(403 days)
When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. 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 TASMIN® R 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.
The basic shape of the TASMIN® R devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open with peaked teeth that assist in anchoring and seating the implant between the vertebral bodies. There are lateral fenestrations for bony in-growth. 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 TASMIN® R device is a spinal intervertebral body fixation orthosis and intervertebral body fusion device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance (TASMIN® R) |
|---|---|
| Mechanical performance, specifically static and dynamic compression, torsion, and compression shear properties, as per ASTM F2077. | Device performance demonstrated substantial equivalence to predicate devices. |
| Subsidence properties, as per ASTM F2267. | Device performance demonstrated substantial equivalence to predicate devices. |
| Material properties (PEEK-OPTIMA® LT1, Invibio® an ASTM F2026; Tantalum an ASTM F560) | TASMIN® R is manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. Integral marker pins are manufactured from tantalum as described by ASTM F560. |
| Basic design (hollow structural frame) | TASMIN® R has a hollow structural frame with a rounded, tapered leading face. Upper and lower aspects are open with peaked teeth. Lateral fenestrations are present. |
| Sizes (widths, lengths, and heights) | Sizes are within the range(s) offered by predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The documentation refers to "worst case TETRIS™ and TASMIN® R devices" for finite element analysis and "worst case TASMIN® R devices" for physical testing. It does not specify the exact number of devices or scenarios considered. It is implied that representative "worst-case" configurations were selected for the evaluation.
- Data Provenance: The studies are described as "Finite element analysis simulations" and "Static and dynamic compression testing." This indicates the data was generated from engineering analyses and laboratory bench testing performed by the sponsor, SIGNUS Medizintechnik GmbH. The country of origin of the data is not explicitly stated, but the sponsor is based in Germany. The data is prospective in the sense that it was generated specifically for the premarket submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies performed were bench testing and finite element analysis, not clinical studies requiring expert consensus on patient data. The "ground truth" for these types of studies is established by adherence to recognized ASTM standards and engineering principles.
4. Adjudication Method for the Test Set
This information is not applicable for bench testing and finite element analysis. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical outcomes.
5. 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
An MRMC comparative effectiveness study was not conducted. The device is a medical implant, not an AI-assisted diagnostic or therapeutic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these studies was derived from:
- Recognized Industry Standards: ASTM F2077 (for compression, torsion, compression-shear) and ASTM F2267 (for subsidence properties). These standards define the methodology and expected performance for intervertebral body fusion devices.
- Engineering Principles: Finite element analysis relies on established biomechanical and engineering principles to simulate mechanical behavior.
- Material Specifications: ASTM F2026 for PEEK-OPTIMA® LT1 and ASTM F560 for Tantalum, defining the accepted properties of the materials.
8. The Sample Size for the Training Set
This information is not applicable. The studies performed were bench testing and simulations, not machine learning studies that require a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there was no training set for a machine learning algorithm. The "ground truth" for the device's performance was established by adherence to ASTM standards and engineering principles as described in point 7.
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K123758
Page 1 of 2
JAN 1 4 2014
| 510(k) Summary | |
|---|---|
| Date: | 30 November 2012 |
| Sponsor: | SIGNUS Medizintechnik GmbH |
| Industriestrasse 2 | |
| D-63755 Alzenau, GERMANY | |
| Tel. + 49 (0) 6023 9166-0 | |
| Fax + 49 (0) 6023 9166-161 | |
| Url: http://www.signus-med.de | |
| Contact Person: | Joachim Schneider, Quality Management/Regulatory Affairs |
| Trade Names: | TASMIN® R |
| Device Classification | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis; Intervertebral body fusiondevice |
| Common Name: | Vertebral Body Replacement Device; Interbody Fusion Device |
| Regulation: | 888.3060; 888.3080 |
| Device ProductCodes: | MQP; MAX |
| Device Description: | The basic shape of the TASMIN® R devices is a hollow structural framehaving a rounded, tapered leading face. The upper and lower aspectsof the implant are open with peaked teeth that assist in anchoring andseating the implant between the vertebral bodies. There are lateralfenestrations for bony in-growth. The device is available in a variety ofsizes and angulations thereby enabling the surgeon to choose the sizebest suited to the individual pathology and anatomical condition. |
| Intended Use: | When used as a vertebral body replacement, the TASMIN® R devicesare indicated for use to replace a vertebral body that has been resectedor excised due to tumor or trauma/fracture. The device is intended foruse as a vertebral body replacement in the thoracolumbar spine (fromT1 to L5) and is intended for use with supplemental internal fixation.When used as an intervertebral fusion device, the TASMIN® R devicesare intended for use at one level in the lumbar spine, from L2 to S1, forthe treatment of degenerative disc disease (DDD) with up to Grade Ispondylolisthesis. DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies.The lumbar device is to be used in patients who have had six monthsof non-operative treatment. The devices are intended for use with asupplemental internal fixation system and with autograft to facilitatefusion. |
| Materials: | The TASMIN® R devices are manufactured from polyetheretherketone(PEEK-OPTIMA® LT1, Invibio®) as described by ASTM F2026. Integralmarker pins used in the PEEK devices are manufactured from tantalumas described by ASTM F560. |
| Predicate Devices: | PEEK TETRIS™ (SIGNUS - K031757, K111792)MC+ (LDR Spine USA - K043479)Hourglass (Medtronic Sofamor Danek - K033926)Ray TFC (Surgical Dynamics – P950019)CoRoent® (NuVasive Inc. - K071795)Capstone Control (Medtronic Sofamor Danek - K120368) |
| Performance Data: | Finite element analysis simulations of the worst case TETRIS™ andTASMIN® R devices were compared. The simulations included thoseprescribed by ASTM F2077 (compression, torsion and compressionshear).Static and dynamic compression testing of the worst case TASMIN® Rdevices was performed according to ASTM F2077. In addition, thesubsidence properties were evaluated according to ASTM F2267.The results demonstrated that the TASMIN® R device performance issubstantially equivalent to the predicate devices. |
| TechnologicalCharacteristics: | The TASMIN® R devices possess the same technologicalcharacteristics as the predicate devices. These include:• performance (as described above),• basic design (hollow structural frame),• material (PEEK polymer and tantalum), and• sizes (widths, lengths and heights are within the range(s)offered by the predicate).Therefore the fundamental scientific technology of the TASMIN® Rdevices is the same as previously cleared devices. |
| Conclusion: | The TASMIN® R devices possess the same intended use and |
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technological characteristics as the predicate devices. Therefore the
TASMIN® R is substantially equivalent for its intended use.
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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 symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2014
SIGNUS Medizintechnik GmbH % Karen Warden, Ph.D. President BackRoads Consulting, Incorporated P.O. Box 566 Chesterland, Ohio 44026-2141
Re: K123758
Trade/Device Name: TASMIN® R · Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP, MAX Dated: November 19, 2013 Received: November 21, 2013
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 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
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Page 2 - Karen Warden, Ph.D
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Indications for Use Statement
510(k) Number: K123758
Device Name: TASMIN® R
Indications for Use:
When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. 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 TASMIN® R 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
OR Over-the-Counter Use
(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)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
§ 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.