(165 days)
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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
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.
I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them in the format you requested.
Specifically, the document is an FDA 510(k) clearance letter and summary for a pedicle screw system. While it mentions "performance testing summary" and "engineering rationales for mechanical testing, biocompatibility assessment, and clinical evidence" to demonstrate substantial equivalence, it does not provide the specific acceptance criteria, reported device performance metrics against those criteria, details of a study (like sample size, data provenance, ground truth establishment, or expert involvement), or any information about AI assistance or standalone algorithm performance.
Therefore, I cannot fulfill your request for items 1 through 9.
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May 22, 2020
Icotec AG % Justin Eggleton Vice President, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K193423
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: April 30, 2020 Received: April 30, 2020
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
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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,
Colin O'Neill, M.B.E. Acting 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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Indications for Use
510(k) Number (if known) K193423
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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
| 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) |
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510(k) Summary
| Device Trade Name: | VADER®one Pedicle System MIS and LightMore® PedicleSystem 6.0 |
|---|---|
| Manufacturer: | icotec agIndustriestrasse 129450 AltstättenSwitzerlandwww.icotec-medical.comPhone: +41 71 757.0000 |
| Contact: | Ms. Marina HessCQO/Management Representativeicotec ag |
| Prepared by: | Mr. Justin EggletonVice President, Spine Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001jeggleton@mcra.com |
| Date Prepared: | April 27, 2020 |
| Classifications: | 21 CFR §888.3070, Pedicle screw spinal system |
| Class: | II |
| Product Codes: | NKB |
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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
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
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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 Devices:
The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to the icotec VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545).
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) ●
- CarboFix Pedicle Screw System (K182377) ●
- Medtronic CD Horizon Astute Spinal System (K19066) o
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 performance of the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 was assessed using engineering rationales for mechanical testing, biocompatibility assessment, and clinical evidence.
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 engineering rationales and justifications demonstrate that the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to legally marketed predicate devices.
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.
N/A