(116 days)
Not Found
No
The summary describes a mechanical pedicle screw system and bone cement, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as "intended to restore the integrity of the spinal column" and is used in patients with advanced stage tumors involving the thoracic and lumbar spine. This indicates a direct medical purpose to treat a condition or restore function.
No
The VADER® Pedicle System is described as a device used to restore the integrity of the spinal column, specifically a posterior pedicle system manufactured from Carbon/PEEK comprising pedicle screws and rods. Its intended use is to provide support in patients with advanced stage tumors involving the thoracic and lumbar spine, not to diagnose medical conditions.
No
The device description explicitly states it is comprised of physical components like polyaxial pedicle screws, rods, and cannulated/fenestrated pedicle screws, all manufactured from Carbon/PEEK. This indicates a hardware-based medical device, not software-only.
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 device used to restore the integrity of the spinal column in patients with advanced stage tumors. This is a therapeutic and structural function performed in vivo (within the body).
- Device Description: The device is described as a posterior pedicle system comprised of screws and rods, which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment decisions.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used directly on the patient's spine.
N/A
Intended Use / Indications for Use
The VADER® Pedicle System is 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle with G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised.
The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes (comma separated list FDA assigned to the subject device)
PML, NKB
Device Description
The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight, S-rods and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System 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
surgeon
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 performed per ASTM F1717 (static/dynamic compression bending, static torsion) ASTM F1798 (flexion, axial gripping), ASTM F543/F2193 (screw driving torque test) and cement injection testing. Results of testing indicate the addition of the 04.5 mm screws and 300 mm spinal rods are substantially equivalent to the predicate device.
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
September 13, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
icotec ag % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K222789
Trade/Device Name: VADER® Pedicle System, G21 Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: PML, NKB
Dear Justin Eggleton:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 9, 2023. Specifically, FDA is updating this SE Letter to correct the Indications for Use Statement as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Colin O'Neill, M.B.E., OHT6: Office of Orthopedic Devices, colin.oneill(@fda.hhs.gov.
Sincerely,
Colin
O'neill -s FDA
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
January 9, 2023
Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services. To the right of the seal, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font. The logo is simple and professional, and it is easily recognizable.
icotec ag % Justin Eggleton Vice President, Spine Regulatory Affairs Mcra, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K222789
Trade/Device Name: VADER® Pedicle System, G21 Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: PML, NKB Dated: December 12, 2022 Received: December 12, 2022
Dear Justin 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
2
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 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 (OS) 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 mediation-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,
Anne D. Talley -S
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222789
Device Name VADER® Pedicle System
Indications for Use (Describe)
The VADER® Pedicle System is 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle with G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised.
The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K222789
Device Name G21 Cement
Indications for Use (Describe)
When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
ട്. 510(k) Summary
| Device Trade Name: | VADER® Pedicle System, G21 Cement |
|---|---|
| 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 |
| Vice President, Spine Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th Street NW | |
| Washington, DC 20001 | |
| jeggleton@mcra.com | |
| Date Prepared: | September 15, 2022 |
| Classifications: | G21 Cement |
| 21 CFR §888.3027, Polymethylmethacrylate (PMMA) Bone Cement | |
| VADER® Pedicle System: | |
| 21 CFR §888.3070, Thoracolumbosacral Pedicle Screw System | |
| Class: | II |
| Product Codes: | PML, NKB |
Indications For Use:
VADER®Pedicle System
The VADER® Pedicle System is 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
6
510(k) Premarket Notification
The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
G21 Cement
When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Device Description:
The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System. The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight, S-rods and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.
Primary Predicate Device:
The subject icotec VADER® Pedicle System is substantially equivalent to the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement (K200596).
Additional Predicate Devices
- . VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545)
- icotec Pedicle System (K151977) ●
Performance Testing Summary:
Mechanical testing was performed per ASTM F1717 (static/dynamic compression bending, static torsion) ASTM F1798 (flexion, axial gripping), ASTM F543/F2193 (screw driving torque test) and cement injection testing. Results of testing indicate the addition of the 04.5 mm screws and 300 mm spinal rods are substantially equivalent to the predicate device.
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to predicates cited in the section above with respect to indications, design, materials, function, manufacturing, and performance. The results of the performed tests demonstrate that the VADER® Pedicle System is substantially equivalent to legally marketed predicate devices.
Conclusion:
The icotec VADER® Pedicle System inclusive of Ø4.5 mm screws and 300 mm spinal rods are substantially equivalent to the cited predicate devices with respect to indication for use, design, function, material, and performance.