(109 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of plates and screws for sternal fixation, with no mention of AI or ML technologies.
Yes
The device is used for stabilization and fixation of fractures to promote bony fusion, which is a therapeutic purpose.
No
Explanation: The device is a system of plates and screws used for the stabilization and fixation of fractures; it does not identify or detect a disease, condition, or state of health.
No
The device description clearly outlines physical components like plates and screws, and the performance studies focus on bench testing of these hardware components. There is no mention of software as a component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion." This describes a surgical implant used in vivo (within the body) to physically support and stabilize bone.
- Device Description: The description details plates and screws, which are physical components used in surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The SternalPlate system is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SternalPlate system is indicated for use in stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion.
Product codes
HRS
Device Description
The Subject Device System contains various plates with different shapes which allow for intraoperative contouring and cutting of the plates as well as for postoperative emergent cutting. The plates accept screws with a diameter of 2.3mm and 2.7mm. The Subject Device System consists of self-drilling locking screws and self-tapping locking screws. The self-drilling locking screws are designed to allow for screw fixation with no pre-drilling. The self-tapping locking screws require pre-drilling before insertion.
The Subject Device plates and screws are provided non-sterile and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall, sternal
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Assessment: Based on guidance, plates and screws are categorized as implants with permanent (>30d) contact in a bone region. Instruments are categorized with limited contact (
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
March 5, 2019
Stryker Hans Geiger Senior Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage, Michigan 49002
Re: K183172
Trade/Device Name: Stryker SternalPlate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: January 17, 2019 Received: January 22, 2019
Dear Mr. Geiger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183172
Device Name Stryker SternalPlate System
Indications for Use (Describe)
The SternalPlate system is indicated for use in stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
- SUBMITTER [§807.92(a)(1)] I.
| 510(k) Owner: | Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
79111 Freiburg, Germany |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/ Contact
Person: | Hans M. Geiger
Sr. Regulatory Affairs Specialist
Stryker Craniomaxillofacial
750 Trade Centre Way
Suite 200
Portage, MI 49002
Phone: 269-389-2323
Fax: 877-648-7114 |
| Date prepared: | February 28, 2019 |
- II. DEVICE [§807.92(a)(2)]
| Trade Name: | Stryker SternalPlate System |
|---|---|
| Common or Usual | |
| name: | Bone Plate and Screws |
| Classification | |
| name: | Single/Multiple Component Metallic Bone Fixation Appliances and |
| Accessories | |
| Regulation | |
| Number: | 21 CFR § 888.3030 |
| Regulatory Class: | Class II |
| Product Code: | HRS |
| III. PREDICATE DEVICE [§807.92(a)(3)] |
Biomet Microfixation Sternal Closure System – K121302 This predicate has not been subject to a design-related recall.
Traditional 510(k)
4
IV. DEVICE DESCRIPTION [§807.92(a)(4)]
The Subject Device System contains various plates with different shapes which allow for intraoperative contouring and cutting of the plates as well as for postoperative emergent cutting. The plates accept screws with a diameter of 2.3mm and 2.7mm. The Subject Device System consists of self-drilling locking screws and self-tapping locking screws. The selfdrilling locking screws are designed to allow for screw fixation with no pre-drilling. The self-tapping locking screws require pre-drilling before insertion.
The Subject Device plates and screws are provided non-sterile and are for single use only.
V. INDICATIONS FOR USE [§807.92(a)(5 )]
Subject Device Predicate - K121302 The SternalPlate System is The Biomet Microfixation Sternal indicated for use in stabilization Closure System is indicated for use and fixation of fractures of the in the stabilization and fixation of anterior chest wall including sternal fractures of the anterior chest wall Indications fixation following sternotomy, including sternal fixation following for Use sternal fracture(s), and sternal sternotomy and sternal reconstructive surgical procedures reconstructive surgical procedures, to promote bony fusion. to promote fusion.
TABLE 1: COMPARISON OF INDICATIONS FOR USE
The Indications for Use statement of the Subject Device falls within the scope of the broader Indications statement of the Predicate Device. The differences in the Indications statement for the proposed device in comparison to the predicate does not constitute a new indications for use.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE [§807.92(a)(6)]
The Subject Device is compared to its predicate devices for substantial equivalence based on the following criteria:
- A. Principle of Operation
- B. Technological and Operational Characteristics
A. Principle of Operation
The basic operational principle of the Subject Device, as well as the Predicate Device is for sternal fixation following sternotomy and sternal reconstructive surgical procedures to promote bony fusion. The method of site preparation and fixation is the same for both the Subject and Predicate Device.
B. Technological and Operational Characteristics
At a high level, the Subject Device and Predicate Device are based on the following technological elements:
- Material: Both the Subject Device and Predicate Device are made of biocompatible ● titanium according to standards.
- Mode of fixation: Implant fixation with screws of the Subject Device is the same as ● the Predicate Device.
- Equivalent plate design: The Subject Device has equivalent plate designs compared ● to the Predicate Device consisting of screw holes connected via bars.
- Similar Dimension: The Subject Device System contains various plates and screws o of different shapes which are in the same range as the screws and plates of the Predicate Device.
Overall these changes do not alter the Subject Device significantly and do not represent a new worst case in design.
Traditional 510(k)
6
VII. PERFORMANCE DATA [§807.92(b)(1)]
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Assessment
For assessment of biocompatibility for the Subject Device System, the following documents
were used for guidance:
· ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
· FDA guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process," issued June 16, 2016.
Based on the guidance stated above, the plates and screws of the Subject Device System are categorized as implants, with permanent (>30d) contact in a bone region. The instruments of the Subject Device are categorized as instruments with limited contact (