(89 days)
Not Found
No
The device description and intended use focus on the mechanical components and surgical application of a vertebral body replacement system, with no mention of AI or ML technologies.
Yes
The device replaces a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which is a therapeutic intervention aimed at restoring function and alleviating symptoms.
No
This device is a vertebral body replacement system, an implant used in surgery to replace a damaged or unstable vertebral body. Its purpose is therapeutic (restorative/supportive), not diagnostic.
No
The device description clearly outlines physical components made of titanium alloy, such as a vertebral body replacement (VBR) and an anterior lateral fixation plate (ALF), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The DSC/ALF Spinal System is a physical implant designed to replace a vertebral body in the spine. It is a surgical device used in vivo (within the body), not in vitro (outside the body).
- Intended Use: The intended use is to replace a damaged vertebral body due to tumor or trauma, which is a surgical intervention, not a diagnostic test performed on a specimen.
The provided information clearly describes a surgical implant and its intended use in the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the use of bone grafting material with the DSC/ALF System is optional.
The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the DSC/ALF system is intended to be used with bone graft.
Product codes
MQP, KWQ
Device Description
The Sintea Biotech DSC/ALF system is a dorsolumbar somatic vertebral body replacement device with its own supplemental fixation. The DSC/ALF Spinal System provides two basic components: A VBR (DSC) and an anterior lateral fixation plate (ALF). The DSC has a hollow internal module that can slide in relation to an external tightening module, which enables the former to be locked in the most suitable position by means of two screws for each individual case. A safety screw is also provided. Both modules can be completed with extremity covers that optimise the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The ALF is composed of two plates that connect to the anterior side of a vertebra by two screws. The two plates are connected by a rod that ranges from 32mm to 92mm in length. All components of the DSC/ALF Spinal System are made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5), thoracolumbar spine (TI-L5)
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 in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 2004 is presented in the body of the 510(k).
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.
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DSC/ALF Spinal System 510(k) Summary December 2006
- I. Company: Sintea Biotech, Inc. 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 (305) 673-6226
| II. Proprietary Trade Name: | DSC/ALF Spinal System |
|---|---|
| Regulation Number: | 888.3060 |
| Regulation Name: | Spinal Intervertebral Body Fixation Orthosis |
| Product Code: | MQP, KWQ |
III. Product Description
The Sintea Biotech DSC/ALF system is a dorsolumbar somatic vertebral body replacement device with its own supplemental fixation. The DSC/ALF Spinal System provides two basic components: A VBR (DSC) and an anterior lateral fixation plate (ALF). The DSC has a hollow internal module that can slide in relation to an external tightening module, which enables the former to be locked in the most suitable position by means of two screws for each individual case. A safety screw is also provided. Both modules can be completed with extremity covers that optimise the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The ALF is composed of two plates that connect to the anterior side of a vertebra by two screws. The two plates are connected by a rod that ranges from 32mm to 92mm in length. All components of the DSC/ALF Spinal System are made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136.
IV. Indications
The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the use of bone grafting material with the DSC/ALF System is optional.
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V. Performance Data
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 2004 is presented in the body of the 510(k).
VI. Substantial Equivalence
Sintea Biotech, Inc. believes that the DSC/ALF Spinal System is substantially equivalent to the VBR™ (K003155) Made by Ulrich GmbH & Co, with respect to functional design, indications for use, principles of operation, and performance. The material used in the Sintea Biotech DSC/ALF Spinal System is the same as the predicate device.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sintea Biotech % Mr. Gustavo A. Rios Regulatory Affairs 407 Lincoln Rd. Suite 10L Miami Beach, Florida 33139
APR 1 8 2007
Re: K070181
Trade/Device Name: DSC/ALF Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP, KWQ Dated: January 8, 2007 Received: January 19, 2007
Dear Mr. Rios:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Gustavo A. Rios
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 marketed 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 Manufacturers, 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/industry/support/index.html.
Sincerely vours.
Harbare Pnechup
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K07018)
Device Name: DSC/ALF Spinal System
Indications for Use:
The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the DSC/ALF system is intended to be used with bone graft.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Carlane Buens
Division of General. Restorati and Neurological Devices
510(k) Number K070181
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