(29 days)
The Blackstone Medical PEEK Vertebral Body Replacement System is indicated for use in the thoraco-lumbar spine (T1-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 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 comprised of a variety of components fabricated and manufactured from Polyetheretherketone (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 Lordotic Lateral Spacers restore the natural curvature of the spine.
This document describes a modification to an existing medical device, the Blackstone PEEK Vertebral Body Replacement (VBR) System, specifically the addition of Lordotic Lateral Spacers. As such, the submission focuses on demonstrating substantial equivalence to the previously cleared device, not on proving device performance for novel indications or a new device.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a new device or a device with new clinical indications, are not applicable to this 510(k) submission.
The core of this submission is a claim of substantial equivalence to a predicate device (Blackstone PEEK Vertebral Body Replacement System, K033702). This means that the product is being presented as being as safe and effective as a legally marketed device.
Here's why each point you requested is not available in this document:
- Table of acceptance criteria and reported device performance: Not applicable. Performance criteria and detailed performance data beyond a description of materials and design are not provided for a substantial equivalence claim where the functionality is largely unchanged.
- Sample size for test set and data provenance: No new clinical or performance test studies are described that would require a test set. This is a modification to an existing, cleared device.
- Number of experts and qualifications for ground truth: Not applicable. No new diagnostic or interpretative claims are being made that would require expert consensus for ground truth.
- Adjudication method: Not applicable, as there's no diagnostic performance study or human reader evaluation described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study assesses human performance with and without AI assistance, which is not relevant to a device modification for a spinal implant.
- Standalone (algorithm only) performance study: Not applicable. This device is a physical implant, not an AI algorithm.
- Type of ground truth used: Not applicable, as no new performance studies are described that would establish a "ground truth" (e.g., pathology, outcomes data for effectiveness).
- Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How ground truth for the training set was established: Not applicable.
Summary of the document's content relevant to device acceptance:
- Acceptance Criteria for a 510(k) of this nature: The primary acceptance criterion for this 510(k) is demonstrating substantial equivalence to a predicate device. This means showing that the new device (Lordotic Lateral Spacers) has the same intended use, technological characteristics, and safety/effectiveness profiles as the predicate device (Blackstone PEEK Vertebral Body Replacement System, K033702).
- Study Proving Acceptance: The "study" (or rather, the justification) provided is the comparison to the predicate device K033702. The document states: "The Blackstone™ PEEK Vertebral Body Replacement System Lordotic Lateral Spacers are substantially equivalent to the Blackstone™ PEEK Vertebral Body Replacement System (K033702), which has received market clearance by the FDA."
- Device Performance (as described for a substantial equivalence claim):
- Material: PEEK Optima LT (ASTM F-2026), chosen for radiolucent properties.
- Features: Titanium markers for visualization, ripples on superior/inferior surfaces for increased stability and to prevent lateral movement.
- New Feature (modification): Lordotic Lateral Spacers restore the natural curvature of the spine.
- Intended Use/Indications: Remain consistent with the predicate device – thoraco-lumbar spine (T1-L5) for vertebral body replacement due to tumors or fractures, to achieve decompression, restore height, and restore biomechanical integrity. Intended for use with bone graft and supplemental internal fixation (specifically Blackstone Medical Spinal Fixation System).
In essence, for this 510(k) modification, the "acceptance criteria" were met by providing a detailed comparison between the modified device and the predicate device, asserting that the changes do not raise new questions of safety or effectiveness and that the intended use remains the same. The FDA's clearance letter (K041939) confirms that this claim of substantial equivalence was accepted.
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AUG 1 7 2004
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PEEK VBR System Lordotic Lateral Spacers (System Modification) Confidential
510(K) SUMMARY
04/1939
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 SystemLordotic Lateral Spacers |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Device Product Code& Classification: | MQP- 888.3060 – Spinal Vertebral Body Replacement Device |
| SubstantiallyEquivalent Devices: | Blackstone PEEK Vertebral Body Replacement System(K033702) |
Device Description:
Blackstone Medical, Inc. PEEK Vertebral Body Replacement (VBR) System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (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 Lordotic Lateral Spacers restore the natural curvature of the spine.
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Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone PEEK VBR System Lordotic Lateral Spacers (System Modification) Confidential
K041939
page 2 of 2
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 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 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:
The Blackstone™ PEEK Vertebral Body Replacement System Lordotic Lateral Spacers are substantially equivalent to the Blackstone™ PEEK Vertebral Body Replacement System (K033702), which has received market clearance by the FDA.
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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features the emblem of the U.S. Department of Health & Human Services, which consists of a stylized caduceus-like symbol with three abstract human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle, following its curvature. The logo appears to be of low resolution, with some blurring and pixelation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2004
Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104
Re: K041939
Trade/Device Name: Blackstone™ PEEK VBR System Lordotic Lateral Spacers Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 16, 2004 Received: July 19, 2004
Dear Mr. Ciporkin:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & no rowed your your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 or any reath 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) This letter will anow you've ough finding of substantial equivalence of your device to a legally premarket hotification: "The PDA mailing of cation 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 If you desire specific acrioliance at (301) 594-4692. Also, please note the regulation entitled, Contact the Ories of Companisemarket notification" (21CFR Part 807.97). You may obtain Missuranting of Terefono to premiers on promessionsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stut Qurlu
Celia M. Witten, Ph.D., M.D.
- Witten, Ph.D., M.D elia 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):
Device Name: Blackstone PEEK VBR System Lordotic Lateral Spacers
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 Fixation System.
Prescription Use X (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 Evaluation (ODE)
Stuart Purdes
Division of General, Restorative, and Neurological Devices
Page 1 of |
510(k) Number K041939
§ 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.