(28 days)
Not Found
No
The device description and performance studies focus on mechanical alignment and image-guided navigation, with no mention of AI or ML for image analysis, planning, or guidance.
No
The device is described as a "rigid trajectory array guide" used to assist with the placement and fixation of surgical instruments or devices for neurological procedures. It guides other instruments, but does not itself provide therapy.
No
The V-TAG is a surgical guide used for placement and fixation of surgical instruments, not for diagnosing conditions. It assists with the operation of neurological procedures, not in identifying diseases or conditions.
No
The device description explicitly states that the V-TAG is a "single-use, skull-mounted, rigid trajectory array guide," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The V-TAG is a surgical guidance device used during a surgical procedure. It assists with the physical placement and fixation of surgical instruments based on imaging data. It does not analyze biological specimens.
- Intended Use: The intended use clearly states its purpose is to "assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures." This is a surgical aid, not a diagnostic test performed on a sample.
The device utilizes imaging (MR imaging) and assists in a surgical procedure, which falls under the category of surgical or interventional devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.
Product codes
HAW
Device Description
The V-TAG™ device is a single-use, skull-mounted, rigid trajectory array guide used in stereotactic surgical procedures. The V-TAG can be manipulated to provide a wide range of surgical trajectories into the head. An image-quided neuronavigational system loaded with a stereotactic surgical plan is used to align the V-TAG to the planned trajectory; once aligned, the V-TAG is securely locked to provide a stable instrument guide. After positioning of the V-TAG, magnetic resonance imaging (MRI) is used to confirm alignment with the planned trajectory. Adjustment of the V-TAG may be performed in the MRI scanner to refine or change the trajectory based on updated intraoperative imaging. Intracranial placement of a neurosurgical device or surgical instrument using the V-TAG device is only to be performed after MRI confirmation of the trajectory.
The V-TAG device is a single use, MR compatible, sterile medical device consisting of a Base that is temporarily attached to the skull with four bone screws during the surgical procedure , a trajectory Guide containing seven channels to quide the insertion of 14-gauge neurosurgical devices or instruments, a Handle to assist with alignment using standard stereotactic surgical procedures, a Center Adaptor to identify the center trajectory of the Guide, an Imaging Cartridge to be filled with an FDA approved diluted gadolinium-based contrast agent (not included, no patient contact), and a Reducer for use with 16-gauge neurosurgical devices or instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging, magnetic resonance imaging (MRI)
Anatomical Site
neurological procedures, head
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
Accuracy testing was performed using the modified alignment technique for the V-TAG. For each trial, the beginning alignment was intentionally set to an error greater than 10mm. Alignment was then performed using rapid-refresh scanner sequences to manually align the center lumen of the V-TAG to the target. Projected errors were then calculated. If the projected error was more than 4mm, alignment was performed again. All placements met the acceptance criteria of X, Y, Z errors ≤2.0mm and angular error of ≤2°.
Performance data demonstrates that the V-TAG is as safe and effective as its predicate.
Key Metrics
X, Y, Z errors ≤2.0mm and angular error of ≤2°
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
The purpose of this Special 510(k) notice was to modify the instructions for use of the device to allow for trajectory adjustments in the MRI scanner based on interoperative imaging.
§ 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 shows 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.
June 21, 2019
MRI Interventions, Inc. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004
Re: K191400
Trade/Device Name: Voyager Trajectory Array Guide (V-TAG) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 24, 2019 Received: May 24, 2019
Dear John Smith:
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
1
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,
Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
K191400
Device Name V-TAG
Indications for Use (Describe)
The V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
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K191400 - Page 1 of 2
510(k) SUMMARY
MRI Interventions V-TAG
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan Lovells, US LLP 555 Thirteenth Street, NW Washington, DC 20004 Phone: 202-637-5600 Fax: 202-637-5910
Contact Person: John J. Smith, M.D., J.D.
Date Prepared: May 24, 2019
Name of Device and Name/Address of Sponsor
ClearPoint System™ MRI Interventions, Inc. 5 Musick Irvine, CA 92618
Common or Usual Name: Neurological Stereotaxic Instrument
Classification: 21 C.F.R. §882.4560
Product Code: HAW
Predicate Device: Voyager Trajectory Array Guide (V-TAG) (K180854)
Purpose of the Special 510(k) notice.
The V-TAG is a modification to the predicate V-TAG (K180854).
Intended Use
The V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.
Device Description
The V-TAG™ device is a single-use, skull-mounted, rigid trajectory array guide used in stereotactic surgical procedures. The V-TAG can be manipulated to provide a wide range of
4
surgical trajectories into the head. An image-quided neuronavigational system loaded with a stereotactic surgical plan is used to align the V-TAG to the planned trajectory; once aligned, the V-TAG is securely locked to provide a stable instrument guide. After positioning of the V-TAG, magnetic resonance imaging (MRI) is used to confirm alignment with the planned trajectory. Adjustment of the V-TAG may be performed in the MRI scanner to refine or change the trajectory based on updated intraoperative imaging. Intracranial placement of a neurosurgical device or surgical instrument using the V-TAG device is only to be performed after MRI confirmation of the trajectory.
Technological Characteristics
The V-TAG device is a single use, MR compatible, sterile medical device consisting of a Base that is temporarily attached to the skull with four bone screws during the surgical procedure , a trajectory Guide containing seven channels to quide the insertion of 14-gauge neurosurgical devices or instruments, a Handle to assist with alignment using standard stereotactic surgical procedures, a Center Adaptor to identify the center trajectory of the Guide, an Imaging Cartridge to be filled with an FDA approved diluted gadolinium-based contrast agent (not included, no patient contact), and a Reducer for use with 16-gauge neurosurgical devices or instruments.
Performance Data
Accuracy testing was performed using the modified alignment technique for the V-TAG. For each trial, the beginning alignment was intentionally set to an error greater than 10mm. Alignment was then performed using rapid-refresh scanner sequences to manually align the center lumen of the V-TAG to the target. Projected errors were then calculated. If the projected error was more than 4mm, alignment was performed again. All placements met the acceptance criteria of X, Y, Z errors ≤2.0mm and angular error of ≤2°.
Substantial Equivalence
The modified V-TAG has the same intended use and similar indications, principles of operation, and technological characteristics as its predicate. The minor differences in the V-TAG's instructions for use do not raise any new questions of safety or effectiveness. Performance data demonstrates that the V-TAG is as safe and effective as its predicate. Thus, the V-TAG is substantially equivalent to its predicate device.
Conclusions
The V-TAG has the exact same intended use, indications for use, and substantially similar technological characteristics as the predicate. The purpose of this Special 510(k) notice was to modify the instructions for use of the device to allow for trajectory adjustments in the MRI scanner based on interoperative imaging. Accuracy testing provided in this submission demonstrate that the modified V-TAG accuracy is equivalent to that of the predicate device. Thus, the V-TAG is substantially equivalent.