(200 days)
Not Found
No
The summary describes a mechanical implant system and associated instruments for surgical fusion and fracture fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for fusion of joints, which is a therapeutic intervention for sacroiliac joint dysfunction. It is also used for fracture fixation, which is a therapeutic treatment for fractures.
No
Explanation: The device description and intended use clearly state that the iFuse-TORQ Implant System is for the "Fusion of the sacroiliac joint" and "Fracture fixation of the pelvis," indicating a therapeutic or surgical purpose rather than diagnosis.
No
The device description explicitly states that the system consists of implants and associated instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fusion of the sacroiliac joint and fracture fixation of the pelvis. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of implants (screws) and instruments used for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fusion.
N/A
Intended Use / Indications for Use
The iFuse-TORQ Implant System is indicated for:
-Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis
-Fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures
Product codes (comma separated list FDA assigned to the subject device)
OUR, HWC
Device Description
The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments. iFuse-TORQ 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 iFuse-TORQ implants, that are 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
Not Found
Anatomical Site
sacroiliac joint, pelvis
Indicated Patient Age Range
Not Found
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)
The verification testing conducted per ASTM F543, including axial pullout, torsional strength, and insertion and removal torque, demonstrated that the technological differences between the subject device and the additional predicate do not raise new questions of safety and effectiveness and that the subject device and the additional predicate are substantially equivalent.
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 K203247, Firebird SI Fusion System, K210667
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
June 10, 2022
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SI-BONE, Inc. Meirav Harsat Director, Regulatory Affairs 471 El Camino Real, Suite 101 Santa Clara, California 95050
Re: K213667
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 Dated: May 17, 2022 Received: May 18, 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,
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
Enclosure
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Indications for Use
510(k) Number (if known) K213667
Device Name iFuse-TORQ Implant System
Indications for Use (Describe) The iFuse-TORQ Implant System is indicated for:
· Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis
· Fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures
Type of Use (Select one or both, as applicable)
| ☑ Executive Director/CEO/COO/Subject Company | ☐ For-Profit Consultant/Advisor/Subject Company |
|---|---|
| ---------------------------------------------- | ------------------------------------------------- |
X 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: June 7, 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 fixation fastener |
| Product Code: | OUR and HWC |
III. PREDICATE AND REFERENCE DEVICES
| Primary Predicate: | iFuse-TORQ Implant System K203247 |
|---|---|
| Additional Predicate: | Firebird SI Fusion System, K210667 |
IV. DEVICE DESCRIPTION
The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments. iFuse-TORQ 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 iFuse-TORQ implants, that are 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 to expand the indications for use the subject device.
VI. INDICATIONS FOR USE
The iFuse-TORQ Implant System is indicated for:
- . Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis
- Fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures
4
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 predicate. The clinical literature review and the design verification test results confirm that the differences do not raise new questions of safety and effectiveness.
VIII. PERFORMANCE DATA
The verification testing conducted per ASTM F543, including axial pullout, torsional strength, and insertion and removal torque, demonstrated that the technological differences between the subject device and the additional predicate do not raise new questions of safety and effectiveness and that the subject device and the additional predicate are substantially equivalent.
IX. CONCLUSIONS
The proposed subject device has the same intended use as the predicates and an indication for use that is substantially equivalent to the predicate devices.
Based on literature search results, it was demonstrated that the differences in the indication for use statement from previous cleared legally marketed predicates are not critical to 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. Based on the performance data test results, it was demonstrated that the differences do not raise new questions of safety and effectiveness and do not affect the safety and effectiveness of the device when used as labeled. As such, the subject device has been shown to be substantially equivalent to the primary and additional predicate devices.