(104 days)
No
The device description and performance studies focus on mechanical properties and usability of physical components (plates, anchors, sutures). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
This device is intended for the fixation and fusion of rib fractures and osteotomies, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is described as a fixation system for rib fractures and osteotomies, utilizing plates and anchors to secure bone. Its intended use is described as "fixation, and fusion," which are therapeutic actions, not diagnostic ones. There is no mention of it being used to identify, detect, or monitor conditions.
No
The device description explicitly states it is comprised of titanium bone plates, suture anchors, washers, and buttons, which are all physical hardware components. The performance studies also focus on mechanical testing of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation, and fusion of rib fractures and osteotomies." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "titanium bone plates that are secured to bone by a deplovable ultra-high molecular weight polyethylene (UHMWPE) suture anchor with a titanium washer and button." This is a physical implant used to stabilize bone.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
The information provided describes a surgical implant used for internal fixation of bone, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RibFix Titan™ Fixation System is indicated 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, HTN
Device Description
The Riverpoint Medical RibFix Titan Fixation System is comprised of titanium bone plates that are secured to bone by a deplovable ultra-high molecular weight polyethylene (UHMWPE) suture anchor with a titanium washer and button. Bone plates are provided in configurations for intrathoracic and extrathoracic use. Intrathoracic bone plates are provided in 60mm and 94mm lengths. Extrathoracic bone plates are provided in 60mm, 94mm, and 120mm lengths.
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 mechanical testing was performed to verify the fixation strength of the RibFix Titan Fixation System and is compared to the predicate device. Testing conducted includes the following:
- Four-point bend testing (static and fatique) of bone plate components per ASTM F382 Standard Specification and Test Method for Metallic Bone Plates.
- Cyclic and Ultimate Tensile Strength (UTS) testing of anchor constructs.
- Cyclic fatique testing of assembled constructs using ASTM F1717 as a quide.
- Usability engineering validation with simulated use in cadaver lab performed per EN62366-1.
- MR Compatibility testing per ASTM F2052. ASTM F2213. ASTM F2119. ASTM F2182.
In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RibFix Titan Fixation System performed as intended.
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.
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
August 19, 2024
Riverpoint Medical Paul Vagts Sr. Regulatory Associate III 825 NE 25th Ave Portland, Oregon 97232
Re: K241282
Trade/Device Name: RibFix Titan™ Fixation 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. HTN Dated: May 16, 2024 Received: July 19, 2024
Dear Paul Vagts:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements. the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4. Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/cdrh-learn). 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher Ferreira -S
Christopher Ferreira Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
RibFix Titan™ Fixation System
Indications for Use (Describe)
The RibFix Titan Fixation System is indicated 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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510(k) SUMMARY RibFix Titan Fixation System K241282
Submitter Information
| Submitter's Name: | Riverpoint Medical |
|---|---|
| Address: | 825 NE 25th Ave. |
| Portland, OR 97232 | |
| Phone Number: | (503) 517-8001 or (971) 288-1083 |
| Fax Number: | (503) 517-8002 |
| Registration Number: | 3006981798 |
| Contact Person: | Paul Vagts |
| (503) 517-8001 | |
| Date of Preparation: | August 19th, 2024 |
| Device Name | |
| Trade Name: | RibFix Titan Fixation System |
| Common or Usual Names: | Thoracic fixation system |
| Primary Device Classification | |
| Product Code: | HRS |
| FDA Class: | 2 |
| Regulation Number: | 888.3030: Single/multiple component metallic bone |
| fixation appliances and accessories | |
| Additional Device Classification | |
| Product Code: | HTN |
| FDA Class: | 2 |
| Regulation Number: | 888.3030: Single/multiple component metallic bone |
fixation appliances and accessories
Primary Predicate Device
K203474 – Biomet Microfixation RibFix Advantage System
Additional Predicate Device
K212608 – RibFix Blu Thoracic Fixation System
Reference Devices
K203740 – JuggerKnot Soft Anchor
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Image /page/4/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters "RP" in a green rounded square, followed by the word "RIVERPOINT" in green, sans-serif font. The logo is simple and modern, and the green color suggests a connection to nature or the environment.
Device Description
The Riverpoint Medical RibFix Titan Fixation System is comprised of titanium bone plates that are secured to bone by a deplovable ultra-high molecular weight polyethylene (UHMWPE) suture anchor with a titanium washer and button. Bone plates are provided in configurations for intrathoracic and extrathoracic use. Intrathoracic bone plates are provided in 60mm and 94mm lengths. Extrathoracic bone plates are provided in 60mm, 94mm, and 120mm lengths.
Intended Use / Indications for Use
The RibFix Titan Fixation System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Performance Data
Non-clinical mechanical testing was performed to verify the fixation strength of the RibFix Titan Fixation System and is compared to the predicate device. Testing conducted includes the following:
- Four-point bend testing (static and fatique) of bone plate components per ASTM . F382 Standard Specification and Test Method for Metallic Bone Plates.
- . Cyclic and Ultimate Tensile Strength (UTS) testing of anchor constructs.
- . Cyclic fatique testing of assembled constructs using ASTM F1717 as a quide.
- . Usability engineering validation with simulated use in cadaver lab performed per EN62366-1.
- MR Compatibility testing per ASTM F2052. ASTM F2213. ASTM F2119. ASTM . F2182.
In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RibFix Titan Fixation System performed as intended.
Comparison of Technical Characteristics
The main difference in technical characteristics of the existing RibFix devices is that the proposed RibFix Titan uses suture for fixation of fracture plate to bone whereas the existing devices use screws or threaded rods. The design of the RibFix Titan bone plates is similar to that of the predicate device.
The RibFix Titan and the JuggerKnot Soft Anchor reference device are sterilized using the same processes, are composed of the same materials, and are tested per comparable performance requirements. The minor differences in technical characteristics between the RibFix Titan and predicate RibFix devices are limited to:
-
the subject device is provided with the adjustable suture anchor to attach the bone plate to rib whereas the predicate RibFix devices use bone screws or threaded rods, and
-
the subject device can be used intrathoracically or extrathoracically whereas the predicate RibFix Advantage System can only be used intrathoracically, and the predicate RibFix Blu System can only be used extrathoracically.
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However. Riverpoint Medical believes these minor differences do not raise any new questions of safety or effectiveness and they were designed to provide better versatility with an improved/simplified user interface. A usability engineering study was performed to evaluate the performance of the proposed RibFix Titan device. In addition, bench testing was performed under simulated clinical conditions in order to evaluate the intended use listed in the elFU for worst case RibFix Titan product configurations. Results of the usability study and performance testing of the RibFix Titan support the use of the RibFix Titan Fixation System and eIFU.
Substantial Equivalence
The RibFix Titan Fixation System has the same intended use and indications for use, similar principles of operation, and similar technical characteristics as the predicate device. The information provided in this Traditional 510(k) demonstrates the (1) any differences in technological characteristics of the predicates do not raise any new questions of safety and effectiveness and (2) the proposed device is at least as safe and as effective as the predicate and reference devices. Therefore, the Riverpoint Medical RibFix Titan Fixation System is substantially equivalent to the predicate device.