(78 days)
Not Found
No
The summary describes a mechanical implant with no mention of AI/ML terms, image processing, or data sets for training/testing.
Yes.
The device is implanted to replace a collapsed or unstable vertebral body due to tumor or trauma to improve stability of the spine, which is a therapeutic function.
No
This device is a vertebral body replacement system, an implant used in surgery, not a device for diagnosing medical conditions.
No
The device description clearly states it is an adjustable vertebral body replacement device manufactured from titanium alloy and cobalt chrome, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "partial or total replacement of a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture)" in the thoracolumbar spine. This is a surgical implant used directly in the body.
- Device Description: The description details a physical implantable device made of titanium and cobalt chrome, designed to be adjusted and locked in place within the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant used to treat a structural issue within the body.
N/A
Intended Use / Indications for Use
The Aesculap Biospine VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The Aesculap Biospine VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Biospine VBR System may be used with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The Aesculap BioSpine VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The device can be adjusted to the exact length required by the patients anatomy affer implantation. Once it is adjusted to the desired length the column is mechanically locked in place by means of locking screws. Spikes on the end plates of the device improve the anchoring of the implant to the vertebral body. It is available in a variety of configurations to accommodate the anatomical requirements of different patients. Components are manufactured from titanium allov (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to 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)
non-clinical testing was performed to demonstrate that the Aesculap BioSpine 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
- 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 Aesculap BioSpine VBR System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K012254/K060416, K010930/K024049, K083311
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
JUN 1 5 2011
| Aesculap Biospine VBR System | |||
|---|---|---|---|
| May 13, 2011 |
| COMPANY: | Aesculap®Implant Systems, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle
800-258-1946 (phone)
610-791-6882 (fax) |
| TRADE NAME: | Aesculap Biospine VBR System |
| COMMON NAME: | Adjustable Vertebral Body Replacement Device |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| REGULATION NUMBER: | 888.3060 |
| PRODUCT CODE: | MQP |
DEVICE DESCRIPTION
The Aesculap BioSpine VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The device can be adjusted to the exact length required by the patients anatomy affer implantation. Once it is adjusted to the desired length the column is mechanically locked in place by means of locking screws. Spikes on the end plates of the device improve the anchoring of the implant to the vertebral body. It is available in a variety of configurations to accommodate the anatomical requirements of different patients. Components are manufactured from titanium allov (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.
INDICATIONS FOR USE
The Aesculap Biospine VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The Aesculap Biospine VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Biospine VBR System may be used with bone graft.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicates)
As is established in this submission, the Aesculap BioSpine 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.
1
PERFORMANCE DATA/SUBSTANTIAL EQUIVALENCE
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the Aesculap BioSpine 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 ●
- 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 Aesculap BioSpine VBR System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
PREDICATE DEVICES
- Osteotech (Ulrich) VBR Systems (K012254/K060416). .
- Medtronic Verte-Span Spinal Systems (K010930/K024049). .
- Aesculap CeSpace PEEK Spinal Implant System (K083311). .
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle or bird symbol, with its wings spread and head facing to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Sr. Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
JUN 1 5 2011
Re: K110864
Trade/Device Name: Aesculap BioSpine Vertebral Body Replacememt (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: May 20, 2011 Received: May 23, 2011
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 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
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Page 2 - Ms. Lisa M. Boyle
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erine Keith
Jo C Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number:
Device Name: Aesculap BioSpine Vertebral Body Replacement (VBR) System
Indications for Use:
The Aesculap Biospine VBR System is indicated for use in the thoracolumbar spine (T1 to The Acoodiap Diogine VEP. Of Collapsed, damaged, or unstable vertebral body due ES) for partial or tetal replaceme). The Aesculap Biospine VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Biospine VBR System may be used with bone graft.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restornitive Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________