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: 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.

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 rod. The VySpan™ pedicle screw component is offered in both poly-axial and mono-axial configuration. In addition to these components, there are also ancillary components such as hooks, connectors, crosslinks, and lateral offset connectors. All of the components discussed above are fabricated from Titanium alloy and should not be used with implants of different materials. The purpose of this submission is to add additional connectors to the VySpan™ PCT System.

AI/ML Overview

The provided text is a 510(k) summary for the VySpan™ PCT System, which is a spinal fixation device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for a diagnostic or AI-based medical device.

Therefore, many of the requested points, such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.

The document states that "Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing was performed on the subject VySpan™ PCT System." This indicates that the device's substantial equivalence is based on its similarity to a predicate device and not on new, specific performance studies directly demonstrating its efficacy against defined acceptance criteria.

Here's an attempt to address the applicable points based on the provided text:

1. Table of acceptance criteria and the reported device performance

Not applicable. The document states "no new performance testing was performed on the subject VySpan™ PCT System." The basis for clearance is substantial equivalence to a predicate device in terms of material, intended use, levels of attachment, size range, and strength.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No new performance testing was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established for a test set as no new performance testing was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical spinal fixation system, not an AI-based diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical spinal fixation system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth was established as no new performance testing was conducted.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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February 24, 2023

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 includes the letters "FDA" in a blue square, followed by 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: K223852

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: January 24, 2023 Received: January 26, 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 (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

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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,

Colin O'neill -S

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) K223852

Device Name VySpan™ PCT System

Indications for Use (Describe)
--------------------------------	--

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

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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K223852 Page 1 of 2

2. 510(k) Summary

Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 Telephone: 866-489-7746 Fax: 850-597-8571

Jordan Hendrickson Contact: Operations Manager

Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Product Code:

Spinal Fixation Device VySpan™ PCT System Posterior cervical screw system (per 21 CFR 888.3075) NKG, KWP

Substantial Equivalence

The VySpan™ PCT System is substantially equivalent to the primary predicate VySpan™ PCT System (K213394) in terms of material, intended use, levels of attachment, size range, and strength.

Device Description

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

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.

23 February 2023

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Performance Data and Substantial Equivalence

Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing was 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 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.

Regulation Number and Section

§ 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.