(29 days)
Not Found
No
The summary describes a surgical implant system and navigation instruments. While navigation systems can sometimes incorporate advanced algorithms, there is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system is described as assisting in locating anatomical structures based on acquired images, which is typical for image-guided surgery and does not inherently require AI/ML.
Yes
The device is indicated for sacroiliac joint fusion and fracture fixation, which are direct interventions aimed at treating a medical condition or injury.
No
The device is an implant system (implants and instruments) used for sacroiliac joint fusion and fracture fixation. While it can be used with navigation instruments that utilize imaging data for surgical planning, the device itself is therapeutic, not diagnostic.
No
The device description explicitly states that the system consists of implants and associated instruments, which are physical hardware components (threaded, fenestrated, cannulated, 3D-printed titanium alloy implants). While there are navigation instruments mentioned, the core device includes physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The iFuse TORQ Implant System is a surgical implant and associated instruments used for fusing the sacroiliac joint and fixing pelvic fractures. The navigation instruments assist in surgical procedures. These are all used in vivo (within the body) during surgery, not in vitro (outside the body) on patient samples.
The device is a surgical implant system and navigation tool, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for: · Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. · Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ 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 TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.
Product codes
OUR, HWC, OLO
Device Description
The iFuse TORQ Implant System consists of the iFuse TORQ Implants and associated Instruments. Implants are threaded, fenestrated, cannulated, 3D-printed from medical grade titanium alloy (Ti-6A1-4V ELI per ASTM F3001). The implants are fully threaded or a lag design that is provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.
This 510(k) covers extension of the porous lattice surface over the entire shank of the Ø10.0 mm screws, an optimized laser path during additive manufacturing process, and use of two implants in the SAI (posteromedial) trajectory for sacroiliac joint fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
sacroiliac joint, pelvis, vertebra
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeon, stereotactic surgery
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)
All necessary bench testing was conducted on the modified iFuse TORQ implants including:
- Porosity testing per ASTM F1854
- Static Shear per ASTM F1044 ●
- Static Fatigue per ASTM F1160
- . Static Tensile per ASTM F1147
- . Abrasion per ASTM F1978
- Dynamic Cantilever Testing per ASTM F2193
- Static Torsion Testing per ASTM F543
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.
iFuse TORQ Implant System (K222605), iFuse TORQ Implant System (K231689), iFuse Bedrock Granite Implant System (K220195)
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
July 2, 2024
Image /page/0/Picture/1 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 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.
SI-BONE Inc. Robyn Capobianco VP Clinical and Regulatory Affairs 471 El Camino Real, Suite 101 Santa Clara, California 95050
Re: K241574
Trade/Device Name: iFuse TORQ® 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 31, 2024 Received: June 3, 2024
Dear Robyn Capobianco:
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 QS 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,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2024.07.02
14:56:32 -04'00'
for
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) K241574
Device Name iFuse TORQ® Implant System
Indications for Use (Describe)
The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:
· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
· Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.
The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ 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 TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.
Type of Use (Select one or both, as applicable) |
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------------------------------------------------- |
☑ Prescription Use (Part 21 CFR 801 Subpart D) |
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☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY- iFuse TORQ® Implant System
Date Prepared: May 31, 2024
I. SUBMITTER
SI-BONE, Inc. 471 El Camino Real, Suite 101, Santa Clara, CA 95050 Phone: 408-207-0700 Fax: 408-557-8312
Contact Person: Robyn Capobianco, VP Clinical & Regulatory Affairs Email: robyn.capobianco(@si-bone.com Phone: 650-219-8342
II. DEVICE
Trade Name of Device: | iFuse TORQ® Implant System |
---|---|
Common or Usual Name: | Sacroiliac Joint Fixation |
Classification: | II |
Regulation Number: | 21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener |
Product Codes: | OUR, HWC, OLO |
III. PREDICATE DEVICE
Primary Predicate: | iFuse TORQ Implant System (K222605) |
---|---|
Additional Predicates: | iFuse TORQ Implant System (K231689) |
iFuse Bedrock Granite Implant System (K220195) |
IV. DEVICE DESCRIPTION
The iFuse TORQ Implant System consists of the iFuse TORQ Implants and associated Instruments. Implants are threaded, fenestrated, cannulated, 3D-printed from medical grade titanium alloy (Ti-6A1-4V ELI per ASTM F3001). The implants are fully threaded or a lag design that is provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.
This 510(k) covers extension of the porous lattice surface over the entire shank of the Ø10.0 mm screws, an optimized laser path during additive manufacturing process, and use of two implants in the SAI (posteromedial) trajectory for sacroiliac joint fusion.
V. INDICATIONS FOR USE
The iFuse TORO Implant System is indicated for sacroiliac joint fusion for:
4
.
iFuse TORQ Implant System
- 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 Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ 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 TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The modifications to the subject implant screws do not alter the device's fundamental scientific technology compared to the predicate. Risk analyses and performance data confirm that the proposed changes do not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
All necessary bench testing was conducted on the modified iFuse TORQ implants including:
- Porosity testing per ASTM F1854
- Static Shear per ASTM F1044 ●
- Static Fatigue per ASTM F1160
- . Static Tensile per ASTM F1147
- . Abrasion per ASTM F1978
- Dynamic Cantilever Testing per ASTM F2193
- Static Torsion Testing per ASTM F543
The test results demonstrate that the device is substantially equivalent to the predicate device.
VIII. CONCLUSIONS
The subject device is substantially equivalent to its predicate in terms of intended use and indications for use, technological characteristics, manufacturing methods, and principles of operation. The differences in the technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Based on the performance testing and the technological characteristics, it can be concluded that the subject device is substantially equivalent to the predicate devices.