(74 days)
No
The summary describes a mechanical fixation system (screws) and does not mention any AI or ML components or functions.
Yes
The device is intended for "fixation of large bones...for conditions including degenerative sacroiliitis and sacroiliac joint disruptions," which directly addresses and treats medical conditions.
No
The device is described as a "Sacroiliac Joint Fusion System" consisting of screws for fixation of bones, which is a therapeutic rather than a diagnostic function. Its intended use is for conditions like degenerative sacroiliitis and sacroiliac joint disruptions, but it does not perform diagnosis of these conditions.
No
The device description explicitly states it consists of cannulated screws made of titanium, 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 the "fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions." This describes a surgical implant used to physically stabilize bones.
- Device Description: The device consists of "cannulated screws." This is a physical medical device used in surgery.
- 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 biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the pelvis
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)
Results for mechanical testing for axial pull out strength, driving torque, static bend strength and bending fatigue strength demonstrates the SImmetry Sacroiliac Joint Fusion System is substantially equivalent with respect to mechanical performance of the K021932 Synthes 6.5mm Cannulated Screw predicate device. Also, the test results establish 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)
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
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 400
Minneapolis, MN 55415-1745 |
|---------------------|--------------------------------------------------------------------------------------------|
| Contact Person | Diane Brinza
Director of Reg/Clin/QA
Ph. 612.455.1061, ext. 104
Fax. 612.455.1064 |
| Date of Preparation | September 30, 2010 |
2. General Information
| Trade Name | SImmetry™ Sacroiliac Joint Fusion System |
|---|---|
| Common / Usual | |
| Name | 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 400 | |
| Minneapolis, MN 55415-1745 | |
| Identification of | |
| Predicate Devices | K021932 |
| Synthes (USA) | |
| Synthes 6.5mm Cannulated Screw | |
| K051296 | |
| DePuy Spine, Inc. | |
| SIJF Cannulated Screw System | |
| K092375 | |
| SI-Bone, Inc. | |
| SI 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. | |
| Intended Use / | |
| 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. | |
| Technological | |
| Characteristic | The principle of operation of the subject devices is |
| identical to that of the identified predicates. A review | |
| of the test data for the subject devices indicates that |
Page 1 of 2
1
| | they are equivalent to predicate devices that are
currently commercially marketed. The subject devices
are capable of withstanding expected loading without |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | failure. |
| Materials | The subject devices are manufactured from Titanium
Alloy (Ti-6Al-4V ELI). |
| Technological
Comparison | The SImmetry Sacroiliac Joint Fusion System
technological characteristics do not raise any new
questions of safety or effectiveness. Performance data
measured against the K021932 Synthes 6.5mm
Cannulated Screw predicate device demonstrates that
the SImmetry Sacroiliac Joint Fusion System is as safe
and effective as predicate devices. |
| Summary of
Non-clinical
Performance Data | Results for mechanical testing for axial pull out
strength, driving torque, static bend strength and
bending fatigue strength demonstrates the
SImmetry Sacroiliac Joint Fusion System is
substantially equivalent with respect to mechanical
performance of the K021932 Synthes 6.5mm
Cannulated Screw predicate device. Also, the test
results establish 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 similarity in indications for use,
design features, operational principles, and material
composition and mechanical performance when
compared to the predicate devices cleared under the
following submissions:
K021932 Synthes 6.5mm Cannulated Screw K051296 DePuy 6.5mm and 8.0mm SIJF
Cannulated Screw System K092375 SI Joint Fusion System |
Page 2 of z
2
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.
3
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
4
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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