(28 days)
The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.
The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.
The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.
The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.
The use of titanium or titanium alloy instrumentation is recommended.
This document describes the Implex Hedrocel® Vertebral Body Replacement System, a medical device, and its 510(k) premarket notification. The information provided focuses on the regulatory submission and does not describe a clinical study in the typical sense (e.g., relating to AI device performance). Instead, it describes engineering performance tests to demonstrate substantial equivalence to previously approved predicate devices.
Here's the breakdown based on your request, adapted to the nature of the provided text:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are based on demonstrating "equivalent mechanical behavior" to predicate devices, as assessed by various tests. The "reported device performance" refers to the successful outcomes of these tests.
| Acceptance Criteria (Demonstrate Equivalent Mechanical Behavior to Predicates) | Reported Device Performance (Test Results) |
|---|---|
| Meet applicable standards for vertebral body replacement systems. | The device was tested per applicable standards (reference K010378). |
| Biocompatibility | Biocompatibility data was provided to support the material's use. |
| Static Compression | Test data was provided regarding static compression, demonstrating equivalent mechanical behavior. |
| Dynamic Compression | Test data was provided regarding dynamic compression, demonstrating equivalent mechanical behavior. |
| Static Torsion | Test data was provided regarding static torsion, demonstrating equivalent mechanical behavior. |
| Dynamic Torsion | Test data was provided regarding dynamic torsion, demonstrating equivalent mechanical behavior. |
| Abrasion | Test data was provided regarding abrasion, demonstrating equivalent mechanical behavior. |
| Overall performance as intended | The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. |
Study Details (Adapted for this type of device submission)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact number of physical device units tested for each mechanical test. However, it implicitly refers to a "test set" of devices that underwent the described mechanical and biocompatibility evaluations.
- Data Provenance: The data was generated through laboratory testing of the Hedrocel® Vertebral Body Replacement System. This is a prospective generation of engineering test data for regulatory submission. The country of origin for the testing is not specified, but the submission is to the US FDA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device and its testing. "Ground truth" usually refers to clinical classifications or diagnoses. Here, the "truth" is established by adherence to engineering standards and by comparing the device's mechanical performance to established predicate devices under controlled laboratory conditions. The experts involved would be engineers and material scientists conducting and evaluating the tests, but no specific number or detailed qualifications are provided in this summary.
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Adjudication method for the test set:
- This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical image interpretation where there might be disagreement among human readers. For engineering performance tests, the results are typically quantitative measurements and comparisons against predefined standards or predicate device performance.
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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:
- No, a MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This concept is not applicable as this is not an algorithm or AI device. The device's performance is standalone in the sense that its mechanical properties were tested directly.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is established through objective engineering measurements and compliance with recognized industry standards, alongside comparison to the established mechanical performance characteristics of predicate devices. Biocompatibility data would also adhere to specific material science standards.
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The sample size for the training set:
- This concept is not applicable to this device submission. "Training set" refers to data used to train an AI algorithm. The Hedrocel® system is a mechanical implant and does not involve AI.
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How the ground truth for the training set was established:
- This concept is not applicable, as there is no training set for an AI algorithm.
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Implex Corp
JUL 1 1 2003
Hedrocel® Vertebral Body Replacement Special 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Hedrocel Vertebral Body Replacement System
| Submitter NameAnd Address: | Implex Corp.80 Commerce DriveAllendale, New Jersey 07401-1600 |
|---|---|
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | June 11, 2003 |
| Device Trade Name: | Hedrocel Vertebral Body Replacement SystemDevice Common Name: Vertebral Body Replacement Device |
| Classification Numberand Name: | 21 CFR § 888.3060Spinal Vertebral Body Replacement Device |
The term "substantial equivalence" as used in this 510(k) Substantial notification is limited to the definition of substantial equivalence Equivalence: found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
- Device The Hedrocel® Vertebral Body Replacement System is designed to be Description: used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.
The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.
The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.
The use of titanium or titanium alloy instrumentation is recommended.
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510(k) Summary (Continued)
The Hedrocel® Vertebral Body Replacement System is a Indications for Use: vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.
The device is unique in comparison to predicates for this Device Technological indication with regard to its geometry. The material has been Characteristics and used in cited predicates for other applications. Comparison to Predicate Device:
Performance Data: The Hedrocel Vertebral Body Replacement System was tested per applicable standards (reference K010378). Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicates. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding:
- . Static compression,
- Dynamic compression. .
- Static torsion, ●
- Dynamic torsion, and .
- . Abrasion.
Conclusion: The Implex Hedrocel Vertebral Body Replacement System is substantially equivalent to the predicate devices identified in this premarket notification.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three wavy lines extending from its head. The eagle is facing to the right.
JUL 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marci Halevi Manager of Regulatory Affairs Implex Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K031823
Trade Name: Hedrocel® Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: June 12, 2003 Received: June 13, 2003
Dear Ms. Halevi:
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 - Ms. Marci Halevi
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) 594-4659. 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.
Miriam C. Provoost
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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known) :
Device Name:
The Implex Hedrocel Vertebral Body Replacernent System
Indications For Use:
The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 -- L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedroce® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| Prescription Use | 510(k) Number OR: K631823 | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 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.