(72 days)
The SI-TECHNOLOGY® SI-DESIS® Device is intended for sacroiliac joint fusion for conditions including sacroiliac (SI) joint disruptions and degenerative sacroiliitis.
The SI-TECHNOLOGY® SI-DESIS® Sacroiliac Joint Fusion Screw System consists of screws designed to assist in the healing of sacroiliac joints for fusion by providing fixation of large bones and large bone fragments of the pelvis. The screws are not intended to replace normal body structures. The screws are offered in 6.5 mm diameter cannulated, partially threaded or fully threaded configurations in various lengths. Additionally, optional supplemental 5 mm diameter screws are offered in various lengths and are to be used only in conjunction with the 6.5 mm screws for supplemental screw fixation to accommodate patient anatomy. The screws are manufactured from titanium alloy per ASTM F136.
This document describes the premarket notification (510(k)) for the SI-TECHNOLOGY® SI-DESIS® Screws, a medical device for sacroiliac joint fusion. The information provided is for device clearance, not for an AI/ML powered device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.
Here's the breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this traditional medical device clearance are typically defined by recognized standards and comparison to predicate devices, rather than specific performance metrics like accuracy, sensitivity, or specificity that would be used for an AI/ML device. The "reported device performance" refers to the results of non-clinical testing demonstrating equivalence to predicate devices.
| Acceptance Criteria (Based on Recognized Standards & Predicate Equivalence) | Reported Device Performance |
|---|---|
| Screw strength (Static) per ASTM F543 | Meets or exceeds the performance of predicate devices. |
| Screw strength (Fatigue) per ASTM F2193 | Meets or exceeds the performance of predicate devices. |
| Technological characteristics (design, intended use, material, function, sizes) comparable to predicate devices. | The subject device has the same technological characteristics as predicate devices and was shown to be substantially equivalent through comparison in these areas. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the document describes non-clinical engineering testing of a physical medical device (screws), not a diagnostic or prognostic AI/ML system that would use a test set of data. The testing involves physical samples of screws, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable for a physical device like screws. "Ground truth" in this context would refer to the established engineering standards (ASTM F543, ASTM F2193) and the documented performance of the predicate devices, which are objective and do not require expert consensus in the way an AI diagnostic system would.
4. Adjudication Method for the Test Set
This information is not applicable for the non-clinical testing of a physical device. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish ground truth for AI algorithms.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable as the document describes the clearance of a physical medical implant (screws), not an AI/ML system. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the document is for a physical medical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
For the non-clinical engineering testing, the "ground truth" is established by:
- Recognized Industry Standards: ASTM F543 (Standard Specification for Metallic Medical Bone Screws) and ASTM F2193 (Standard Test Method for Static and Fatigue Testing of Sacroiliac Joint Fusion Implants). These standards define the mechanical properties and testing methodologies.
- Predicate Device Performance: The performance of legally marketed predicate devices (K112028 – Globus SI-LOK Sacroiliac Joint Fixation System, K021932 - Synthes 6.5 mm Cannulated Screw) served as a benchmark for comparison.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of clearing a physical medical device through non-clinical engineering tests. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a physical medical device clearance based on non-clinical testing.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. 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 Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2015
SI-TECHNOLOGY, LLC % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K151462
Trade/Device Name: SI-TECHNOLOGY® SI-DESIS® Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: May 22, 2015 Received: June 1, 2015
Dear Dr. Braddon:
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 – Dr. Linda Braddon
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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with the letters 'si' in black on the left and the word 'DESIS' in gray on the right. The 'si' is stylized with a curved design, and the 'DESIS' is in a simple sans-serif font. The logo has a modern and minimalist look.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known) K151462
Device Name
SI-TECHNOLOGY® SI-DESIS® Screws
Indications for Use (Describe)
The SI-TECHNOLOGY Device is intended for sacroiliac joint fusion for conditions including sacroillac (SI) joint disruptions and degenerative sacroiliitis.
Type of Use (Select one or both, as applicable) 区 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 (1/14)
PSC Publishing Services(301)443-6740 EF
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In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the SI-TECHNOLOGY® SI-DESIS® Screws is provided below.
| Date Summary Prepared | July 30, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | SI-TECHNOLOGY, LLC320 East Vine Drive, Suite 217Fort Collins, Colorado 80524Phone: 970-422-1212 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681LGB@SecureBME.com |
| Trade Name | SI-TECHNOLOGY® SI-DESIS® Screws |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Code -Classification | OUR, HWC21 CFR 888.3040 : Class II |
| Predicate Devices | K112028 – Globus SI-LOK Sacroiliac Joint Fixation SystemK021932 - Synthes 6.5 mm Cannulated Screw |
| Device Description | The SI-TECHNOLOGY® SI-DESIS® Sacroiliac Joint Fusion Screw Systemconsists of screws designed to assist in the healing of sacroiliac joints forfusion by providing fixation of large bones and large bone fragments ofthe pelvis. The screws are not intended to replace normal bodystructures. The screws are offered in 6.5 mm diameter cannulated,partially threaded or fully threaded configurations in various lengths.Additionally, optional supplemental 5 mm diameter screws are offeredin various lengths and are to be used only in conjunction with the 6.5mm screws for supplemental screw fixation to accommodate patientanatomy. The screws are manufactured from titanium alloy per ASTMF136. |
| Indications for Use | The SI-TECHNOLOGY® SI-DESIS® Device is intended for sacroiliac jointfusion for conditions including sacroiliac (SI) joint disruptions anddegenerative sacroiliitis. |
| Technological Characteristics | As was established in this submission, the subject SI-TECHNOLOGY® SI-DESIS® Screws are substantially equivalent to other predicate devicescleared by the FDA for commercial distribution in the United States. Thesubject device was shown to be substantially equivalent and has the sametechnological characteristics to its predicate devices through comparisonin areas including design, intended use, material composition, function,and range of sizes. |
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| Non-Clinical Performance TestingConclusion | Non-clinical testing was performed to demonstrate the SI-TECHNOLOGY® SI-DESIS® Screw System is substantially equivalent to other predicate devices. In order to demonstrate the substantial equivalence, the following tests were performed:Screw strength via ASTM F543 Static and Fatigue testing via ASTM F2193 The results of these studies show the subject SI-TECHNOLOGY® SI-DESIS® Screws meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent. |
|---|---|
| Substantial EquivalenceSummary (Conclusion) | Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject SI-TECHNOLOGY® SI-DESIS® Screws has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use. |
§ 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.