(29 days)
Not Found
No
The 510(k) summary describes a physical implant (vertebral body replacement) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended for the treatment of tumors and fractures and to restore height and stability in the spine, which are therapeutic interventions.
No
The device, Atlas Spine Vertebral Body Replacement (VBR), is an implant used for partial or complete replacement of a diseased vertebral body. Its function is to restore spinal integrity and height, not to diagnose a condition.
No
The device description clearly describes a physical implant (Vertebral Body Replacement) made of material with specific dimensions and features, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Atlas Spine Vertebral Body Replacement is a physical implant intended for surgical use within the human body to replace a diseased or fractured vertebral body. It is a structural device used to restore spinal integrity.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens.
Therefore, the Atlas Spine Vertebral Body Replacement 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 Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.
The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Product codes
MQP
Device Description
The Atlas Spine VBR is generally rectangular in shape with anterior and posterior walls that are concentric arcs. The device is available in various sizes with an anterior height ranging from 10mm to 18mm and anterior width of 28mm while providing 0 or 5 degrees of lordosis. The posterior aspect is tapered, or bulleted, for ease of insertion. All devices are 20.0mm in length. The device design includes four radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Atlas Spine, Inc. Special 510(k) Premarket Notification: Atlas Spine Vertebral Body Replacement
510(k) SUMMARY
| Manufacturer: | Atlas Spine, Inc. |
|---|---|
| Address: | 1555 Jupiter Park Drive, Suite #4 |
| Jupiter, FL 33458 | |
| Telephone: | 561-741-1108 |
| Fax: | 561-741-1870 |
| Official Correspondent: | Jeannette G. Dailey |
| Title: | VP Regulatory Affairs |
| Telephone: | 561-354-4319 |
| Device Classification | |
| Name: | Spinal intervertebral body fixation orthosis |
| Trade/Proprietary Name: | Atlas Spine Vertebral Body Replacement |
| Common Name: | Spinal vertebral body replacement device |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | MQP |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Device: | Atlas Spine Vertebral Body Replacement |
| K063464 |
Intended Use:
The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.
The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
1
Device Description:
The Atlas Spine VBR is generally rectangular in shape with anterior and posterior walls that are concentric arcs. The device is available in various sizes with an anterior height ranging from 10mm to 18mm and anterior width of 28mm while providing 0 or 5 degrees of lordosis. The posterior aspect is tapered, or bulleted, for ease of insertion. All devices are 20.0mm in length. The device design includes four radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.
Equivalence to Marketed Product
Atlas Spine, Inc. has submitted information to demonstrate that, for the purpose of FDA's regulation of medical devices, the Atlas Spine VBR is substantially equivalent in indications and design principles to the predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices.
The intended use, design, materials and functional characteristics of the Atlas Spine VBR and the predicate devices are substantially the same. Each system is intended to be used to provide support after resection or removal of a damaged, collapsed, or unstable vertebral body due to tumor, fracture, or other disease. The subject device and predicate devices are placed within the area of removed or resected spine and are functionally complemented by supplemental internal fixation. The subject device and the predicate devices are intended to be used with bone graft. The Atlas Spine VBR and the predicate devices are made from implantable PEEK [polyetheretherketone] polymer.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
Atlas Spine, Inc. % Mrs. Jeannette Dailey Vice President, Regulatory Affairs 1555 Jupiter Park Drive, Suite 4 Jupiter, Florida 33458
Re: K071497
Trade/Device Name: Atlas Spine Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 30, 2007 Received: May 31, 2007
Dear Mrs. Dailey:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 mav 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); good 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.
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Page 2 - Mrs. Jeannette Dailey
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 2760-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Sincerely yours
Enclosure
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Atlas Spine, Inc. Special 510(k) Premarket Notification: Atlas Spine Vertebral Body Replacement
Indications for Use
510(k) Number (if known):
Device Name: Atlas Spine Vertebral Body Replacement
Indications for Use:
:
The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.
The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of General, Restorative, and Neurological Devices
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) Number | 1071497 |
|---|---|
| --------------- | --------- |
(Posted November 13, 2003)