(77 days)
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 Hedrocel Vertebral Body Replacement System is a medical device designed to replace a diseased or damaged vertebral body in the thoracic and lumbar spine. The acceptance criteria and performance of the device are based on demonstrating substantial equivalence to predicate devices through mechanical performance testing and biocompatibility data.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static compression | Equivalent to predicate devices | Device performs as intended and is equivalent to cited predicate devices. |
| Dynamic compression | Equivalent to predicate devices | Device performs as intended and is equivalent to cited predicate devices. | |
| Static torsion | Equivalent to predicate devices | Device performs as intended and is equivalent to cited predicate devices. | |
| Dynamic torsion | Equivalent to predicate devices | Device performs as intended and is equivalent to cited predicate devices. | |
| Abrasion | Equivalent to predicate devices | Device performs as intended and is equivalent to cited predicate devices. | |
| Material Safety | Biocompatibility | Safe for human implantation | Biocompatibility data provided to support the material's use. |
| Indications for Use | Spinal Region | Thoracolumbar spine (T1-L5) | Intended for use in the thoracolumbar spine (T1-L5). |
| Conditions for Use | Collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) | Replaces collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). | |
| Intended Augmentation | Used with supplemental internal spinal fixation systems | Intended for use with supplemental internal spinal fixation systems. | |
| Optional Augmentation | May be used with bone graft | May be used with bone graft. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the mechanical performance tests. It states that "Predicate devices that are a part of the Hedrocel Vertebral Body Replacement System were tested per applicable standards (reference K010378)." It also mentions "Performance testing was provided to support equivalent mechanical behavior to the predicate devices."
Data Provenance: The data appears to be from retrospective testing of the device and its predicate components/materials, conducted by the manufacturer, Implex Corp., in the United States (as indicated by the submission to the U.S. FDA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. The "ground truth" for mechanical performance and material safety is established through adherence to recognized mechanical testing standards and biocompatibility testing guidelines, rather than expert consensus on imaging or clinical findings.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging) to resolve disagreements among experts. This submission focuses on objective mechanical and biocompatibility testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic or screening devices where human readers interpret results, often with and without AI assistance, to assess improvements in diagnostic accuracy. This submission concerns a surgical implant, not a diagnostic tool requiring human interpretation of results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical surgical implant, not an algorithm or AI system. Its performance is evaluated through physical mechanical tests and biocompatibility, not through algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Mechanical Testing Standards: Established engineering standards for evaluating the static and dynamic strength, fatigue, and wear characteristics of spinal implants. The "ground truth" is that the device must meet or exceed the performance of predicate devices or established safety thresholds defined by these standards.
- Biocompatibility Standards: Standards to ensure the material (Hedrocel Porous Tantalum) is safe for implantation in the human body and does not elicit adverse biological responses. The "ground truth" is that the material must demonstrate satisfactory biocompatibility as per relevant ISO or ASTM standards.
8. The Sample Size for the Training Set
Not applicable. This submission does not describe a training set in the context of machine learning or AI. The term "training set" is not relevant here as the device is a physical implant, not an AI or algorithm. The development of the device likely involved engineering design iterations and material selection, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As a training set for an AI or algorithm is not relevant, the establishment of ground truth for such a set is also not applicable. The design and validation of the Hedrocel VBR System would have relied on engineering principles, materials science data, and pre-clinical testing to optimize its mechanical properties and biocompatibility.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS KO32521 Hedrocel Vertebral Body Replacement System OCT 3 1 2003 Submitter Name Implex Corp. And Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Contact Person: Marci Halevi Phone Number: (201) 818-1800 ext. 507 Fax Number: (973) 829-0825 Date Prepared: August 13, 2003 Device Trade Name: Hedrocel Vertebral Body Replacement System Device Common Name: Vertebral Body Replacement Device 21 CFR § 888.3060 Classification Number and Name: Spinal Vertebral Body Replacement Device
Substantial The term "substantial equivalence" as used in this 510(k) 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.
- The Hedrocel® Vertebral Body Replacement System is designed to be Device 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.
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KQ32527
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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 Characteristics and indication with regard to its geometry. The material has been Comparison to used in cited predicates for other applications. Predicate Device:
Performance Data: Predicate devices that are a part of the Hedrocel Vertebral Body Replacement System were 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 predicate devices. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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OCT 31 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: K032527
Trade/Device Name: Hedrocel Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: September 30, 2003 Received: October 2, 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 mancfacturing 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,
Sincerely yours,
Mark McMahon
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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1
510(k) Number (if known) :
032527
Device Name:
The Implex Hedrocel Vertebral Body Replacement System
Indications For Use:
Hedrocel® Vertebral Body Replacement System is a vertebral body The 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED |
Concurrence of CDRH: Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K032527 |
|---|---|
| Prescription Use(Per 21 CFR 801.109) | Over-The-Counter Use |
(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.