(83 days)
Not Found
No
The document does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithms. The navigation system relies on image data and anatomical reference, not AI/ML processing.
Yes
The device is indicated for fracture fixation and joint fusion, which are therapeutic interventions aimed at treating conditions like pelvic fractures and sacroiliac joint dysfunction.
No
The device, iFuse TORQ TNT Implant System, is an implant and instrument system used for fracture fixation and joint fusion. While it mentions navigation instruments that use imaging to assist in surgical procedures, its primary purpose is therapeutic (fixation and fusion) rather than diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states that the system consists of a "fully threaded, 3D-printed porous implant with optional washers along with instruments used to place the implant". This indicates the device includes physical hardware components (implants and instruments), not just software. While it mentions navigation instruments used with a navigation system, the core device is the implant and its associated physical instruments.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The iFuse TORQ TNT Implant System is a surgical implant and associated instruments used for fracture fixation and joint fusion within the pelvis and spine. It is a device that is physically placed within the body or used to guide the placement of such a device.
- Intended Use: The intended use clearly describes a surgical procedure for treating fractures and joint dysfunction, not for analyzing biological samples.
- Device Description: The description details a physical implant and surgical instruments, not equipment for laboratory testing.
The device is a surgical implant system and navigation tools, which fall under a different category of medical devices than In Vitro Diagnostics.
Yes
FDA's substantial equivalence determination explicitly states the "review and clearance of your Predetermined Change Control Plan (PCCP)".
Intended Use / Indications for Use
The iFuse TORQ TNT Implant System is indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.
The iFuse TORO TNT Implant System is indicated for:
- Sacroiliac joint fusion for Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacrollitis.
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORQ TNT Navigation instruments are intended to be used with the iFuse TORO TNT Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ TNT Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ TNT Navigation instruments are intended to be used with the Medtronic StealthStation System.
Product codes
OUR, HWC, OLO
Device Description
iFuse TORQ TNT System consists of a fully threaded, 3D-printed porous implant with optional washers along with instruments used to place the implant under either fluoroscopic guidance or with certain navigation systems. The implant is made from titanium alloy (Ti-6Al-4V ELI) and manufactured using 3D printing. The implant has features specific to pelvic anatomy. The subject device is very similar to its primary predicate, iFuse TORQ implant system, except that it is longer in length (up to 170 mm) and smaller in diameter. The longer length enables placement in the transiliac transsacral trajectory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image reconstruction, 3D fluoroscopic image reconstruction
Anatomical Site
pelvis, sacroiliac joint, sacropelvic, lumbar, thoracolumbar, vertebra
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeon / 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)
SI-BONE performed the following performance tests:
- Static and dynamic cantilever testing per ASTM F2193
- Torsion, driving torque, and axial pullout per ASTM F543
- Elemental Analysis per ASTM F3001
- Stereological evaluation of the porous layer ASTM 1854 and 21 CFR 888.3358
- Navigation Instruments Positional Error Verification per ASTM F2554
- Simulated Use Testing of the navigation instruments
Evaluation of design changes do not affect the testing previously conducted on the primary predicate (K203247); this testing leveraged from the iFuse TORQ Implant System (K203247):
- Static Shear Testing per ASTM F1044
- Shear Fatigue Testing per ASTM F1160 and ISO 13179-1
- Static Tensile Testing per ASTM F1147
- Abrasion Properties per ASTM F1978
The test results demonstrate that the device is substantially equivalent to the predicate device.
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).
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP) titled "Predetermined Change Control Plan for Additional Trajectories and Implant Modifications" Version 2. Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
This 510(k) submission included a Predetermined Change Control Plan, described below. Following completion of activities listed below, the changes described herein will be implemented.
