(128 days)
Not Found
No
The summary describes a mechanical sternal fixation system and its mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as a system for stabilizing the sternum via mechanical fixation using cable ties, rather than providing or supporting treatment of disease.
No
The device is a system for sternal closure and stabilization, used to promote fusion after sternotomy or sternal fracture. It is a treatment device, not a diagnostic one. Its purpose is to physically fix and stabilize an anatomical structure, not to identify or characterize a disease or condition.
No
The device description clearly states it consists of physical components (PEEK cable ties, stainless steel needle) and the performance studies focus on mechanical testing of these physical components. There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Synthes Sternal ZipFix™ System is a surgical implant used to physically stabilize and repair the sternum within the body. It is a mechanical device used for fixation, not for analyzing biological samples.
The information provided clearly describes a surgical device for internal fixation, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Synthes Sternal ZipFix™ System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
Product codes
JDQ
Device Description
The Synthes Sternal ZipFix™ System consists of polyetheretherketone (PEEK Optima LT-3) cable ties with detachable, stainless steel needle. The ZipFix are placed in peristernal fashion through the intercostal space, with the help of the detachable needle. Once inserted, the needle is removed and the ZipFix™ are tightened and secured in place to provide stable fixation of the sternum. The ZipFix™ can be cut and removed for emergent, and long-term, re-entry through the sternum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Mechanical testing was performed to compare the Synthes ZipFix™ Sternal Fixation System to the predicated device, stainless steel surgical wire, for sternal closure. The Sternal ZipFix™ and stainless steel wire were compared based on single implant static and dynamic tests and cut through resistance testing. Based on a worst case construct, simulated-use construct testing was also performed compared to the predicate. Needle pull-out force testing was performed on the Sternal ZipFix™ device to determine the amount of force required to remove the needle from the implant. Creep testing was performed on the Sternal ZipFix™ device to determine the amount of deformation when held under a constant load. The ZipFix™ application instrument was tested for tensioning performance and life cycle testing.
The mechanical testing showed that Sternal ZipFix™ had equivalent or better performance compared to stainless steel surgical wire with respect to static loading strength and stiffness, fatigue strength, resistance to cut-through, and construct strength. The Sternal ZipFix™ passed the mechanical test acceptance criteria for needle pull out and creep testing. The ZipFix™ application instrument passed the mechanical testing acceptance criteria for tensioning performance and life cycle testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
JUL 2 8 2011
| 3.0 | 510(k) Summary |
|---|---|
| ----- | ---------------- |
| Date Prepared | May 24, 2011 |
|---|---|
| Submitter | SYNTHES (USA) |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact | Andrea M. Tasker |
| tasker.andrea@synthes.com | |
| phone: (610) 719-6290 | |
| Trade Name | Synthes Sternal ZipFix™ System |
| Common Name | cerclage, fixation |
| Regulation Name | Bone Fixation Cerclage |
| Regulation Number | 21 CFR §888.3010 |
| Device Class | 2 |
| Review Panel | Orthopedic |
| Product Codes | Primary: JDQ |
| Predicate Devices | K931271- Ethicon Stainless Steel Suture Wire |
| K946173- Ethicon Stainless Steel Suture Wire | |
| K093772 - Synthes Sternal Fixation System | |
| Device Description | The Synthes Sternal ZipFix™ System consists of polyetheretherketone |
| (PEEK Optima LT-3) cable ties with detachable, stainless steel needle. | |
| The ZipFix are placed in peristernal fashion through the intercostal | |
| space, with the help of the detachable needle. Once inserted, the needle | |
| is removed and the ZipFix™ are tightened and secured in place to | |
| provide stable fixation of the sternum. The ZipFix™ can be cut and | |
| removed for emergent, and long-term, re-entry through the sternum. | |
| Intended Use | The Synthes Sternal ZipFix™ System is intended for use in primary or |
| secondary closure/repair of the sternum following sternotomy or fracture | |
| of the sternum to stabilize the sternum and promote fusion. | |
| Technological | |
| Characteristics | The Synthes ZipFix™ Sternal System is similar to the predicate devices |
| in terms of intended use, principles of operation and mechanical | |
| performance. The Synthes ZipFix™ Sternal System has the same | |
| intended use as K093772 - Synthes Sternal Fixation System. The | |
| Synthes ZipFix™ Sternal System has the same principles of operation as | |
| K931271/ K946173- Ethicon Stainless Steel Suture Wire in that they | |
| placed in peristernal fashion through the intercostal space, with the help | |
| of the detachable needle and tightened and secured to provide stable | |
| fixation of the sternum. The Synthes ZipFix™ Sternal System has had | |
| equivalent or better performance compared to K931271/ K946173- | |
| Ethicon Stainless Steel Suture Wire with respect to static loading | |
| strength and stiffness, fatigue strength, resistance to cut-through, and | |
| construct strength. | |
| Clinical Testing | |
| Data | No clinical testing was performed to support this submission. |
| Non-Clinical | |
| Testing Data | Mechanical testing was performed to compare the Synthes ZipFix™ |
| Sternal Fixation System to the predicated device, stainless steel surgical | |
| wire, for sternal closure. The Sternal ZipFix™ and stainless steel wire | |
| were compared based on single implant static and dynamic tests and cut | |
| through resistance testing. Based on a worst case construct, simulated- | |
| use construct testing was also performed compared to the predicate. | |
| Needle pull-out force testing was performed on the Sternal ZipFix™ | |
| device to determine the amount of force required to remove the needle | |
| from the implant. Creep testing was performed on the Sternal ZipFix™ | |
| device to determine the amount of deformation when held under a | |
| constant load. The ZipFix™ application instrument was tested for | |
| tensioning performance and life cycle testing. |
The mechanical testing showed that Sternal ZipFix™ had equivalent or
better performance compared to stainless steel surgical wire with respect
to static loading strength and stiffness, fatigue strength, resistance to cut-
through, and construct strength. The Sternal ZipFix™ passed the
mechanical test acceptance criteria for needle pull out and creep testing.
The ZipFix™ application instrument passed the mechanical testing
acceptance criteria for tensioning performance and life cycle testing.
The new Synthes Sternal ZipFix™ System implants are manufactured
from (PEEK Optima LT-3). This material has a well-established
biocompatibility history. According to the results of biocompatibility
testing on the finished device, the biocompatibility requirements have
been met. Cytotoxicity testing was also performed on the finished device
after sterilization. The finished product was determined to be non-
cytotoxic. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Ms. Andrea M. Tasker CMF Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380
JUL 2 8 2011
Re: K110789
Trade/Device Name: Synthes Sternal ZipFix™ System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: July15, 2011 Received: July 18, 2011
Dear Ms. Tasker:
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
4
Page 2 - Ms. Andrea M. Tasker
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 (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/CDRH0ffices/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,
Mark H. Millican
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K1107.89 510(k) Number (if known):
Device Name: Synthes Sternal ZipFix™ System
The Synthes Sternal ZipFix™ System is intended for use in primary or Indications for Use: secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
X Prescription Use (Per 21 CFR 801.109)
AND/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)
Daniel Krane for MXM
(Division Sign-Off)
Division of Surgical. Orthopedit and Restorative Devices
§10(k) Number K110789
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