(29 days)
No
The description focuses on the mechanical properties and surgical placement of the implant, with no mention of AI or ML.
Yes
The device is intended for sacroiliac fusion to treat sacroiliac joint dysfunction and degenerative sacroiliitis, which directly addresses a medical condition to restore function and alleviate symptoms.
No
The device is described as an implant system for sacroiliac fusion to stabilize the joint, not to diagnose a condition.
No
The device description clearly states it consists of titanium implants and an instrument system, which are hardware components.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The iFuse Implant System is a surgical implant designed to be placed directly into the sacroiliac joint to stabilize and fuse it. It is a physical device used in vivo (within the body), not a test performed on a sample in vitro (outside the body).
- Intended Use: The intended use is for sacroiliac fusion, which is a surgical procedure, not a diagnostic test.
The information provided clearly describes a surgical implant and its associated instruments, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The iFuse Implant System is intended for sacroiliac fusion for conditions including 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.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The iFuse Implant System® consists of cannulated triangular, titanium (iFuse implants: Ti 6Al 4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti 6Al 4V ELI, ASTM F3001) implants with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint. The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sacroiliac joint (SI joint)
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)
No performance testing was required to support the modified labeling that is the subject of this 510(k).
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 Implant System® by SI-BONE, Inc., K162733
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.
VIPER® Systems (Pedicle Screw Spinal System), K121020
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
November 27, 2018
SI-BONE, Inc. Roxanne J. Dubois Vice President, Regulatory Affairs 471 El Camino Real, Suite 101 Santa Clara, California 95050
Re: K182983
Trade/Device Name: iFuse Implant System® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: October 26, 2018 Received: October 29, 2018
Dear Ms. Dubois:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182983
Device Name iFuse Implant System®
Indications for Use (Describe)
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
| 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 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: Roxanne J. Dubois, VP, Regulatory Affairs, SI-BONE, Inc. Email: rdubois@si-bone.com Phone: 408-828-5019; Fax: 408-557-8312 Date Prepared: October 26, 2018
II. DEVICE
| Trade Name of Device: | iFuse Implant System ® |
|---|---|
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Regulation Number: | 21 CFR 888.3040, Smooth or threaded metallic bone fastener |
| Product Code: | OUR |
III. PREDICATE AND REFERENCE DEVICES
| Predicate: | iFuse Implant System® by SI-BONE, Inc., K162733 |
|---|---|
| Reference Device: | VIPER® Systems (Pedicle Screw Spinal System), K121020 |
IV. DEVICE DESCRIPTION
The iFuse Implant System® consists of cannulated triangular, titanium (iFuse implants: Ti 6Al 4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti 6Al 4V ELI, ASTM F3001) implants with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint. The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).
V. INDICATIONS FOR USE
The iFuse Implant System is intended for sacroiliac fusion for conditions including 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.
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TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE VI.
The iFuse Implant System® consists of manual instruments and a series of triangular titanium implants intended for surgical implantation to provide immediate SI joint stabilization and allow long-term fusion. There are no changes to the technological characteristics of the device that is the subject of this 510(k).
VII. PERFORMANCE DATA
No performance testing was required to support the modified labeling that is the subject of this 510(k).
VIII. CONCLUSIONS
The intended use, indications for use and the technological characteristics are unchanged compared to the predicate device and support that the proposal contained within this 510(k) is substantially equivalent to the predicate device.