(27 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of the metallic rods, with no mention of AI or ML.
Yes
Explanation: The device is intended for sacroiliac joint fusion, which treats medical conditions (sacroiliac joint disruptions and degenerative sacroiliitis) by creating fixation within the bone.
No
The device is described as a system of metallic rods intended for surgical implantation to create fixation in the sacroiliac joint, rather than for diagnosing conditions. Its purpose is treatment through fusion, not diagnosis.
No
The device description explicitly states it consists of metallic rods intended for surgical implant, 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 (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- iFuse System Description: The iFuse System is a surgical implant made of metallic rods intended for fixation within the bone (specifically the sacroiliac joint). It is a physical device implanted into the body, not used to test samples taken from the body.
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure to stabilize the joint. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a surgical implant used for treatment, not a device used for testing biological samples.
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 (comma separated list FDA assigned to the subject device)
OUR
Device Description
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.
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)
Axial pull-out testing, Finite Element Analysis (FEA), and cadaver testing demonstrate that the iFuse is substantially equivalent with respect to fixation of the SI joint.
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.
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
KII0838
510(k) SUMMARY
SI-Bone's iFuse SI Fusion System
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103
(267) 675-4611 Phone: Facsimile: (267) 675-4601
Janice M. Hogan Contact Person:
March 25, 2011 Date Prepared:
Name of Device and Name/Address of Sponsor
iFuse SI Joint Fusion System
SI-Bone, Inc. 550 South Winchester Blvd., Suite 620, San Jose, CA 95128
Common or Usual Name (Product Code/Definition): Sacroiliac Joint Fixation (OUR/ sacroiliac joint fusion)
Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fixation fastener
Predicate Devices
SI-Bone, Inc's SI Joint Fusion System (K080398; K092375)
Intended Use
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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.
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KII D838
Performance Data
Axial pull-out testing, Finite Element Analysis (FEA), and cadaver testing demonstrate that the iFuse is substantially equivalent with respect to fixation of the SI joint.
Substantial Equivalence
The iFuse has the same intended use, principles of operation, and technological characteristics and similar indications for use as the predicate SI Joint Fusion System. There are no differences in the SI Joint Fusion System's technological characteristics or principles of operation, thus the device does not raise any new questions of safety or effectiveness. Performance data demonstrate that the SI Joint Fusion System is as safe and effective as previously cleared SI Joint Fusion System. Thus, the SI Joint Fusion System is substantially equivalent to its predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 1 2011
SI-Bone, Inc. % Ms. Janice M. Hogan Hogan & Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K110838
Trade/Device Name: SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: OUR Dated: March 25, 2011 Received: March 25, 2011
Dear Ms. Hogan:
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
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Page 2 - Ms. Janice M. Hogan
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 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-frec number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htmi.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
11 0636 510(k) Number (if known):
iFuse SI Joint Fusion System Device Name:
Indications for Use:
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Prescription Use X (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K11 0838
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\\DC - 032510/000001 - 3224875 v2