(125 days)
The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The AIS Modulift VBR System may be used with bone graft.
The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.
The document describes the AIS Modulift VBR System, an adjustable vertebral body replacement device. This device is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). It is intended for use with supplemental spinal fixation systems and may be used with bone graft.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Performance (Result) |
|---|---|
| Static and Dynamic Torsion (ASTM F2077) | Met or exceeded the performance of predicate devices |
| Static and Dynamic Compression (ASTM F2077) | Met or exceeded the performance of predicate devices |
| Subsidence (ASTM F2267) | Met or exceeded the performance of predicate devices |
| Wear Debris (ASTM F2077 & ASTM F1877) | Met or exceeded the performance of predicate devices |
| Expulsion (ASTM Draft Standard F-04.25.02.02) | Met or exceeded the performance of predicate devices |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical performance testing of the device. It does not provide details on specific sample sizes for each test beyond stating that "non-clinical testing was performed." The data provenance is from laboratory testing performed on the device itself, not from human data or clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for this device's performance is established by a set of ASTM and draft standards for orthopedic implants, which define the testing methodology and acceptance criteria. There is no mention of human experts establishing ground truth for the performance tests, as these are engineering and material science tests.
4. Adjudication method for the test set:
Not applicable. The tests are based on engineering standards, and the results are objective measurements against specified criteria, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical medical device (vertebral body replacement system), not an AI/software device that requires human readers or clinical image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth used for demonstrating device performance is based on established engineering standards and safety/performance benchmarks for spinal implants, specifically various ASTM standards (F2077, F2267, F1877) and a draft ASTM standard (F-04.25.02.02). The device's performance is compared against these standards and against predicate devices.
8. The sample size for the training set:
Not applicable. This refers to a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This refers to a physical medical device, not a machine learning model.
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B. 510(k) SUMMARY (as required by 21 CFR 807.92)
APR 1 7 2014
Aesculap Implant Systems, LLC. (AIS) Modulift (Modulift) VBR System March 28, 2014
| COMPANY: | Aesculap®Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 |
|---|---|
| CONTACT: | Lisa M. Boyle800-258-1946 (phone)610-791-6882 (fax) |
| TRADE NAME: | AIS Modulift VBR System |
| COMMON NAME: | Adjustable Vertebral Body Replacement Device |
| CLASSIFICATION NAME: | Spinal Vertebral Body Replacement Device |
| REGULATION NUMBER: | 888.3060 |
| PRODUCT CODE: | MQP |
PURPOSE FOR PREMARKET NOTIFICATION
The AIS Modulift VBR System described in this submission introduces new VBR's with differenct size end caps, new instruments, and device modifications that have been implemented to the existing product line cleared under K110864.
DEVICE DESCRIPTION
The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.
INDICATIONS FOR USE
The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with
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supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The AIS Modulift VBR System may be used with bone graft.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicates)
As is established in this submission, the AIS Modulift VBR System is a mechanically adjustable vertebral body replacement device that is substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.
PERFORMANCE DATA
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the AIS Modulift VBR System is substantially equivalent to other predicate devices. The following testing was performed:
- . Static and dynamic torsion per ASTM F2077
- Static and dynamic compression per ASTM F2077 .
- Subsidence per ASTM F2267 .
- t Wear Debris per ASTM F2077 & ASTM F1877
- Expulsion per ASTM Draft Standard F-04.25.02.02 .
The results of these studied showed that the subject AIS Modulift VBR System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
PREDICATE DEVICE
- Aresoular Modulift VBR System (K110864) O
- Osteotch (Ulrich) VBR Systems (K012254/K060416) .
- . Globus Expand (K050850)
- . DePuy X-MESH (K080568)
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2014
Aesculap® Implant Systems, Incorporated Ms. Lisa M. Bovle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K133802 Trade/Device Name: AIS Modulift Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: March 21, 2014 Received: March 21, 2014
Dear Ms. Boyle:
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 warrantics. 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 or any reading and 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 device-related adverse cvents) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 - Ms. Lisa M. Boyle
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You mav obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P: Jean -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) K133802
Device Name
AIS Modulift Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
The AIS Modulfift VBR System is indicated for use in the thoracolumbar spine (T) to LS) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Modulift VBR System may be used with bone graft.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
CART FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR CONTRACT FOR STORES OF CONSTITUTION
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
A. O. Smith
Division of Orthopedie Devices
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§ 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.