(231 days)
No
The device description and performance studies focus solely on the mechanical properties and design of spinal implants (screws, rods, crosslinks, and connectors). There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions, which directly relates to treating medical conditions.
No.
Explanation: The provided text describes a "Posterior Lumbar System Multi-Axial Screw" which is a surgical implant designed to provide immobilization and stabilization to the spine. Its intended use is therapeutic (adjunct to fusion, treatment of instabilities/deformities) rather than diagnostic. The "Indications for Use" section lists conditions it treats, not conditions it diagnoses.
No
The device description clearly states the components are made of medical grade titanium alloy and describes physical components like crosslinks and rod-to-rod connectors. This indicates a hardware-based medical device.
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 system for stabilizing the spine in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a spinal implant system (screws, rods, crosslinks, connectors) made of medical-grade materials. This aligns with a surgical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is implanted in vivo (inside the body) to provide structural support.
N/A
Intended Use / Indications for Use
The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.
The Posterior Lumbar System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to Sacrum) with removal of the implants after the attainment of a solid fusion.
Product codes
KWP, MNH, MNI
Device Description
As a special 510(k) submission, the predicate device to which we are claiming equivalence is our own product, Sintea Biotech's Posterior Lumbar System Multi-axial Screws - DESCO (K081631). This 510(k) submission represents a modification to the predicate, in which the cross-links and connectors are added to the already cleared system.
The crosslinks and rod-to-rod connectors are used to connect two rods in a pedicle screw construct. The purpose is to add further stability to the system. The components are made of medical grade, FDA recognized, titanium alloy (ASTM F316). The rigid crosslinks come in sizes ranging from 15mm to 48mm, in increments of 3mm, and the modular crosslinks come in 3 sizes (small 30-38mm, medium 37-52mm, and large 50-70mm), but can lock at any size in between the ranges. The variable flat crosslinks contain 2 components an SX (left) and DX (right). The two are connected by a nut that can lock the connector along any length: small 26.6-33.6mm, medium 36.6-53.6mm, and large 46.6-73.6mm. The cross-links are used to connect parallel constructs along the spinal column to stabilize the system. The rod-to-rod connectors come in domino form and longitudinal. The rod-to-rod connectors will connect two rods in series either along the same axis by utilizing the longitudinal connector or offset the rod laterally by approximately 5.5mm (the diameter of a rod) utilizing the domino connector. The crosslinks and rod-to-rod connectors utilize a nut which threads through the component and comes to contact with the rod to lock the component to the rod along the construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine, thoracic, lumbar, and sacral spine, L5-S1 vertebra
Indicated Patient Age Range
skeletally mature patients
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)
The mechanical tests performed on the worst case crosslink construct were performed in accordance with ASTM F1717. The tests performed were static compression, static torsion, and dynamic compression/fatigue. The tests performed on the rod-to-rod connectors were in accordance with ASTM F1798 and included static compression and torsion tests. In all cases. the worst case construct of the new cross-link versions performed better than the previously cleared cross-link. In addition the new version obtained results demonstrating greater stiffness, and higher vield and ultimate strength.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
K112611 Page lot?
APR 2 5 2012
sinteaPLUSTEK
Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312
Sintea Plustek's Posterior Lumbar System 510(k) Summary March 2012
1. Company: Sintea Plustek, LLC. 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 (305) 673-6226
| II. | Proprietary Trade Name: | Sintea Plustek's Posterior Lumbar System. |
|---|---|---|
| Regulation Number: | 888.3050, 888.3070 | |
| Regulation Name: | Spinal Interlaminal Fixation Orthosis, | |
| Spondylolosthesis Spinal Fixation Device System, and | ||
| Pedicle Screw Spinal System | ||
| Product Class: | Class II | |
| Product Code: | KWP, MNH, MNI |
III. Product Description
As a special 510(k) submission, the predicate device to which we are claiming equivalence is our own product, Sintea Biotech's Posterior Lumbar System Multi-axial Screws - DESCO (K081631). This 510(k) submission represents a modification to the predicate, in which the cross-links and connectors are added to the already cleared system.
IV. Indications
The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.
The Posterior Lumbar System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).
The Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to Sacrum) with removal of the implants after the attainment of a solid fusion.
1
Page 2 of 2 K112611
Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312
sinteaplustek
V. Device Description
The crosslinks and rod-to-rod connectors are used to connect two rods in a pedicle screw construct. The purpose is to add further stability to the system. The components are made of medical grade, FDA recognized, titanium alloy (ASTM F316). The rigid crosslinks come in sizes ranging from 15mm to 48mm, in increments of 3mm, and the modular crosslinks come in 3 sizes (small 30-38mm, medium 37-52mm, and large 50-70mm), but can lock at any size in between the ranges. The variable flat crosslinks contain 2 components an SX (left) and DX (right). The two are connected by a nut that can lock the connector along any length: small 26.6-33.6mm, medium 36.6-53.6mm, and large 46.6-73.6mm. The cross-links are used to connect parallel constructs along the spinal column to stabilize the system. The rod-to-rod connectors come in domino form and longitudinal. The rod-to-rod connectors will connect two rods in series either along the same axis by utilizing the longitudinal connector or offset the rod laterally by approximately 5.5mm (the diameter of a rod) utilizing the domino connector. The crosslinks and rod-to-rod connectors utilize a nut which threads through the component and comes to contact with the rod to lock the component to the rod along the construct.
·Performance Data VI.
The mechanical tests performed on the worst case crosslink construct were performed in accordance with ASTM F1717. The tests performed were static compression, static torsion, and dynamic compression/fatigue. The tests performed on the rod-to-rod connectors were in accordance with ASTM F1798 and included static compression and torsion tests. In all cases. the worst case construct of the new cross-link versions performed better than the previously cleared cross-link. In addition the new version obtained results demonstrating greater stiffness, and higher vield and ultimate strength.
VII. Substantial Equivalence
Sintea Plustek, LLC. has confirmed through FEA and mechanical testing that the additions to the Posterior Lumbar System Multi-axial Screws - DESCO are substantially equivalent to Sintea Biotech's Posterior Lumbar System - DESCO (K081631) with respect to functional design, indications for use, and principles of operation, performance, and materials.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, symbolizing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 5 2012
Sintea Plustek, LLC % Ms. Danielle Wernikowski 407 Lincoln Road, Suite 10L Miami Beach, Florida 33139
Re: K112611
Trade/Device Name: Posterior Lumbar System Multi-Axial Screws - DESCO Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: March 19, 2012 Received: March 29, 2012
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Danielle Wernikowski
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/CDRH0ffices/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,
Erinell Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Sintea Plustek, LLC. 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312
Indications for Use
510(k) Number (if known): K112611
Device Name: Posterior Lumbar System Multi-Axial Screws - DESCO
Indications for Use:
The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.
The Posterior Lumbar System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1,3 to Sacrum) with removal of the implants after the attainment of a solid fusion.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Dage I of I
sinteaplusTEK
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Diffsion of Surgical, Orthopedic, and Restorative Devices
KII 26 III 510(k) Number_
-Page 1 of _