(276 days)
Not Found
No
The summary describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
Yes
The device is indicated for sacroiliac joint fusion, which aims to treat debilitating conditions, indicating its therapeutic purpose.
No
The device description states its purpose is to provide stabilization of the sacroiliac joint until fusion occurs, which is a treatment function, not a diagnostic one.
No
The device description explicitly states that the device consists of an implant and ancillary instruments, which are physical hardware components. The performance studies also focus on the mechanical properties of these physical components.
Based on the provided information, 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 on the human body. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an implantable system (screws and an interarticular component) designed to stabilize a joint. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
The BowTie™ SI Joint Fusion System is a surgical implant used for musculoskeletal stabilization.
N/A
Intended Use / Indications for Use
The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Bow Tie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The BowTie™ SI Joint Fusion System is intended to provide stabilization of the sacroiliac joint until fusion occurs. The device consists of an implant and a set of ancillary instruments. The implant is comprised of an interarticular component, an iliac screw, and a transfix screw. All implant components are titanium and available in various sizes to accommodate varying patient anatomy. The implant components are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and will be sterilized by the end user.
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)
The following bench testing was performed on the BowTie™ SI Joint Fusion System:
- Cadaveric Biomechanical Evaluation of SAIL Implant Construct ●
- Implant Static Torsion per ASTM F3574
- . Fatigue Vertical Shear Testing per ASTM F3574
- Porous Coating Characterization per ASTM F1854
- Implant Fatigue Torsion Testing per ASTM F3574
- . Static Vertical Shear Testing per ASTM F3574
- Bone Screw Mechanical Testing – Torsion Strength per ASTM F543
- Bone Screw Mechanical Testing – Insertion Torque per ASTM F543
- . Bone Screw Mechanical Testing – Pull-Out per ASTM F543
- Bone Screw Mechanical Testing – Static Cantilever Bending Testing per ASTM F2193
- . Bone Screw Mechanical Testing – Fatigue Cantilever Bending Testing per ASTM F2193
In summary, rationales and mechanical testing of the BowTie™ SI Joint Fusion System indicated there are no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
April 20, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG".
SAIL Fusion, LLC Benjamin Arnold Official Applicant 2010 Jimmy Durante Blvd Suite 200 Del Mar, California 92014
Re: K232149
Trade/Device Name: BowTie™ 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 13, 2024 Received: March 21, 2024
Dear Benjamin Arnold:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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/6 description: The image contains the text "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. To the right of the text is a faded, light blue logo that appears to be the letters "FDA".
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
2
Indications for Use
510(k) Number (if known) K232149
Device Name BowTie™ SI Joint Fusion System
Indications for Use (Describe)
The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. When the Bow Tie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used.
| 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:
| Company Name: | SAIL Fusion, LLC |
|---|---|
| Address: | 2010 Jimmy Durante Blvd, Suite 200 |
| Del Mar, CA 92014 | |
| Telephone: | 607.351.6131 |
| CONTACT PERSON: | Benjamin Arnold |
| DATE PREPARED: | 7/18/2023 |
| TRADE NAME: | BowTie™ SI Joint Fusion System |
| COMMON NAME: | Sacroiliac Joint Fixation Device |
| CLASSIFICATION NAME: | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| REGULATORY CLASS: | II |
| PRODUCT CODE: | OUR |
SUBSTANTIAL EQUIVALENCE:
The BowTie™ SI Joint Fusion System is substantially equivalent to the primary predicate device in all facets including function, design, performance, material, and intended use.
| Primary Predicate Device: | Aurora Spine, Inc. SILO TFX MIS Sacroiliac Joint Fixation System
(K221047) |
| --------------------------- | ------------------------------------------------------------------------------- |
|---|
DEVICE DESCRIPTION:
The BowTie™ SI Joint Fusion System is intended to provide stabilization of the sacroiliac joint until fusion occurs. The device consists of an implant and a set of ancillary instruments. The implant is comprised of an interarticular component, an iliac screw, and a transfix screw. All implant components are titanium and available in various sizes to accommodate varying patient anatomy. The implant components are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and will be sterilized by the end user.
MATERIALS:
The BowTie™ SI Joint Fusion System interarticular component is additively manufactured from Ti-6Al-4V ELI per ASTM F3001. The Posterior Sacroiliac Joint Fusion Device screws are machined from Ti-6Al-4V ELI per ASTM F136.
INDICATIONS FOR USE:
The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Bowtie Sl Fusion System is implanted, both the Iliac and Transfix Screw components must be used.
4
TECHNOLOGICAL CHARACTERISTICS:
The BowTie™ SI Joint Fusion System implant components are made from similar materials and have equivalent design philosophy, sizing, configurations, fixation methods, sterilization and packaging, and surgical approach to the predicate device. Any differences between the Posterior Sacroillac Joint Fusion Device and the predicate are considered minor and do not raise questions concerning safety or effectiveness.
PERFORMANCE TESTING:
The following bench testing was performed on the BowTie™ SI Joint Fusion System:
- Cadaveric Biomechanical Evaluation of SAIL Implant Construct ●
- Implant Static Torsion per ASTM F3574
- . Fatigue Vertical Shear Testing per ASTM F3574
- Porous Coating Characterization per ASTM F1854
- Implant Fatigue Torsion Testing per ASTM F3574
- . Static Vertical Shear Testing per ASTM F3574
- Bone Screw Mechanical Testing – Torsion Strength per ASTM F543
- Bone Screw Mechanical Testing – Insertion Torque per ASTM F543
- . Bone Screw Mechanical Testing – Pull-Out per ASTM F543
- Bone Screw Mechanical Testing – Static Cantilever Bending Testing per ASTM F2193
- . Bone Screw Mechanical Testing – Fatigue Cantilever Bending Testing per ASTM F2193
In summary, rationales and mechanical testing of the BowTie™ SI Joint Fusion System indicated there are no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
CONCLUSIONS:
The BowTie™ SI Joint Fusion System is substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing, and comparison to predicate devices.