(59 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant (cervical plate system) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended for screw fixation to the cervical spine for conditions like degenerative disc disease, trauma, tumors, and deformity, which are all therapeutic interventions for medical conditions.
No
Explanation: The device is an anterior cervical plate system intended for surgical fixation of the cervical spine. Its purpose is to physically stabilize the spine, not to identify or determine the presence of a disease or condition.
No
The device description clearly states it consists of physical components made of Titanium Alloy (plates and screws) intended for surgical implantation. It is a hardware device, not software.
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 intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The EMERGE™ Anterior Cervical Plate System is a surgical implant designed for anterior screw fixation to the cervical spine. It is a physical device used within the body to provide structural support and stability.
- Lack of In Vitro Testing: The description of performance studies mentions mechanical testing (static compression, static torsion, dynamic compression) on the device itself, not testing of human specimens.
- No Mention of Specimen Analysis: The intended use and device description do not involve the analysis of blood, tissue, or any other human specimen.
Therefore, the EMERGE™ Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis or scoliosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Product codes
KWQ
Device Description
The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate a variety of spinal levels based on surgical need and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle or variable angle screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
cervical spine (C2-C7)
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
Testing on the EMERGE™ Anterior Cervical Plate System included static compression, static torsion, and dynamic compression per ASTM F1717. The results demonstrate that the EMERGE™ Anterior Cervical Plate is substantially equivalent to the performance criteria identified in Spinal Plating Systems -Performance Criteria for Safety and Performance Based Pathway Guidance document; FDA-2019-D-1647.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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September 30, 2021
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 seal of the Department of Health and Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Evolution Spine Todd Wallenstein VP Regulatory/Quality 2300 N. Haskell Ave Dallas, Texas 75204
Re: K212405
Trade/Device Name: EMERGE™ 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: July 30, 2021 Received: August 2, 2021
Dear Todd Wallenstein:
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/cdrl/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 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 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 (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 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/cdrl-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.
for
Colin O'Neill, M.B.E. 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
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Indications for Use
510(k) Number (if known) K212405
Device Name EMERGETM Anterior Cervical Plate System
Indications for Use (Describe)
The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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) Summa
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
| Company: | Evolution Spine
2300 N Haskell Rd
Dallas, TX 75204 |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Todd Wallenstein
Evolution Spine
2300 N Haskell Ave
Dallas, TX 75204
Phone: 571-594-7409
twallenstein@evolutionspine.com |
| Date Prepared: | July 30, 2021 |
| Device Trade Name:
Common Name:
Classification:
Class:
Product Code: | EMERGE™ Anterior Cervical Plate System
Anterior Cervical Plate System
21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosi
II
KWQ |
| Primary Predicate:
Additional Predicate: | Evolution Spine Anterior Cervical Plate System (K173375)
None |
Device Description:
The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate a variety of spinal levels based on surgical need and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle or variable angle screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws.
Indications For Use:
The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis or scoliosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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Substantial Equivalence:
The subject EMERGE™ Anterior Cervical Plate System has been demonstrated to be substantially equivalent with respect to indications, design, materials, function, manufacturing, and/or performance as compared to the predicate devices and as identified in Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway Guidance document; FDA-2019-D-1647.
Performance Data:
Testing on the EMERGE™ Anterior Cervical Plate System included static compression, static torsion, and dynamic compression per ASTM F1717. The results demonstrate that the EMERGE™ Anterior Cervical Plate is substantially equivalent to the performance criteria identified in Spinal Plating Systems -Performance Criteria for Safety and Performance Based Pathway Guidance document; FDA-2019-D-1647.
Conclusion:
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject EMERGE™ Anterior Cervical Plate System has been shown to be substantially equivalent to legally marketed predicate devices.