(98 days)
The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The SI-Restore® Sacroiliac Joint Fixation System consists of a cannulated titanium (Ti 6AI4V ELI, per ATSM F136) screw with a titanium (Ti 6AI4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The Implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation for and placement of the implant.
The provided document is a 510(k) Premarket Notification for the Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System. This document describes a medical device (a bone fixation system), not a software or AI/ML-based device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device, such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this submission.
The document discusses the following types of performance data for this physical medical device:
- Static Axial Pull-out and Static Torque to Failure testing (per ASTM F543-13)
- Static Three-Point Bending and Dynamic Three-Point Bending (per ASTM F1264-14)
These tests confirmed that the device performed as intended and supported the claim of substantial equivalence to a legally marketed predicate device (SI-LOK™ Sacroiliac Joint Fixation System, K112028).
Since the request specifically asks about acceptance criteria and studies for an AI/ML device, and this document pertains to a physical orthopedic implant, I can only state that the requested information is not present in the provided text because the device in question is not an AI/ML product.
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January 25, 2019
Biofusion Medical % Daniel Lanois Principal Consultant SurgOp Support LLC 7512 Lancaster Gate Frisco. Texas 75035
Re: K182919
Trade/Device Name: SI-Restore® Sacroiliac Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: December 21, 2018 Received: December 26, 2018
Dear Daniel Lanois:
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
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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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.
Colin O'neill -S
for MNM
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) K182919
Device Name
SI-Restore® Sacroiliac Joint Fixation System
Indications for Use (Describe)
The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation 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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| Date Prepared | October 18, 2018 | ||
|---|---|---|---|
| Manufacturer | Biofusion Medical LLC | ||
| Address | 2503 Cedarview Drive, Austin, Texas 78704 | ||
| Telephone | 866-489-0602 | ||
| Fax | 866-441-5351 | ||
| Contact Person | Daniel Lanois | ||
| Consultant | |||
| Address | SurgOp Support LLC | ||
| 7512 Lancaster Gate, Frisco, Texas 75035 | |||
| Telephone | 678-371-3605 | ||
| Fax | |||
| daniel@surgopsupport.com | |||
| Trade Name | SI-Restore® Sacroiliac Joint Fixation System | ||
| Common Name | Bone Screw or Internal Fixation Device | ||
| Panel Code | Orthopedic/87 | ||
| Classification Name | Smooth of threaded metallic bone fixation fastener | ||
| Class | Class II | ||
| Regulation Number | 21 CFR 888.3040 | ||
| Product Code | OUR | ||
| Name of Predicate Device | 510(k) # | Manufacturer | |
| SI-LOKTM Sacroiliac Joint Fixation System | K112028 | Globus Medical | |
| Description | The SI-Restore® Sacroiliac Joint Fixation System consists of a cannulatedtitanium (Ti 6AI4V ELI, per ATSM F136) screw with a titanium (Ti 6AI4V ELI,per ATSM F136) washer affixed to the head of the screw for full cortexengagement. The Implant is designed to prevent motion of the sacroiliac (SI)joint. The delivery system uses guide pins for accurate preparation for andplacement of the implant. | ||
| Indications and Intended Use | The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System isintended for sacroiliac joint fusion for conditions including sacroiliac jointdisruptions and degenerative sacroiliitis. | ||
| Technological Characteristics/Substantial Equivalence | Documentation was provided to demonstrate that the Subject device, issubstantially equivalent to the Predicate. The Subject device is substantiallyequivalent to the Predicate device in intended use, indications for use,materials, technological characteristics, and labeling. | ||
| Performance Data | Static Axial Pull-out and Static Torque to Failure testing (per ASTM F543-13)confirmed that the Subject device performed as intended. Also, Static Three-Point Bending and Dynamic Three-Point Bending (per ASTM F1264-14)confirmed that the Subject device performed as intended. | ||
| Conclusion | Based on the intended use, indications for use, technological characteristics,materials, and comparison to Predicate devices, the Subject device has beenshown to be substantially equivalent to legally marketed Predicate devices. |
| 510(k) Summary (as required by 21 CFR 807.92) | |||||
|---|---|---|---|---|---|
| ----------------------------------------------- | -- | -- | -- | -- | -- |
§ 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.