(128 days)
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.
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.
Here's an analysis of the provided text regarding the Synthes Sternal ZipFix™ System's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Single Implant Static | Equivalent or better than stainless steel surgical wire | Sternal ZipFix™ had equivalent or better performance for static loading strength and stiffness compared to stainless steel surgical wire. |
| Single Implant Dynamic | Equivalent or better than stainless steel surgical wire | Sternal ZipFix™ had equivalent or better performance for fatigue strength compared to stainless steel surgical wire. |
| Cut-through Resistance | Equivalent or better than stainless steel surgical wire | Sternal ZipFix™ had equivalent or better performance for resistance to cut-through compared to stainless steel surgical wire. |
| Construct Strength | Equivalent or better than predicate (worst case construct) | Sternal ZipFix™ had equivalent or better performance for construct strength compared to the predicate (stainless steel surgical wire). |
| Needle Pull-out Force | Specific force threshold (not detailed, but implied) | The Sternal ZipFix™ passed the mechanical test acceptance criteria for needle pull out. |
| Creep Testing | Specific deformation limit under constant load (implied) | The Sternal ZipFix™ passed the mechanical test acceptance criteria for creep testing. |
| Tensioning Performance | Functional performance (implied) | The ZipFix™ application instrument passed the mechanical testing acceptance criteria for tensioning performance. |
| Life Cycle Testing | Functional performance over expected lifespan (implied) | The ZipFix™ application instrument passed the mechanical testing acceptance criteria for life cycle testing. |
| Biocompatibility | Meet biocompatibility requirements | Biocompatibility requirements have been met. |
| Cytotoxicity | Non-cytotoxic | The finished product was determined to be non-cytotoxic after sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the mechanical testing, nor does it specify the country of origin of testing (though "Synthes (USA)" suggests the testing was likely conducted in the US or under US regulations). The studies were non-clinical (mechanical testing), so the concept of "retrospective or prospective" data provenance for patient data does not apply here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device underwent non-clinical (mechanical) testing, not clinical studies requiring expert consensus on patient data. The "ground truth" for these tests would be the established engineering and material science standards and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. As this was non-clinical mechanical testing, there was no expert adjudication in the sense of reviewing clinical cases. Test results against pre-defined engineering criteria and comparison to a predicate device served as the evaluation method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states: "No clinical testing was performed to support this submission." Furthermore, this is a medical device for physical sternal fixation, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical mechanical testing was based on:
- Established engineering measurement standards and methodologies for static loading strength, stiffness, fatigue strength, resistance to cut-through, needle pull-out force, creep, tensioning performance, and life cycle.
- The performance of a predicate device (Ethicon Stainless Steel Suture Wire), which served as a comparative benchmark for several key performance indicators.
- Biocompatibility and cytotoxicity standards for medical device materials.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no concept of a "training set" as understood in machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for a physical medical device.
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JUL 2 8 2011
| 3.0 | 510(k) Summary |
|---|---|
| ----- | ---------------- |
| Date Prepared | May 24, 2011 |
|---|---|
| Submitter | SYNTHES (USA)1301 Goshen ParkwayWest Chester, PA 19380United States of America |
| Contact | Andrea M. Taskertasker.andrea@synthes.comphone: (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 WireK946173- Ethicon Stainless Steel Suture WireK093772 - 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 intercostalspace, with the help of the detachable needle. Once inserted, the needleis removed and the ZipFix™ are tightened and secured in place toprovide stable fixation of the sternum. The ZipFix™ can be cut andremoved for emergent, and long-term, re-entry through the sternum. |
| Intended Use | The Synthes Sternal ZipFix™ System is intended for use in primary orsecondary closure/repair of the sternum following sternotomy or fractureof the sternum to stabilize the sternum and promote fusion. |
| TechnologicalCharacteristics | The Synthes ZipFix™ Sternal System is similar to the predicate devicesin terms of intended use, principles of operation and mechanicalperformance. The Synthes ZipFix™ Sternal System has the sameintended use as K093772 - Synthes Sternal Fixation System. TheSynthes ZipFix™ Sternal System has the same principles of operation asK931271/ K946173- Ethicon Stainless Steel Suture Wire in that theyplaced in peristernal fashion through the intercostal space, with the helpof the detachable needle and tightened and secured to provide stablefixation of the sternum. The Synthes ZipFix™ Sternal System has hadequivalent or better performance compared to K931271/ K946173-Ethicon Stainless Steel Suture Wire with respect to static loadingstrength and stiffness, fatigue strength, resistance to cut-through, andconstruct strength. |
| Clinical TestingData | No clinical testing was performed to support this submission. |
| Non-ClinicalTesting Data | Mechanical testing was performed to compare the Synthes ZipFix™Sternal Fixation System to the predicated device, stainless steel surgicalwire, for sternal closure. The Sternal ZipFix™ and stainless steel wirewere compared based on single implant static and dynamic tests and cutthrough 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 needlefrom the implant. Creep testing was performed on the Sternal ZipFix™device to determine the amount of deformation when held under aconstant load. The ZipFix™ application instrument was tested fortensioning performance and life cycle testing.The mechanical testing showed that Sternal ZipFix™ had equivalent orbetter performance compared to stainless steel surgical wire with respectto static loading strength and stiffness, fatigue strength, resistance to cut-through, and construct strength. The Sternal ZipFix™ passed themechanical test acceptance criteria for needle pull out and creep testing.The ZipFix™ application instrument passed the mechanical testingacceptance criteria for tensioning performance and life cycle testing.The new Synthes Sternal ZipFix™ System implants are manufacturedfrom (PEEK Optima LT-3). This material has a well-establishedbiocompatibility history. According to the results of biocompatibilitytesting on the finished device, the biocompatibility requirements havebeen met. Cytotoxicity testing was also performed on the finished deviceafter 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
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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
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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
PAGE 6
§ 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.