(24 days)
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
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
The provided document does not contain information regarding a study that proves a device meets acceptance criteria related to AI or algorithm performance.
Instead, this document is an FDA 510(k) clearance letter for a medical device called the "Cyclops™ Anterior Cervical Plate System." This system is described as an implantable device used for spinal fusion and stabilization in the cervical spine.
The document discusses:
- Device Name: Cyclops™ Anterior Cervical Plate System
- Regulation Number and Name: 21 CFR 888.3060, Spinal intervertebral body fixation orthosis
- Regulatory Class: Class II
- Indications for Use: Aid in cervical spinal fusion, temporary stabilization of the anterior spine for various conditions (Degenerative Disc Disease, Spinal Stenosis, Trauma, Deformity, Spinal Tumors, Pseudoarthrosis, Spondylolisthesis, Decompression).
- Substantial Equivalence: The clearance is based on the device being substantially equivalent to previously cleared predicate devices (K191786 Cyclops™ Anterior Cervical Plate System and K150759 DeGen Medical Hyper-C Anterior Cervical Plate System). The equivalence is established through comparison of design, intended use, material composition, function, and range of sizes.
- Non-Clinical Performance Testing: A risk review was conducted on existing verification and validation data for the Cyclops™ Anterior Cervical Plate System regarding the addition of two-level plates. The conclusion was that no impacts to safety or effectiveness would result.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/algorithm-based device as this document is for a physical implantable medical device, not a software or AI product.
The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are relevant for evaluating AI/ML-based medical devices, but not for the type of device described in this 510(k) summary.
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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
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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 DriveFlorence, SC 29501Phone 877-240-7838Fax 843-407-0545 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@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 |
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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 UseStatement | The DeGen Medical Cyclops™ Anterior Cervical Plate system is intended foruse as an aid in cervical spinal fusion and is intended for unilateral fixation.The Cyclops™ Anterior Cervical Plate system is intended for anteriorintervertebral screw fixation of the cervical spine at levels C2 to T1. Thesystem is indicated for temporary stabilization of the anterior spine during thedevelopment of cervical spine fusions in patients with following indications:Degenerative Disc Disease (as defined by neck pain of discogenicorigin with degeneration of the disc confirmed by patient history andradiographic 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 cervicalvertebrectomy |
|---|---|
| TechnologicalCharacteristics | As was established in this submission, the subject Cyclops™ AnteriorCervical Plate System is substantially equivalent to other predicate devicescleared by the FDA for commercial distribution in the United States. Thesubject device was shown to be substantially equivalent and has the sametechnological characteristics to its predicate devices through comparison inareas including design, intended use, material composition, function, andrange of sizes. |
| Non-ClinicalPerformanceTesting Conclusion | A risk review was conducted on existing verification and validation data forthe Cyclops™ Anterior Cervical Plate System regarding the additional two-levelplates. The results of this risk review indicated that there would be no impactsto safety or effectiveness of the system by including this device. |
| SubstantialEquivalenceSummary(Conclusion) | Based on the indications for use, technological characteristics, performancetesting, and comparison to predicate devices, the subject DeGen MedicalCyclops™ Anterior Cervical Plate System (CACP) has been shown to besubstantially equivalent to legally marketed predicate devices. |
§ 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.