(53 days)
Not Found
No
The description focuses on the mechanical design and material of a surgical implant for sacroiliac joint fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for sacroiliac fusion to treat sacroiliac joint dysfunction and degenerative sacroilitis, which directly addresses a medical condition to restore function.
No
The device is a sacroiliac joint fusion system, which is an implant designed to provide fixation for the sacroiliac joint for conditions like sacroiliac joint dysfunction and degenerative sacroiliitis. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of an "X shaped implant" manufactured from "titanium alloy," which is a physical hardware component.
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 fusion, which is a surgical procedure to stabilize and fuse the sacroiliac joint. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is an implant designed to provide fixation of the sacroiliac joint. It is a physical device used in surgery.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information for diagnosis. IVD devices are used in vitro (outside the body) to examine specimens and provide diagnostic information.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in one size. The implant is manufactured from titanium alloy per ASTM F136.
The SI-TECHNOLOGY® SI-DESIS® XTM Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.
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
skeletally mature patients
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)
Non-clinical testing was performed to demonstrate the subject device is substantially equivalent to other predicate devices. The following tests were performed to show equivalency:
• Static Shear Testing
• Dynamic Shear Testing
• Pushout Testing
• Biomechanical Cadaver Testing
• Simulated Use Testing
The results of these studies show the subject device is substantially equivalent to the predicate devices.
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.
K190230, K180818 / K231944, K151462, K021932
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
August 13, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a larger font size than the name.
SI-Technology, LLC % Mr. Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K241813
Trade/Device Name: SI-Technology® SI-DESIS® X™ 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: June 21, 2024 Received: June 21, 2024
Dear Mr. Gracyalny:
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).
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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 medical devices and radiation-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,
Colin
O'neill -S
for
Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
Indications for Use (Describe)
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroillac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients underqoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
Type of Use (Select one or both, as applicable)
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
| Date | June 19, 2024 |
|---|---|
| Sponsor | SI-TECHNOLOGY, LLC |
| 320 East Vine Drive, Suite 217 | |
| Fort Collins, Colorado, USA 80524 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Justin Gracyalny, MSE | |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System |
| Common Name | Sacroiliac Joint Fixation |
| Code- | |
| Classification | OUR |
| 21 CFR 888.3040 : Class II | |
| Primary | |
| Predicate | K190230 SI-BONE, Inc. iFuse Implant System® |
| Additional | |
| Predicates | K180818 / K231944 Tenon Catamaran Sacroiliac Joint Fixation System |
| K151462 SI-TECHNOLOGY® SI-DESIS® Screws | |
| K021932 Synthes 6.5mm Cannulated Screw | |
| Device | |
| Description | The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System |
| consists of an X shaped implant designed to assist in the healing of sacroiliac | |
| (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant | |
| is not intended to replace normal body structures. The implant is offered in one | |
| size. The implant is manufactured from titanium alloy per ASTM F136. |
The SI-TECHNOLOGY® SI-DESIS® XTM Sacroiliac Joint Fusion System
was designed as a less invasive alternative to traditional open posterior surgical
SI joint fusion. The titanium implant consists of a sacrum engaging side and an
ilium engaging side connected by a bridge. During the procedure, bone graft
material is placed in the window of the implant to facilitate stabilization. The
implant is intended for single-use only. Implants are provided clean and non-
sterile and designed for routine steam sterilization prior to use. |
| Indications for
Use | The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion
System is intended for sacroiliac fusion for conditions including sacroiliac
joint dysfunction that is a direct result of sacroiliac joint disruption and
degenerative sacroiliitis. This includes conditions whose symptoms began
during pregnancy or in the peripartum period and have persisted
postpartum for more than 6 months.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
is also intended for sacroiliac fusion to augment immobilization and
stabilization of the sacroiliac joint in skeletally mature patients undergoing
sacropelvic fixation as part of a lumbar or thoracolumbar fusion. |
| Technological
Characteristics | There are no significant technological differences between the subject and
predicate devices. The technological design features of the subject implants
were compared to the predicates in intended use, indications for use, design,
function and technology and it was demonstrated that they are substantially
equivalent. |
| Performance
Testing | Non-clinical testing was performed to demonstrate the subject device is
substantially equivalent to other predicate devices. The following tests were
performed to show equivalency:
• Static Shear Testing
• Dynamic Shear Testing
• Static Pushout Testing
• Biomechanical Cadaver Testing
• Simulated Use Testing
The results of these studies show the subject device is substantially
equivalent to the predicate devices. |
| Conclusions | Based on the indications for use, technological characteristics, performance
testing, and comparison to the predicate device, the subject device is as safe
and as effective as the legally marketed predicates. |
510(k) Summary: SI-TECHNOLOGY® SI-DESIIS® XTM
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