(31 days)
Not Found
No
The document describes a surgical implant system and navigation instruments that use image data for anatomical localization, but there is no mention of AI or ML being used for image processing, analysis, or any other function. The navigation system relies on referencing anatomical structures relative to acquired images.
Yes
The device is an implantable system used for sacroiliac joint fusion and fracture fixation of the pelvis, which are therapeutic interventions.
No
The device is an implant system used for sacroiliac joint fusion and fracture fixation. While it includes navigation instruments that use imaging to assist in locating anatomical structures, its primary function is therapeutic (implant and fixation), not diagnostic.
No
The device description explicitly states that the system consists of implants and associated instruments, which are physical hardware components made of titanium alloy. While there are navigation instruments that likely involve software, the core device is not software-only.
Based on the provided text, the iFuse TORQ Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- iFuse TORQ System Function: The description clearly states that the iFuse TORQ Implant System is used for sacroiliac joint fusion and fracture fixation of the pelvis. These are surgical procedures involving the direct implantation of a device into the body to treat a condition.
- Intended Use: The intended use describes a surgical intervention, not a diagnostic test performed on a sample outside the body.
- Device Description: The device description details implants and instruments used in surgery, not reagents or equipment for analyzing biological samples.
Therefore, the iFuse TORQ Implant System falls under the category of a surgical implant and associated instruments, not an In Vitro Diagnostic device.
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 sacropelyic 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.
Product codes
OUR, HWC, OLO
Device Description
The iFuse TORQ Implant System consists of the iFuse-TORQ Implants and associated Instruments. consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded or with a lag design and 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-theshelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.
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)
An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
iFuse TORQ Implant System K213667, iFuse TORQ Implant System K203247, iFuse-3D Implant System, K190230, K182983, K172268
Reference Device(s)
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
September 29, 2022
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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SI-BONE, Inc. Meirav Harsat Director, Regulatory Affairs 471 El Camino Real Suite 101 Santa Clara, California 95050
Re: K222605
Trade/Device Name: iFuse TORO® 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: August 26, 2022 Received: August 29, 2022
Dear Meirav Harsat:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/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 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 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,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K22605
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 sacropelyic 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) | |
---|---|
☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY - iFuse TORQ® Implant System
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: Meirav Harsat, Director of Regulatory Affairs, SI-BONE, Inc. Email: mharsat(@si-bone.com Phone: 650-862-4942 Date Prepared: August 30, 2022
II. DEVICE
Trade Name of Device: | iFuse TORQ® Implant System |
---|---|
Common or Usual Name: | Sacroiliac Joint Fixation |
Regulation Number: | 21 CFR 888.3040, Smooth or threaded metallic bone fastener |
Product Code: | OUR, HWC and OLO |
III. PREDICATE AND REFERENCE DEVICES
Primary Predicate: | iFuse TORQ Implant System K213667 |
---|---|
Additional Predicates: | iFuse TORQ Implant System K203247 |
iFuse-3D Implant System, K190230, K182983, K172268 |
IV. DEVICE DESCRIPTION
The iFuse TORQ Implant System consists of the iFuse-TORQ Implants and associated Instruments. consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded or with a lag design and 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-theshelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.
V. 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 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.
4
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 subject device has identical technological characteristics compared to the primary predicate device and similar technological characteristics compared to the additional predicate. Risk analyses confirm that the differences do not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent.
VIII. CONCLUSIONS
The subject device has been shown to be substantially equivalent to the primary and additional predicate devices. The proposed subject device has the same intended use as the predicates and an indication for use that is similar to the predicate devices. The differences in the indications for use do not affect the safety and effectiveness of the device and do not alter the intended therapeutic, diagnostic, prosthetic, or surgical use of the device. The proposed device has identical technological characteristics to the primary predicate and similar technological characteristics to the additional predicate. The differences in the technological characteristics between the subject device and the additional predicate do not raise different questions of safety and effectiveness.