(29 days)
The Construx™ Mini PEEK VBR System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of 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 Construx™M Mini PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The ConstruxTM Mini PEEK VBR 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 of time. The VBR device is intended to be used with bone graft material
The Construx™ Mini PEEK VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.
Blackstone Medical, Inc. Contrux™ Mini PEEK Vertebral Body Replacement (VBR) System is comprised of a variety of implants fabricated and manufactured from Polyetheretherketone (PEEK Optima LT1) 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. The teeth on the superior and inferior surfaces of the construct provide increased stability and help prevent anterior/posterior movement of the device.
This document is a 510(k) premarket notification for a medical device called the Construx™ Mini PEEK VBR System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data in the way a PMA (Premarket Approval) submission would.
Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this 510(k) submission.
Here's why and what information is provided:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. For a 510(k), the "acceptance criteria" for performance are primarily based on demonstrating that the new device is as safe and effective as a predicate device already on the market. There are no specific quantitative performance metrics (like sensitivity, specificity, accuracy, etc.) for the device itself that are 'accepted' by reaching a certain threshold. Instead, the "performance" demonstrated is that it is substantially equivalent to existing devices through comparison of design, materials, indications for use, and possibly bench testing to show similar mechanical properties (though specific bench test results are not detailed in this public summary).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This 510(k) does not mention clinical trials with test sets involving human subjects or data provenance in the context of device performance metrics. The demonstration of substantial equivalence typically relies on comparison to predicate devices, material specifications, and potentially non-clinical (e.g., mechanical) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth establishment by experts for a test set is mentioned, as this is not a study focused on diagnostic accuracy or clinical outcomes in the same way a diagnostic AI device would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication is described in this 510(k) summary.
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 device is a spinal implant (Vertebral Body Replacement System), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. As mentioned above, this is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth is established in the context of performance metrics for this type of device submission. The "ground truth" for a 510(k) is effectively the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a physical medical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is used for this physical medical device.
What is provided in this 510(k) summary is the basis for substantial equivalence:
- Device Name: Construx™ Mini PEEK VBR System
- Intended Use/Indications for Use: Replacement of diseased vertebral body (T1-L5) for tumors, anterior decompression, restoration of height, and treatment of fractures. Intended for use with bone graft material and supplemental internal fixation.
- Device Description: Made from Polyetheretherketone (PEEK Optima LT1) for radiolucency. Designed to restore biomechanical integrity.
- Predicate Devices:
- Basis of Substantial Equivalence: The Construx™ Mini PEEK VBR System is deemed substantially equivalent to the listed predicate devices which "have been cleared by FDA for use in patients with tumor, trauma or fractures." This implies that the new device shares similar technological characteristics, materials, design, and indications for use with these already cleared devices, making it equally safe and effective.
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KOS 1246
Premarket Notification 510(k) Blackstone Medical, Inc. Construx™Mini PEEK VBR System
510(K) SUMMARY
JUN 1 4 2005
| Name of Firm: | Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104 |
|---|---|
| 510(k) Contact: | Dean E. CiporkinDirector, Regulatory Affairs and Quality Assurance |
| Trade Name: | Construx™ Mini PEEK VBR System |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Device Product Code& Classification: | MQP - 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
Substantially Equivalent Devices:
Blackstone™ Surgical Titanium Mesh System (K030744) Blackstone™ PEEK Vertebral Body Replacement System (K033702) Rabea™ Spinal Implant (K043316) Spinal Concepts, Inc. FIDJI® Vertebral Body Replacement Types 1, 2, 3 and 4 (K042714)
Device Description:
Blackstone Medical, Inc. Contrux™ Mini PEEK Vertebral Body Replacement (VBR) System is comprised of a variety of implants fabricated and manufactured from Polyetheretherketone (PEEK Optima LT1) 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. The teeth on the superior and inferior surfaces of the construct provide increased stability and help prevent anterior/posterior movement of the device.
Intended Use / Indications for Use:
The ConstruxTM Mini PEEK VBR System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of 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 Construx™M Mini PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
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Premarket Notification 510(k) Blackstone Medical, Inc. Construx™Mini PEEK VBR System
The ConstruxTM Mini PEEK VBR 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 of time. The VBR device is intended to be used with bone graft material
The Construx™ Mini PEEK VBR System is intended for use with supplemental internal fixation. 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:
Construx™ Mini PEEK VBR System is substantially equivalent to the Blackstone™ Surgical Titanium Mesh System (K030744), the Blackstone™ PEEK Vertebral Body Replacement System (K033702), the Rabea™ Spinal Implant (K043316), and the Spinal Concepts, Inc. FIDJI® Vertebral Body Replacement Types 1, 2, 3 and 4 (K042714), which have been cleared by FDA for use in patients with tumor, trauma or fractures.
Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird in flight. The text is arranged in a circular fashion around the image.
JUN 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical Incorporated 90 Brookdale Drive Springfield, Massachusetts 01104
Re: K051246
Trade/Device Name: Construx™ Mini PEEK VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 13, 2005 Received: May 16, 2005
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Hipt Purda
Miriam C. Provost, Ph.D. Acting 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): K051246
Device Name: Construx™ Mini PEEK VBR System
Indications for Use:
The Construx™ Mini PEEK VBR System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of 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 Construx™ Mini PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The Construx™ Mini PEEK VBR 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 of time. The VBR device is intended to be used with bone graft material
The Construx™ Mini PEEK VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation 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 Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________ KOSIZYE Page 1 of
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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.