(74 days)
The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm.
The provided text describes the SImmetry™ Sacroiliac Joint Fusion System which is a fixation device/bone screw, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and testing (like MRMC studies, training set details, or ground truth for AI) are not applicable to this submission.
The "study" referenced in this 510(k) is a non-clinical performance evaluation comparing the device's mechanical properties to predicate devices to establish substantial equivalence.
Here's the information extracted and categorized based on the available text:
Acceptance Criteria and Device Performance for SImmetry™ Sacroiliac Joint Fusion System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstand expected loading without failure | "capable of withstanding expected loading without failure." |
| Mechanical properties equivalent to predicate device (Synthes 6.5mm Cannulated Screw K021932) | "substantially equivalent with respect to mechanical performance of the K021932 Synthes 6.5mm Cannulated Screw predicate device." |
| Provide necessary rigidity to support intended use | "provides the necessary rigidity to support the intended use." |
| Axial pull out strength | Demonstrates substantial equivalence to predicate. |
| Driving torque | Demonstrates substantial equivalence to predicate. |
| Static bend strength | Demonstrates substantial equivalence to predicate. |
| Bending fatigue strength | Demonstrates substantial equivalence to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a numerical sample size for each mechanical test. It refers to "test data" and "test results" in a general sense.
- Data Provenance: The data is from "mechanical testing" performed by the manufacturer, Zyga Technology, Inc. The country of origin is not explicitly stated, but the company is based in Minneapolis, Minnesota, USA, implying the testing was likely conducted in the USA. The testing is for non-clinical performance of the device, not patient data, so "retrospective or prospective" is not applicable in the typical clinical study sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a mechanical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for a test set. The "ground truth" for mechanical testing is established by engineering standards and measurement techniques.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a mechanical device performance study, there's no "adjudication" for human interpretation of results in the traditional sense. The mechanical testing results are compared directly against established performance benchmarks or predicate device results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance:
- No. This is a non-AI medical device; therefore, an MRMC study and AI assistance effects are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This product is a physical medical device (bone screw), not an algorithm or software. "Standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used:
- For the mechanical performance testing, the "ground truth" is typically derived from engineering standards, material science principles, and direct comparative measurements against a legally marketed predicate device's known performance characteristics. It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set, there is no ground truth to establish for it in this context.
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Image /page/0/Picture/1 description: The image shows the logo for Zyga Technology, Inc. The logo features a stylized letter Z on the left, followed by the company name in a bold, sans-serif font. The words "Technology" is underlined, and "Inc." is abbreviated with a period.
DEC 1 4 2010 ﺒﻴﺮ...
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ph (612) 455-1061
fax (612) 455-1529
700 10th Avenue South, Suite 400
Minneapolis, Minnesota 55415
510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Submitter / Contact Person / Date of Preparation
| Submitter | Zyga Technology, Inc.700 10th Ave South, Suite 400Minneapolis, MN 55415-1745 |
|---|---|
| Contact Person | Diane BrinzaDirector of Reg/Clin/QAPh. 612.455.1061, ext. 104Fax. 612.455.1064 |
| Date of Preparation | September 30, 2010 |
2. General Information
| Trade Name | SImmetry™ Sacroiliac Joint Fusion System |
|---|---|
| Common / UsualName | Fixation device/ Bone Screw |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Classification | Class II (per 21 CFR § 888.3040) |
| Manufacturer | Zyga Technology, Inc.700 10th Ave South, Suite 400Minneapolis, MN 55415-1745 |
| Identification ofPredicate Devices | K021932Synthes (USA)Synthes 6.5mm Cannulated ScrewK051296DePuy Spine, Inc.SIJF Cannulated Screw SystemK092375SI-Bone, Inc.SI Joint Fusion System |
| Device Description | The SImmetry Sacroiliac Joint Fusion System consistsof cannulated screws available in titanium havingdiameters ranging from 6.5mm-12.5mm; and lengthsof 30mm-70mm. |
| Intended Use /Indications for Use | The SImmetry Sacroiliac Joint Fusion System isintended for fixation of large bones, including: bones ofthe pelvis, for conditions including degenerativesacroiliitis and sacroiliac joint disruptions. |
| TechnologicalCharacteristic | The principle of operation of the subject devices isidentical to that of the identified predicates. A reviewof the test data for the subject devices indicates that |
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| they are equivalent to predicate devices that arecurrently commercially marketed. The subject devicesare capable of withstanding expected loading without | |
|---|---|
| failure. | |
| Materials | The subject devices are manufactured from TitaniumAlloy (Ti-6Al-4V ELI). |
| TechnologicalComparison | The SImmetry Sacroiliac Joint Fusion Systemtechnological characteristics do not raise any newquestions of safety or effectiveness. Performance datameasured against the K021932 Synthes 6.5mmCannulated Screw predicate device demonstrates thatthe SImmetry Sacroiliac Joint Fusion System is as safeand effective as predicate devices. |
| Summary ofNon-clinicalPerformance Data | Results for mechanical testing for axial pull outstrength, driving torque, static bend strength andbending fatigue strength demonstrates theSImmetry Sacroiliac Joint Fusion System issubstantially equivalent with respect to mechanicalperformance of the K021932 Synthes 6.5mmCannulated Screw predicate device. Also, the testresults establish that the SImmetry Sacroiliac JointFusion System provides the necessary rigidity tosupport the intended use. |
| Conclusion | Equivalence for the SImmetry Sacroiliac Joint FusionSystem is based on the similarity in indications for use,design features, operational principles, and materialcomposition and mechanical performance whencompared to the predicate devices cleared under thefollowing submissions:K021932 Synthes 6.5mm Cannulated Screw K051296 DePuy 6.5mm and 8.0mm SIJFCannulated Screw System K092375 SI Joint Fusion System |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its wings are angled upwards. The logo is simple and clean, and it is easily recognizable.
APR - 7 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zyga Technology, Inc. % Ms. Diane Brinza Director of Regulatory, Clinical and Ouality Assurance 700 10th Avenue South, Suite 400 Minneapolis, Minnesota 55415
Re: K102907
Trade/Device Name: SImmetryTM 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 3, 2010 Received: December 6, 2010
Dear Ms. Brinza:
This letter corrects our substantially equivalent letter of December 14, 2010.
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.
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Page 2 - Ms. Diane Brinza
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Alig B. R. to
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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): 102907
Device Name: SImmetry™ Sacroiliac Joint Fusion System
Indications For Use: The SImmetry™ Sacroiliac Joint Fusion System|is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
Over-The-Counter Use _ Prescription Use __ V_________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THISS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for U. Melleprom
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102907
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§ 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.