(30 days)
Not Found
Not Found
No
The summary describes a mechanical implant system and its performance through FEA, with no mention of AI/ML terms, image processing, or data-driven algorithms.
Yes
The device is intended for fracture fixation and fusion of the sacroiliac joint, which are therapeutic interventions.
No
The device description states it is a "surgical implant within the bone to create fixation," which is a treatment, not a diagnostic, function. Its intended use is "fracture fixation," further supporting its role as a therapeutic device.
No
The device description explicitly states the system consists of metallic rods intended for surgical implant, indicating it is a hardware 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 for diagnosis, monitoring, or screening.
- Device Description: The SI Joint Fusion System is a system of metallic rods intended for surgical implantation within the bone for fracture fixation. This is a surgical implant, not a device that analyzes biological specimens.
- Intended Use: The intended use is for fracture fixation of large bones and large bone fragments of the pelvis, specifically for sacroiliac joint disruptions and degenerative sacroiliitis. This is a therapeutic and structural intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant used for structural support and fixation within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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 (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
pelvis, sacroiliac joint
Indicated Patient Age Range
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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. Results demonstrate that the SI Fusion System is substantially equivalent with respect to fixation of the SI joint.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
SI-Bone, Inc's SI Joint Fusion System
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
SEP - 4 2009
SI-Bone's SI Fusion System
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
Hogan & Hartson LLP 555 13th St., NW Washington, DC 20004
Phone: (202) 637-5813 Facsimile: (202) 637-5910
Contact Person: Howard M. Holstein
Date Prepared: July 31, 2009
Name of Device and Name/Address of Sponsor
SI Joint Fusion System
SI-Bone, Inc. 20045 Stevens Creek Blvd. Suite 1F Cupertino, CA 95014
Common or Usual Name: Orthopedic Rods
Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fastener
Predicate Devices
SI-Bone, Inc's SI Joint Fusion System
Purpose of the Special 510(k) notice.
The SI Joint Fusion System is a modification to SI-Bone's cleared SI Joint Fusion System.
Intended Use
The 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.
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K092375
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
A Finite Element Analysis (FEA) was performed on the SI Fusion System in comparison to its predicate. Results demonstrate that the SI Fusion System is substantially equivalent with respect to fixation of the SI joint. で
Substantial Equivalence
The SI Joint Fusion System has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate SI Joint Fusion System. The minor differences in the SI Joint Fusion System's technological characteristics, namely the inclusion of 4.0 mm diameter rods in the system, do not raise any new questions of safety or effectiveness. Performance data demonstrates 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 U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a staff with a snake winding around it, topped with a stylized bird or wing-like element.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SI-Bone, Inc. % Hogan & Hartson LLP Mr. Howard M. Holstein Hogan & Hartson LLP 555 13th Street North West Washington, District of Columbia 20004
APR - 7 2011
Re: K092375
Trade/Device Name: SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: II Product Code: OUR Dated: August 3, 2009 Received: August 5, 2009
Dear Mr. Holstein:
This letter corrects our substantially equivalent letter of September 04, 2009.
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
3
Page 2 - Mr. Howard M. Holstein
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 (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kij B. Den h
for
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
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
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 (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)
Joutu for mxn
(Division Sign-Off)
(Division Sign-G Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092375
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