(86 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI/ML or related concepts.
Yes
The device is described as a "Rib Plating System" intended for the "fixation, stabilization, and fusion of rib fractures and osteotomies," which directly implies its use in treating and restoring function to damaged ribs, aligning with the definition of a therapeutic device.
No
Explanation: The device is a surgical plating system used for the fixation, stabilization, and fusion of rib fractures and osteotomies. It is a therapeutic device, not a diagnostic one, as it does not perform any diagnostic functions or provide diagnostic information.
No
The device description explicitly states it consists of physical implants (plates, posts, and caps) made of titanium, indicating it is a hardware medical device, not software-only.
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 "fixation, stabilization, and fusion of rib fractures and osteotomies." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "stability plate with threaded locking posts, and locking caps" made of titanium. These are implants designed to be surgically placed within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health.
This device is clearly designed for surgical intervention and not for testing samples outside of the body.
N/A
Intended Use / Indications for Use
The MatrixRIB Endo Thoracoscopic Rib Plating System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The MatrixRIB Endo Thoracoscopic Rib Plating System consists of a pre-assembled stability plate with threaded locking posts, and locking caps intended for the minimally invasive thoracoscopic fixation and stabilization of ribs. The implants are manufactured from titanium (CPTi4) and titanium alloy (Ti-6Al-7Nb).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rib
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)
Non-clinical testing and analyses comparing the proposed devices to the predicates within this submission include:
- Biomechanical Cadaveric Testing
- Static Compression Bending
- Dynamic Compression Bending
The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixRIB Endo Thoracoscopic Rib Plating System is comparable to that of the predicates.
Clinical testing was not necessary for the determination of substantial equivalence.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized graphic. The graphic depicts three overlapping human profiles facing to the right, symbolizing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Synthes (USA) Products LLC Ms. Susan Lewandowski Project Leader, Regulatory Affairs - CMF 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K141241
Trade/Device Name: MatrixRIB Endo Thoracoscopic Rib Plating 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: May 12, 2014 Received: May 13, 2014
Dear Ms. Lewandowski:
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 - Ms. Susan Lewandowski
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,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indications for Use Statement
510(k) Number (if known): K141241
Device Name:
MatrixRIB Endo Thoracoscopic Rib Plating System
Indications for Use:
The MatrixRIB Endo Thoracoscopic Rib Plating System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Prescription Use X (Per 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)
Elizabet隔边吸rank -S
Division of Orthopedic Devices
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5.0 510(k) Summary
| Date Prepared: | May 12, 2014 |
|---|---|
| Submitter: | Synthes (USA) Products LLC |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact: | Susan Lewandowski |
| Lewandowski.susan@synthes.com | |
| Telephone 610-719-5852 | |
| Facsimile 484-356-9682 |
MatrixRIB Endo Thoracoscopic Rib Plating System Device Name:
Device Classification Information:
| Product Code | Device Name | Device Class | Regulation Number | Regulation Description |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | 2 | 21 CFR 888.3030 | Single, multiple component metallic bone fixation appliances and accessories |
The MatrixRIB Endo Thoracoscopic Rib Plating System contains Class 2 implants as well as Class 1 instruments and accessories.
Predicate Devices:
- Synthes MatrixRIB Fixation System (K081623) ●
- Acute Innovations Modular RibLoc System (K113318) o
- Synthes Sternal Fixation System (K112689)
Indications for Use:
The MatrixRIB Endo Thoracoscopic Rib Plating System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Device Description:
The MatrixRIB Endo Thoracoscopic Rib Plating System consists of a pre-assembled stability plate with threaded locking posts, and locking caps intended for the minimally invasive thoracoscopic fixation and stabilization of ribs. The implants are manufactured from titanium (CPTi4) and titanium alloy (Ti-6Al-7Nb).
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Image /page/4/Picture/0 description: The image shows the Synthes logo. 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 next to the word "SYNTHES". A horizontal line is present below the logo.
Comparison to Predicate Devices:
Indications
The MatrixRIB Endo Thoracoscopic Rib Plating System has the same general Indications for Use as the predicate devices.
Technological Similarities of MatrixRIB Endo Thoracoscopic Rib Plating System to Predicates
- Same general principle of operation for all components; provide fixation and stabilization to rib fractures so that fusion may occur.
- Both MatrixRIB Endo and RibLoc Systems rely on strong mechanical fixation that lags the plate to the rib.
- All Systems are used with smaller incisions allowing a less invasive (RibLoc) or ● minimally invasive (MatrixRIB splint, MatrixRIB Endo) surgical technique to provide access to the fracture and implantation of internal fixation.
- For all Systems, same or similar materials used for construction of fixation devices e.g. Titanium and/or Titanium Alloy
- The MatrixRIB Endo stability plate lengths are within those of the predicates ●
- o All Systems are designed to accommodate the anatomy of the rib
- MatrixRIB Endo and RibLoc Systems both have plates that can be contoured both external to the patient and intraoperatively.
- Both MatrixRIB Endo and MatrixRIB (splint) are designed to be used without removing periosteum in order to maximize blood supply to the bone.
- Both the MatrixRIB Endo and RibLoc Systems "sandwich" the rib; the MatrixRIB Endo, the rib lies between the stability plate placed posteriorly and the locking caps placed anteriorly and the RibLoc, the rib lies between the plate which is placed anteriorly and supports with anterior, superior, and posterior rib surfaces due to its ushaped channel supports.
Technological Differences of MatrixRIB Endo
- Stability Plates are pre-assembled with threaded locking posts that can pivot about the ● plate slot to accommodate both the surgical technique and the final implantation
- Prior to fixation with the threaded locking caps, threaded locking post slides freely along the plate slot to accommodate intraoperative positioning.
- Locking caps are sized to accommodate a variety of rib thicknesses ●
- MatrixRIB Endo uses a standard thoracoscopic approach with anterior stab incisions; RibLoc uses a standard thoracoscopic approach with large incision over rib fracture
- o MatrixRIB splints are placed into the intramedullary canal of the rib, while the MatrixRIB Endo "sandwiches" the rib; the rib lies between the stability plate placed posteriorly and the locking caps placed anteriorly.
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Non-clinical performance data:
Non-clinical testing and analyses comparing the proposed devices to the predicates within this submission include:
- Biomechanical Cadaveric Testing ●
- o Static Compression Bending
- . Dynamic Compression Bending
The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixRIB Endo Thoracoscopic Rib Plating System is comparable to that of the predicates.
Clinical performance data:
Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence:
The proposed devices have the same intended use as the predicate devices. The mechanical testing included in this submission demonstrates that:
- Any differences in technological characteristics of the predicates do not raise any new questions of safety and effectiveness.
- The proposed devices are at least as safe and effective as the predicates.
It is concluded that the information included in this submission supports substantial equivalence.
(End of summary)