiliac Joint Fusion System consists of cannulated, fully threaded screws with double helix threads designed to be able to screw into pre-drilled bone. It is fabricated from medical grade titanium alloy, Ti-6AI-4V (ASTM F-136). The Outlet System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.
The information provided pertains to a 510(k) premarket notification for a medical device called the "Outlet Sacroiliac Joint Fusion System." This document primarily focuses on establishing substantial equivalence to legally marketed predicate devices through technological characteristics and bench testing. It does not describe a study involving device performance in a clinical setting, nor does it detail acceptance criteria related to diagnostic accuracy, human-in-the-loop performance, or reader studies.
Therefore, many of the requested categories cannot be answered from the provided text, as they apply to studies evaluating diagnostic or clinical performance, which are not present here.
However, I can extract the relevant information regarding the bench testing conducted.
1. A table of acceptance criteria and the reported device performance
The document states, "The results of this non-clinical testing show that the strength of the Outlet Sacroiliac Joint Fusion System is substantially equivalent to legally marketed predicate devices." While specific numerical acceptance criteria are not provided, the implicit acceptance criterion is "substantial equivalence" to the predicate devices in terms of mechanical strength as measured by the listed tests. The reported performance is that this substantial equivalence was met.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in strength to legally marketed predicate devices, as demonstrated by mechanical testing. | The Outlet Sacroiliac Joint Fusion System's mechanical performance (strength) is substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "bench testing" which is laboratory-based mechanical testing. It does not refer to clinical test sets, data provenance such as country of origin, or retrospective/prospective study design, which are terms typically associated with clinical trials. The sample sizes for each specific mechanical test (e.g., number of screws tested for static bending) are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for studies evaluating diagnostic or clinical outcomes, not for mechanical bench testing of an orthopedic implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used in clinical studies, typically for resolving discrepancies in expert opinion or medical diagnoses, not for mechanical bench testing.
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
This question is not applicable. The document describes mechanical bench testing of a physical implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or evaluation of human reader improvement with AI was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical bench testing, the "ground truth" is typically established by physical measurement against known engineering standards and specifications. The document implies compliance with ASTM standards (e.g., ASTM F2193-14, ASTM F543-13), which define methodologies for measuring mechanical properties.
8. The sample size for the training set
This question is not applicable. The document describes mechanical bench testing and does not involve specific training sets as would be used in machine learning or AI development.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned in the context of this device's evaluation.
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October 3. 2018
SIJ Surgical % Meredith L. May, MS, RAC Partnership Manager Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K181881
Trade/Device Name: Outlet Sacroiliac 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: July 12, 2018 Received: July 13, 2018
Dear Ms. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181881
Device Name Outlet Sacroiliac Joint Fusion System
Indications for Use (Describe)
The Outlet Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac 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) |
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5.510(K) SUMMARY
| Submitter's Name: | SIJ Surgical |
|---|---|
| Submitter's Address: | 6829 Falls of Neuse Rd.Suite 103Raleigh, NC 27615 |
| Submitter's Telephone: | 314-494-0313 |
| Contact Person: | Meredith L. May MS, RACEmpirical Consulting719.337.7579 |
| Date Summary was Prepared: | 12 July 2018 |
| Trade or Proprietary Name: | Outlet Sacroiliac Joint Fusion System |
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Classification: | Class II per 21 CFR §888.3040 Smooth Or ThreadedMetallic Bone Fixation Fastener |
| Product Code: | OUR |
| Classification Panel: | Office of Device Evaluation, Division of OrthopedicDevices, Posterior Spine Devices Branch |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Outlet Sacroiliac Joint Fusion System consists of cannulated, fully threaded screws with double helix threads designed to be able to screw into pre-drilled bone. It is fabricated from medical grade titanium alloy, Ti-6AI-4V (ASTM F-136). The Outlet System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.
INDICATIONS FOR USE
The Outlet Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
The indications for use for the Outlet Sacroiliac Joint Fusion System is similar to that of the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
The Outlet Sacroiliac Joint Fusion System consists of cannulated, fully threaded screws with double helix threads designed to be able to screw into pre-drilled bone. It is fabricated from medical grade titanium alloy, Ti-6Al-4V (ASTM F-136). The screws are offered in 11 and 13mm diameters with lengths ranging from 30 - 80mm to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.
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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 ●
- Physical Characteristics
- Surgical Site/Approach ●
- Material
- Sterility ●
| 510k Number | Trade or Proprietary orModel Name | Manufacturer | PredicateType |
|---|---|---|---|
| K021932 | 6.5mm Cannulated Screw | Synthes | Primary |
| K110472 | MSB Sacroiliac Joint FusionSystem | Medtronic SofamorDanek, Inc | Additional |
| K112028 | SI-LOK Sacroiliac JointFixation System | Globus Medical, Inc | Additional |
| K141549 | SImmetry Sacroiliac JointFusion System | Zyga Technology, Inc. | Additional |
Table 5-1 Predicate Devices
PERFORMANCE DATA
Bench testing has been conducted to establish performance to design requirements and specification and to support the substantial equivalence of the device. The Outlet Sacroiliac Joint Fusion System was mechanically characterized with the following tests:
- . Static Three-point bending per ASTM F2193-14
- . Dynamic Three-point bending per ASTM F2193-14
- Static Torsion per ASTM F543-13 .
- Screw Axial Pullout per ASTM A543-13 ●
- . Static Driving Torque per ASTM A543-13
The results of this non-clinical testing show that the strength of the Outlet Sacroiliac Joint Fusion System is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Outlet Sacroiliac 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.