(403 days)
No
The summary describes a physical implant device for spinal surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing and finite element analysis, not algorithmic performance metrics.
Yes
The device is indicated for use in surgical procedures to replace vertebral bodies or to facilitate intervertebral fusion, which are therapeutic interventions aimed at treating medical conditions such as spine tumors, trauma-induced fractures, and degenerative disc disease.
No
The device is described as an implantable vertebral body replacement and intervertebral fusion device, not a tool for diagnosing medical conditions.
No
The device description clearly describes a physical implant (hollow structural frame, teeth, fenestrations) intended for surgical implantation, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace or fuse vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of a structural frame with features for anchoring and bone growth. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical properties and structural integrity of the implant (compression, torsion, shear, subsidence), which are relevant to a surgical device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
MQP, MAX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from T1 to L5), lumbar spine (from L2 to S1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Finite element analysis simulations of the worst case TETRIS™ and TASMIN® R devices were compared. The simulations included those prescribed by ASTM F2077 (compression, torsion and compression shear).
Static and dynamic compression testing of the worst case TASMIN® R devices was performed according to ASTM F2077. In addition, the subsidence properties were evaluated according to ASTM F2267.
The results demonstrated that the TASMIN® R device performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031757, K111792, K043479, K033926, P950019, K071795, K120368
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 fusion |
| device | |
| Common Name: | Vertebral Body Replacement Device; Interbody Fusion Device |
| Regulation: | 888.3060; 888.3080 |
| Device Product | |
| Codes: | MQP; MAX |
| Device Description: | 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. | |
| Intended 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 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 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. | |
| Materials: | The TASMIN® R devices are manufactured from 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. | |
| 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™ and |
| TASMIN® R devices were compared. The simulations included those | |
| prescribed by ASTM F2077 (compression, torsion and compression | |
| shear). |
Static and dynamic compression testing of the worst case TASMIN® R
devices was performed according to ASTM F2077. In addition, the
subsidence properties were evaluated according to ASTM F2267.
The results demonstrated that the TASMIN® R device performance is
substantially equivalent to the predicate devices. |
| Technological
Characteristics: | The TASMIN® R devices possess the same technological
characteristics 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® R
devices is the same as previously cleared devices. |
| Conclusion: | The TASMIN® R devices possess the same intended use and |
:
1
.
:
.
technological characteristics as the predicate devices. Therefore the
TASMIN® R is substantially equivalent for its intended use.
·
2
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
3
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
4
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