(122 days)
Not Found
No
The document describes a surgical implant system and navigation instruments. While the navigation instruments use imaging data for localization, there is no mention of AI or ML being used for image analysis, decision support, or any other function. The performance studies focus on mechanical and biocompatibility testing, not algorithmic performance.
Yes
The device is described as an implant system intended for sacroiliac joint fusion and stabilization of spinal segments, which are therapeutic interventions.
No
The device is an implant system (iFuse Bedrock Granite Implant System) intended for sacroiliac joint fusion and to augment immobilization and stabilization of spinal segments. While it uses navigation instruments that assist in locating anatomical structures with imaging modalities, its primary function is therapeutic (fusion and stabilization), not diagnostic.
No
The device description explicitly states it consists of implants and associated instrument sets, which are hardware components. While it includes navigation instruments that likely involve software, the core device is a physical implant system.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Function: The iFuse Bedrock Granite Implant System is a surgical implant and associated instruments used for stabilizing and fusing bones in the sacroiliac joint and spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes surgical procedures for treating specific musculoskeletal conditions.
- Device Description: The description details the materials and design of the implant and instruments, consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing diagnostic tests, or providing diagnostic information based on laboratory analysis.
Therefore, the iFuse Bedrock Granite Implant System falls under the category of a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion for the following conditions: ·Sacrollac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6months. • To augment immobilization and stabilization of the sacroliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
When connected to the SeaSpine Mariner Pedicle Screw System, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • Degenerative disc disease (DDD) as defined by back pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies · Spondylolisthesis ·Trauma (i.e., fracture or dislocation) ·Spinal stenosis · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) •Spinal tumor •Pseudarthrosis •Failed previous fusion
The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite 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 Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation System.
Product codes
OUR, NKB, OLO
Device Description
The iFuse Bedrock Granite™ Implant System consists of implants of various lengths and diameters, and associated instruments sets (Open and MIS). The titanium (Ti-6AI-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant placement features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to the SeaSpine Mariner Pedicle Screw System in both the SAI and the Iliac trajectories. It is designed for connection to the SeaSpine Mariner Pedicle Screw System via Ø5.5mm or Ø6.0mm titanium alloy or cobalt chrome spinal fixation rods.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
Sacroiliac joint, Lumbar, Thoracolumbar, Thoracic, Sacral Spine
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)
SI-BONE performed comprehensive Design Verification and Validation Testing to demonstrate the safety and performance of SI-BONE's iFuse Bedrock Granite Implant System for its intended clinical use.
Biocompatibility Testing: The biocompatibility evaluation for the iFuse Bedrock Granite Implant System was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Applicable testing was successfully completed.
Mechanical Testing:
- Static and Dynamic Cantilever Bending
- Static Torsion
- Static Axial Pullout
- Stereological Evaluation of the Porous Layer
- Static Shear
- Shear Fatigue
- Static Tension
- Abrasion
- Static and Dynamic Axial Compression
- Static Axial Torsion
- Static Anterior-Posterior Loading
- Static Axial Slip
- Static Flexion/Extension
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
May 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
SI-BONE, Inc. Meirav Harsat Director of Regulatory Affairs 471 El Camino Real, Suite 101 Santa Clara, California 95050
Re: K220195
Trade/Device Name: iFuse Bedrock Granite™ Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, NKB, OLO Dated: April 27, 2022 Received: April 28, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
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) K220195
Device Name
iFuse Bedrock Granite™ Implant System
Indications for Use (Describe)
The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion for the following conditions: ·Sacrollac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6months.
