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.

Device Description

The Vy Spine™ VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachment elements with a set screw and rod. The VySpan™ pedicle screw component is offered in both poly-axial and monoaxial 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 and should not be used with implants of different materials.

AI/ML Overview

This document describes the Vy Spine™ VySpan™ PCT System, a posterior cervical screw system. The provided text is a 510(k) premarket notification and does not contain information typically found in a study proving a device meets acceptance criteria related to its performance in vivo or clinical outcomes. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of design characteristics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth establishment for training set, training set size) are not applicable to the information provided in this regulatory document.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it implicitly relies on demonstrating that the subject device's non-clinical performance and characteristics are substantially equivalent to legally marketed predicate devices. The "performance" described refers to mechanical and material characteristics tested non-clinically.

Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implicit from Substantial Equivalence Basis)	Reported Device Performance (as stated in document)
Material	Similar material composition to predicate devices.	Fabricated from Titanium alloy, similar to predicate devices.
Design	Similar design to predicate devices.	Similar design to predicate devices.
Sizes	Similar size range to predicate devices.	Similar sizes to predicate devices.
Intended Use	Same intended use as predicate devices.	Same as predicate devices: to promote fusion of the cervical spine and cervicothoracic (C1-T3) for various indications (DDD, Spondylolisthesis, Spinal stenosis, Fracture/dislocation, Revision, Tumors). Hooks and rods for stabilization following reduction of fracture/dislocation or trauma in C1-T3.
Biocompatibility	Similar biocompatibility to predicate devices.	Similar biocompatibility to predicate devices.
Non-Clinical Testing	Expected to meet standards or equivalent performance as predicate devices when tested using various ASTM Standard tests.	Undergone Non-Clinical Testing using various ASTM Standard tests at a third-party facility.
Strength	Similar strength characteristics to predicate devices.	Similar strength to predicate devices.

Study Proving Device Meets Acceptance Criteria

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the actual physical devices undergoing non-clinical mechanical testing, not a patient dataset. The document doesn't specify the number of devices or components tested. The "provenance" refers to a "third-party facility."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For non-clinical mechanical testing, "ground truth" is typically defined by engineering specifications and objective measurements against ASTM standards, not expert consensus.
Adjudication method for the test set: Not applicable. Formal adjudication methods (like 2+1 or 3+1) are used for clinical data interpretation or image analysis, not for non-clinical mechanical testing.
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 implant, not an AI-assisted diagnostic or therapeutic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used: For non-clinical testing, the "ground truth" is adherence to established engineering standards (e.g., ASTM standards) and the measured mechanical properties of the device components compared to those of the predicate devices.
The sample size for the training set: Not applicable. This device is not an AI/ML product developed with training data.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary of the Study:

The "study" referenced is a series of Non-Clinical Tests conducted at a third-party facility using various ASTM Standard tests. The purpose of these tests was to demonstrate the substantial equivalence of the Vy Spine™ VySpan™ PCT System to its predicate devices (Reliance Posterior Cervical-Thoracic System K142867 and K122292) in terms of material, design, sizes, intended use, biocompatibility, and strength. The document explicitly states that the subject device "has similar design, sizes, indication of use & biocompatibility as the predicate devices."

The document does not provide specific results from these ASTM tests (e.g., exact load-to-failure values, fatigue life), but rather summarizes that the testing was performed and supports the claim of substantial equivalence.

Summary

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December 10, 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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Vy Spine, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee, Florida 32308

Re: K213394

Trade/Device Name: Vy Spine™ VySpan™ PCT System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: October 13, 2021 Received: October 15, 2021

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213394

Device Name Vy Spine™ VySpan™ PCT System

Indications for Use (Describe)

Vy Spine™ VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), is indicated for the following:

vddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient historyand 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 of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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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December 9, 2021

Vy Spine, LLC
2236 Capital Circle NE,
Suite 103-1
Tallahassee, FL 32308
Telephone:	866-489-7746
Fax:	850-597-8571
Contact:	Jordan HendricksonOperations Manager
Common or Usual Name:	Spinal Fixation Device
Proposed Proprietary or Trade Name:	Vy Spine™ VySpan™ PCT System
Classification Name:	Posterior cervical screw system (per 21 CFR888.3075), Spinal interlaminal fixation orthosis (per 21CFR 888.3050)
Product Code:	NKG, KWP

Substantial Equivalence

The Vy Spine™ VySpan™ PCT System is substantially equivalent to the primary predicate Reliance Posterior Cervical-Thoracic System (K142867), and the additional predicate Reliance Posterior Cervical-Thoracic System (K122292), in terms of material, intended use, levels of attachment, size range, and strength.

Device Description

Intended Use/Indications for Use

Vy Spine™ VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), 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

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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.

Performance Data and Substantial Equivalence

The Reliance Posterior Cervical-Thoracic System (K122292, K142867) has undergone Non-Clinical Testing using various ASTM Standard tests at a third party facility. The subject Vy Spine™ VySpan™ PCT System has similar design, sizes, indication of use & biocompatibility as the predicate devices.

Technological Modifications

The subject Vy Spine™ VySpan™ PCT System has similar material, design, sizes, indication of use & biocompatibility as the predicate devices.

Technological Characteristics

The subject Vy Spine™ 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

N/A