(59 days)
Not Found
No
The summary describes a mechanical implant for spinal surgery and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended to treat tumors and fractures in the spine, replace diseased vertebral bodies, restore height, and provide biomechanical integrity to the spinal column. These are all therapeutic actions.
No
The device description indicates it is a "vertebral body replacement device comprised of an anatomically shaped titanium implant" intended for surgical implantation, not for diagnosing a condition.
No
The device description clearly states it is a vertebral body replacement device comprised of an anatomically shaped titanium implant, which is a physical hardware component.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The EBI AIS Spine System is a physical implant designed to replace or support vertebral bodies in the spine. Its purpose is structural and biomechanical, not diagnostic testing of biological samples.
The information provided clearly describes a surgical implant used for structural support and restoration in the spine, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The EBI AIS Spine System is intended for use in the thoracolumbar spine (i.e., T1 to LS) to replace 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 EBI AIS Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI AIS Spine System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI Omega21 System or the EBI SpineLink System.
Product codes
MQP
Device Description
The EBI AIS Spine System is a vertebral body replacement device comprised of an anatomically shaped titanium implant. The EBI AIS is a single component device with a solid center core that provides structural integrity and slotted platforms that allows for bone growth around the center core. The superior and inferior platforms are flared outward to allow greater surface contact. The platforms are also designed with fins, which grip into the endplates of the vertebral body to reduce implant migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., T1 to LS), thoracic and lumbar spine
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)
Mechanical testing comparing the AIS System to a predicate system demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K841189, K990148, K001340, K003275, K010530
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
MAY 16 2002
page 1 of 2
510(k) Summary
This 510(k) Summary for the EBI AIS System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.
- Submitter: Jon Caparotta, RAC 1. Manager Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Frederic Testa, RAC Telephone: 973-299-9300 Fax: 973-257-0232
Date prepared: May 1, 2002
| 2. Proprietary Name: | EBI AIS Spine System | |
|---|---|---|
| Common Name: | Spinal Fixation Device | |
| Classification Name/Code: | Spinal Vertebral Body Replacement Device/MQP |
Predicate or legally marketed devices that are substantially equivalent: 3.
- Rezaian Spinal Fixator by OEM (K841189) 비
- Stackable Cage™ System by Depuy Acromed (K990148, K001340) 트
- SynMesh™ System by Synthes (K003275) 트
- 체 Geo™ Structure by Interpore Cross (K010530)
- Description of the device: The EBI AIS Spine System is a vertebral body replacement device 4. comprised of an anatomically shaped titanium implant. The EBI AIS is a single component device with a solid center core that provides structural integrity and slotted platforms that allows for bone growth around the center core. The superior and inferior platforms are flared outward to allow greater surface contact. The platforms are also designed with fins, which grip into the endplates of the vertebral body to reduce implant migration.
- Intended Use: The EBI AIS Spine System is intended for use in the thoracolumbar spine (i.e., T1 5. to LS) to replace 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 EBI AIS Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI AIS Spine System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI Omega21 System or the EBI SpineLink System.
-
- Materials: The AIS Spine System is manufactured from Titanium, Ti-6AI-4V ELI, per ASTM F136.
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@20887 page 2 of 2
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- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the AIS Spine System and other currently marketed spine systems. The AIS Spine System is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Mechanical testing comparing the AIS System to a predicate system demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements.
- Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Mr. Frederic Testa, RAC Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K020887
Trade/Device Name: EBI AIS Spine System Regulation Number: 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 15, 2002 Received: March 18, 2002
Dear Mr. Testa:
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 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); 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 - Frederic Testa, RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
( Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative. and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known): KO20887
Device Name: EBI AIS Spine System
Indications For Use:
The EBI AIS Spine System is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace 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 EBI AIS Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI AIS Spine System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI Omega 21 System or the EBI SpineLink System. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
Division of General, Restorative and Neurological Devices
5120-Voucher K020887