(218 days)
The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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 surgical 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).
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies involving a test set, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training sets.
The document is a 510(k) premarket notification from the FDA for the Zyga Technology, Incorporated's SImmetry® Sacroiliac Joint Fusion System. It discusses the device's classification, predicate devices, description, intended use, and a summary of non-clinical performance data.
The "Summary of Non-clinical Performance Data" section mentions:
- "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."
However, it does not provide any specific acceptance criteria or detailed results of these tests (e.g., numerical values for torque, strength, or fatigue life). There's no mention of a test set, data provenance, experts, ground truth, or any methodology typically associated with validating an AI/ML medical device.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the studies as described in your prompt, as that information is not present in the provided text.
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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 200Minnetonka, MN 55343 |
|---|---|
| Contact Person | Diane BrinzaDirector of Regulatory AffairsPh. 952-698-9959Fax. 952-698-9940dbrinza@zyga.com |
| Date of Preparation | January 14, 2015 |
General Information
| Trade Name | SImmetry® Sacroiliac Joint Fusion System |
|---|---|
| Common / UsualName | Sacroiliac Joint Fixation |
| Classification | 21 CFR Part 888.3040Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | Class II |
| Product Code | OUR |
| Manufacturer | Zyga Technology, Inc.5600 Rowland Road, Suite 200Minnetonka, MN 55343 |
| Identification ofPredicate Devices | Zyga Technology, Inc. - Slmmetry Sacroiliac Joint FusionSystem (K130092)Globus Medical, Inc. - SI-LOK Sacroiliac Joint FixationSystem (K112028)Pioneer Surgical Technology, Inc. – Pioneer CannulatedScrew System (K102903)Synthes (USA) - Synthes 6.5mm Cannulated Screw(K021932) |
| Device Description | The SImmetry Sacroiliac Joint Fusion System consists ofsterile packaged lag or fully threaded, self-tappingcannulated titanium implants designed to transfix thesacrum and ilium, providing stability for bony fusion. Thesurqical implants are available in various sizes toaccommodate patient anatomy. Implants have major |
| diameters ranging from 6.5mm - 14.5mm, in 2mmincrements. Lengths in 5mm increments range from 30mm-110mm for fully threaded implants and 50mm to 110mmfor partially threaded implants. All partially threadedimplants and 6.5mm diameter fully threaded implants havea pre-assembled washer. Individually sterile packagedwashers are available for fully threaded implants havingdiameters ranging from 8.5mm - 14.5mm. All devices aremanufactured from Titanium Alloy (Ti-6Al-4V ELI). | |
| Intended Use | The SImmetry Sacroiliac Joint Fusion System is intendedfor sacroiliac joint fusion for conditions including sacroiliacjoint disruptions and degenerative sacroiliitis. |
| Summary of Non-clinicalPerformance Data | Tests completed for insertion torque and axial pulloutstrength demonstrate the subject devices are substantiallyequivalent with respect to mechanical performance of theK130092 predicate device. Cadaveric testing demonstratesthe subject devices can be safely implanted using theSImmetry surgical technique. Additionally testing for torqueto failure, mean bending yield strength and bending fatiguelife provide evidence the device is capable of withstandingexpected loading without failure. This performance datademonstrates that the devices included in the SImmetrySacroiliac Joint Fusion System do not raise any newquestions of safety or effectiveness. |
| TechnologicalComparison | The principle of operation of the subject devices is identicalto that of the predicate devices cleared under the followingsubmissions: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 sameTitanium Alloy (Ti-6Al-4V ELI) and manufactured using thesame manufacturing processes as the K130092 predicatedevice. |
| Conclusion | Equivalence for the SImmetry System is based onsimilarities in indications for use, design features,operational principles, and material composition whencompared to the predicate devices cleared under thefollowing 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
§ 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.