(82 days)
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis," indicating its use for treating a medical condition.
No
The device is described as a "Sacroiliac Joint Fusion System" consisting of screws and washers, intended for fusing the sacroiliac joint. Its description and intended use focus on treatment and structural support, rather than diagnosis.
No
The device description explicitly states it consists of physical components (cannulated, fully threaded screws, washers) fabricated from medical grade titanium alloy. The performance studies are bench tests on these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sacroiliac joint fusion," which is a surgical procedure performed in vivo (within the living body). IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information about a patient's health.
- Device Description: The device is a system of screws and washers designed to be implanted into bone. This is a surgical implant, not a diagnostic tool used with biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
This device is a surgical implant used for musculoskeletal fusion.
N/A
Intended Use / Indications for Use
The Outlet Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021932, K110472, K112028, K141549
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
1
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
2
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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3
5.510(K) SUMMARY
| Submitter's Name: | SIJ Surgical |
|---|---|
| Submitter's Address: | 6829 Falls of Neuse Rd. |
| Suite 103 | |
| Raleigh, NC 27615 | |
| Submitter's Telephone: | 314-494-0313 |
| Contact Person: | Meredith L. May MS, RAC |
| Empirical Consulting | |
| 719.337.7579 | |
| 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 Threaded |
| Metallic Bone Fixation Fastener | |
| Product Code: | OUR |
| Classification Panel: | Office of Device Evaluation, Division of Orthopedic |
| Devices, 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.
4
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 or
Model Name | Manufacturer | Predicate
Type |
|-------------|--------------------------------------------|---------------------------------|-------------------|
| K021932 | 6.5mm Cannulated Screw | Synthes | Primary |
| K110472 | MSB Sacroiliac Joint Fusion
System | Medtronic Sofamor
Danek, Inc | Additional |
| K112028 | SI-LOK Sacroiliac Joint
Fixation System | Globus Medical, Inc | Additional |
| K141549 | SImmetry Sacroiliac Joint
Fusion 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.