(38 days)
The Trabecular Metal 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 Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
The Trabecular Metal Vertebral Body Replacement System is designed to be a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracolumbar 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 provided text describes a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Vertebral Body Replacement System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way one would expect for a novel AI/software as a medical device (SaMD).
Here's an analysis based on the information provided, highlighting what is present and what is not:
Acceptance Criteria and Device Performance Study (as per provided text)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| - Static compression | - Passed (equivalent to predicate) |
| - Dynamic compression | - Passed (equivalent to predicate) |
| - Static torsion | - Passed (equivalent to predicate) |
| - Dynamic torsion | - Passed (equivalent to predicate) |
| - Abrasion | - Passed (equivalent to predicate) |
| Biocompatibility: | - Passed (material supported for use) |
| Intended Use: | - Performed as intended (equivalent to predicate) |
Note: The acceptance criteria are implied as meeting or being equivalent to the predicate devices and applicable standards. Specific numerical thresholds for each test (e.g., "withstanding X N of static compression") are not provided in this summary.
2. Sample Size and Data Provenance for Test Set
- Sample Size (Test Set): Not explicitly stated. The documentation refers to "test data" and "performance testing" but does not specify the number of units or samples tested for each mechanical test.
- Data Provenance: Not explicitly stated. Given the nature of mechanical and biocompatibility testing for a physical implant, the data would typically be generated in laboratory settings. There is no indication of patient data (e.g., country of origin, retrospective/prospective) because this submission is not focused on clinical performance in patients but rather on mechanical and chemical properties.
3. Number and Qualifications of Experts for Ground Truth
- Not applicable to this type of device submission. The ground truth for mechanical and biocompatibility testing is typically based on standardized testing procedures and material science principles, not expert consensus on interpretations of data like in diagnostic imaging.
4. Adjudication Method for Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for human interpretation tasks, especially in diagnostic studies, not for the direct measurement of mechanical properties or biocompatibility of an implant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This study type is used to evaluate the impact of AI on human reader performance for diagnostic tasks (e.g., imaging). The Trabecular Metal Vertebral Body Replacement System is a physical implant, not a diagnostic AI device.
6. Standalone Performance (Algorithm Only)
- Not applicable. This concept pertains to AI algorithms. The device is a physical implant, so there is no "algorithm only" performance to assess in this context.
7. Type of Ground Truth Used
- Mechanical Testing Results: The "ground truth" for the mechanical tests would be the measured physical properties (e.g., strength, durability) obtained through standardized engineering tests, compared against established performance benchmarks for predicate devices and relevant ASTM/ISO standards.
- Biocompatibility Data: The "ground truth" for biocompatibility would be the results of laboratory tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 series standards, demonstrating that the material does not elicit an unacceptable biological response.
8. Sample Size for Training Set
- Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not described here.
9. How Ground Truth for Training Set Was Established
- Not applicable. (See point 8).
Summary of what the document indicates for substantial equivalence:
The Zimmer TMT Trabecular Metal Vertebral Body Replacement System demonstrated substantial equivalence by showing that it performs equivalently to the cited predicate devices (K010378, K021025, K021967, K022563, K031823, and K032527) based on mechanical performance data and biocompatibility data. The mechanical tests included static compression, dynamic compression, static torsion, dynamic torsion, and abrasion. The conclusion was that the device will perform as intended and is equivalent to the predicate devices.
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JUN 17 2005
Zimmer TMT
Trabecular Metal Vertebral Body Replacement Special 510(k) Premarket Notification
K05 1196
Page 1 of 2
510(k) SUMMARY Trabecular Metal Vertebral Body Replacement System
| Submitter NameAnd Address: | Zimmer Trabecular Metal Technology, Inc.80 Commerce DriveAllendale. New Jersey 07401-1600 |
|---|---|
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818-1800 ext. 507 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | May 2, 2005 |
| Device Trade Name: | Trabecular Metal Vertebral Body Replacement System |
| Device Common Name: | Vertebral Body Replacement Device |
| Classification Numberand Name: | 21 CFR § 888.3060Spinal Intervertebral Body Fixation Orthrosis |
The Trabecular Metal Vertebrai Body Replacement System is Device The Traocoural Motar va replacement for a single diseased or Description: designed to be and the adjacent disc when spinal surgery through an anterior approach is indicated.
The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the available to accommon 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 Zimmer TMT Trabecular Metal Vertebral Body Replacement Indications for Use: System is comprised of vertebral body replacement devices 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 Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal 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. The Zimmer TMT Comparison to Vertebral Body Replacement System is substantially equivalent Predicate Device:
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(051196 to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, and K032527). Predicate devices that are a part of the Trabecular Metal Performance Data: 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. . Metal Vertebral Bodv TMT Trabecular Conclusion:
The Zimmer 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 2005
Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology Incorporated 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K051196
Trade/Device Name: The Trabecular Metal Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 6, 2005 Received: June 7, 2005
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. Iisting 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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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,
Stut Rurdu
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): _____K051196 _______________________________________________________________________________________________________________________________________
The Trabecular Metal Vertebral Body Replacement System Device Name:
Indications for Use:
The Trabecular Metal 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 Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
Prescription Use _ ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hupt Rhodes
Division of General, Restorative, and Neurological Devices
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.