PCCP1 - Trajectories. Placement of the subject device in one or more of the following trajectories will be subject to: 1) review of prior surgical techniques, 2) review of post-market surveillance data for similar implants, 3) risk analysis (hazard analysis, failure modes and effects analysis), 4) confirmation of placements in anatomic models [if required]), and 5) review with experienced surgeons:
- Various trajectories for fracture fixation (e.g., anterior iliac spine to posterior ilium)
- Sacroalar iliac (SAI)
When analysis for the SAI trajectory is complete, the indication statement will read:
The iFuse TORQ TNT Implant System is indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
The iFuse TORQ TNT Implant System is indicated for sacroiliac joint fusion for:
- Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORQ TNT Navigation instruments are intended to be used with the iFuse TORQ TNT Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ TNT Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ TNT Navigation instruments are intended to be used with the Medtronic StealthStation System.
PCCP 2 - modified version. A version of the subject device will be developed, with changes to thread length and pitch. The device will undergo assessment and/or testing similar to that performed for the fully threaded versions cleared herein. Testing will include the following: Fatigue testing per ASTM F2193-20, pullout testing per ASTM F543-23.
§ 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
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.
August 19, 2024
SI-Bone Inc. Jayasri Prabakaran Associate Director, Regulatory Affairs 471 El Camino Real, Suite 101 Santa Clara, California 95050
Re: K241504
Trade/Device Name: iFuse TORQ TNT™ Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, HWC, OLO Dated: May 24, 2024 Received: May 28, 2024
Dear Jayasri Prabakaran:
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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP) titled "Predetermined Change Control Plan for Additional Trajectories and
1
Implant Modifications" Version 2. Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
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).
Your device is also subject to, among other requirements, the Quality System (OS) 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
2
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,
STEPHANIE SMITH -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
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Indications for Use
510(k) Number (if known) K241504
Device Name iFuse TORQ TNT™ Implant System
Indications for Use (Describe)
The iFuse TORQ TNT Implant System is indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.
The iFuse TORO TNT Implant System is indicated for:
- Sacroiliac joint fusion for Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacrollitis. - Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORO TNT Navigation instruments are intended to be used with the iFuse TORO TNT Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ TNT Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ TNT Navigation instruments are intended to be used with the Medtronic StealthStation System.
| 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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iFuse TORQ TNT™ Implant System
510(k) SUMMARY
iFuse TORQ TNT™ Implant System
I. 510(k) SUBMITTER
SI-BONE, Inc. 471 El Camino Real, Suite 101, Santa Clara, CA 95050 Phone: 408-207-0700 Fax: 408-557-8312
| Contact Person: | Jayasri Prabakaran, Associate Director, Regulatory Affairs |
|---|---|
| FDA Establishment Registration No.: | 3007700286 |
| Date Prepared: | May 24, 2024 |
- II. DEVICE
| Trade Name of Device | iFuse TORQ TNT™ Implant System |
|---|---|
| Classification Name | Sacroiliac Joint Fixation |
| Classification | II |
| Regulation Number | 21 CFR 888.3040; Smooth or threaded metallic bone fixation fastener |
| Product Code | OUR, HWC, OLO |
III. PREDICATE DEVICES
Primary Predicate:
| Predicate Device | Manufacturer | 510(k)# | Clearance Date |
|---|---|---|---|
| iFuse TORQ Implant System | SI-BONE, Inc. | K203247 | 25 February 2021 |
Additional Predicate:
| Predicate Device | Manufacturer | 510(k)# | Clearance Date |
|---|---|---|---|
| 7.3 mm Cannulated Screw | Depuy Synthes | K161616 | 16 February 2017 |
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IV. PURPOSE
This 510(k) includes:
- A description of testing sufficient to establish substantial equivalence between the subject ■ device and its predicates.
- . A description of a pre-determined change control plan (PCCP) for adding use of the subject device in 4 new trajectories and a modified version with changes to implant thread length and pitch.
V. DEVICE DESCRIPTION
iFuse TORQ TNT System consists of a fully threaded, 3D-printed porous implant with optional washers along with instruments used to place the implant under either fluoroscopic guidance or with certain navigation systems. The implant is made from titanium alloy (Ti-6Al-4V ELI) and manufactured using 3D printing. The implant has features specific to pelvic anatomy. The subject device is very similar to its primary predicate, iFuse TORQ implant system, except that it is longer in length (up to 170 mm) and smaller in diameter. The longer length enables placement in the transiliac transsacral trajectory.
