(287 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for fracture fixation and fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which aims to provide therapy for these medical conditions.
No
The device is a surgical implant intended for fracture fixation, not for diagnosing conditions.
No
The device description explicitly states the system consists of metallic rods intended for surgical implant, indicating it is a hardware-based medical device.
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.
- Device Description and Intended Use: The description clearly states that the SI-Bone SI Joint Fusion system consists of metallic rods intended for surgical implant within the bone for fracture fixation. This is a surgical procedure performed directly on the patient's body, not an examination of a specimen outside the body.
The device is a surgical implant used for structural support and fixation within the body, which falls under the category of implantable medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The SI-Bone SI Joint Fusion system is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
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. Their intended use is for fracturc fixation of large bones and large bone fragments of the pelvis for such conditions as sacroiliac joint disruptions and degenerative sacroiliitis. The system includes 7.0 mm 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
Pelvis, 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)
A Finite Element Analysis (FEA) was performed on the SI Fusion System in comparison to its predicate. In addition, the company has conducted bench-top testing of axial pullout resistance and stability in dynamic cantilever bending. The results demonstrate that the SI Fusion Rod is substantially similar to the predicate devices with respect 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
510(k) SUMMARY
SI-Bone, Inc.'s SI Joint Fusion System
Submitter's Name, Address, Telephone Number
NOV 2 6 2008
SI-Bone, Inc. 15370 Pepper Lane Saratoga, CA 95070 USA
- Contact Person: Jeff Dunn President/CEO SI-Bone, Inc. 15370 Pepper Lane Saratoga, CA 95070
- November 20, 2008 Date Prepared:
- SI Joint Fusion System Name of Device:
Common or Usual Name: Orthopedic Rods
Classification Name: 21 CFR 888.3040 - Smooth or threaded metallic bone fastener
Predicate Devices:
Synthes (USA) 6.5 mm Cannulated Screw (K021932) Reiley Orthopedics ROI Fusion Rods and Plates (K051309) SIJF Cannulated Screw System (K051296)
Intended Use:
The SI-Bonc SI Joint Fusion system is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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. Their intended use is for fracturc fixation of large bones and large bone fragments of the pelvis for such conditions as sacroiliac joint disruptions and degenerative sacroiliitis. The system includes 7.0 mm fusion rods, which range in length from 30 mm to 70 mm.
1
K080340 pg 22
Performance Data
A Finite Element Analysis (FEA) was performed on the SI Fusion System in comparison to its predicate. In addition, the company has conducted bench-top testing of axial pullout resistance and stability in dynamic cantilever bending. The results demonstrate that the SI Fusion Rod is substantially similar to the predicate devices with respect fixation of the SI joint.
2
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 tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SI-Bone, Inc. % Mr. Jeffery Dunn 15370 Pepper Lane Saratoga, California 95070
APR 1 5 2011
Re: K080398
Trade/Device Name: SI-Bone SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: OUR Dated: October 24, 2008 Received: October 24, 2008
Dear Mr. Dunn:
This letter corrects our substantially equivalent letter of November 26, 2008.
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
3
Page 2 - Mr. Jeffery Dunn
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/CDRH0ffices/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,
For Pete Thomas
DEP DA
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
510(k) Number (if known): K080398
Device Name: ST-Bone SI Joint Fusion System
Indications for Use:
The SI-Bone SI Joint Fusion system is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Prescription Use X (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)
Page ___ of __________________________________________________________________________________________________________________________________________________________________
Mark A. Millkern
(Division Sign-Off) (Division Sigu-On)
Division of General, Restorative, and Neurologi
510(k) Number
WDC - 0225154000001 - 2767199 w