(55 days)
Not Found
No
The summary describes a mechanical implant system (anterior cervical plate) and its associated instruments. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical strength equivalence.
Yes
The device is indicated for stabilization of the anterior cervical spine in cases of instability caused by trauma, fracture, deformity, pseudoarthrosis, tumors, or degenerative disk disease, which are therapeutic applications.
No
The device description and intended use indicate that the VyPlate™ Anterior Cervical Plate System is an implant used for stabilization of the cervical spine, not for diagnosing conditions.
No
The device description explicitly states that the VyPlate™ Anterior Cervical Plate System is comprised of implant, instrument, and tray components, which are physical hardware.
Based on the provided information, the VyPlate™ Anterior Cervical Plate System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "stabilization of the anterior cervical spine" in various clinical situations. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is described as comprising "implant, instrument, and tray components," with the implant components being "anterior cervical plates, cover plates, and bone screws." These are physical devices designed to be surgically implanted.
- 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. The VyPlate™ system is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The VyPlateIM Anterior Cervical Plate System is indication of the anterior cervical spine from C2 to C7 employing unicotical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
· instability caused by trauma or fracture;
· instability associated with correction of cervical lordosis and kyphosis deformity;
· instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
· instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
· instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The VyPlate™ Anterior Cervical Plate System is comprised of implant, instrument, and tray components. The implant components, the VyPlate™ device, consists of anterior cervical plates, cover plates, and bone screws. The implant components of the VyPlate™ Anterior Cervical Plate System are composed of Titanium alloy 6A1-4V as described in ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cervical spine from C2 to 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design information and finite element analysis were utilized to establish that the subject VyPlate™ Anterior Cervical Plates have substantially equivalent mechanical strength to the predicate Reliance Anterior Cervical Plate System (K122216, K140742).
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.
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
July 26, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Vy Spine, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee. Florida 32308
Re: K221572
Trade/Device Name: VyPlate™ 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: May 31, 2022 Received: June 1, 2022
Dear Jordan Hendrickson:
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K221572
Device Name
VyPlate™ Anterior Cervical Plate System
Indications for Use (Describe)
The VyPlateIM Anterior Cervical Plate System is indication of the anterior cervical spine from C2 to C7 employing unicotical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
· instability caused by trauma or fracture;
· instability associated with correction of cervical lordosis and kyphosis deformity;
· instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
· instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
· instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved 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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FORM FDA 3881 (8/14)
3
510(k) Summary
1 June 2022
Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 Telephone: 866-489-7746 Fax: 850-597-8571
Contact: Jordan Hendrickson Operations Manager
Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:
Anterior Cervical Plate VyPlate™ Anterior Cervical Plate System Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060 KWQ
Substantial Equivalence
The VyPlate™ Anterior Cervical Plate System is substantially equivalent to the primary predicate Reliance Anterior Cervical Plate System (K122216, K140742), in terms of material, intended use, levels of attachment, size range, and strength.
Device Description
The VyPlate™ Anterior Cervical Plate System is comprised of implant, instrument, and tray components. The implant components, the VyPlate™ device, consists of anterior cervical plates, cover plates, and bone screws. The implant components of the VyPlate™ Anterior Cervical Plate System are composed of Titanium alloy 6A1-4V as described in ASTM F-136.
Intended Use/Indications for Use
The VyPlate™ Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
- instability caused by trauma or fracture;
- instability associated with correction of cervical lordosis and kyphosis deformity; ●
- instability associated with pseudoarthosis as a result of previously failed cervical spine surgery:
- instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
- . instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Performance Data
4
Design information and finite element analysis were utilized to establish that the subject VyPlate™ Anterior Cervical Plates have substantially equivalent mechanical strength to the predicate Reliance Anterior Cervical Plate System (K122216, K140742).
Conclusions
The subject VyPlate™ 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 have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function.