VI. INDICATIONS FOR USE
The iFuse TORQ TNT Implant System is indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
The iFuse TORQ TNT Implant System is indicated for sacroiliac joint fusion for:
- Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. ●
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORO TNT Navigation instruments are intended to be used with the iFuse TORO TNT Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ TNT Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ TNT Navigation instruments are intended to be used with the Medtronic StealthStation System.
VII. SUMMARY OF SUBSTANTIAL EQUIVALENCE
The subject device is substantially equivalent to its predicate in terms of intended use and indications for use, technological characteristics, materials, manufacturing methods, and principles of operation. The differences in the indication for use statement from the previously cleared legally marketed predicate are not critical to the intended therapeutic, prosthetic, or surgical use of the device. Therefore, based on the intended use, indications for use, technological characteristics, and principles of operation, iFuse TORQ TNT Implant System is substantially equivalent to its predicate device.
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VIII. PERFORMANCE DATA
SI-BONE performed the following performance tests:
- Static and dynamic cantilever testing per ASTM F2193
- Torsion, driving torque, and axial pullout per ASTM F543 ●
- Elemental Analysis per ASTM F3001 ●
- Stereological evaluation of the porous layer ASTM 1854 and 21 CFR 888.3358
- . Navigation Instruments Positional Error Verification per ASTM F2554
- Simulated Use Testing of the navigation instruments ●
Evaluation of design changes do not affect the testing previously conducted on the primary predicate (K203247); this testing leveraged from the iFuse TORQ Implant System (K203247):
- · Static Shear Testing per ASTM F1044
- · Shear Fatigue Testing per ASTM F1160 and ISO 13179-1
- · Static Tensile Testing per ASTM F1147
- · Abrasion Properties per ASTM F1978
The test results demonstrate that the device is substantially equivalent to the predicate device.
IX. PRE-DETERMINED CHANGE CONTROL PLAN
This 510(k) submission included a Predetermined Change Control Plan, described below. Following completion of activities listed below, the changes described herein will be implemented.
PCCP1 - Trajectories. Placement of the subject device in one or more of the following trajectories will be subject to: 1) review of prior surgical techniques, 2) review of post-market surveillance data for similar implants, 3) risk analysis (hazard analysis, failure modes and effects analysis), 4) confirmation of placements in anatomic models [if required]), and 5) review with experienced surgeons:
- Various trajectories for fracture fixation (e.g., anterior iliac spine to posterior ilium) ■
- Sacroalar iliac (SAI)
When analysis for the SAI trajectory is complete, the indication statement will read:
The iFuse TORQ TNT Implant System is indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
The iFuse TORQ TNT Implant System is indicated for sacroiliac joint fusion for:
- . Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
- . Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORQ TNT Navigation instruments are intended to be used with the iFuse TORQ TNT Implant System to assist the surgeon in precisely locating anatomical structures in iFuse
7
TORQ TNT Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ TNT Navigation instruments are intended to be used with the Medtronic StealthStation System.
PCCP 2 - modified version. A version of the subject device will be developed, with changes to thread length and pitch. The device will undergo assessment and/or testing similar to that performed for the fully threaded versions cleared herein. Testing will include the following: Fatigue testing per ASTM F2193-20, pullout testing per ASTM F543-23.
X. CONCLUSION
The iFuse TORQ TNT implant is substantially equivalent to its predicate in terms of intended use and indications for use, technological characteristics, materials, manufacturing methods, and principles of operation. Testing has shown substantially equivalent benchtop performance. The difference in the indication for use statement from the previously cleared, legally marketed predicates are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device. Test results demonstrate that the device is substantially equivalent to the legally marketed device and does not raise different questions of safety and effectiveness than the predicate device.