(15 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a traditional anterior cervical plate system, with no mention of AI or ML.
Yes
The device is intended for anterior cervical fixation for various medical conditions, including degenerative disc disease, trauma, and spinal stenosis, with the goal of providing stability and promoting fusion in the cervical spine. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is an implantable plate and screw system designed for surgical fixation in the cervical spine. Its function is to provide structural support, not to diagnose a condition.
No
The device description explicitly states it consists of bone plates and screws made from Titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The TOSCA® Anterior Cervical Plate System is a surgical implant consisting of plates and screws made of titanium alloy. It is used to fix the cervical spine.
- Intended Use: The intended use is for anterior cervical fixation for various spinal conditions. This involves surgically implanting the device into the body.
The device is a surgical implant used in vivo (within the body) for structural support and fixation, not for testing samples in vitro (outside the body).
N/A
Intended Use / Indications for Use
The TOSCA® Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities on curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The TOSCA® Anterior Cervical Plate System consists of various sizes of bone plates and screws that are either fixed angle or variable angle. The screws are used to secure the plates to the vertebral bodies of the cervical spine though the anterior approach. The plates and screws are made from Titanium alloy Ti64Al4V, are in conformance with ASTM F136-98, and are supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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)
Mechanical testing was conducted, and data collected, in accordance with ASTM 1717 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose.
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
§ 888.3060 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
NOV 2 3 2004
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | SIGNUS Medizintechnik GMBH
Brentanostr 9, Alzenau, Germany D-63755
Phone: 49-6023 9166-0 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy L. Gray RN, BS, RAC |
| Date Prepared: | November 5, 2004 |
| Trade Name: | The TOSCA® Anterior Cervical Plate System |
| Classification, Name
and Number: | Class II
21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Product Code: | KWQ |
| Predicate Device(s): | The subject device is equivalent to the following devices:
The SCI Anterior Cervical Plate System (K990005), manufactured
by Spinal Concepts, Inc.; and The EBI Anterior Plate System (K943694 - K002980)
Manufactured by EBI, L.P. |
| Device Description: | The TOSCA® Anterior Cervical Plate System consists of various sizes of
bone plates and screws that are either fixed angle or variable angle. The
screws are used to secure the plates to the vertebral bodies of the cervical
spine though the anterior approach. The plates and screws are made from
Titanium alloy Ti64A14V, are in conformance with ASTM F136-98, and
are supplied non-sterile. |
| Intended Use: | The TOSCA® Anterior Cervical Plate System is intended for anterior
cervical fixation for the following indications: degenerative disc disease
(as defined by neck pain of discogenic origin with degeneration of the disc
confirmed by patient history and radiographic studies), spondylolisthesis,
trauma (i.e. fracture or dislocation), spinal stenosis, deformities on
curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor,
pseudoarthrosis, and failed previous fusion. |
| Functional and
Safety Testing: | Mechanical testing was conducted, and data collected, in accordance with
ASTM 1717 to ensure the device performs according to specification, to
verify that the device is able to withstand clinical loading and maintain
mechanical integrity, and is suited for its intended purpose. |
| Conclusion: | SIGNUS Medizintechnik GMBH considers the TOSCA® Anterior
Cervical Plate System to be equivalent to the predicate devices listed
above. This conclusion is based upon the devices' similarities in
functional design, materials, and indications for use. |
Confidential
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
Ms. Tracy L. Gray Principal Consultant Alquest, Inc. 4050 Olson Memorial Hwy, Suite 350 Minneapolis, Minnesota 55422
Re: K043082
Trade/Device Name: The TOSCA® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 5, 2004 Received: November 8, 2004
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimered prior to rialy 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 r ou may, mereleve, mains of the Act include requirements for annual registration, listing 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 n your de rise is exactional controls. Existing major regulations affecting your device can may or can been 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.
2
Page 2 – Ms. Tracy L. Gray
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 precred 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 Mace gacturers, 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/dsma/dsmamain.html
Sincerely yours,
Mark Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K
Device Name: The TOSCA® Anterior Cervical Plate System
Indications For Use: The TOSCA® Anterior Cervical Plate System is intended for Indications i of OSC. The TOGON - Allenter Conomic degenerative disc disease (as arnehol cervical likation for the rollowing mith degeneration of the disc confirmed by detined by neck pain of alooogenis shift min designing and trauma (i.e. fracture or patient filstory and fadiographie stadios), open in the scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.
Prescription Use __ X_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ffice of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices 1043087 510(k) Number.
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