(56 days)
No
The summary describes a mechanical implant (plate and screws) for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is used for temporary stabilization of the anterior spine during the development of cervical spinal fusions, addressing conditions like degenerative disc disease, trauma, and tumors. Its purpose is to treat or alleviate a medical condition, which aligns with the definition of a therapeutic device.
No
Explanation: This device is described as an anterior screw fixation system for the cervical spine, used as an adjunct to fusion. Its purpose is to provide temporary stabilization and fixation, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components like plates and screws, indicating it is a hardware-based medical device for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the cervical spine during fusion. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details physical components like plates and screws, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
No
The provided clearance letter does not contain any information indicating that this device is authorized under a Predetermined Change Control Plan (PCCP). The section "Predetermined Change Control Plan (PCCP) - All Relevant Information" specifically states "Not Found".
Intended Use / Indications for Use
The Xenco Medical Multilevel CerviKit is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.
Product codes
KWQ
Device Description
The Xenco Medical Multilevel CerviKit is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with bone screws using an anterior approach. Plates are available in a variety of lengths addressing multiple levels of fixation. The Xenco Medical Multilevel CerviKit plate incorporates graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
Indicated Patient Age Range
skeletally mature patients
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
Non-clinical Test Summary: The following analyses were conducted:
• Static and dynamic compression testing per ASTM F1717
• Static torsion testing per ASTM F1717
• Push-out testing for screws
The results of these evaluations indicate that the Xenco Medical Multilevel CerviKit is equivalent to the predicate devices.
Clinical Test Summary: No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
December 21, 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 Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Xenco Medical, LLC % Linda Braddon, PhD President / CEO Secure BioMed Evaluations 7828 Hickory Flat Hwy, Suite 120 Woodstock. Georgia 30188
Re: K213456
Trade/Device Name: Xenco Medical Multilevel CerviKit Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 25, 2021 Received: October 26, 2021
Dear Dr. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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
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
2
Indications for Use
510(k) Number (if known)
K213456
Device Name Xenco Medical Multilevel CerviKit
Indications for Use (Describe)
The Xenco Medical Multilevel CerviKit is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) 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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Image /page/3/Picture/0 description: The image is a logo for Xenco Medical. The logo is a green hexagon with the letters "Xm" in white. The word "Xenco" is stacked on top of the word "Medical". The hexagon is made up of smaller triangles of different shades of green.
510(k) Summary: Xenco Medical Multilevel CerviKit
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
Date Prepared | December 20, 2021 |
---|---|
Submitted By | Xenco Medical, LLC |
9930 Mesa Rim Rd | |
San Diego, CA 92121 | |
858-202-1505 | |
email: sales@xencomedical.com | |
Contact | Secure BioMed Evaluations |
7828 Hickory Flat Hwy, Suite 120 | |
Woodstock, GA 30188 | |
770-837-2681 | |
Contact: Linda Braddon | |
e-mail: Regulatory@SecureBME.com | |
Trade Name | Xenco Medical Multilevel CerviKit |
Common Name | Anterior Cervical Plate |
Classification Name | Spinal intervertebral body fixation orthosis |
Class | II |
Product Code | KWQ |
CFR Section | 21 CFR section 888.3060 |
Device Panel | Orthopedic |
Primary Predicate | |
Device | K160702 Astura Medical ZION Anterior Cervical Fixation System |
Additional Predicate | |
Device | K080646 Biomet C-TekV MaxAnrm Anterior Cervical Plate |
Reference Devices | K160313 Xenco Medical Cervical Interbody System |
K191074 Xenco Medical Sorrento Bone Graft Substitute | |
Device Description | The Xenco Medical Multilevel CerviKit is intended for anterior screw |
fixation of the plate to the cervical spine. The fixation construct consists | |
of a cervical plate that is attached to the vertebral body of the cervical | |
spine with bone screws using an anterior approach. Plates are available | |
in a variety of lengths addressing multiple levels of fixation. The Xenco | |
Medical Multilevel CerviKit plate incorporates graft windows on the | |
longitudinal center line for intraoperative visualization and for screw | |
fixation of bone graft. Fixed or variable bone screws are available in two | |
diameters and a variety of lengths. | |
Materials | Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 |
Substantial | |
Equivalence Claimed | |
to Predicate Devices | The Xenco Medical Multilevel CerviKit is substantially equivalent to the |
predicate devices in terms of intended use, design, materials used, and | |
mechanical performance. | |
Indications for Use | The Xenco Medical Multilevel CerviKit is intended for anterior screw |
fixation to the cervical spine. It is to be used in skeletally mature patients | |
as an adjunct to fusion of the cervical spine (C2 to T1). The system is | |
indicated for use in the temporary stabilization of the anterior spine during | |
the development of cervical spinal fusions in patients with: 1) degenerative | |
disc disease (as defined by neck pain of discogenic origin with | |
degeneration of the disc confirmed by patient history and radiographic | |
studies), 2) spondylolisthesis, 3) trauma (including fractures or | |
dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or | |
scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal | |
stenosis. | |
Non-clinical Test | |
Summary | The following analyses were conducted: |
• Static and dynamic compression testing per ASTM F1717 | |
• Static torsion testing per ASTM F1717 | |
• Push-out testing for screws | |
The results of these evaluations indicate that the Xenco Medical Multilevel | |
CerviKit is equivalent to the predicate devices. | |
Clinical Test | |
Summary | No clinical studies were performed |
Conclusions: Non- | |
clinical and Clinical | Xenco Medical considers the Multilevel CerviKit to be substantially |
equivalent to the predicate devices listed above. This conclusion is | |
based upon the devices' similarities in principles of operation, | |
technology, materials, and indications for use. |
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Image /page/4/Picture/0 description: The image is a logo for Xenco Medical. The logo is a green hexagon with the text "Xenco Medical" written in white. The "X" is larger than the rest of the text. The hexagon is made up of smaller triangles of varying shades of green.