(24 days)
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to 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 DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed 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.
The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).
The additional size cages are identical to the previously cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified.
The provided text describes specific details about a medical device known as the DePuy AcroMed VBR System, focusing on its acceptance criteria and the study used to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Modification | Risk Associated with Change | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Addition of Sizes | New sizes will not have the same mechanical characteristics as the predicate sizes. | The proposed device will perform the same as or better than the device previously cleared in K990148 and K001340. | By design, these parts are thicker in cross section than the existing devices and are therefore not worst case for the system. The worst case testing for the system has been provided in Test Report ACRO-0400-01. (This implies that the new sizes meet or exceed the performance of the predicate devices). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "worst case testing for the system has been provided in Test Report ACRO-0400-01" and that a "Design Risk Analysis was used to assess risk for the additional sizes... performed in accordance with DePuy AcroMed Design Control and Quality procedures using static testing."
- Sample Size for Test Set: Not explicitly stated in terms of number of devices or scenarios. The phrase "worst case testing" suggests a selection of samples representing the most challenging conditions.
- Data Provenance: The testing was "performed in accordance with DePuy AcroMed Design Control and Quality procedures," indicating an internal, manufacturer-driven study. The provided text doesn't specify the country of origin of the data or if it was retrospective or prospective, though internal product testing is typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This study refers to mechanical testing of a spinal implant, not a diagnostic or algorithmic device that requires expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set:
Not applicable. This is a physical device testing, not a study involving human interpretation or subjective assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is a submission for a physical medical device (spinal implant), not an AI/software device that would typically involve an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is a physical device submission.
7. The Type of Ground Truth Used:
The ground truth used for demonstrating compliance with acceptance criteria was mechanical performance metrics obtained through static testing. The performance of the new sizes was compared against the "previously cleared" predicate devices K990148 and K001340.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device and does not involve machine learning algorithms with a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is a physical device.
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APR 1 0 2003
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IX. 510 (k) Summary
| SUBMITTER: | DePuy AcroMed ™ , Inc.325 Paramount DriveRaynham, MA 02780 |
|---|---|
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | March 13, 2003 |
| CLASSIFICATION NAME: | Implant, Fixation DeviceSpinal Intervertebral Body Fixation Orthosis Device |
| PROPRIETARY NAME: | DePuy AcroMed VBR System |
| PREDICATE DEVICES: | Stackable Cage System (K990148, K001340)Surgical Titanium Mesh System(K003043, K020522, K023835, K034209) |
| INTENDED USE: | The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to 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 DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.The DePuy AcroMed 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.The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile). |
| MATERIALS: | Carbon-fiber reinforced polymer |
| DESCRIPTION: | The additional size cages are identical to the previously cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified. |
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030833
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Summary of Design Control Activities VIII.
A Design Risk Analysis was used to assess risk for the additional sizes. This risk analysis was performed in accordance with DePuy AcroMed Design Control and Quality procedures using static testing. The results of this analysis are on file at DePuy AcroMed, Inc.
| Modification | RiskAssociatedwith Change | How Risk is Addressed | AcceptanceCriteria |
|---|---|---|---|
| Addition ofSizes | New sizes willnot have thesamemechanicalcharacteristicsas the predicatesizes. | By design, these parts arethicker in cross sectionthan the existing devicesand are therefore notworst case for the system.The worst case testing forthe system has beenprovided in Test ReportACRO-0400-01. | The proposeddevice will performthe same as orbetter than thedevice previouslycleared inK990148 andK001340. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, formed by three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2003
Mr. Frank Maas Director, Regulatory Affairs DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K030833
Trade/Device Name: DePuy AcroMed VBR System Regulation Numbers: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Codes: MQP Dated: March 14, 2003 Received: March 17, 2003
Dear Mr. Maas:
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. Iisting of devices, good manufacturing practice, labeiing, 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. Frank Maas
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 A. Mulkeran
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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III. Indications for Use
KO30832 510(k) Number (if known): __
Device Name: DePuy AcroMed VBR System
Indications For Use:
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to 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 DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed 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.
The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) OR Over-The-Counter Use:
Mark N. Millerson
Division Sign-Off storative Division of Cit and Neurological L Vices
510(k) Number .
§ 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.