(90 days)
No
The summary describes reusable surgical instruments used in conjunction with a navigation system. There is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself is mentioned, but the focus is on the instruments' compatibility and accuracy with that system, not on any AI/ML capabilities within the instruments or the navigation process described.
No.
The device is described as surgical instruments used to assist the surgeon in precisely locating anatomical structures during spinal surgery for the preparation and placement of pedicle screws. It does not provide any therapeutic effect itself but rather aids in a surgical procedure.
No
The device is a set of surgical instruments used for the preparation and placement of pedicle screws during spinal surgery, intended to assist in accurately locating anatomical structures. It is used in conjunction with a stereotactic navigation system. Its purpose is to guide the surgeon, not to diagnose a medical condition.
No
The device description explicitly lists physical instruments (awls, probes, taps, drivers, and adapters) as components of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that these are "reusable instruments used for the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures."
- Intended Use: The intended use is to assist in surgical procedures, not to perform diagnostic tests on biological samples.
- Input: The input is imaging data (CT, MR, fluoroscopy, digitized landmarks), not biological samples.
The device is a surgical instrument intended for use in a surgical setting, not a diagnostic test performed in a laboratory or clinical setting on patient samples.
N/A
Intended Use / Indications for Use
icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Product codes
OLO
Device Description
The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System Navigated Instruments.
icotec's VADER® Pedicle System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with navigation system Medtronic StealthStation® in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®II clamps and arrays.
The VADER® Pedicle System Navigated Instruments include awls, probes, taps, drivers and adapters. The VADER® Pedicle System Navigated Instruments are to be used with the FDAcleared icotec pedicle screws cleared under K222789. K200596. K193423 and K190545.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
vertebra
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)
The performance evaluation included a one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the VADER® Pedicle System Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock™ tracker and SureTrak®II clamps and arrays, and to demonstrate substantial equivalence to the predicate instruments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K222789, K200596, K193423, K190545
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym "FDA" appearing above the full name of the agency.
September 1, 2023
Icotec ag % Justin Eggleton VP, Spine Regulatory Affairs Mcra, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K230861
Trade/Device Name: VADER® Pedicle System Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO
Dear Justin Eggleton:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on June 26, 2023. Specifically, FDA is updating this SE Letter due to a typo in the clearance date, which was incorrectly dated as September 27, 2023.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, M.P.H., OHT6: Office of Orthopedic Devices, 301-796-2356, Shumaya.Ali@fda.hhs.gov.
Sincerely,
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
September 27, 2023
Image /page/1/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is the acronym FDA in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
icotec ag % Justin Eggleton VP. Spine Regulatory Affairs MCRA, LLC 803 7th Street North West Washington, District of Columbia 20001
Re: K230861
Trade/Device Name: VADER® Pedicle System Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 29, 2023 Received: March 29, 2023
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
2
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 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,
Image /page/2/Picture/5 description: The image shows the name "Shumaya Ali-S" in a simple, sans-serif font. The text is black and appears to be against a white or light-colored background. The name is likely a person's name, possibly for identification or labeling purposes.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230861
Device Name
VADER® Pedicle System Navigated Instruments
Indications for Use (Describe)
icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☒ Production Use (Part 21 CFR 601 Subpart D) ☐ Own-Use Stock (21 CFR 601 Subpart C) | ☒ Production Use (Part 21 CFR 601 Subpart D) | ☐ Own-Use Stock (21 CFR 601 Subpart C) |
| ☒ Production Use (Part 21 CFR 601 Subpart D) | ☐ Own-Use Stock (21 CFR 601 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K230861
| Device Trade Name: | VADER® Pedicle System Navigated Instruments | ||||||
|---|---|---|---|---|---|---|---|
| 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, Head of Musculoskeletal Regulatory Affairs | |||||||
| MCRA, LLC | |||||||
| 803 7th Street NW | |||||||
| Washington, DC 20001 | |||||||
| jeggleton@mcra.com | |||||||
| Date Prepared: | June 27, 2023 | ||||||
| Classifications: | 21 CFR §882.4560, Stereotaxic instrument | ||||||
| Class: | II | ||||||
| Product Codes: | OLO |
Indications For Use:
icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Device Description:
The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System Navigated Instruments.
icotec's VADER® Pedicle System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist
5
the surgeon in precisely locating anatomical structures. These instruments are designed for use with navigation system Medtronic StealthStation® in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®II clamps and arrays.
The VADER® Pedicle System Navigated Instruments include awls, probes, taps, drivers and adapters. The VADER® Pedicle System Navigated Instruments are to be used with the FDAcleared icotec pedicle screws cleared under K222789. K200596. K193423 and K190545.
Primary Predicate Device:
The subject VADER® Pedicle System Navigated Instruments are substantially equivalent to the VERTICALE® Navigation Instruments (K223649).
Reference Device:
The 510(k) submission referenced the FDA-cleared icotec pedicle screws cleared under K222789, K200596. K193423 and K190545 since the subject Navigation instruments are designed solely for use with these devices.
Performance Testing Summary:
The performance evaluation included a one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the VADER® Pedicle System Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock™ tracker and SureTrak®II clamps and arrays, and to demonstrate substantial equivalence to the predicate instruments.
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to the predicate device cited in the section above with respect to indications, design, and performance. The performance testing results demonstrate that the VADER® Pedicle System Navigated Instruments are substantially equivalent to legally marketed predicate devices.
Conclusion:
The VADER® Pedicle System Navigated Instruments are substantially equivalent to the cited predicate device with respect to indication for use, design, and performance.