(88 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fusion system made of metal components. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is described as "intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion" and "to provide structural stability and mechanical support to the cervical spine following posterior cervical fusion" for various medical conditions, indicating a therapeutic purpose.
No
Explanation: This device is a surgical implant system designed for spinal fusion, providing immobilization and stabilization. It does not perform any diagnostic functions.
No
The device description explicitly states it consists of physical components like rods, pedicle screws, connectors, and instrumentation made from specific alloys and metals. It also details sterilization requirements for these physical components and describes mechanical performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The EUROPA™ Posterior Cervical Fusion System is described as a "posterior cervical screw system intended to provide structural stability and mechanical support to the cervical spine following posterior cervical fusion." It consists of implants (rods, screws, connectors) and instrumentation.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions. This involves surgically implanting the device into the patient's body.
The device is a surgical implant used to treat structural issues in the spine, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The EUROPA™ Posterior Cervical Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):
- · Traumatic spinal fractures and/or traumatic dislocations
- · Instability or deformity
- · Failed previous fusions (e.g. pseudarthrosis)
- · Tumors involving the cervical/thoracic spine
- · Degenerative disease, including intractable radiculopathy and/or myelopathy
- · Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
- · Degenerative disease of the facets with instability
The EUROPA™ Posterior Cervical Fusion System is also intended to restore the intearity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA™ Pedicle Screw System via the rod to rod connectors.
Product codes
NKG
Device Description
The EUROPA™ Posterior Cervical Fusion System is a posterior cervical screw system intended to provide structural stability and mechanical support to the cervical spine following posterior cervical fusion.
The EUROPA™ Posterior Cervical Fusion System consists of rods manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, pedicle screws and connectors manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136, and instrumentationmanufactured from Stainless Steel per ASTM F899. The EUROPA™ Posterior Cervical Fusion System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements.
The rods are provided sterile packed and are intended for single use only. The pedicle screws and connectors must be steam sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3)
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)
The mechanical performance profile of the EUROPA™ Posterior Cervical Fusion System was assessed through static and dynamic testing in accordance with the following test methods:
- · Static and dynamic compression bending testing (ASTM F1717-21)
- · Static torsion testing (ASTM F1717-21)
- · Axial gripping strength testing (ASTM F1798-21)
- · Axial torque gripping strength testing (ASTM F1798-21)
Performance data demonstrate that the EUROPA™ Posterior Cervical Fusion System is substantially equivalent to other legally marketed predicate systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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 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.
November 19, 2024
MiRus, LLC Anuradha Nagulapati Senior Regulatory Affairs Engineer 1755 W. Oak Parkway Suite 100 Marietta, Georgia 30062
Re: K242516
Trade/Device Name: EUROPA™ Posterior Cervical Fusion System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG Dated: August 23, 2024 Received: August 23, 2024
Dear Anuradha Nagulapati:
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/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.
1
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).
Your device is also subject to, among other requirements, the Quality System (QS) 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-device-safety/medical-device-reportingmdr-how-report-medical-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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/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/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
RYAN
TROMBETTA -S
For: Colin O'Neill, M.B.Ε.
Digitally signed by RYAN
TROMBETTA -S
Date: 2024.11.19 16:46:24
-05'00'
Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
EUROPA™ Posterior Cervical Fusion System
Indications for Use (Describe)
The EUROPA™ Posterior Cervical Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):
- · Traumatic spinal fractures and/or traumatic dislocations
- · Instability or deformity
- · Failed previous fusions (e.g. pseudarthrosis)
- · Tumors involving the cervical/thoracic spine
- · Degenerative disease, including intractable radiculopathy and/or myelopathy
- · Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
- · Degenerative disease of the facets with instability
The EUROPA™ Posterior Cervical Fusion System is also intended to restore the intearity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA™ Pedicle Screw System via the rod to rod connectors.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
)ver-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
Prepared on: 2024-11-15
Contact Details
21 CFR 807 92(a)(1)
21 CFR 807.92(a)(5)
| Applicant Name | MiRus, LLC | |||
|---|---|---|---|---|
| Applicant Address | 1755 W. Oak Parkway Suite 100 Marietta GA 30062 United States | |||
| Applicant Contact Telephone | 470-428-8684 | |||
| Applicant Contact | Ms. Anuradha Nagulapati | |||
| Applicant Contact Email | anagulapati@mirusmed.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | EUROPA™ Posterior Cervical Fusion System | |||
| Common Name | Posterior cervical screw system | |||
| Classification Name | Posterior Cervical Screw System | |||
| Regulation Number | 888.3075 | |||
| Product Code(s) | NKG | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K182508 | Saxxony™ Posterior Cervical Thoracic System | NKG | ||
| K180337 | EUROPA™ Pedicle Screw System | NKB | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The EUROPA™ Posterior Cervical Fusion System is a posterior cervical screw system intended to provide structural stability and | ||||
| mechanical support to the cervical spine following posterior cervical fusion. | ||||
| The EUROPA™ Posterior Cervical Fusion System consists of rods manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM | ||||
| F3273, pedicle screws and connectors manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136, and instrumentation | ||||
| manufactured from Stainless Steel per ASTM F899. The EUROPA™ Posterior Cervical Fusion System implants are offered in multiple | ||||
| configurations and different sizes to accommodate various patient anatomical requirements. |
The rods are provided sterile packed and are intended for single use only. The pedicle screws and connectors must be steam sterilized prior to use.
Intended Use/Indications for Use
The EUROPA™ Posterior Cervical Fusion System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):
- · Traumatic spinal fractures and/or traumatic dislocations
- · Instability or deformity
- · Failed previous fusions (e.g. pseudarthrosis)
5
· Tumors involving the cervical/thoracic spine
· Degenerative disease, including intractable radiculopathy and/or myelopathy
· Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
· Degenerative disease of the facets with instability
The EUROPA™ Posterior Cervical Fusion System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA ™ Pedicle Screw System via the rod to rod connectors.
Indications for Use Comparison
The indications for the use are identical for the subject device and predicate device.
Technological Comparison
The EUROPA™ Posterior Cervical Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate system, including the same design features, sizes, and materials. The predicate device components are manufactured from titanium alloy (ASTM F136) and cobalt chromium alloy (ASTM F1537). The EUROPA™ Posterior Cervical Fusion System components are manufactured from titanium alloy (ASTM F136) and molybdenum-rhenium alloy (ASTM F3273), which are the same materials as the reference device. Performance data demonstrate that the EUROPA™ Posterior Cervical Fusion System is substantially equivalent to other legally marketed predicate systems.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The mechanical performance profile of the EUROPA™ Posterior Cervical Fusion System was assessed through static and dynamic testing in accordance with the following test methods:
- · Static and dynamic compression bending testing (ASTM F1717-21)
- · Static torsion testing (ASTM F1717-21)
- · Axial gripping strength testing (ASTM F1798-21)
- · Axial torque gripping strength testing (ASTM F1798-21)
The EUROPA™ Posterior Cervical Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate system, including the same design features, sizes, and materials. The predicate device components are manufactured from titanium alloy (ASTM F136) and cobalt chromium alloy (ASTM F1537). The EUROPA™ Posterior Cervical Fusion System components are manufactured from titanium alloy (ASTM F136) and molybdenum-rhenium alloy (ASTM F3273), which are the same materials as the reference device. Performance data demonstrate that the EUROPA™ Posterior Cervical Fusion System is substantially equivalent to other legally marketed predicate systems.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)