(28 days)
When used as a vertebral body replacement, the TETRIS™ II devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.
When used as an intervertebral fusion device, the TETRIS™ II devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.
The basic shape of the TETRIS™ II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
The information provided in the document describes the TETRIS™ II devices, which are spinal vertebral body replacement and intervertebral fusion devices. The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting.
Instead, the performance data provided is related to bench testing and finite element analysis (FEA), which compares the new device to its predicates.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance for TETRIS™ II Devices
The primary acceptance criteria for the TETRIS™ II devices in this submission hinge on demonstrating that their technological characteristics and mechanical performance are equivalent to predicate devices, ensuring they are "as safe and as effective."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Technological Characteristics | The TETRIS™ II devices must possess the same technological characteristics as the predicate devices. This includes intended use, basic design (hollow structural frame), material (PEEK polymer and/or titanium alloy), and sizes (widths, lengths, and heights). | The TETRIS™ II devices possess the "same technological characteristics" as the predicate devices. Specifically, they match in intended use, basic design (hollow structural frame), material (PEEK and/or titanium alloy), and available sizes (widths, lengths, and heights within the predicate range). |
| Mechanical Performance (Worst Case) | Finite element analysis (FEA) simulations of the worst-case TETRIS™ II devices should demonstrate equivalence to, or no degradation compared to, the worst-case predicate devices under ASTM F2077 prescribed tests (compression, torsion, and compression shear). | FEA simulations of the worst-case TETRIS™ II and TETRIS™ devices were compared for ASTM F2077 prescribed tests (compression, torsion, and compression shear). The results "demonstrate that the additional TETRIS™ II devices do not create a new worst case device." |
| Interpretation of Performance | The performance data should support the conclusion that the new devices are "as safe and as effective" as the predicates. | The FEA results lead to the conclusion that Tetris II devices are "as safe and as effective as the predicates." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This notification does not detail a clinical test set with human or animal subjects. The "test set" in this context refers to the simulated models used in the finite element analysis. The specific number of models or simulations is not provided, but it states "Finite element analysis simulations of the worst case TETRIS™ and TETRIS™ II devices were compared."
- Data Provenance: The data provenance is from finite element analysis (FEA) simulations, which are computational models. It is not clinical data, and thus concepts like "country of origin" or "retrospective/prospective" don't apply in the traditional sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for the FEA simulations is based on engineering principles, material properties (ASTM F136 for Ti-6Al-4V, ASTM F2026 for PEEK-OPTIMA® LT1, ASTM F560 for Tantalum), and the defined ASTM F2077 standards for mechanical testing of spinal implants. There's no indication of human experts establishing a ground truth in a diagnostic or clinical sense for these engineering simulations.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this involves engineering simulations and comparison to established ASTM standards, a human adjudication method (like 2+1, 3+1 consensus) is not relevant. The outcome is determined by adherence to engineering analysis principles and the resulting numerical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission relies on engineering bench testing and FEA, not human reader studies of clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable in the context of an algorithm or AI. The "performance" assessment refers to the mechanical integrity and equivalence of the physical device design via FEA.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth is based on established engineering standards and material properties. Specifically, the mechanical performance is evaluated against the requirements set forth in ASTM F2077 (Standard Test Methods for Static, Dynamic, and Torsional Axial Compression, Distraction, and Shear Testing of Spinal Arthrodesis Implants) and the material specifications of ASTM F136, ASTM F2026, and ASTM F560. The "ground truth" is that the device, when subjected to these simulated load conditions, performs comparably to the predicate devices and does not create a new "worst case."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This submission does not involve machine learning or AI, so there is no "training set." The FEA models are built based on geometries and material properties, not trained on data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set.
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KIZZ317
AUG 2 9 2012
510(k) Summary 8.
| Date: | |
|---|---|
| Sponsor: |
30 July 2012 SIGNUS Medizintechnik GmbH Industriestrasse 2 D-63755 Alzenau, GERMANY Tel. + 49 (0) 6023 9166-136 Fax + 49 (0) 6023 9166-161 Url: http://www.signus-med.de
Contact Person:
TETRIS™ II Trade Names: Device Classification
Classification Name:
Class II
MQP; MAX
Spinal vertebral body replacement device; Intervertebral fusion device with bone graft, lumbar 888.3060; 888.3080
Joachim Schneider, Quality Management/Regulatory Affairs
Regulation:
Device Product Codes:
Device Description:
Intended Use:
Materials:
Predicate Devices:
The basic shape of the TETRIS™ II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
When used as a vertebral body replacement, the TETRIS™ II devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.
When used as an intervertebral fusion device, the TETRIS™ II devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.
The TETRIS™ II devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 or polyetheretherketone (PEEK-OPTIMA® LT1, Invibio®) as described by ASTM F2026. Integral marker pins used in the PEEK devices are manufactured from tantalum as described by ASTM F560.
Titanium TETRIS™ (K022793) PEEK TETRIS™ (K031757) PEEK and Titanium TETRIS™ (K111792)
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| TechnologicalCharacteristics: | The TETRIS™ II devices possess the same technologicalcharacteristics as the predicate devices. These include:intended use (as described above), basic design (hollow structural frame), material (PEEK polymer and/or titanium alloy), and sizes (widths, lengths and heights are within the range(s) offered by the predicate). Therefore the fundamental scientific technology of the TETRIS™ II devices is the same as previously cleared devices. |
|---|---|
| Performance Data: | Finite element analysis simulations of the worst case TETRIS™and TETRIS™ II devices were compared. The simulationsincluded those prescribed by ASTM F2077 (compression, torsionand compression shear).The results demonstrate that the additional TETRIS™ II devicesdo not create a new worst case device. Hence these devices areas safe and as effective as the predicates. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sigmus Medizintechnik GMBH % Backroads Consulting Karen E. Warden Ph.D. President PO Box 566 Chesterland. Ohio 44026-2141
AUG 2 9 2012
Re: K122317
Trade/Device Name: TETRIS™ II devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: July 30, 2012 Received: August 01, 2012
Dear Dr. Warden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Karen E. Warden Ph.D.
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark A. Mellema
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 7.
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: TETRIS™ II devices
Indications for Use:
When used as a vertebral body replacement, the TETRIS™ II devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.
When used as an intervertebral fusion device, the TETRIS™ II devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.
Prescription Use X
Over-the-Counter Use_ . OR
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carl D'Orsi
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122317
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.