(30 days)
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.
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.
The SI-Bone's SI Fusion System is a medical device. Based on the provided 510(k) summary, the device is a modification to a previously cleared SI Joint Fusion System, and its purpose is for fracture fixation of large bones and large bone fragments of the pelvis, including sacroiliac joint disruptions and degenerative sacroiliitis.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (overall) | Performance data demonstrates that the SI Joint Fusion System is as safe and effective as previously cleared SI Joint Fusion System. The minor differences in technological characteristics (inclusion of 4.0 mm diameter rods) do not raise new questions of safety or effectiveness. |
| Fixation of SI Joint (Specific to functionality) | Results from Finite Element Analysis (FEA) demonstrate that the SI Fusion System is substantially equivalent with respect to fixation of the SI joint compared to its predicate. |
| Material (implicitly, due to substantial equivalence claim) | Metallic (titanium), porous plasma spray coated rods. Inherits material safety and biocompatibility from the predicate device through substantial equivalence. |
| Dimensions (for new rod sizes) | The system includes 4.0 mm and 7.0 mm diameter fusion rods, ranging in length from 30 mm to 70 mm. The 4.0 mm rods are new compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The primary performance data presented is derived from a Finite Element Analysis (FEA), which is a computational simulation, not a study performed on a physical test set or human/animal subjects with a sample size.
- Data Provenance: Not applicable for FEA. It's a computational analysis.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. The performance data is from a Finite Element Analysis (FEA), which does not involve establishing ground truth through expert review in the clinical sense. The "ground truth" for an FEA would be the accuracy of the computational model itself and its parameters, which are validated against engineering principles and known material properties. The document does not specify details of this validation.
4. Adjudication Method for the Test Set
- Not applicable, as there was no test set requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance data is based on a Finite Element Analysis (FEA), which is a non-clinical, computational study, not a clinical study involving human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system. Its performance is inherent to its mechanical design and material properties. The FEA is a simulation of the device's mechanical performance, not a standalone algorithm in the context of AI.
7. The Type of Ground Truth Used
- The primary "ground truth" for the performance data (FEA) would be the established principles of biomechanics, material science, and engineering validation methods for computational models. The document does not explicitly state how this "ground truth" of the FEA model itself was validated or established. The outcome of the FEA demonstrated substantial equivalence to the predicate device, implying that the predicate's performance served as the comparative benchmark.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning system that requires training data or a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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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
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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
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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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§ 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.