(90 days)
No
The summary describes a physical implantable device and its mechanical properties. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as an "Expandable Cervical Interbody System" intended for "intervertebral body fusion of the spine" and used to address "cervical disc degeneration and/or cervical spinal instability" to alleviate symptoms like "radiculopathy, and/or pain." These applications directly relate to treating a disease or condition, which is characteristic of a therapeutic device.
No
The device is an implantable interbody fusion system designed to facilitate fusion in patients with cervical disc degeneration and/or spinal instability. Its purpose is therapeutic, not diagnostic. While imaging studies are used to confirm the patient's condition, the device itself does not perform diagnostics.
No
The device description clearly states it is an implantable system made of Ti6AI4V and Peek Optima LT1, which are hardware materials. The performance studies also describe bench testing of physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Atlas Spine Expandable Cervical Interbody System is an implant intended for surgical implantation into the cervical spine to facilitate fusion. It is a physical device that is placed within the body, not a device used to analyze samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such tests.
Therefore, the Atlas Spine Expandable Cervical Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Product codes
ODP
Device Description
The Atlas Spine Expandable Cervical Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft post expansion.
The implants components are manufactured from implantable grade Ti6AI4V per ASTM F136 alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
cervical spine, C2 - T1
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
Bench testing was performed and consisted of the following test methods per ASTM F2077 and ASTM F2267:
- Static testing in a load to failure mode in axial compression,
- Static testing in a load to failure mode in shear,
- Static testing in a load to failure mode in torsion,
- Static testing in expulsion,
- Static testing in subsidence,
- Dynamic axial compression testing to estimate the maximum run out load
- Dynamic compression shear testing to estimate the maximum run out load
- Dynamic torsion testing to estimate the maximum run out load
Key Metrics
Not Found
Predicate Device(s)
NuVasive CoRoent Small Interbody System (K163491), Orthofix CONSTRUX™ MINI Peek Ti Spacer System (K121649), Southern Spine C-Fuse PEEK Cervical Fusion System (K130948), Atlas Spine Expandable Interbody System (K162918)
Reference Device(s)
Not Found
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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Image /page/0/Picture/11 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The Department of Health and Human Services logo features a stylized eagle emblem, while the FDA text logo displays the agency's name in blue, with "FDA" in a square and "U.S. FOOD & DRUG ADMINISTRATION" written out to the right of the square.
June 14, 2018
Atlas Spine, Inc. % Ms. Meredith May VP, Empirical Consulting, LLC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K180675
Trade/Device Name: Atlas Spine Expandable Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 30, 2018 Received: May 30, 2018
Dear Ms. May:
This letter corrects our substantially equivalent letter of June 13, 2018.
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 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. 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180675
Device Name
Atlas Spine Expandable Cervical Interbody System
Indications for Use (Describe)
The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
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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510(k) Summary
| Applicant/Sponsor: | Atlas Spine, Inc.
1555 Jupiter Park Drive, Suite 4
Jupiter, FL, 33458
(561) 741-1108 |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Meredith May
Empirical Consulting, LLC
4628 Northpark Drive
Colorado Springs, CO 80918
(719) 264-9937 |
| Proposed Trade Name: | Atlas Spine Expandable Cervical Interbody System |
| Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Cervical
(21 CFR 888.3080) |
| Device Class: | Orthopedics panel Class II device |
| Device Product Code: | ODP |
| Predicate Devices:
Primary:
Additional:
Additional:
Additional: | NuVasive CoRoent Small Interbody System (K163491)
Orthofix CONSTRUX™ MINI Peek Ti Spacer System (K121649)
Southern Spine C-Fuse PEEK Cervical Fusion System (K130948)
Atlas Spine Expandable Interbody System (K162918) |
Device Description:
The Atlas Spine Expandable Cervical Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft post expansion.
The implants components are manufactured from implantable grade Ti6AI4V per ASTM F136 alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.
4
Indications for Use:
The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myclopathy, and/or pain at mulitple contiquous levels from C2 - T1. This system is intended to be used with supplemental fixation. The System is designed for use with autogenous and/ or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Substantial Equivalence
The Atlas Spine Expandable Cervical Interbody System has the same intended use, indications for use and similar manufacturing materials as the predicate device(s). The range of sizes of the Atlas Spine Expandable Interbody System is similar to the predicate device(s).
Non-Clinical Testing
The Atlas Spine Expandable Cervical Interbody System was evaluated as recommended in FDA's Guidance for Industry and FDA Staff: Class II Special controls guidance document: Intervertebral body Fusion Device, dated June 12, 2007.
Bench testing was performed and consisted of the following test methods per ASTM F2077 and ASTM F2267:
- . Static testing in a load to failure mode in axial compression,
- . Static testing in a load to failure mode in shear,
- Static testing in a load to failure mode in torsion, ●
- Static testing in expulsion, ●
- Static testing in subsidence, ●
- o Dynamic axial compression testing to estimate the maximum run out load
- Dynamic compression shear testing to estimate the maximum run out load ●
- Dynamic torsion testing to estimate the maximum run out load ●
Test results demonstrated that the Atlas Spine Expandable Cervical Interbody System is found to be substantially equivalent to the predicate
Clinical Performance Data Summary
No clinical testing was required.
Conclusion
Based upon similarities in design, materials, intended use, indications for use and the results of mechanical testing, the Atlas Spine Expandable Cervical Interbody System is substantially equivalent to the predicate devices.