The Addivation Medical Cervical Interbody System is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The Addivation Medical Cervical Interbody System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, and is to be implanted via an open, anterior approach.

The Addivation Medical Cervical Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

Device Description

The Addivation Medical Cervical Interbody System is a series of hollow, titanium interbody fusion cages intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Addivation Medical Cervical Interbody System implants are simultaneously built using Electron Beam Melting (EBM) method of additive manufacturing. Addivation Medical Cervical Interbody System Implants are provided sterile.

AI/ML Overview

This document describes the marketing authorization for the Addivation Medical Cervical Interbody System. It is a cervical interbody fusion device intended for use in patients with degenerative disc disease.

Here's an analysis of the provided text in relation to acceptance criteria and study data:

Table of acceptance criteria and reported device performance:

Acceptance Criterion (Type of Test)	Reported Device Performance
Static and dynamic compression per ASTM F2077	"meets or exceeds the performance of the predicate devices"
Static and dynamic torsion per ASTM F2077	"meets or exceeds the performance of the predicate devices"
Subsidence testing per ASTM F2267	"meets or exceeds the performance of the predicate devices"

Sample size used for the test set and data provenance:
The document does not specify sample sizes for the testing. It mentions that "Non-clinical testing was performed." These are in-vitro mechanical tests, not clinical studies with human data. Therefore, the concept of country of origin or retrospective/prospective data provenance does not apply in the typical sense for a clinical study.
Number of experts used to establish the ground truth for the test set and their qualifications:
This question is not applicable. The device's performance was evaluated through laboratory mechanical testing based on established ASTM standards, not through expert review of clinical data to establish ground truth.
Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical studies. This document describes mechanical testing.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical interbody fusion system, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance evaluation was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used:
For the mechanical performance tests, the "ground truth" is defined by the requirements and thresholds established by the referenced ASTM standards (F2077, F2267) and the performance characteristics of the predicate devices. The device had to demonstrate comparable or superior mechanical properties under these controlled laboratory conditions.
The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning algorithm. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical implant.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 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.

July 30, 2019

Addivation Medical, LLC. % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K190291

Trade/Device Name: Addivation Medical Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 25, 2019 Received: May 1, 2019

Dear Linda 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

{1}------------------------------------------------

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 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 medical devices and radiation-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 CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K190291

Device Name Addivation Medical Cervical Interbody System

Indications for Use (Describe)

The Addivation Medical Cervical Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Date SummaryPrepared	July 30, 2019
Sponsor	Addivation Medical, LLC44 Riverdale AvenueMonmouth Beach, NJ 07750Phone 908-910-1256
510(k) Contact	Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat Highway Suite 120Woodstock, GA 30188Phone 770-837-2681Regulatory@SecureBME.com
Trade Name	Addivation Medical Cervical Interbody System
Common Name	Intervertebral body fusion device
Code -Classification	ODP21 CFR 888.3080: Class II
PrimaryPredicate	K171496 Tritanium C Anterior Cervical Cage (Stryker)
AdditionalPredicate	K142152 CONSTRUX Mini PEEK Spacer System (ORTHOFIX)
ReferencePredicate	K153207 Additive Orthopaedics Bone Wedge System
DeviceDescription	The Addivation Medical Cervical Interbody System is a series of hollow, titanium interbody fusion cages intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Addivation Medical Cervical Interbody System implants are simultaneously built using Electron Beam Melting (EBM) method of additive manufacturing. Addivation Medical Cervical Interbody System Implants are provided sterile.
Indications forUse	The Addivation Medical Cervical Interbody System is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.The Addivation Medical Cervical Interbody System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, and is to be implanted via an open, anterior approach.The Addivation Medical Cervical Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
TechnologicalCharacteristics	The Addivation Medical Cervical Interbody System has the same technologicalcharacteristics as the predicate devices including the materials, design, function,range of sizes and intended use.
	Non-clinical testing was performed to demonstrate the Addivation MedicalCervical Interbody System is substantially equivalent to other predicate devices inaccordance with “Guidance for Industry and FDA Staff, Guidance for SpinalSystem 510(k)s”, May 3, 2004 and Class II Special Controls Guidance Document:Intervertebral Body Fusion Device, June 12, 2007.
PerformanceData	The following tests were performed:Static and dynamic compression testing per ASTM F2077 Static and dynamic torsion testing per ASTM F2077 Subsidence testing per ASTM F2267
	The results of these studies show the subject Addivation Medical CervicalInterbody System meets or exceeds the performance of the predicate devices,and the device was therefore found to be substantially equivalent.
SubstantialEquivalenceSummary(Conclusion)	Based on the indications for use, technological characteristics, performance testing,and comparison to predicate devices, the subject Addivation Medical CervicalInterbody System has been shown to be substantially equivalent to legally marketedpredicate devices.

510(k) Summary of Safety and Effectiveness

{4}------------------------------------------------

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.