(41 days)
The Synthes Sternal Fixation 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 (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated 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 (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.
The provided text is a 510(k) summary for the Synthes Sternal Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for an AI/device study is not available in these documents.
Here's a breakdown of what can be extracted and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document explicitly states: "Clinical data was not needed for this device." The submission is for a medical device (Sternal Fixation System), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC. The "performance" assessment for this type of device usually involves mechanical testing and comparison to predicate devices, which is not detailed here in terms of acceptance criteria and results.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No test set for performance evaluation of an AI model is mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No ground truth establishment for an AI model is mentioned.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI-assisted device, and no MRMC study is mentioned.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical medical device (plates and screws), not an algorithm.
7. Type of Ground Truth Used
Not applicable.
8. Sample Size for the Training Set
Not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Information Available from the Document:
- Device Trade Name: Synthes Sternal Fixation System
- Intended Use/Indications for Use: Primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
- Comparison to Predicate Device: "The design features, material, and indications for use of the subject Sternal Fixation System are substantially equivalent to the predicate devices identified. Additionally, the safety and effectiveness of this system is adequately supported by documentation within this premarket notification."
- Performance Data (Nonclinical and/or Clinical): "Clinical data was not needed for this device." This implies that non-clinical data (e.g., mechanical testing, material biocompatibility) was used to establish substantial equivalence, though the details of these tests and their criteria are not provided in this summary.
In summary, the provided document is a 510(k) summary for a physical medical device aiming for substantial equivalence. It does not contain the type of AI-related performance data, acceptance criteria, or study details requested in the prompt.
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KII2689 に OCT 2 6 2011
2.2 510(k) Summary
| Name of Firm: | Synthes1301 Goshen ParkwayWest Chester, PA 19380 |
|---|---|
| 510(k) Contact: | Elizabeth KierzekAssociate Regulatory Affairs SpecialistPhone: 610-719-6565Fax: 484-356-9682Email: Kierzek.Elizabeth@synthes.com |
| Date Prepared: | September 16, 2011 |
| Device Trade Name: | Synthes Sternal Fixation System |
| Device Generic Name: | Plate, fixation, bone |
| Product Code: | HRS, HWC |
| Regulation Number: | 888.3030, 888.3040 |
| Predicate Devices: | Synthes Sternal Fixation System (K093772) |
| Device Description: | The Synthes (USA) Sternal Fixation System consists ofmachined titanium plates, a quick-release pin and 3.0mm locking screws. The plates utilize screw fixation tocreate the construct. |
| Intended Use /Indications for Use: | The Synthes Sternal Fixation System is intended foruse in primary or secondary closure/repair of thesternum following sternotomy or fracture of thesternum to stabilize the sternum and promote fusion.The Synthes (USA) Titanium 2.4 mm UniversalLocking Plates (12, 13 and 20 hole) are indicated foruse in primary or secondary closure/repair of thesternum following stemotomy or fracture of thesternum to stabilize the sternum and promote fusion.Contraindications:The Synthes Titanium 2.4 mm Universal LockingPlates are contraindicated for use in acute cardiacpatients. |
| Comparison of thetechnologicalcharacteristics of the deviceto the predicate device: | The design features, material, and indications for use ofthe subject Sternal Fixation System are substantiallyequivalent to the predicate devices identified.Additionally, the safety and effectiveness of thissystem is adequately supported by documentationwithin this premarket notification. |
| Performance Data(Nonclinical and/orClinical): | Clinical data was not needed for this device. |
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@ SYNTHES * CMF
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Image /page/2/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and uses a serif font.
OCT 2 6 2011
Synthes % Ms. Elizabeth Kierzek 1301 Goshen Parkway West Chester, PA 19380
Re: K112689
Trade/Device Name: Synthes Sternal Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 4, 2011 Received: October 5, 2011
Dear Ms. Kierzek:
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. Elizabeth Kierzek
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 forth in the quanty by router ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. p vou 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.fdaggov/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,
Eunice Keith
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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Indications for Use Statement 6
510(k) Number:
(if known)
Device Name: Synthes Sternal Fixation System
KII 2689
Indications for Use:
The Synthes Sternal Fixation 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 (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated 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.
Contraindications:
The Synthes Titanium 2.4 mm Universal Locking Plates are contraindicated for use in acute cardiac patients.
Prescription Use X (21 CFR 801 Subpart D) 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)
Winhel Olsen for MWM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112689
CONFIDENTIAL
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.