(30 days)
The VBR Spinal System is indicated 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, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The VBR Spinal 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 period.
The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™, M-2 ANTERIOR PLATE™, ISOLA®, VSP®, MOSS®MIAMI, TiMX™, MONARCH™, EXPEDIUM™, VIPER™, and PROFILE™).
The additional size cages are identical to the previously cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified.
The document provided is a 510(k) summary for a medical device called the "Bengal Stackable Cage System" (also referred to as "VBR Spinal System"). This is a premarket notification to the FDA for a medical device and not a study report for an AI/ML device. Therefore, the information requested in the prompt, which is specific to AI/ML device studies and acceptance criteria, is not present in the provided text.
The document discusses the device's intended use, materials, classification, and substantial equivalence to predicate devices, but it does not detail any AI/ML components, acceptance criteria for an algorithm, or a study proving an algorithm meets such criteria.
Therefore, I cannot extract the requested information from the provided text.
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19
IX. 510 (k) Summary
| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780 | JAN 25 2008 |
|---|---|---|
| CONTACT PERSON: | Frank S. Jurczak | |
| DATE PREPARED: | December 21, 2007 | |
| CLASSIFICATION NAME: | 21 CFR 888.3060 Implant, Fixation DeviceSpinal Intervertebral Body Fixation Orthosis Device | |
| PROPRIETARY NAME: | Bengal Stackable Cage System | |
| PREDICATE DEVICES: | Stackable Cage System (K990148, K001340)Surgical Titanium Mesh System(K003043, K020522)DePuy Acromed VBR System (K031635) | |
| INTENDED USE: | The VBR Spinal System is indicated for use in thethoracolumbar spine (i.e., T1 to L5) to replace a diseasedvertebral body resected or excised for the treatment oftumors, to achieve anterior decompression of the spinalcord and neural tissues, and to restore the height of acollapsed vertebral body.The VBR Spinal System is also indicated for treatingfractures of the thoracic and lumbar spine.The VBR Spinal Cage System is designed to restore thebiomechanical integrity of the anterior, middle andposterior spinal column even in the absence of fusion for aprolonged period.The VBR Spinal System is intended for use withsupplemental internal fixation. The supplemental internalfixation systems that may be used include titanium plate orrod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™,M-2 ANTERIOR PLATE™, ISOLA®, VSP®,MOSS®MIAMI, TiMX™, MONARCH™, EXPEDIUM™,VIPER™, and PROFILE™). | |
| MATERIALS: | Carbon-fiber reinforced polymer (CFRP)Titanium alloy conforming to ASTM F-136Tantalum conforming with ASTM 560 |
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The additional size cages are identical to the previously DESCRIPTION: cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, rendered in black lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in public health and human services.
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DuPuy Spine, Inc. % Mr. Frank S. Jurczak 325 Paramount Drive Raynham, MA 02780
Re: K073649 Trade/Device Name: VBR Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 21, 2007 Received: December 26, 2007
Dear Mr. Jurczak:
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 (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 -- Mr. Frank S. Jurczak
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Mikkelsen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IV. Indications for Use
510(k) Number (if known):
Device Name: VBR Spinal System
Indications For Use:
The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusio of a prolonged period.
The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium platton: rnd Systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™, M-2 ANTERIOR PLATE™, ISOLA®, VSP®, MOSS®MIAMI, TiMX™, MONARCH™, EXPEDIUM™, VIPER™, and PROFILE™).
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)
Mark A. Milkers
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
§ 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.