(127 days)
The Blackstone Medical PEEK Vertebral Body Replacement System is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a deseased 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 PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine. It is recommended that bone graft material be packed inside the system prior to implantation. The PEEK VBR System is intended to be used with supplemental internal fixation. Specifically, the supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.
Blackstone Medical, Inc. PEEK Vertebral Body Replacement (VBR) System is of a variety of components fabricated and manufactured from comprised Polyctheretherketone (PEEK Optima LT) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Titanium markers are inserted into components to give surgeons a visual aid in determining the location of the implant both inter and postoperatively. The superior and inferior surfaces of the construct have a pattern of ripples to provide increased stability and help prevent lateral movement of the device.
The provided document is a 510(k) summary for the Blackstone PEEK Vertebral Body Replacement System. It does not contain information about acceptance criteria or a study proving that a device meets those criteria.
Instead, it's a submission to the FDA for market clearance based on substantial equivalence to a previously cleared device. The document explicitly states:
- Basis of Substantial Equivalence: "By its very nature, the Blackstone™ PEEK Vertebral Body Replacement System is substantially equivalent to the Blackstone Surgical Titanium Mesh System (K030744), which has been cleared by FDA for use in patients with tumor, trauma or fractures."
This means the manufacturer is asserting their device is similar enough to an already approved device that it doesn't require new clinical trials or the establishment of new performance acceptance criteria. The FDA's letter confirms that they have determined the device is "substantially equivalent."
Therefore, I cannot provide the requested information, as it is not present in the provided text. The document focuses on regulatory clearance via substantial equivalence, not on a study demonstrating adherence to specific performance acceptance criteria.
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MAR 3 1 2004
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PEEK Vertebral Body Replacement System Confidential
510(K) SUMMARY
K033702
page 1 of 2
| Name of Firm: | Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104 |
|---|---|
| 510(k) Contact: | Dean E. CiporkinDirector, Regulatory Affairs and Quality Assurance |
| Trade Name: | Blackstone™ PEEK Vertebral Body Replacement System |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Device Product Code& Classification: | MQP- 888.3060 - Spinal Vertebral Body Replacement Device |
| SubstantiallyEquivalent Devices: | Blackstone Surgical Mesh System (K030744) |
Device Description:
Blackstone Medical, Inc. PEEK Vertebral Body Replacement (VBR) System is of a variety of components fabricated and manufactured from comprised Polyctheretherketone (PEEK Optima LT) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Titanium markers are inserted into components to give surgeons a visual aid in determining the location of the implant both inter and postoperatively. The superior and inferior surfaces of the construct have a pattern of ripples to provide increased stability and help prevent lateral movement of the device.
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Image /page/1/Picture/1 description: The image shows handwritten text that reads "KQ33708 page 2 of 2". The text is written in a casual, slightly slanted style. The numbers are clearly visible, and the phrase "page 2 of 2" indicates that this is the second page of a document.
Intended Use / Indications for Use:
The Blackstone Medical PEEK Vertebral Body Replacement System is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a deseased 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 PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine. It is recommended that bone graft material be packed inside the system prior to implantation. The PEEK VBR System is intended to be used with supplemental internal fixation. Specifically, the supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.
Basis of Substantial Equivalence:
By its very nature, the Blackstone™ PEEK Vertebral Body Replacement System is substantially equivalent to the Blackstone Surgical Titanium Mesh System (K030744), which has been cleared by FDA for use in patients with tumor, trauma or fractures.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2004
Mr. Dean E. Ciporkin: Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104
Re: K033702
Trade/Device Name: Blackstone™ PEEK Vertebral Body Replacement System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: February 26, 2004 Received: February 26, 2004
Dear Mr. Ciporkin:
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. Dean E. Ciporkin:
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 (301) 594-4639. 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 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.
Mark N Millman
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
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Indications for Use
510(k) Number (if known): #K033702
Device Name: Blackstone PEEK Vertebral Body Replacement System
Indications For Use:
The Blackstone VBR device is indicated for use in the thoraco-lumbar spine (T1-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 Blackstone VBR device is also indicated for treating fractures of the thoracic and lumbar spine.
The Blackstone VBR device 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. Additionally, the VBR device is intended to be used with bone graft.
The Blackstone VBR device is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used is the Blackstone Spinal Fix tion System.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device
e of Device Evaluation (ODE)
Mark A. Mikkelsen
for Division Sign Off
neral, Restorative. and Neurological Devices
510(k) Number K033702
Page 1 of _
§ 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.