K Number
K151462
Device Name
SI-TECHNOLOGY® SI-DESIS® SCREWS
Manufacturer
Date Cleared
2015-08-12

(72 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SI-TECHNOLOGY® SI-DESIS® Device is intended for sacroiliac joint fusion for conditions including sacroiliac (SI) joint disruptions and degenerative sacroiliitis.
Device Description
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.
More Information

Not Found

No
The description focuses on the mechanical properties and design of a surgical screw system for sacroiliac joint fusion, with no mention of AI or ML capabilities.

Yes.

The device is intended for "sacroiliac joint fusion for conditions including sacroiliac (SI) joint disruptions and degenerative sacroiliitis," which are medical conditions that the device aims to treat or alleviate.

No.
The device description clearly states it is a "Sacroiliac Joint Fusion Screw System" intended for fixation of bones and bone fragments to assist in healing and fusion, indicating a therapeutic rather than diagnostic purpose.

No

The device description explicitly states it is a "Sacroiliac Joint Fusion Screw System" consisting of physical screws made of titanium alloy, which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure performed on the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
  • Device Description: The device is a system of screws designed for surgical implantation to fix bones. This is a medical device, not a diagnostic test.
  • No mention of in vitro testing: There is no indication that this device is used to test samples outside of the body.

Therefore, the SI-TECHNOLOGY® SI-DESIS® Device is a surgical implant/medical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The SI-TECHNOLOGY Device is intended for sacroiliac joint fusion for conditions including sacroillac (SI) joint disruptions and degenerative sacroiliitis.

Product codes (comma separated list FDA assigned to the subject device)

OUR, HWC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Sacroiliac (SI) joint, pelvis

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)

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.

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.

K112028, K021932

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.

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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 PreparedJuly 30, 2015
Manufacturer/Distributor/SponsorSI-TECHNOLOGY, LLC
320 East Vine Drive, Suite 217
Fort Collins, Colorado 80524
Phone: 970-422-1212
510(k) ContactSecure BioMed Evaluations
Linda Braddon, Ph.D.
7828 Hickory Flat Highway
Suite 120
Woodstock, GA 30188
770-837-2681
LGB@SecureBME.com
Trade NameSI-TECHNOLOGY® SI-DESIS® Screws
Common NameSmooth or threaded metallic bone fixation fastener
Code -ClassificationOUR, HWC
21 CFR 888.3040 : Class II
Predicate DevicesK112028 – Globus SI-LOK Sacroiliac Joint Fixation System
K021932 - Synthes 6.5 mm Cannulated Screw
Device DescriptionThe 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.
Indications for UseThe SI-TECHNOLOGY® SI-DESIS® Device is intended for sacroiliac joint
fusion for conditions including sacroiliac (SI) joint disruptions and
degenerative sacroiliitis.
Technological CharacteristicsAs was established in this submission, the subject SI-TECHNOLOGY® SI-
DESIS® Screws are substantially equivalent to other predicate devices
cleared by the FDA for commercial distribution in the United States. The
subject device was shown to be substantially equivalent and has the same
technological characteristics to its predicate devices through comparison
in areas including design, intended use, material composition, function,
and range of sizes.

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| Non-Clinical Performance Testing
Conclusion | 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 Equivalence
Summary (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. |