(111 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical sternal fixation system with no mention of AI or ML technology in the intended use, device description, or any other section.
Yes
The device is described as a sternal fixation system intended for the closure/repair of the sternum to stabilize it and promote fusion, which are therapeutic actions.
No
Explanation: The device is intended for the "closure/repair of the sternum" and "to stabilize the sternum and promote fusion," indicating a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of machined titanium plates, a quick-release pin, and locking screws, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion." This describes a surgical implant used to physically stabilize bone.
- Device Description: The device is described as consisting of "machined titanium plates, a quick-release pin and 3.0 mm locking screws." These are physical components 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
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.
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
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)
Not Found
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.
Not Found
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
§ 888.3030 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.
0
K093772
Image /page/0/Picture/1 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a registered trademark symbol after the word "SYNTHES".
MAR 2 9 2010
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| ----- | ---------------- | ------------- |
| Sponsor: | Synthes
1301 Goshen Parkway
West Chester, PA 19380 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact: Andrea M. Tasker
tasker.andrea@synthes.com
(610) 719-6290 |
| Device Name: | Synthes Sternal Fixation System-Modification to Surgical Technique |
| Classification: | 888.3030 - Plate, Fixation, Bone, Non-Spinal, Metallic (HRS)
888.3040 - Screw, Fixation, Bone, Non-Spinal, Metallic (HWC) |
| Predicate
Devices: | Synthes Sternal Fixation System
Synthes Sterile Sternal Fixation System
Ethicon Stainless Steel Suture Wire |
| Device
Description: | 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. |
| Intended 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. |
| Substantial
Equivalence: | Documentation provided in this submission demonstrates the Synthes
Sternal Fixation System - Modification to Surgical Technique to be
substantially equivalent to other legally marketed devices. |
.
·
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Ms. Andrea M. Tasker 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAR 2 9 2010
Re: K093772 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: February 9, 2010 Received: February 16, 2010
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.
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 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.
2
Page 2 - Ms. Andrea M. Tasker
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/Resourcesfor_You/Industry/default.htm.
Sincerely vours.
Barbara Buehler
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small "R" in a circle is located to the right of the word.
2.0
Indications for Use
| 510(k) Number (if known): | K093772 |
|---|---|
| Device Name: | Synthes Sternal Fixation System |
| 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 | |
| (Per 21 CFR 801.109) | X |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Set for murrence of CDRH, Office of Device Evaluation (ODE)
Division Sigh-Off)
Division of Surgical, Orthopedic, and Restorative Devices
.
510(k) Number K093772
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