(28 days)
No
The summary describes a physical implant for spinal fusion and replacement, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on finite element analysis, not AI/ML model evaluation.
Yes.
The device is used to treat medical conditions such as spine tumor, trauma/fracture, and degenerative disc disease, which are therapeutic applications.
No
Explanation: The descriptions of the "Intended Use" and "Device Description" clearly identify the TETRIS™ II device as an implant used to replace vertebral bodies or facilitate intervertebral fusion. This is an active treatment device, not one designed to diagnose conditions.
No
The device description clearly describes a physical implant (hollow structural frame, surface spikes) 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:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the TETRIS™ II devices clearly indicate they are implantable surgical devices used to replace or fuse vertebral bodies in the spine. They are physical implants, not devices used to analyze biological samples.
The information provided focuses on the structural properties, surgical application, and mechanical performance of the implant, which are characteristic of a medical device used in vivo (within the body), not in vitro (outside the body).
N/A
Intended Use / 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 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.
Product codes
MQP, MAX
Device Description
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.
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 TETRIS™ II devices were compared. The simulations included those prescribed by ASTM F2077 (compression, torsion and compression shear). The results demonstrate that the additional TETRIS™ II devices do not create a new worst case device. Hence these devices are as safe and as effective as the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
1
| Technological
Characteristics: | The TETRIS™ II devices possess the same technological
characteristics 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 simulations
included those prescribed by ASTM F2077 (compression, torsion
and compression shear).
The results demonstrate that the additional TETRIS™ II devices
do not create a new worst case device. Hence these devices are
as 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
3
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
4
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