(108 days)
No
The summary describes a mechanical pedicle screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to restore the integrity of the spinal column in patients with advanced stage tumors, which addresses a medical condition and aims to provide therapeutic benefit by stabilizing the spine.
No
Explanation: The device description states that the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are "posterior pedicle systems manufactured from Carbon/PEEK... and comprised of polyaxial pedicle screws and curved, straight and J-rods." These are implantable devices used in spinal surgery, not diagnostic tools. Their intended use is to restore spinal column integrity and provide surgical approaches, not to identify or characterize diseases or conditions.
No
The device description explicitly states that the device is comprised of physical components (polyaxial pedicle screws and rods) manufactured from Carbon/PEEK. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text describes a surgical implant (pedicle system) used to stabilize the spine. It is physically implanted into the patient's body during surgery.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The VADER® one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
NKB, NKR
Device Description
The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 can be used for single or multiple level fixations in the non-cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine (non-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)
The testing of the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0includes:
- ASTM F543 Screw Testing
- ASTM F1717 Pedicle Screw System Testing
- ASTM F1798 Flexion Bending and Torsional Gripping
- Biocompatibility Assessment
- Clinical Data
The non-clinical tests performed by the company include static and dynamic compression per ASTM F1717 and screw testing per ASTM F543 and ASTM F1798. The results of the performed tests demonstrate that the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to legally marketed predicate devices.
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.
K182377, K151977, K082797, K113058
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.
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
§ 888.3070 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2019
icotec ag % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K190545
Trade/Device Name: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: May 24, 2019 Received: May 28, 2019
Dear Mr. Eggleton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190545
Device Name
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
Indications for Use (Describe)
The VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The VADER® one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| Device Trade Name: | VADER®one Pedicle System MIS and LightMore® Pedicle
System 6.0 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | icotec ag
Industriestrasse 12
9450 Altstätten
Switzerland
www.icotec-medical.com
Phone: +41 71 757.0000 |
| Contact: | Ms. Marina Hess
CQO/Management Representative
icotec ag |
| Prepared by: | Mr. Justin Eggleton
Senior Director, Spine Regulatory Affairs
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
jeggleton@mcra.com |
| Date Prepared: | March 1, 2019 |
| Classifications: | 21 CFR §888.3070, Pedicle screw spinal system |
| Class: | II |
| Product Codes: | NKR |
Indications for Use:
The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion
The VADER®one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.
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Device Description:
The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 can be used for single or multiple level fixations in the non-cervical spine.
Primary Predicate Device:
The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to the CarboFix CarboClear Pedicle System (K182377).
Additional Predicate Devices:
The VADER one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to additional predicate devices:
- icotec Pedicle System (K151977)
- Blackstone Pedicle Screw System (K082797)
- Corelink Tiger Spine System (K113058)
Reference Device:
The subject 510(k) references the icotec Interbody Cage System (K172480) since it has the same BlackArmor® material, surface coating (Ti-iT®), and the device is used in the same anatomical area.
Performance Testing Summary:
The testing of the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0includes:
- ASTM F543 Screw Testing ●
- ASTM F1717 Pedicle Screw System Testing ●
- ASTM F1798 Flexion Bending and Torsional Gripping ●
- Biocompatibility Assessment ●
- Clinical Data
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance. The non-clinical tests performed by the company include static and dynamic compression per ASTM F1717 and screw testing per ASTM F543 and ASTM F1798. The results of the performed tests demonstrate that the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to legally marketed predicate devices.
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Conclusion:
The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate devices.