(68 days)
No
The document describes a spinal implant system and its components, focusing on materials, configurations, and intended use for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies section also indicates no new testing was performed, relying on predicate device data, which further suggests the absence of new, potentially AI/ML-driven features.
Yes
The device is described as an implantable system (VySpan™ PCT System) composed of various components (screws, rods, hooks, connectors) made of Titanium alloy or Cobalt Chrome. Its stated "Intended Use / Indications for Use" directly references the promotion of fusion in the cervical and cervicothoracic spine for conditions like neck pain, spondylolisthesis, spinal stenosis, fracture/dislocation, revision surgery, and tumors. These are all therapeutic applications aimed at treating medical conditions and restoring physiological function.
No
The provided text describes the VySpan™ PCT System as an implant and instrument system used to promote fusion and provide stabilization in the spine, not to diagnose medical conditions.
No
The device description explicitly states that the VySpan™ PCT System is comprised of implant and instrument components made from Titanium alloy or Cobalt Chrome, which are physical hardware components.
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 system used to promote fusion and provide stabilization in the cervical and cervicothoracic spine. This is a therapeutic device used in vivo (within the body).
- Device Description: The device is described as being comprised of implant and instrument components made from Titanium alloy or Cobalt Chrome. These are physical implants and surgical tools, not reagents or instruments used to test biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The VySpan™ PCT System, which is used to promote fusion of the cervicothoracic (C1-T3), and is indicated for the following:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-torod connectors.
Product codes
NKG, KWP
Device Description
The VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachments with a set screw and The VySpan™ pedicle screw component is offered in both poly-axial and mono-axial rod. configuration. In addition to these components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. All of the components discussed above are fabricated from Titanium alloy, or Cobalt Chrome, and should not be used with implants of different materials. The purpose of this submission is to add additional connectors and rods to the VySpan™ PCT System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervicothoracic (C1-T3), upper thoracic spine (T1-T3)
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)
Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing has been performed on the subject VySpan™ PCT System. The subject VySpan™ PCT System has the same design, sizes, indication of use & biocompatibility as the predicate devices.
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
September 27, 2023
Image /page/0/Picture/1 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".
Vy Spine, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee. Florida 32308
Re: K232167
Trade/Device Name: VySpan™ PCT System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: August 29, 2023 Received: August 29, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S". The text is arranged vertically, with "Colin" on the top line, "O'neill" on the second line, and "-S" on the third line. The text is in a simple, sans-serif font and is black in color. There is a faint FDA logo in the background.
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
2
Indications for Use
510(k) Number (if known) K232167
Device Name VySpan™ PCT System
Indications for Use (Describe)
The VySpan™ PCT System, which is used to promote fusion of the cervicothoracic (C1-T3), and is indicated for the following:
· ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
· Spondylolisthesis
· Spinal stenosis
· Fracture/dislocation
· Revision of previous cervical spine surgery
• Tumors
The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-torod connectors.
| 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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K232167 Page 1 of 2
510(k) Summary
22 July 2023
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:
Spinal Fixation Device VySpan™ PCT System Posterior cervical screw system (per 21 CFR 888.3075) NKG, KWP
Product Code:
Substantial Equivalence
The VySpan™ PCT System is substantially equivalent to the primary predicate VySpan™ PCT System (K223852) in terms of material, intended use, levels of attachment, size range, and strength.
Device Description
The VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachments with a set screw and The VySpan™ pedicle screw component is offered in both poly-axial and mono-axial rod. configuration. In addition to these components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. All of the components discussed above are fabricated from Titanium alloy, or Cobalt Chrome, and should not be used with implants of different materials. The purpose of this submission is to add additional connectors and rods to the VySpan™ PCT System.
Intended Use/Indications for Use
The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and is indicated for the following:
· ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- · Spinal stenosis
- Fracture/dislocation
- · Revision of previous cervical spine surgery
- Tumors
The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Hooks and Rods
4
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-to-rod connectors.
Performance Data and Substantial Equivalence
Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing has been performed on the subject VySpan™ PCT System. The subject VySpan™ PCT System has the same design, sizes, indication of use & biocompatibility as the predicate devices.
Technological Modifications
The subject VySpan™ PCT System has the same material, design, sizes, indication of use & biocompatibility as the predicate devices. Additional connector and rod components are being added to the VySpan™ PCT System.
Technological Characteristics
The subject VySpan™ PCT 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. This device does not contain software or electrical equipment.