(24 days)
Not Found
No
The summary describes a mechanical implant system (screws and washers) for sacroiliac joint fusion and mentions only mechanical performance testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is intended for sacroiliac joint fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which directly involves treatment and restoration of function.
No
The device is described as a "Sacroiliac Joint Fusion System" consisting of cannulated screws and washers intended for "sacroiliac joint fusion". This is a therapeutic device designed for surgical intervention, not for diagnosing conditions.
No
The device description clearly states it consists of cannulated screws and washers, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The SImmetry™ Sacroiliac Joint Fusion System is a system of screws and washers intended for surgically fusing the sacroiliac joint. This is a surgical implant, not a device used for testing samples.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure, not for diagnostic testing.
The information provided clearly describes a surgical implant used for structural support and fusion, which falls under the category of a surgical device, not an in vitro diagnostic device.
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 sacroillitis.
Product codes (comma separated list FDA assigned to the subject device)
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 use with 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)
Mechanical testing for axial pull out strength, driving torque, static bend strength and bending fatigue provided in this and previous 510(k)s demonstrate that the SImmetry Sacroiliac Joint Fusion System provides the necessary rigidity to support the intended use.
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.
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.
0
JUL 2 1 2011
510(k) Summary
[As required by 21 CFR 807.92(c)]
1. Submitter / Contact Person / Date of Preparation
| Submitter | Zyga Technology, Inc.
700 10th Ave South, Suite 20
Minneapolis, MN 55415-1745 |
|---------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person | Diane Brinza
Director of Regulatory and Clinical Affairs
Ph. 612.455.1061, ext. 104
Fax. 612.455.1064 |
| Date of Preparation | June 22, 2011 |
2. General Information
| Trade Name | SImmetry™ Sacroiliac Joint Fusion System |
|---|---|
| Common / Usual | |
| Name | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion |
| 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 | |
| Minneapolis, MN 55415-1745 | |
| Identification of | |
| Predicate Devices | K110512 |
| Zyga Technology, Inc. | |
| SImmetry™ Sacroiliac Joint Fusion System | |
| 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 use with 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 joint 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 principle of operation and fundamental scientific |
| technology of the subject devices is identical to that of | |
| the identified predicate device. |
Page of 2
1
长川时时
.
| Summary of
Non-clinical
Performance Data | Mechanical testing for axial pull out strength, driving
torque, static bend strength and bending fatigue
provided in this and previous 510(k)s demonstrate
that the SImmetry Sacroiliac Joint Fusion System
provides the necessary rigidity to support the intended
use. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Equivalence for the SImmetry Sacroiliac Joint Fusion
System is based on the same intended use, design
features, operational principles, and material
composition and mechanical performance when
compared to the predicate device cleared under
K110512. |
and the comments of the comments of the comments of
:
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zyga Technology, Incorporated % Ms. Diane Brinza Director of Regulatory Clinical and Quality Assurance 700 10th Avenue South, Suite 400 Minneapolis, Minnesota 55415
JUL 2 1 2011
Re: K111801
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: June 22, 2011 Received: June 27, 2011
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
3
Page 2 - Ms. Diane Brinza
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/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,
Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
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 sacroillitis.
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)
for M. Melkerson
(Division/Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K11180/
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