(88 days)
Not Found
No
The device description focuses on physical implants and surgical instruments, with no mention of software, algorithms, or AI/ML terms.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis," indicating it treats medical conditions.
No
The device is described as an implant system for sacroiliac joint fusion, indicating a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states that the iFuse Implant System consists of titanium implants and associated surgical instruments, 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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- iFuse System Function: The iFuse System is a surgical implant designed to fuse the sacroiliac joint. It is a physical device implanted into the body to provide structural support and promote bone fusion.
- Lack of Specimen Analysis: The description of the iFuse System and its intended use does not involve the analysis of any specimens taken from the body.
The iFuse System is a surgical implant used for bone fixation and fusion, not a device for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30mm to 70mm in 5mm increments with a diameter of 4.0 and 7.0 mm. The device is classified as smooth or threaded metallic bone fixation fasteners as Class II devices pursuant to 21 C.F.R. § 888,3040. The fusion rods are implanted using the same instrumentation previously described in K080398, K092375 and K110838.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac 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 the 510(k).
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
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
510(k) SUMMARY
OCT 1 2 2012
iFuse Implant System®
510(k) Owner's Name, Address, and Telephone Number SI-BONE, Inc. 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 (408) 207-0700
Contact Person
Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Regulatory Consultant to SI-BONE. Inc. domecusconsulting@comcast.net Email: Phone: 650-343-4813 Mobile: 650-773-3445 Facsimile: 650-343-7822
Date Prepared: July 5, 2012
Trade Name of Device: iFuse Implant System®
Common or Usual Name: Orthopedic Rod
Classification Name:
21 C.F.R. 888.3040 - Smooth or threaded metallic bone fastener; Product Code OUR
Predicate Devices: SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375 and K110838)
Intended Use
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description
The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30mm to 70mm in 5mm increments with a diameter of 4.0 and 7.0 mm. The device is classified as smooth or threaded metallic bone fixation fasteners as Class II devices pursuant to 21 C.F.R. § 888,3040. The fusion rods are implanted using the same instrumentation previously described in K080398, K092375 and K110838.
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Technological Characteristics
The SI Fusion System consists of a series of metallic (titanium), porous plasma spray coated rods, intended for surgical implant within the bone to create fixation. The system includes 4.0 mm and 7.0 mm diameter fusion rods, which range in length from 30 mm to 70 mm.
Performance Data
No performance testing was required to support the modified labeling that is the subject of the 510(k).
Substantial Equivalence
The iFuse Implant System has the same intended use, indications for use, and technological characteristics as the predicate device. Thus, the iFuse Implant System is substantially equivalent to its predicate device.
Conclusions
The iFuse Implant System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 2 2012
SI-Bone, Incorporated % Domecus Consulting Services, LLC Ms. Cindy Domecus Principal 3055 Olin Avenue, Suite 2200 San Jose, California 95128
Re: K122074
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: July 9, 2012 Received: July 16, 2012
Dear Ms. Domecus:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Cindy Domecus
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Alule A. Allillerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: SI-BONE iFuse Implant System
Indications for Use:
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Af
K 122074
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
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