(114 days)
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for spinal fusion procedures to alleviate back pain associated with degenerative disc disease, which qualifies it as a therapeutic intervention designed to treat a medical condition.
No
This device is an implantable medical device (interbody system) used for spinal fusion procedures. It is not designed to diagnose a condition but rather to treat it.
No
The device description explicitly states that the system consists of implants manufactured from implantable grade Ti6Al4V alloy and Peek Optima LT1, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Atlas Spine Expandable Interbody System is a physical implant designed to be surgically placed in the lumbar spine to facilitate spinal fusion. It is a medical device used in vivo (within the body), not in vitro (in a lab).
- Lack of Diagnostic Function: The device's purpose is structural support and promoting bone fusion, not analyzing biological samples for diagnostic purposes.
- Performance Studies: The performance studies described are bench tests evaluating the mechanical properties of the implant, not clinical studies evaluating the accuracy of a diagnostic test.
Therefore, the Atlas Spine Expandable Interbody System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Atlas Spine Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The Atlas Spine Expandable Interbody System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Firebird® Spinal Fixation System).
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Atlas Spine Expandable Interbody System.
Product codes
MAX
Device Description
The Atlas Spine Expandable 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 infinitely within its design limitations. 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 material post expansion.
The implants components are manufactured from implantable grade Ti6Al4V 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
Not Found
Anatomical Site
lumbar spine (L2-S1)
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:
The Atlas Spine Expandable 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:
- Static testing in a load to failure mode in axial compression,
- Static testing in a load to failure mode in shear,
- 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
Test results demonstrated that the Atlas Spine Expandable Interbody System is found to be substantially equivalent to the predicate devices.
Clinical Performance Data Summary:
No clinical testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Caliber™ Spacer (K102293)
Reference Device(s)
ProLift® Expandable System (K153400), FORZA® PTC Spacer System (K152475), Spinal Jaxx Interbody Fusion Device (K152501), L-Varlock Lumbar Cage (K080537), Atlas Spine Verterbral Body Replacement (K063205), Bluefin™ Interbody System (K143479), Dorado™ Intervertebral Body Cage (K091638 & K072289)
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.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Atlas Spine, Inc. % Ms. Meredith Mav Vice President Empirical Consulting, LLC. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K162918
Trade/Device Name: Atlas Spine Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 10, 2017 Received: January 12, 2017
Dear Ms. May:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162918
Device Name
Atlas Spine Expandable Interbody System
Indications for Use (Describe)
The Atlas Spine Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The Atlas Spine Expandable Interbody System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Firebird® Spinal Fixation System).
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Atlas Spine Expandable Interbody System.
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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Image /page/3/Picture/0 description: The image shows the logo for Atlas Spine. The logo features a stylized globe above the word "ATLAS" in gray, with the word "spine" in blue next to it. Below the words is the tagline "Fusing Science with Simplicity" in gray.
K162918 Page 1 of 2
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 |
| Date: | January 10, 2017 |
| Proposed Trade Name: | Atlas Spine Expandable Interbody System |
| Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral fusion device with bone graft, lumbar per 21 CFR
888.3080. This falls under the Orthopedics panel/87 as a Class
II device. |
| Device Product Code: | MAX |
| Predicate Devices: | Caliber™ Spacer (K102293) - Primary
ProLift® Expandable System (K153400) - Additional
FORZA® PTC Spacer System (K152475) - Additional
Spinal Jaxx Interbody Fusion Device (K152501) - Ref
L-Varlock Lumbar Cage (K080537) - Ref
Atlas Spine Verterbral Body Replacement (K063205) - Ref
Bluefin™ Interbody System (K143479) - Ref
Dorado™ Intervertebral Body Cage (K091638 & K072289) - Ref |
Device Description:
The Atlas Spine Expandable 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 infinitely within its design limitations. 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 material post expansion.
The implants components are manufactured from implantable grade Ti6Al4V alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.
4
Indications for Use:
The Atlas Spine Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The Atlas Spine Expandable Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. Firebird® Spinal Fixation System).
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Atlas Spine Expandable Interbody System.
Summary of Technological Characteristics
The Atlas Spine Expandable 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 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:
- Static testing in a load to failure mode in axial compression,
- Static testing in a load to failure mode in shear,
- 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 ●
Test results demonstrated that the Atlas Spine Expandable Interbody System is found to be substantially equivalent to the predicate devices.
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 Interbody System is substantially equivalent to the predicate devices.