(42 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of a physical implant (anterior cervical plate system), with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical implant intended to provide temporary stabilization and fixation of the anterior cervical spine to aid in the development of cervical spine fusions for various medical conditions, indicating a direct therapeutic purpose.
No
The device is an anterior cervical plate system used for fixation and temporary stabilization of the spine, which is a therapeutic purpose, not diagnostic.
No
The device description clearly states it is a "cervical plate" and "bone screws," which are physical hardware components intended for surgical implantation. The performance studies also describe mechanical testing of these physical components.
No, 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, tissue) to detect diseases, conditions, or infections.
- Device Description: The ARENAL Anterior Cervical Plate System is a surgical implant designed for the mechanical fixation and stabilization of the cervical spine. It is physically implanted into the body.
- Intended Use: The intended use describes the device's purpose as providing structural support and stabilization during spinal fusion, not for analyzing biological samples.
The information provided clearly indicates this is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The ARENAL Anterior Cervical Plate System is intended for fixation and temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions with the following indications:
- Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
- Tumors
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- Pseudarthrosis
- Spondylolisthesis
- Spinal stenosis
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The ARENAL Anterior Cervical Plate System is interior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cervical spine (C2-T1)
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 following tests were performed in determining substantial equivalence of the ARENAL Anterior Cervical Plate:
-
Static compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
*Static Compression Bending Yield was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.
*Static Compression Bending Stiffness was in exceptance criteria listed in FDA Spinal Plating Systems quidance document. -
Dynamic compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
*Dynamic Compression Bending Runout Load @ 5M cycles was in excess of the acceptance criteria listed in FDA Spinal Plating Systems quidance document. -
Static torsion per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
*Static Torsion Yield was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.
*Static Torsion Stiffness was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
May 17, 2024
Image /page/0/Picture/1 description: The image shows 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.
EffortMed, LLC % J.D. Webb President The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven. Utah 84401
Re: K240935
Trade/Device Name: Arenal Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 3, 2024 Received: April 5, 2024
Dear J.D. Webb:
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.
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 (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 OS 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.
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-regulatoryassistance/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,
Colin
O'neill -S FDA
Colin O'Neill, MBE Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Arenal Anterior Cervical Plate System
Indications for Use (Describe)
The ARENAL Anterior Cervical Plate System is intended for fixation and temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions with the following indications:
-
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
Trauma (including fractures)
-
Tumors
-
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
-
Pseudarthrosis
-
Spondylolisthesis
-
Spinal stenosis
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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3
| 510(k) #: K240935 | 510(k) Summary | Prepared on: 2024-04-04 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | EffortMed, LLC | ||
| Applicant Address | 4766 NW 91st Way Coral Springs FL 33067 United States | ||
| Applicant Contact Telephone | 917-566-3479 | ||
| Applicant Contact | Mr. Steven Brown | ||
| Applicant Contact Email | sbrown@effortmed.com | ||
| Correspondent Name | The OrthoMedix Group, Inc. | ||
| Correspondent Address | 4313 W. 3800 S. West Haven UT 84401 United States | ||
| Correspondent Contact Telephone | 512-590-5810 | ||
| Correspondent Contact | Mr. J.D. Webb | ||
| Correspondent Contact Email | jdwebb@orthomedix.net | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Arenal Anterior Cervical Plate System | ||
| Common Name | Spinal intervertebral body fixation orthosis | ||
| Classification Name | Appliance, Fixation, Spinal Intervertebral Body | ||
| Regulation Number | 888.3060 | ||
| Product Code(s) | KWQ | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K162638 | CETRA™ Anterior Cervical Plate System | KWQ | |
| K211718 | Venus Cervical Plate System | KWQ | |
| Device Description Summary | 21 CER 807.92(a)(4) |
The ARENAL Anterior Cervical Plate System is interior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation.
Intended Use/Indications for Use
The ARENAL Anterior Cervical Plate System is intended for fixation and temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions in patients with the following indications:
21 CFR 807.92(a)(5)
4
- Degenerative Disc Disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies) - Trauma (including fractures)
- Tumors
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- Pseudarthrosis
- Spondylolisthesis
- Spinal stenosis
Indications for Use Comparison
The Arenal Anterior Cervical Plate System has the same Indications for Use as the predicate.
Technological Comparison
Indications for Use: no difference Materials: no difference Design/geometry: similar Dimensions: similar Operating Principle: no difference Sterility: no difference There are no substantial differences between the Arenal Anterior Cervical Plate System and
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following tests were performed in determining substantial equivalence of the ARENAL Anterior Cervical Plate:
-Static compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
*Static Compression Bending Yield was in exceptance criteria listed in FDA Spinal Plating Systems quidance document. *Static Compression Bending Stiffness was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.
-Dynamic compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
*Dynamic Compression Bending Runout Load @ 5M cycles was in excess of the acceptance criteria listed in FDA Spinal Plating Systems quidance document.
-Static torsion per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a
Vertebrectomy Model
*Static Torsion Yield was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.
*Static Torsion Stiffness was in exceptance criteria listed in FDA Spinal Plating Systems quidance document.
Not Applicable
The Arenal Anterior Cervical Plate System is substantially equivalent to the legally marketed device identified above.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)