(24 days)
Not Found
No
The document describes a mechanical implant (cervical plate system) and does not mention any software, algorithms, or AI/ML capabilities. The submission is for adding new plate lengths to an existing system.
No
The device is a medical implant intended for mechanical stabilization of the cervical spine, aiding in fusion, and is not designed to directly treat or cure a disease or condition, which is characteristic of a therapeutic device.
No
Explanation: The device description and intended use clearly state that the Cyclop™ Anterior Cervical Plate System is an implant designed for spinal fusion and stabilization. It does not mention any function related to identifying, analyzing, or diagnosing medical conditions.
No
The device description explicitly states that the system consists of cervical plates and bone screws, which are physical hardware components made of Titanium alloy. The submission is for adding additional plate lengths, further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant used for stabilizing the cervical spine during fusion procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details plates and screws made of titanium alloy, designed for physical fixation of vertebrae. This aligns with a surgical implant, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, tissue, etc.) to provide information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The DeGen Medical Cyclop™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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)
- · Spinal Stenosis
- · Trauma (i.e. fracture or dislocation)
- · Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
- Spinal Tumors
- Pseudoarthrosis or failed previous fusion
- · Spondylolisthesis
- · Decompression of the spinal following total or partial cervical vertebrectomy
Product codes
KWQ
Device Description
The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The purpose of this submission is to add additional two-level plate lengths to the Cyclops™ Anterior Cervical Plate System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine at levels C2 to 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)
A risk review was conducted on existing verification and validation data for the Cyclops™ Anterior Cervical Plate System regarding the additional two-level plates. The results of this risk review indicated that there would be no impacts to safety or effectiveness of the system by including this device.
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
§ 888.3060 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
January 7, 2022
DeGen Medical % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K213901
Trade/Device Name: CyclopsTM 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: December 13, 2021 Received: December 14, 2021
Dear Linda Braddon:
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
1
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 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 mediation-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, 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) K213901
Device Name Cyclops™ Anterior Cervical Plate System
Indications for Use (Describe)
The DeGen Medical Cyclop™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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)
- · Spinal Stenosis
- · Trauma (i.e. fracture or dislocation)
- · Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
- Spinal Tumors
- Pseudoarthrosis or failed previous fusion
- · Spondylolisthesis
- · Decompression of the spinal following total or partial cervical vertebrectomy
| 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 DeGen Medical. The logo features three curved lines emanating from a point, each ending in a blue circle. The lines are also blue and appear to be thicker in the middle. Below the graphic is the text "DeGen" in a larger, bolder blue font, with the word "Medical" underneath in a smaller, gray font.
510(k) SUMMARY: Cyclops™ Anterior Cervical Plate System
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
| Date Prepared | December 13, 2021 |
|---|---|
| Sponsor | DeGen Medical, Inc. |
| 1321-C North Cashua Drive | |
| Florence, SC 29501 | |
| Phone 877-240-7838 | |
| Fax 843-407-0545 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | Cyclops™ Anterior Cervical Plate System |
| Common Name | Spinal intervertebral body fixation orthosis |
| Product Code | KWQ |
| Classification | 21 CFR 888.3060, Class II |
| Primary Predicate | K191786 Cyclops™ Anterior Cervical Plate System |
| Additional Predicate | K150759 DeGen Medical Hyper-C Anterior Cervical Plate System |
| Device Description | The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. |
The purpose of this submission is to add additional two-level plate lengths to the Cyclops™ Anterior Cervical Plate System |
4
Image /page/4/Picture/1 description: The image shows the logo for DeGen Medical. The logo features three curved lines emanating from three blue circles at the top, resembling a stylized representation of motion or technology. Below the graphic is the text "DeGen" in a bold, blue font, with the word "Medical" in a smaller, gray font underneath.
| Indications for Use
Statement | The DeGen Medical Cyclops™ Anterior Cervical Plate system is intended for
use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The Cyclops™ Anterior Cervical Plate system is intended for anterior
intervertebral screw fixation of the cervical spine at levels C2 to T1. The
system is indicated for temporary stabilization of the anterior spine during the
development of cervical spine fusions in patients with 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) Spinal Stenosis Trauma (i.e., fracture or dislocation) Deformity or curvatures (including scoliosis, kyphosis, or lordosis) Spinal Tumors Pseudoarthrosis or failed previous fusion Spondylolisthesis Decompression of the spinal following total or partial cervical
vertebrectomy |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | As was established in this submission, the subject Cyclops™ Anterior
Cervical Plate System is substantially equivalent to other predicate devices
cleared by the FDA for commercial distribution in the United States. The
subject device was shown to be substantially equivalent and has the same
technological characteristics to its predicate devices through comparison in
areas including design, intended use, material composition, function, and
range of sizes. |
| Non-Clinical
Performance
Testing Conclusion | A risk review was conducted on existing verification and validation data for
the Cyclops™ Anterior Cervical Plate System regarding the additional two-level
plates. The results of this risk review indicated that there would be no impacts
to safety or effectiveness of the system by including this device. |
| Substantial
Equivalence
Summary
(Conclusion) | Based on the indications for use, technological characteristics, performance
testing, and comparison to predicate devices, the subject DeGen Medical
Cyclops™ Anterior Cervical Plate System (CACP) has been shown to be
substantially equivalent to legally marketed predicate devices. |