(218 days)
Not Found
No
The device description focuses on the physical characteristics and mechanical performance of surgical implants for sacroiliac joint fusion, with no mention of AI or ML technology.
Yes
The device is intended for sacroiliac joint fusion, which addresses medical conditions and restores stable bony fusion, thereby providing a therapeutic effect.
No
The device is a system of implants used for sacroiliac joint fusion, which is a therapeutic intervention, not a diagnostic one. Its purpose is to physically stabilize the joint.
No
The device description explicitly states the system consists of "sterile packaged lag or fully threaded, self-tapping cannulated titanium implants," which are physical 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 for conditions including sacroiliac joint disruptions and degenerative sacroiliitis." This describes a surgical procedure to treat a physical condition.
- Device Description: The device is described as "sterile packaged lag or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion." This is a description of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is an implant used in vivo (inside the body) for a surgical procedure.
N/A
Intended Use / Indications for Use
The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged lag or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surqical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm - 14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm- 110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm - 14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint, sacrum, ilium
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)
Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K130092 predicate device. Cadaveric testing demonstrates the subject devices can be safely implanted using the SImmetry surgical technique. Additionally testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. This performance data demonstrates that the devices included in the SImmetry Sacroiliac Joint Fusion System do not raise any new questions of safety or effectiveness.
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.
K130092, K112028, K102903, 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
Zyga Technology, Incorporated Ms. Diane Brinza Director of Regulatory Affairs 5600 Rowland Road, Suite 200 Minnetonka, Minnesota 55343
Re: K141549
Trade/Device Name: SImmetry® Sacroiliac Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: December 12, 2014 Received: December 15, 2014
Dear Ms. Brinza:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Diane Brinza
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.
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K141549
Device Name: SImmetry® Sacroiliac Joint Fusion System
Indications For Use: The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
[As required by 21 CFR 807.92(c)]
Submitter / Contact Person / Date of Preparation
| Submitter | Zyga Technology, Inc.
5600 Rowland Road, Suite 200
Minnetonka, MN 55343 |
|---------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person | Diane Brinza
Director of Regulatory Affairs
Ph. 952-698-9959
Fax. 952-698-9940
dbrinza@zyga.com |
| Date of Preparation | January 14, 2015 |
General Information
| Trade Name | SImmetry® Sacroiliac Joint Fusion System |
|---|---|
| Common / Usual | |
| Name | Sacroiliac Joint Fixation |
| Classification | 21 CFR Part 888.3040 |
| Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | Class II |
| Product Code | OUR |
| Manufacturer | Zyga Technology, Inc. |
| 5600 Rowland Road, Suite 200 | |
| Minnetonka, MN 55343 | |
| Identification of | |
| Predicate Devices | Zyga Technology, Inc. - Slmmetry Sacroiliac Joint Fusion |
| System (K130092) | |
| Globus Medical, Inc. - SI-LOK Sacroiliac Joint Fixation | |
| System (K112028) | |
| Pioneer Surgical Technology, Inc. – Pioneer Cannulated | |
| Screw System (K102903) | |
| Synthes (USA) - Synthes 6.5mm Cannulated Screw | |
| (K021932) | |
| Device Description | The SImmetry Sacroiliac Joint Fusion System consists of |
| sterile packaged lag or fully threaded, self-tapping | |
| cannulated titanium implants designed to transfix the | |
| sacrum and ilium, providing stability for bony fusion. The | |
| surqical implants are available in various sizes to | |
| accommodate patient anatomy. Implants have major | |
| diameters ranging from 6.5mm - 14.5mm, in 2mm | |
| increments. Lengths in 5mm increments range from 30mm- | |
| 110mm for fully threaded implants and 50mm to 110mm | |
| for partially threaded implants. All partially threaded | |
| implants and 6.5mm diameter fully threaded implants have | |
| a pre-assembled washer. Individually sterile packaged | |
| washers are available for fully threaded implants having | |
| diameters ranging from 8.5mm - 14.5mm. All devices are | |
| manufactured from Titanium Alloy (Ti-6Al-4V ELI). | |
| Intended Use | The SImmetry Sacroiliac Joint Fusion System is intended |
| for sacroiliac joint fusion for conditions including sacroiliac | |
| joint disruptions and degenerative sacroiliitis. | |
| Summary of Non- | |
| clinical | |
| Performance Data | Tests completed for insertion torque and axial pullout |
| strength demonstrate the subject devices are substantially | |
| equivalent with respect to mechanical performance of the | |
| K130092 predicate device. Cadaveric testing demonstrates | |
| the subject devices can be safely implanted using the | |
| SImmetry surgical technique. Additionally testing for torque | |
| to failure, mean bending yield strength and bending fatigue | |
| life provide evidence the device is capable of withstanding | |
| expected loading without failure. This performance data | |
| demonstrates that the devices included in the SImmetry | |
| Sacroiliac Joint Fusion System do not raise any new | |
| questions of safety or effectiveness. | |
| Technological | |
| Comparison | The principle of operation of the subject devices is identical |
| to that of the predicate devices cleared under the following | |
| submissions: | |
| K130092 Slmmetry Sacroiliac Joint Fusion System K112028 SI-LOK Sacroiliac Joint Fixation System K102903 Pioneer Cannulated Screw System K021932 Synthes 6.5mm Cannulated Screw Additionally the subject devices are comprised of the same | |
| Titanium Alloy (Ti-6Al-4V ELI) and manufactured using the | |
| same manufacturing processes as the K130092 predicate | |
| device. | |
| Conclusion | Equivalence for the SImmetry System is based on |
| similarities in indications for use, design features, | |
| operational principles, and material composition when | |
| compared to the predicate devices cleared under the | |
| following submissions: | |
| K130092 Slmmetry Sacroiliac Joint Fusion System K112028 SI-LOK Sacroiliac Joint Fixation System K102903 Pioneer Cannulated Screw System K021932 Synthes 6.5mm Cannulated Screw |
5600 Rowland Road, State 200, Minnetorka, MN 55343 Phone 952.698.9942 Fax 952.698.9940 zyga.com
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5600 Rowland Road, Siate 200, Minnetorka, MN 55343 Phone 952.698.9942 Fax 952.698.9940 zyga.com