(21 days)
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 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.
The iFuse TORQ Implant System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6A1-4V 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-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) premarket notification is for the iFuse TORQ® Implant System, which is a medical device for sacroiliac joint fusion and fracture fixation of the pelvis. The submission is to request clearance for an additional trajectory for placement of the device. Since this is an update seeking clearance for an additional trajectory for an already cleared device, the submission focuses on demonstrating substantial equivalence to the existing cleared device and predicates rather than presenting novel performance studies typical for a new device's initial clearance. Typically, updates like this rely on existing performance data of the cleared device and rationale for why the new trajectory does not introduce new safety or effectiveness concerns.
Therefore, the provided document does not contain independent studies with acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as one would expect for a novel AI/software device. Instead, it relies on the previous clearance of the iFuse TORQ Implant System (K222605) and demonstrates that the current changes do not raise new questions of safety and effectiveness.
Here's an analysis based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent." However, it does not provide a table of acceptance criteria or specific numerical performance metrics for the device itself or for any new trajectory. This suggests that the performance evaluation for this submission relies on demonstrating similarity to already cleared devices, rather than establishing new performance benchmarks for this specific modification.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document does not describe a new test set or study conducted to evaluate the device with the new trajectory. The assessment is likely based on engineering analysis and comparison to existing data for the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. No new test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set:
Not applicable. No new test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not mentioned in the provided text. This type of study is more common for diagnostic imaging AI algorithms and less so for implantable hardware modifications unless there's a significant impact on interpretation or surgical planning.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a medical device (implant system), not a standalone algorithm. The iFuse TORQ Navigation instruments are intended for human-in-the-loop assistance.
7. The Type of Ground Truth Used:
Not applicable. No new ground truth data is mentioned for this specific submission. The existing clearance for the iFuse TORQ Implant System (K222605) would have relied on appropriate ground truth for its initial evaluation, likely including clinical outcomes, radiographic assessment, and potentially cadaveric or biomechanical testing.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML algorithm that requires a training set in that context. The "training" for such medical devices typically refers to design iterations, engineering tests, and potentially cadaveric studies prior to marketing authorization.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
In summary, for this particular 510(k) submission (K231689) requesting clearance for an additional trajectory for the iFuse TORQ Implant System:
The primary method of demonstrating acceptance criteria is by showing substantial equivalence to already legally marketed predicate devices. The document explicitly states:
- "The subject device has identical technological characteristics compared to the primary predicate device and similar technological characteristics compared to the additional predicates. Risk analyses confirm that the differences do not raise different questions of safety and effectiveness."
- "An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent."
- "The subject device has been shown to be substantially equivalent to the primary and additional predicate devices. The subject device has the same intended use and indications for use as the primary predicate and an indication for use that is similar to the additional predicate devices. The differences in the indications for use between the subject device and the additional predicate 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 subject device is the primary predicate and has similar technological characteristics to the additional predicates. The differences in the technological characteristics between the subject device and the additional predicates do not raise different questions of safety and effectiveness."
This means that the "acceptance criteria" are implicitly met by demonstrating that the modified device (with the additional trajectory) is as safe and effective as the predicate devices, and that the changes do not introduce new risks or alter the fundamental function of the device in a way that would require new performance studies. The specific performance data and criteria would have been part of the original K222605 submission for the iFuse TORQ Implant System.
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June 30, 2023
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Si-Bone, Inc. Meirav Harsat Director, Regulatory Affairs 47 El Camino Real, Suite 101 Santa Clara, California 95050
Re: K231689
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: June 8, 2023 Received: June 9, 2023
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 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.
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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
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Indications for Use
510(k) Number (if known) K231689
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 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 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) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: June 08, 2023
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 (K222605) |
|---|---|
| Additional Predicates: | TransLoc 3DTM (K211496)SpineFrontier® SIJFuseTM Sacroiliac Joint Fusion DeviceSystem (K150017) |
IV. DEVICE DESCRIPTION
The iFuse TORQ Implant System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6A1-4V 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-the-shelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.
V. PURPOSE
This 510(k) premarket notification is submitted to request clearance for an additional trajectory for placement of the device.
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VI. 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.
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 TORQ Navigation instruments are intended to be used with the Medtronic StealthStation System.
VII. 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 predicates. Risk analyses confirm that the differences do not raise different questions of safety and effectiveness.
VIII. PERFORMANCE DATA
An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent.
IX. CONCLUSIONS
The subject device has been shown to be substantially equivalent to the primary and additional predicate devices. The subject device has the same intended use and indications for use as the primary predicate and an indication for use that is similar to the additional predicate devices. The differences in the indications for use between the subject device and the additional predicate 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 subject device is the primary predicate and has similar technological characteristics to the additional predicates. The differences in the technological characteristics between the subject device and the additional predicates do not raise different questions of safety and effectiveness.
§ 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.