(148 days)
The SambaScrew 3D SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The SambaScrew 3D SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as sterile, 11mm and 12mm cannulated screws of various lengths featuring multiple fenestrations along the shaft. The 11mm cannulated screw features a tapered proximal end and dual-pitch threads while the 12mm cannulated screw features a single pitch thread on the proximal and distal ends. The SambaScrews are constructed from medicalgrade titanium alloy (Ti-6AI-4V ELI). The 11mm and 12mm SambaScrews are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. SambaScrew allows for packing of autograft and allograft materials.
The document provided does not describe a study involving acceptance criteria and device performance in the context of a diagnostic or AI-powered medical device. Instead, it is a 510(k) premarket notification for a medical device called "SambaScrew 3D SI Fusion System," which is a surgical implant.
The "acceptance criteria" discussed in this document refer to the mechanical performance of the implant, which is evaluated through physical tests rather than clinical study outcomes. The "study" mentioned is a series of non-clinical mechanical tests comparing the device to predicate devices.
Therefore, many of the requested categories (like sample size for test set, data provenance, expert qualifications for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
The document describes mechanical performance testing but does not provide specific acceptance criteria values or detailed reported performance data in a comparative table for each test type. It merely states that the tests were conducted according to ASTM standards to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Meets ASTM F2193-18a standards | SambaScrew 3D SI Fusion implants underwent Static and Dynamic cantilever beam tests per ASTM F2193-18a. (Implied: met standards for substantial equivalence) |
| Meets ASTM F543-17 standards | SambaScrew 3D SI Fusion implants underwent Static torsion test and Static axial pull-off test per ASTM F543-17. (Implied: met standards for substantial equivalence) |
| Performance similar to predicate devices | "The technological characteristics of the SambaScrew 3D SI Fusion System is similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics." |
| No adverse effect on product use | "There are no significant differences between the SambaScrew 3D SI Fusion System and the predicate devices which would adversely affect the use of the product." |
2. Sample sized used for the test set and the data provenance: Not applicable. These were mechanical tests on physical implants, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical tests is determined by physical measurements against established standards, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical 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: Not applicable. This is a surgical implant, not an AI-powered diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical implant.
7. The type of ground truth used: The "ground truth" for the performance evaluation consisted of established mechanical test standards (ASTM F2193-18a and ASTM F543-17) and comparative performance with legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 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.
April 30, 2019
Orthofix Inc. Ms. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K183342
Trade/Device Name: SambaScrew 3D SI 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: April 1, 2019 Received: April 2, 2019
Dear Ms. Koch:
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.
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)
Device Name SambaScrew 3D SI Fusion System
Indications for Use (Describe)
The SambaScrew 3D SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac 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) |
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}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. A small registration mark is visible to the upper right of the "X" in "ORTHOFIX".
510(k) SUMMARY
SambaScrew 3D SI Fusion System
| 510(k) Owner InformationName:Address: | Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056 |
|---|---|
| Telephone Number:Fax Number:Email: | 214.937.2100214-937-3322jackikoch@orthofix.com |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch, Senior Regulatory Affairs Specialist |
| Date Prepared: | April 1, 2019 |
| Name of DeviceTrade Name / ProprietaryName: | SambaScrew 3D SI Fusion System |
| Common Name: | Sacroiliac Joint Fixation Bone |
| Product Code: | OUR |
| Regulatory Classification: | Class II – 21 CFR § 888.3040 |
| Review Panel: | Orthopedic Device Panel |
| Primary Predicate Device: | K121148 – SAMBA Screw System – Orthofix Inc. |
| Additional PredicateDevices: | K151818 - Simmetry Sacroiliac Joint Fusion System – ZygaTechnology, Inc.K182983 - iFuse Implant System – SI-Bone, Inc. |
| Reference Devices: | K172437 – CONSTRUX Mini PEEK Ti Spacer System – Orthofix Inc. |
Reason for 510(k) Submission:
Orthofix is submitting this Traditional 510(k) premarket notification for the new SambaScrew 3D SI Fusion System.
Device Description
The SambaScrew 3D SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as sterile, 11mm and 12mm cannulated screws of various lengths featuring multiple fenestrations along the shaft. The 11mm cannulated screw features a
{4}------------------------------------------------
tapered proximal end and dual-pitch threads while the 12mm cannulated screw features a single pitch thread on the proximal and distal ends. The SambaScrews are constructed from medicalgrade titanium alloy (Ti-6AI-4V ELI). The 11mm and 12mm SambaScrews are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. SambaScrew allows for packing of autograft and allograft materials.
Indications for Use
The SambaScrew 3D SI Fusion System is intended for fixation of sacroillac joint disruptions, and intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the SambaScrew 3D SI Fusion System is similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the SambaScrew 3D SI Fusion System and the predicate devices which would adversely affect the use of the product.
PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Mechanical testing consisting of Static and Dynamic cantilever beam Test. Static Torsion Test and Static Axial Pull-Off Test were conducted in accordance to ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and in accordance to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws.
| Subject Device | Mechanical Testing |
|---|---|
| SambaScrew 3D SI Fusionimplants | Static cantilever beam test per ASTM F2193-18a StandardSpecifications and Test Methods for Components Used in theSurgical Fixation of the Spinal Skeletal System |
| SambaScrew 3D SI Fusionimplants | Dynamic cantilever beam test per ASTM F2193-18a StandardSpecifications and Test Methods for Components Used in theSurgical Fixation of the Spinal Skeletal System |
| SambaScrew 3D SI Fusionimplants | Static torsion test per ASTM F543-17, Standard Specificationand Test Methods for Metallic Medical Bone Screws |
| SambaScrew 3D SI Fusionimplants | Static axial pull-off test per ASTM F543-17 StandardSpecification and Test Methods for Metallic Medical BoneScrews |
Table 1: Mechanical Performance Testing
Basis of Substantial Equivalence
The new SambaScrew 3D SI Fusion System has the same intended use, the same indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate SAMBA Screw System (K121148), the Slmmentry Sacroiliac Joint Fusion System (K151818) and the iFuse Implant System (K162733).
§ 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.