• To augment immobilization and stabilization of the sacroliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
When connected to the SeaSpine Mariner Pedicle Screw System, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies
· Spondylolisthesis
·Trauma (i.e., fracture or dislocation)
·Spinal stenosis
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
•Spinal tumor
•Pseudarthrosis
·Failed previous fusion
The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite 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 Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation System.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
iFuse Bedrock Granite™ 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: Meirav Harsat, Director Regulatory Affairs
| FDA Establishment | |
|---|---|
| Registration No.: | 3007700286 |
II. DEVICE
| Trade Name of Device | iFuse Bedrock Granite™ Implant System |
|---|---|
| Classification Name | Sacroiliac Joint Fixation |
| Classification | II |
| Regulation Number | 21 CFR 888.3040; metallic bone fastener Smooth or threaded |
| 21 CFR 888.3070, Thoracolumbosacral pedicle screw system | |
| 21 CFR 882.4560, Stereotaxic instrument | |
| Product Code | OUR, NKB, OLO |
III. PREDICATE DEVICE
| Primary Predicate
| Device | Manufacturer | 510(k)# | Clearance Date |
|---|---|---|---|
| iFuse-3D Implant System | SI-BONE, Inc. | K193524 | March 31, 2020 |
| Additional Predicate | |||
| Device | Manufacturer | 510(k)# | Clearance Date |
| Mariner Pedicle Screw | |||
| System® | SeaSpine | ||
| Orthopedics | |||
| Corporation | K212692 | September 21, | |
| 2021 | |||
| iFuse Implant System- | |||
| iFuse Navigation | SI-BONE, Inc. | K172268 | October 31, |
| 2017 |
IV. DEVICE DESCRIPTION
The iFuse Bedrock Granite™ Implant System consists of implants of various lengths and diameters, and associated instruments sets (Open and MIS). The titanium (Ti-6AI-4V ELI) implant consists of a porous fusion sleeve with threaded length attached to a solid post that has connection and implant placement features of a typical pedicle fixation screw. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and foundational stabilization when connected to the SeaSpine Mariner Pedicle Screw System in both the SAI and the Iliac trajectories. It is designed for connection to the SeaSpine Mariner Pedicle Screw System via Ø5.5mm or Ø6.0mm titanium alloy or cobalt chrome spinal fixation rods.
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V. INDICATIONS FOR USE
The iFuse Bedrock Granite Implant System is intended for sacroiliac joint fusion for the following conditions:
- Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
When connected to the SeaSpine Mariner Pedicle Screw System, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- Spondylolisthesis ●
- . Trauma (i.e., fracture or dislocation)
- Spinal stenosis .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Spinal tumor ●
- Pseudarthrosis ●
- Failed previous fusion ●
The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite 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. Fuse Bedrock Granite Navigation instruments are intended to be used with the Medtronic StealthStation System.
VI. SUMMARY OF SUBSTANTIAL EQUIVALENCE
The iFuse Bedrock Granite Implant System is substantially equivalent to its predicates in terms of intended use and indications for use, technological characteristics, manufacturing methods, and principles of operation as the predicate devices: the SI-BONE iFuse-3D Implant System (most recently cleared in K193524) and the SeaSpine Mariner Pedicle Screw System (most recently cleared in K212692). Any differences between the iFuse Bedrock Granite Implant System and the predicate devices do not raise different questions of safety or effectiveness, as demonstrated by the results of the verification and validation testing. Therefore, based on the intended use, indications for use, technological characteristics and principles of operation, iFuse Bedrock Grante Implant System is substantially equivalent to the predicate devices.
VII. PERFORMANCE DATA
SI-BONE performed comprehensive Design Verification and Validation Testing to demonstrate the safety and performance of SI-BONE's iFuse Bedrock Granite Implant System for its intended clinical use.
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The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the iFuse Bedrock Granite Implant System was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Applicable testing was successfully completed.
Mechanical Testing
- Static and Dynamic Cantilever Bending ●
- Static Torsion ●
- Static Axial Pullout ●
- Stereological Evaluation of the Porous Layer
- Static Shear ●
- Shear Fatigue
- Static Tension .
- Abrasion ●
- Static and Dynamic Axial Compression ●
- Static Axial Torsion ●
- Static Anterior-Posterior Loading ●
- Static Axial Slip ●
- Static Flexion/Extension ●
VIII. CONCLUSION
The iFuse Bedrock Granite Implant System is substantially equivalent to both the primary and secondary predicate. The iFuse Bedrock Granite Implant System is substantially equivalent to its predicates in terms of intended use and indications for use, technological characteristics, materials, manufacturing methods, and principles of operation as the predicate devices: the SI-BONE iFuse-3D Implant System (most recently cleared in K193524) and the SeaSpine Mariner Pedicle Screw System (most recently cleared in K212692). Any differences between the iFuse Bedrock Granite Implant System and the predicate devices do not raise any different questions of safety or effectiveness, as demonstrated by the results of the verification and validation testing. Therefore, based on the intended use, indications for use, technological characteristics, and principles of operation, iFuse Bedrock Granite Implant System is substantially equivalent to the predicate devices.