(58 days)
Not Found
No
The summary describes a mechanical implant (plate and screws) for spinal fusion and the performance studies are mechanical tests. There is no mention of software, image processing, or AI/ML terms.
Yes
The device is described as an "aid in cervical spinal fusion" and is intended for "temporary stabilization of the anterior spine during the development of cervical spine fusions" for various conditions like degenerative disc disease, spinal stenosis, and trauma. This falls under the definition of a therapeutic device as it treats or alleviates a medical condition.
No
The device is described as an anterior cervical plate system intended for stabilization of the cervical spine during fusion, which is a treatment, not a diagnostic, function.
No
The device description explicitly states it consists of cervical plates and bone screws, which are physical hardware components made of Titanium alloy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior intervertebral screw fixation of the cervical spine at levels C2 to T1" and is used as an "aid in cervical spinal fusion." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like "cervical plates and bone screws" made of "Titanium alloy." These are physical implants, not reagents or instruments used to test samples outside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided describes a surgical implant used for spinal fixation, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
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 .
Product codes (comma separated list FDA assigned to the subject device)
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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical testing was performed to demonstrate the DeGen Medical Cyclops™ Anterior Cervical Plate System (CACP) is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following tests were performed:
Static and dynamic compression testing per ASTM F1717 Static torsion testing per ASTM F1717 Screw strength via ASTM F543 Push-out testing for Screws The results of these studies show the subject DeGen Medical Cyclops™ Anterior Cervical Plate System (CACP) meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
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.
K150759, K971883, K030866, K031276, K926453, K945700, K052292, K013877, K121658, K080646, K133518
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
August 30, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
DeGen Medical INC % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K191786
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: July 31, 2019 Received: August 1, 2019
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,
for RPJ
Ronald Jean, Ph.D. 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) K191786
Device Name
Cyclops™ Anterior Cervical Plate System
Indications for Use (Describe)
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 .
| Type of Use (Select one or both, as applicable) | |
|---|---|
X 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 features the logo for Degen Medical. The logo consists of a stylized graphic above the text "DEGEN MEDICAL". The graphic is composed of three curved lines that converge at a point on the left and terminate in circles on the right. The lines are blue, and the circles are solid blue. The text "DEGEN" is in a bold, sans-serif font, and "MEDICAL" is in a smaller, sans-serif font below it.
510(k) Summary of Safety and Effectiveness
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical Cyclops Anterior Cervical Plate (CACP) is provided below.
| Date | July 2, 2019 |
|---|---|
| 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 |
| Code -Classification | KWQ |
| 21 CFR 888.3060: Class II | |
| Primary Predicate | K150759 Hyper-C Anterior Cervical Plate System |
| Additional Predicates | K971883 Synthes Small Stature Anterior Cervical Locking Plate System |
| K030866, K031276, K926453, K945700 Synthes CSLP | |
| K052292 X-Spine Spider Cervical Plate | |
| K013877, K121658 Orthofix Hallmark Anterior Cervical Plate System | |
| K080646, K133518 Biomet Maxan 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. | |
| Indications for Use | 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 (CACP) 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 | Non-clinical testing was performed to demonstrate the DeGen Medical Cyclops™ |
| Anterior Cervical Plate System (CACP) is substantially equivalent to other predicate | |
| devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal | |
| System 510(k)s", May 3, 2004. The following tests were performed: | |
| Static and dynamic compression testing per ASTM F1717 Static torsion testing per ASTM F1717 Screw strength via ASTM F543 Push-out testing for Screws The results of these studies show the subject DeGen Medical Cyclops™ Anterior Cervical | |
| Plate System (CACP) meets or exceeds the performance of the predicate devices, and | |
| the device was therefore found to be substantially equivalent. | |
| 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. |
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Image /page/4/Picture/1 description: The image shows the logo for Degen Medical. The logo features a stylized blue graphic above the words "DEGEN" and "MEDICAL", which are stacked on top of each other. The graphic consists of three curved lines, each with a blue circle at the end, resembling a stylized representation of medical technology or innovation.