(162 days)
No
The summary describes a mechanical implant system for sacroiliac fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is intended to treat sacroiliac joint dysfunction by stabilizing and fusing the joint, which is a therapeutic purpose.
No
The device is an implant system designed for sacroiliac fusion, which is a treatment for joint dysfunction, not a tool for diagnosing conditions.
No
The device description clearly states it consists of physical implants made of titanium and an instrument system, which are hardware components.
Based on the provided information, the iFuse Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for sacroiliac fusion, which is a surgical procedure to stabilize a joint within the body. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant designed to be surgically placed within the body. IVD devices are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect biomarkers, or provide diagnostic information based on in vitro testing.
Therefore, the iFuse Implant System is a surgical implant, not an in vitro diagnostic device.
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 (Ti 6A1 4V ELI, ASTM F136/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 SI 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). Fenestrations allow packing of autograft and/or allograft material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac (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)
Performance testing was conducted to support the design and development of the proposed implant including mechanical testing, simulated use testing, and biocompatibility testing. The mechanical testing included static and fatigue bending testing, as well as pull-out testing of the finished device. Additionally, MR safety testing to establish that the device is MR conditional was conducted as well as Limulus amebocyte lysate (LAL) testing to establish that the device meets the specified 20 EU/device limit. The test results show that the exhibited characteristics are comparable to the predicate and reference devices. The interconnected porous surface was found to have comparable porosity and mechanical characteristics compared to the predicates and acceptable performance in a simulated use test. Characterization of the porous structure was performed. The device was also found to be MR conditional, non-pyrogenic and biocompatible. The performance tests demonstrate that the device is as safe, as effective and performs at least as well as the legally marketed devices identified in Section III. Validation tests included printing validation (e.g. build parameters), powder bed recycling validation and cleaning validation.
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.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017
SI-BONE, Inc. Roxanne Dubois VP, Regulatory and Quality 3055 Olin Ave, Suite 2200 San Jose, California 95128
Re: K162733
Trade/Device Name: iFuse Implant System® - iFuse-3D implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 31, 2017 Received: February 2, 2017
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
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 Statement
510(k) Number (if known): K162733
Device Name: iFuse Implant System® - iFuse-3D implant
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.
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510(k) SUMMARY - iFuse Implant System®
I. SUBMITTER
SI-BONE, Inc. 3055 Olin Avenue, Suite 2200, San Jose, CA 95128 Phone: (408) 207-0700; Fax: 408-557-8312 Contact Person: Roxanne Dubois, VP, Regulatory and Quality, SI-BONE, Inc. Email: rdubois@si-bone.com Mobile: 408-828-5019; Office: 408-207-0700 x2236 Date Prepared: March 9, 2017
II. DEVICE
| Trade Name of Device: | iFuse Implant System® - iFuse-3D implant |
|---|---|
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Regulation Number: | 21 CFR 888.3040 – Smooth or threaded metallic bone fastener |
| Product Code: | OUR; Sacroiliac Joint Fixation |
III. PREDICATE DEVICES
| Primary Predicate: | iFuse Implant System by SI-BONE, K160652 |
|---|---|
| Reference Predicate: | Synthes Cannulated Screw, K021932 |
| Spine Frontier, K150017 |
DEVICE DESCRIPTION IV.
The iFuse Implant System consists of cannulated triangular, titanium (Ti 6A1 4V ELI, ASTM F136/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 SI 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). Fenestrations allow packing of autograft and/or allograft material.
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
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pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
VI. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THEPREDICATE
The iFuse Implant System consists of manual instruments and a series of triangular titanium implants intended for surgical implantation across the sacroiliac joint to create immediate stabilization and fusion. The proposed implant is additively manufactured.
VII. PERFORMANCE DATA
Performance testing was conducted to support the design and development of the proposed implant including mechanical testing, simulated use testing, and biocompatibility testing. The mechanical testing included static and fatigue bending testing, as well as pull-out testing of the finished device. Additionally, MR safety testing to establish that the device is MR conditional was conducted as well as Limulus amebocyte lysate (LAL) testing to establish that the device meets the specified 20 EU/device limit. The test results show that the exhibited characteristics are comparable to the predicate and reference devices. The interconnected porous surface was found to have comparable porosity and mechanical characteristics compared to the predicates and acceptable performance in a simulated use test. Characterization of the porous structure was performed. The device was also found to be MR conditional, non-pyrogenic and biocompatible. The performance tests demonstrate that the device is as safe, as effective and performs at least as well as the legally marketed devices identified in Section III. Validation tests included printing validation (e.g. build parameters), powder bed recycling validation and cleaning validation.
VIII. CONCLUSIONS
The intended use is unchanged compared to the predicate devices and the verification and validation results, technological characteristics, and the performance data support that the proposed implants are substantially equivalent to the predicate devices. The performance data also demonstrate that the device is as safe, as effective and performs at least as well as the legally marketed devices identified in Section III.