(43 days)
Not Found
No
The summary describes a system of screws and washers for sacroiliac joint fusion, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended for "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis," which is a therapeutic purpose.
No
This device is described as a "Sacroiliac Joint Fusion System" consisting of cannulated screws and washers, and its intended use is for "sacroiliac joint fusion." This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states it consists of cannulated screws and washers, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The SImmetry Sacroiliac Joint Fusion System is described as a system of cannulated screws and washers made of titanium. These are implants designed to be surgically placed within the body.
- Intended Use: The intended use is for "sacroiliac joint fusion," which is a surgical procedure to stabilize the sacroiliac joint.
The device is a surgical implant used in the body, not a device used to test samples from the body.
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 cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
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 bench tests were performed using the worst case SImmetry implant in bending fatigue per ASTM F1264 and in torsion per ASTM F543. Results demonstrate that the implants perform as well or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K130092
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
Minneapolis, MN 55415-1745 |
|---------------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Diane Brinza
Director of Regulatory Affairs
Ph. 612.455.1061, ext. 104
Fax. 612.455.1064 |
| Date of Preparation | January 11, 2013 |
2. General Information
| Trade Name | SImmetry® Sacroiliac Joint Fusion System |
|---|---|
| Common / Usual | |
| Name | Fixation Device/Bone Screw |
| Classification | Smooth or threaded metallic bone fixation fastener |
| Product Code, OUR | |
| 21 CFR § 888.3040 | |
| Class II | |
| Manufacturer | Zyga Technology, Inc. |
| 700 10th Ave South Suite 20 | |
| Minneapolis, MN 55415-1745 | |
| Identification of | |
| Predicate Devices | K111801 |
| Zyga Technology, Inc. | |
| SImmetry Sacroiliac Joint Fusion System | |
| Reason for Premarket | |
| Notification | This premarket notification addresses the addition of a new |
| washer component and geometrical modifications to the | |
| device including modification of the surface finish, thread | |
| profile, and drive features for the implant. |
1
:
| Device Description | 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;
titanium washers are available for the 6.5mm diameter
screws. | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use /
Indications for Use | The SImmetry® Sacroiliac Joint Fusion System is intended
for sacroiliac joint fusion for conditions including sacroiliac
ioint disruptions and degenerative sacroiliitis. | |
| Technological
Characteristic | The principle of operation and fundamental scientific
technology of the subject devices is identical to that of the
identified predicate. | |
| Materials | The subject devices are manufactured from Titanium Alloy
(Ti-6Al-4V ELI). | |
| Technological
Comparison . | The modification of the SImmetry Sacroiliac Joint Fusion
System does not represent a change in technological
characteristics from that of the indicated predicate device.
and therefore does not raise any new questions of safety or
effectiveness. | |
| Summary of
Non-clinical
Performance Data | Non-Clinical bench tests were performed using the worst
case SImmetry implant in bending fatigue per ASTM F1264
and in torsion per ASTM F543. Results demonstrate that the
implants perform as well or better than the predicate
devices. | |
| Conclusion | Equivalence for the SImmetry Sacroiliac Joint Fusion
System is based on the same indications for use, design
features, operational principles, and material composition
and mechanical performance when compared to the
predicate device cleared under K111801. | |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2013
Zyga Technology, Incorporated % Ms. Diane Brinza Director of Regulatory, Clinical and Quality Assurance 700 10th Avenue South, Suite 20 Minneapolis, Minnesota 55415-1745
Re: K130092
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: February 1, 2013 Received: February 4, 2013
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
3
Page 2 - Ms. Diane Brinza
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ErinI.D.Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Attachment A | |
|---|---|
| Indications for Use Statement |
| 510(k) Number (if known) | K130092 |
|---|---|
| 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 (Per 21 CFR 801.109) | √ |
| OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| -- | ---- | --------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth 詞詞ank -S
Division of Orthopedic Devices
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