(76 days)
Not Found
No
The device description and performance studies focus on mechanical fixation and sterilization, with no mention of AI/ML capabilities or data processing.
Yes
The device is intended for the fixation, stabilization, and fusion of rib fractures, which is a therapeutic intervention aimed at treating a medical condition.
No
The device description indicates that the AdvantageRib System is a surgical implant designed for the "fixation, stabilization, and fusion of rib fractures and osteotomies." It consists of bridges and caps used to physically repair ribs. There is no mention of it being used to gather information about a patient's health condition or make a diagnosis.
No
The device description clearly outlines physical implants (bridges, locking posts, and locking caps) made of titanium and titanium alloys, which are hardware components. The performance studies also focus on the mechanical properties and sterilization of these physical implants.
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 "bridges," "locking posts," and "locking caps" made of titanium. These are implants designed to be surgically placed within the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnostic purposes. The AdvantageRib System is a surgical implant used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Product codes
HRS, HWC
Device Description
The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys (Ti-6Al-7N per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:
- Titanium alloy AdvantageRib Bridge with threaded locking posts
- Commercially pure locking caps
When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ribs
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
Non-Clinical Testing:
The AdvantageRib System is identical in geometry and manufacturing process to the predicate device. Dynamic and static testing was performed on the bridge, locking post, locking cap construct demonstrating that neither the material or dimensional changes introduced a new worst case. Sterilization validation was performed on the subject device per ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices to establish SAL of 10-6.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 14, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SIG Medical Corporation % Lauren Smith Project Engineer JALEX Medical, LLC. 30311 Clemens Road, Suite #5D Westlake, Ohio 44145
Re: K183317
Trade/Device Name: AdvantageRib 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 Dated: January 14, 2019 Received: January 15, 2019
Dear Lauren Smith:
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 mav, 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 avare 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, 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
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.
Shumaya Ali -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
510(k) Number (if known)
Device Name AdvantageRib System
Indications for Use (Describe)
The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for SIGMEDICAL. The logo consists of a stylized ribcage on the left, followed by the text "SIG" in black and "MEDICAL" in a light blue color. The ribcage graphic is a simplified representation of the human ribcage, with the sternum and ribs clearly visible.
510(k) Summary
| Submitted For: | SIG Medical Corp.
238 E. Chocolate Ave. Suite 2
Hershey, PA 17033 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 02/14/2019 |
| Contact Person: | Lauren Smith, Project Engineer, JALEX Medical |
| Contact Telephone: | (440) 541-0060 |
| Contact Fax: | (440) 933-7839 |
| Contact Address: | 30311 Clemens Rd. Suite 5D, Westlake, OH 44145 |
| Device Trade Name: | AdvantageRib System |
| Common Names: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Regulation Names: | Single/multiple component metallic bone fixation appliances and
accessories and Smooth or threaded metallic bone fixation fastener |
| Regulation Numbers: | 21 CFR 888.3030, 21 CFR 888.3040 |
| Regulatory Class: | Class II |
| Product Codes: | HRS, HWC |
| Reviewing Panel: | Orthopedic |
| Primary Predicate Device: | MatrixRIB Endo Thorascopic Rib Plating System (K141241) |
Device Description:
The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys (Ti-6Al-7N per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:
- Titanium alloy AdvantageRib Bridge with threaded locking posts ●
- . Commercially pure locking caps
When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.
Indications for Use:
The AdvantageRib System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Substantial Equivalence:
The AdvantageRib System has the same intended use, indications for use, principles of operation, and technological characteristics of the predicate. The modifications are not being made as a corrective action for any quality or compliance issues with the predicate version. Modifications summarized in the following table do not raise new questions of safety or effectiveness. Therefore, the AdvantageRib System is substantially equivalent to the predicate.
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Image /page/4/Picture/0 description: The image contains the logo for SIGMEDICAL. The logo features a stylized image of a ribcage on the left. To the right of the ribcage is the text "SIGMEDICAL" in a sans-serif font, with "SIG" in black and "MEDICAL" in a light blue color.
| Item | Modified
AdvantageRib System | MatrixRIB Endo
Thorascopic Rib Plating
System | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HRS, HWC | HRS, HWC | Same |
| Classification
Name | Plate, fixation, bone and
Screw, fixation, bone | Plate, fixation, bone and
Screw, fixation, bone | Same |
| Class | II | II | Same |
| Indications
for Use | The AdvantageRib
System is intended for
the fixation,
stabilization, and fusion
of rib fractures and
osteotomies of normal
and osteoporotic bone. | The Synthes Matrix Rib
Fixation System is
indicated for the fixation
and stabilization of rib
fractures, fusions and
osteotomies of normal and
osteoporotic bone. | Same |
| Materials | Bridge (plate) and
locking posts: Ti-6Al-
7N per ASTM F1295,
Ti-6Al-4V per ASTM
F136, Ti-6Al-4V per
ASTM F1472
Locking cap and
washer: Commercially
Pure Titanium Grade 4
per ASTM F67 | Plate and locking posts:
Ti-6Al-7N per ASTM
F1295
Locking cap:
Commercially Pure
Titanium Grade 4 per
ASTM F67 | The modified
AdvantageRib System
includes the option of
manufacturing the
bridges (plates) and
locking posts from Ti-
6Al-4V per ASTM
F136 or Ti-6Al-4V per
ASTM F1472. |
| Design
Features | Optional washer
Increased lengths of
locking posts and
locking caps with
internal X-drive feature. | No washer included
Locking caps with
external hex drive feature. | Optional washer
distributes the load of
tightening the locking
posts in poor bone
quality.
Increased length of
locking posts allows
for increased thread
engagement. Locking
cap modified drive
feature minimizes soft
tissue obstruction. |
| Sterilization | Steam Sterilization (All
implants and
instruments) | Gamma radiation (plates
and locking posts), Steam
sterilization (locking caps
and instruments) | All implants can be
steam sterilized and
provided non-sterile. |
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Image /page/5/Picture/0 description: The image contains the logo for SIGMEDICAL. To the left of the company name is a grey image of a ribcage. The company name is in all caps, with SIG in black and MEDICAL in a light blue color.
Non-Clinical Testing:
The AdvantageRib System is identical in geometry and manufacturing process to the predicate device. Dynamic and static testing was performed on the bridge, locking post, locking cap construct demonstrating that neither the material or dimensional changes introduced a new worst case. Sterilization validation was performed on the subject device per ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices to establish SAL of 10-6.
Conclusion:
The conclusions drawn from the nonclinical testing demonstrates that the device is as safe and as effective as the identified predicate.