(57 days)
Not Found
No
The device description and performance studies focus on mechanical components and testing, with no mention of AI or ML.
Yes
The device is described as a Sternal Closure System intended for stabilization and fixation of sternal fractures, which is a therapeutic intervention.
No
Explanation: The device description and intended use clearly indicate that it is a system for stabilizing sternal fractures, involving bone screws, plates, and fasteners for implantation. It performs a therapeutic, not diagnostic, function.
No
The device description explicitly states it is comprised of bone screw, bone plate, and fastener components and instruments for implantation, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures." This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The device is comprised of "bone screw, bone plate and fastener components and instruments for implantation." These are physical components designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used for mechanical stabilization.
N/A
Intended Use / Indications for Use
The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, JDQ
Device Description
The Sternal Closure System is comprised of bone screw, bone plate and fastener components and instruments for implantation. The plates are offered in a fixed one-piece and a fastenable two-piece style. Bone screws are available in a single diameter having a range of lengths. The interconnecting components come in solid and cable versions and fasten the halves of the two-piece plate.
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)
Mechanical testing of the worst case Sternal Closure System constructs was performed in static and dynamic lateral distraction and static longitudinal shear. Sternal Closure System bone screws were evaluated according to ASTM F543. The mechanical test results demonstrate that the Sternal Closure System construct performance is substantially equivalent to the Ethicon Stainless Steel Suture Wire and that the Sternal Closure System screw performance is substantially equivalent to the Biomet Microfixation Sternal Closure System screws.
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.
K110574, K111908, K121302, K931271, K946173, K051165, K070169
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2014
JACE Medical LLC Mr. Justin May Director of Engineering 536 East 200 North Warsaw, Indiana 46582
Re: K142484 Trade/Device Name: Sternal Closure 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, HWC, JDQ Dated: August 29, 2014 Received: September 4, 2014
Dear Mr. May:
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 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
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Page 2 - Mr. Justin May
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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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 N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Sternal Closure System
Indications for Use (Describe)
The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date: | 29 August 2014 |
|---|---|
| Sponsor: | JACE Medical, LLC |
| 536 East 200 North | |
| Warsaw, IN 46582 USA | |
| (574) 527-1663 | |
| Contact Person: | Justin May, Director of Engineering |
| Trade Name: | Sternal Closure System |
| Common Name: | Cable/rod, plate and screw system |
| Device Classification: | Class II |
| Regulation, Name: | 888.3010, Bone fixation cerclage |
| 888.3030, Single/multiple component metallic bone fixation | |
| appliances and accessories | |
| 888.3040, Smooth or threaded metallic bone fixation fastener | |
| Device Product | |
| Codes: | JDQ, HRS, HWC |
| Device Description: | The Sternal Closure System is comprised of bone screw, bone plate |
| and fastener components and instruments for implantation. The | |
| plates are offered in a fixed one-piece and a fastenable two-piece | |
| style. Bone screws are available in a single diameter having a range | |
| of lengths. The interconnecting components come in solid and cable | |
| versions and fasten the halves of the two-piece plate. | |
| Intended Use: | The Sternal Closure System is intended for use in the stabilization |
| and fixation of fractures of the sternum, including sternal fixation | |
| following sternotomy and sternal reconstructive surgical procedures. | |
| Materials: | The Sternal Closure System implant components are manufactured |
| titanium alloy as described by ASTM F136. | |
| Predicate Devices: | Biomet Microfixation Sternal Closure System (Biomet Microfixation: |
| K110574, K111908, K121302) | |
| Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271, | |
| K946173) | |
| Sternal Talon (KLS Martin, LP: K051165, K070169) | |
| Performance Data: | Mechanical testing of the worst case Sternal Closure System |
| constructs was performed in static and dynamic lateral distraction | |
| and static longitudinal shear. Sternal Closure System bone screws | |
| were evaluated according to ASTM F543. | |
| The mechanical test results demonstrate that the Sternal Closure | |
| System construct performance is substantially equivalent to the | |
| Ethicon Stainless Steel Suture Wire and that the Sternal Closure | |
| System screw performance is substantially equivalent to the Biomet | |
| Microfixation Sternal Closure System screws. | |
| Technological | |
| Characteristics: | The Sternal Closure System possesses the same technological |
| characteristics as the predicate devices. These include: | |
| • performance, | |
| • implant grade materials, and | |
| • basic design. | |
| Technological characteristics which are different have been | |
| supported with descriptive information and/or performance data. | |
| Therefore the fundamental scientific technology of the Sternal | |
| Closure System devices is the same as previously cleared devices. | |
| Conclusion: | The Sternal Closure System possesses the same intended use and |
| technological characteristics as the predicate devices. Therefore the | |
| Sternal Closure System is substantially equivalent for its intended | |
| use. |
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