(380 days)
Not Found
No
The description focuses on mechanical components and performance testing, with no mention of AI or ML.
Yes
The device is a vertebral body replacement system intended to treat collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, which is a therapeutic purpose.
No
Explanation: The device is a vertebral body replacement system, an implantable medical device used to replace a damaged vertebral body, not to diagnose a condition.
No
The device description clearly details physical components made of medical grade titanium alloy, such as vertebral body replacements, plates, screws, and rods. There is no mention of software as a component of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a vertebral body replacement system for surgical implantation in the thoracolumbar spine. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the physical components of a spinal implant (VBR and anterior lateral fixation plate) and their materials. This aligns with a surgical device, not an IVD.
- Performance Studies: The performance studies listed (static compression, torsion, subsidence, expulsion, fatigue) are mechanical tests relevant to the structural integrity and performance of a spinal implant, not tests related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the DSC/ALF Spinal System is a surgical implant device, not an In Vitro Diagnostic device.
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 (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 spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with Sintea Biotech's PLS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autograft.
Product codes (comma separated list FDA assigned to the subject device)
MQP, KWQ
Device Description
This 510(k) consists on the submission to add additional lengths and cross-sections, an improved locking mechanism, cage body redesign, and end-plate charges to a previously cleared system. 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 module, which enables the former to be locked in the most suitable position by means of two screws. These screws are inserted into two tooth rails on the internal cage, on both the anterior and posterior part, and mechanically lock the two modules. Both modules have endplates that optimize the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The cages present a symmetrical geometry in order to make device placement simpler for the surgeon. 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. 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 (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)
- Static compression - This test on the new device achieved better results than those of the predicate device.
- Static torsion - This test on the new device achieved better results than those of the predicate device.
- Subsidence – This test on the new device achieved better results than those of the predicate device.
- Expulsion - This test on the new device achieved comparable results to those of the predicate device.
- Fatigue compression - This test on the new device achieved better results than those of the predicate device.
- Fatigue torsion - This test on the new device achieved comparable results to those of the predicate device.
Testing standards followed: ASTM F2077 ASTM F2267
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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JUL 21 2011
sintea PLUSTEK
DSC/ALF Spinal System 510(k) Summary June 2010
Sintea Plustek, LLC. Company: 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 (305) 673-6226
Proprietary Trade Name: DSC/ALF System II.
888.3060 Regulation Number: Spinal Intervertebral Body Fixation Orthosis Regulation Name: Product Code: MQP, KWQ
III. Product Description
Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L
Miami Beach, FL 33139
P. 305-673-6226 F. 305-673-3312
l.
This 510(k) consists on the submission to add additional lengths and cross-sections, an improved locking mechanism, cage body redesign, and end-plate charges to a previously cleared system. 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 module, which enables the former to be locked in the most suitable position by means of two screws. These screws are inserted into two tooth rails on the internal cage, on both the anterior and posterior part, and mechanically lock the two modules. Both modules have endplates that optimize the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The cages present a symmetrical geometry in order to make device placement simpler for the surgeon. 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. 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 (TI-LS) 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 spinal 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 spinal system is intended to be used with autograft.
Performance Data - Overview V.
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Static compression - This test on the new device achieved better results than those of the predicate device.
-
Static torsion - This test on the new device achieved better results than those of the predicate device.
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Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312
Image /page/1/Picture/1 description: The image shows the logo for sinteaPLUSTEK. The logo consists of the word "sinteaPLUSTEK" in a simple, sans-serif font. The word is enclosed in a curved shape that resembles a parenthesis or a crescent moon. The logo is simple and modern, and the use of a single color makes it easy to reproduce.
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Subsidence – This test on the new device achieved better results than those of the predicate device.
-
Expulsion - This test on the new device achieved comparable results to those of the predicate device.
-
Fatigue compression - This test on the new device achieved better results than those of the predicate device.
-
Fatigue torsion - This test on the new device achieved comparable results to those of the predicate device.
Testing standards followed: ASTM F2077 ASTM F2267
VI. Substantial Equivalence
Sintea Plustek, LLC. believes that the additions to the DSC/ALF Spinal System are substantially equivalent to the Sintea Biotech's DSC/ALF Spinal System (K070181) with respect to functional design, indications for use, principles of operation, performance, and materials.
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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sintea Plustek, LLC % Ms. Danielle Wernikowski 407 Lincoln Road, Suite 10L Miami Beach, FL 33139
JUL 2 1 2011
Re: K101886
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: July 06, 2011 Received: July 11, 2011
Dear Ms. Wernikowski:
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
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Page 2 - Ms. Danielle Wernikowski
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.
E. I. Keith
o Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312
Image /page/4/Picture/1 description: The image shows the logo for "sintea PLUSTEK". The logo consists of the company name written in a simple, sans-serif font. The entire name is enclosed within a double-lined oval shape, adding a visual element to the design. The text and oval are black.
Indications for Use
K101886 510(k) Number (if known):
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 spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with Sintea Biotech's PLS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autograft.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
signature
(Division Sign-Off) Dision of Surgical, Orthopedic. and Restorative Devices
510(k) Number K101886
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