(109 days)
The SIJFuse™ Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroilitis.
The SIJFuse™ Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy (Ti-6A1-4V Eli). Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall. Solid and Fenestrated screws have a cannulated core. Fenestrated screws allow packing of allograft or autograft material.
This document is a 510(k) premarket notification for the "SpineFrontier® SIJFuse™ Sacroiliac Joint Fusion Device System". It describes the device, its intended use, and presents data to demonstrate substantial equivalence to predicate devices. However, this is NOT a study describing acceptance criteria and device performance as typically understood for AI/software devices.
The information provided describes a medical device (implants), specifically screws for sacroiliac joint fusion, and is not an AI/Software as a Medical Device (SaMD). Therefore, the requested information categories (AI-specific acceptance criteria, sample sizes for AI training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, AI ground truth, etc.) are not applicable to this document.
Instead, this document focuses on mechanical performance data to demonstrate the physical characteristics and safety of a hardware implant.
Here's the relevant information provided by the document regarding the device's performance and acceptance:
1. Table of Acceptance Criteria (or rather, performance data compared to predicates):
The document states: "The results of this non-clinical testing show that the strength of the SIJFuse™ Sacroiliac Joint Fusion Device System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
The following tests were performed:
| Acceptance Criteria (Test Modes) | Reported Device Performance (Conclusion) |
|---|---|
| Static three-point bending per ASTM F2193 | Sufficient for intended use; substantially equivalent to predicate devices. |
| Static axial pull out per ASTM F543 | Sufficient for intended use; substantially equivalent to predicate devices. |
| Dynamic three-point bending per ASTM F2193 | Sufficient for intended use; substantially equivalent to predicate devices. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count of devices or tests, but "multiple tests" are implied by the nature of the standards. ASTM F2193 and F543 are standards that specify test methodologies, which would include guidelines on the number of samples required for statistically valid results. This document only states that the tests were performed.
- Data Provenance: The tests were non-clinical, meaning they were performed in a laboratory setting. No country of origin for data is specified beyond the company being US-based (Beverly, MA). It is not retrospective or prospective in the clinical sense, as it refers to engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware device. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles, not by expert medical interpretation.
4. Adjudication method for the test set:
- Not Applicable. Mechanical tests are adjudicated by meeting specified physical criteria outlined in the ASTM standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a hardware implant, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware implant, not an algorithm.
7. The type of ground truth used:
- Mechanical Engineering Standards: The "ground truth" for this device's performance is compliance with established ASTM (American Society for Testing and Materials) standards for orthopedic implants (F2193 and F543) and demonstrable equivalence in mechanical properties to legally marketed predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a hardware implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable.
In summary, the provided document relates to a physical medical implant and its mechanical performance testing for FDA 510(k) clearance, not an AI or software device. The acceptance is based on demonstrating substantial equivalence in mechanical properties to already cleared devices, as proven by adherence to specific ASTM testing standards.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2015
SpineFrontier, Incorporated % Mr. Kenneth C. Maxwell II Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K150017
Trade/Device Name: SpineFrontier® SIJFuse™ Sacroiliac Joint Fusion Device System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: March 31, 2015 Received: April 2, 2015
Dear Mr. Maxwell:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Kenneth C. Maxwell II
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement on last page. | |
| 510(k) Number ( if known ) | K150017 |
| Device Name | SpineFrontier® SIJFuse™ Sacroiliac Joint Fusion Device System |
| Indications for Use ( Describe ) |
The SIJFuse™ Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for
conditions including sacroiliac joint disruptions and degenerative sacroilitis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | [ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
FORM FDA 3881 (9/13)
PSC Publishing Services (301) 443-6740 EF
FORM FDA 3881 (9/13)
PSC Publishing Services (301) 443-6740 EF
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510(K) SUMMARY
| Submitter's Name: | SpineFrontier |
|---|---|
| Submitter's Address: | 500 Cummings Center, Suite 3500 |
| Beverly, MA 01915 | |
| Submitter's Telephone: | 978.232.3990 x252 |
| Company Contact Person: | Manthan Damani, MSRA |
| Senior Regulatory Affairs Associate | |
| Official Contact Person: | Kenneth C Maxwell II |
| Empirical Consulting LLC | |
| 719.291.6874 | |
| Date Summary was Prepared: | 14 April 2015 |
| Trade or Proprietary Name: | SIJFuse™ Sacroiliac Joint Fusion Device System |
| Common or Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II per 21 CFR §888.3040 Device Classification |
| Product Code: | OUR |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SIJFuse™ Sacroiliac Joint Fusion Device System implants consist of Solid and Fenestrated Screws. Solid and Fenestrated Screws are available in varying diameters and lengths. Solid and Fenestrated Screws are fabricated from medical grade titanium alloy (Ti-6A1-4V Eli). Solid Screws have a solid outer wall, while Fenestrated Screws have fenestrations on the outer wall. Solid and Fenestrated screws have a cannulated core. Fenestrated screws allow packing of allograft or autograft material.
INDICATIONS FOR USE
The SIJFuse™ Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroilitis.
The indications for use for the SIJFuse™ Sacroiliac Joint Fusion Device System is similar to that of the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
SIJFuse™ Sacroiliac Joint Fusion Device System is made from material that conforms to ASTM F136. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Materials of manufacture
- Structural support mechanism ●
- Principle of operation ●
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|---|---|---|---|---|
| 510k Number Trade or Proprietary or Model Name | Predicate Type | |||
| K122074 | iFuse Implant System® | SI-BONE | Primary | |
| K021932 | 6.5mm Cannulated Screw | Synthes | Reference |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The SIJFuse™ Sacroiliac Joint Fusion Device System has been tested in the following test modes:
- Static three-point bending per ASTM F2193
- Static axial pull out per ASTM F543
- o Dynamic three-point bending per ASTM F2193
The results of this non-clinical testing show that the strength of the SIJFuse™ Sacroiliac Joint Fusion Device System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the SIJFuse™ Sacroiliac Joint Fusion Device System is substantially equivalent to the predicate device.
§ 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.