(169 days)
No
The device description and performance studies focus on the mechanical properties and design of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in cervical interbody fusion procedures to treat degenerative disc disease, which falls under the definition of a therapeutic intervention.
No
The device is an interbody fusion cage designed for surgical implantation to treat degenerative disc disease, not to diagnose it. Its purpose is structural support and fusion, not diagnostic measurement or analysis.
No
The device description explicitly states it is a series of hollow, titanium interbody fusion cages, which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (cervical interbody fusion) involving the implantation of a device into the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Description: The device is a physical implant (a fusion cage) made of titanium. IVDs are typically reagents, instruments, or systems used for testing biological samples.
- Anatomical Site: The device is used within the cervical spine. IVDs analyze samples taken from the body.
- Performance Studies: The performance studies described are mechanical tests (compression, torsion, subsidence) to assess the structural integrity and performance of the implant. IVD performance studies would involve evaluating the accuracy and reliability of the test results compared to a reference standard.
The Addivation Medical Cervical Interbody System is a medical device intended for surgical implantation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
ODP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (from the C2 to T1 disc)
Indicated Patient Age Range
skeletally mature patients
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)
Non-clinical testing was performed to demonstrate the Addivation Medical Cervical Interbody System is substantially equivalent to other predicate devices in accordance with “Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s”, May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007.
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 Cervical Interbody System meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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 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.
| 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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| Date Summary
| Prepared | July 30, 2019 |
|---|---|
| Sponsor | Addivation Medical, LLC |
| 44 Riverdale Avenue | |
| Monmouth Beach, NJ 07750 | |
| Phone 908-910-1256 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway Suite 120 | |
| Woodstock, GA 30188 | |
| Phone 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | Addivation Medical Cervical Interbody System |
| Common Name | Intervertebral body fusion device |
| Code - | |
| Classification | ODP |
| 21 CFR 888.3080: Class II | |
| Primary | |
| Predicate | K171496 Tritanium C Anterior Cervical Cage (Stryker) |
| Additional | |
| Predicate | K142152 CONSTRUX Mini PEEK Spacer System (ORTHOFIX) |
| Reference | |
| Predicate | K153207 Additive Orthopaedics Bone Wedge System |
| 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. |
| Indications for | |
| Use | 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. |
| Technological
Characteristics | The Addivation Medical Cervical Interbody System has the same technological
characteristics as the predicate devices including the materials, design, function,
range of sizes and intended use. |
| | Non-clinical testing was performed to demonstrate the Addivation Medical
Cervical Interbody System is substantially equivalent to other predicate devices in
accordance with “Guidance for Industry and FDA Staff, Guidance for Spinal
System 510(k)s”, May 3, 2004 and Class II Special Controls Guidance Document:
Intervertebral Body Fusion Device, June 12, 2007. |
| Performance
Data | 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 Cervical
Interbody System meets or exceeds the performance of the predicate devices,
and the device was therefore found to be substantially equivalent. |
| Substantial
Equivalence
Summary
(Conclusion) | Based on the indications for use, technological characteristics, performance testing,
and comparison to predicate devices, the subject Addivation Medical Cervical
Interbody System has been shown to be substantially equivalent to legally marketed
predicate devices. |
510(k) Summary of Safety and Effectiveness
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