(95 days)
No
The summary describes a mechanical fixation system for rib fractures and osteotomies, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is described as "intended for the fixation, and fusion of rib fractures and osteotomies," which are therapeutic interventions.
No
The device is described as a system for fixation and fusion of rib fractures and osteotomies, composed of titanium plates and screws. Its intended use is to provide rigid fixation, not to diagnose medical conditions.
No
The device description explicitly states it is composed of titanium plates and screws, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation, and fusion of rib fractures and osteotomies". This describes a surgical implant used to physically stabilize and repair bone, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details the materials (titanium plates and screws) and function (rigid fixation) of a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
The AdvantageRib Anterior System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The AdvantageRib Anterior System is composed of commercially pure titanium locking bone plates per ASTM F67 and titanium alloy locking and non-locking screws per ASTM F1472 that provide rigid fixation in instances of fractures and osteotomies in normal and osteoporotic bone. The implant and associated screws are provided to the end user in non-sterile packaging, in a variety of sizes and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rib fractures and osteotomies
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)
Performance was evaluated in accordance with ASTM F382, ASTM F543, and ASTM F2193. Engineering and geometric analysis was conducted to demonstrate substantial equivalence to the predicate device.
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.
Zimmer-Biomet Microfixation RibFix Blue Thoracic Fixation System (K142823 and K151173)
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.
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
Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
SIG Medical Corp. % Jennifer Palinchik President JALEX Medical, LLC 30331 Clemens Road, Suite #5D Westlake, Ohio 44145
November 16, 2018
Re: K182179
Trade/Device Name: AdvantageRib Anterior 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: October 22, 2018 Received: October 23, 2018
Dear Jennifer Palinchik:
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, 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
1
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.htm); 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,
| Jesse | Digitally signed
by Jesse Muir -S |
|---------|--------------------------------------|
| Muir -S | Date: 2018.11.16
16:49:56 -05'00' |
For. Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182179
Device Name AdvantageRib Anterior System
Indications for Use (Describe)
The AdvantageRib Anterior System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for SIGMEDICAL. The logo consists of a stylized image of a ribcage on the left, followed by the text "SIGMEDICAL" in a sans-serif font. The "SIG" portion of the text is in black, while the "MEDICAL" portion is in a light blue color. The logo appears to be for a medical company.
510(k) Summary
| Submitted By: | SIG Medical Corp.
238 E. Chocolate Ave. Suite 2
Hershey, PA 17033 |
|---------------------------|--------------------------------------------------------------------------------------------------|
| Date: | 10/22/2018 |
| Contact Person: | Jennifer Palinchik, President |
| Contact Telephone: | (440) 541-0060 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | AdvantageRib Anterior System |
| Common Names: | Plate, Fixation, Bone |
| | Screw, Fixation, Bone |
| Regulation Names: | Single/multiple component metallic bone fixation appliances and
accessories |
| | 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: | Zimmer-Biomet Microfixation RibFix Blue Thoracic Fixation
System (K142823 and K151173) |
| | The primary predicate device has never been subject to a recall. |
| | Reference Predicate Device: Synthes MatrixRIB Endo Thoracoscopic Rib Plating System
(K141241) |
Device Description:
The AdvantageRib Anterior System is composed of commercially pure titanium locking bone plates per ASTM F67 and titanium alloy locking and non-locking screws per ASTM F1472 that provide rigid fixation in instances of fractures and osteotomies in normal and osteoporotic bone. The implant and associated screws are provided to the end user in non-sterile packaging, in a variety of sizes and lengths.
Intended Use:
The AdvantageRib Anterior System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
4
Image /page/4/Picture/0 description: The image shows the logo for SIGMEDICAL. The logo consists of a stylized ribcage on the left, followed by the word "SIGMEDICAL" in a sans-serif font. The "SIG" portion of the word is in black, while the "MEDICAL" portion is in a lighter blue color.
Summary of Technological Characteristics:
The AdvantageRib Anterior System shares many similarities to the predicate device. These similarities include:
- . Intended use
- . Materials
- Design features ●
- Dimensions ●
- Function ●
- Surgical technique and labeling ●
Clinical and Non-Clinical Performance Data:
Clinical testing is not necessary to demonstrate substantial equivalence.
Performance was evaluated in accordance with ASTM F382, ASTM F543, and ASTM F2193. Engineering and geometric analysis was conducted to demonstrate substantial equivalence to the predicate device.
Conclusion:
Based on the intended use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence and does not raise additional questions of safety or effectiveness.