(112 days)
Not Found
No
The description focuses on a mechanical, skull-mounted guide and its use with existing neuronavigational systems and imaging, with no mention of AI/ML in its function or processing.
No.
The device is intended to assist with stereotactic guidance, placement, and fixation of surgical instruments and devices, enabling neurological procedures, rather than directly treating a condition itself.
No
The device is a surgical guidance tool, specifically a rigid trajectory array guide used for stereotactic surgical procedures, and is not designed to diagnose diseases or conditions. Its purpose is to assist in the placement of surgical instruments or devices based on pre-existing imaging data.
No
The device description clearly 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, the V-TAG device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The V-TAG is a surgical device used on the human body to guide instruments during neurological procedures. It does not analyze blood, tissue, or other bodily fluids or substances.
- The intended use is for surgical guidance and placement. The description clearly states its purpose is to assist with stereotactic guidance, placement, and fixation of surgical instruments during neurological procedures.
- The device interacts directly with the patient's skull. It is a skull-mounted device used to create a stable trajectory for surgical tools.
The V-TAG is a surgical instrument guide, not a diagnostic tool that analyzes biological samples.
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 (comma separated list FDA assigned to the subject device)
HAW
Device Description
The V-TAG device is a single-use, skull-mounted, rigid trajectory array guide used in stereotactic surgical procedures in adults. The V-TAG can be manipulated to provide a wide range of surgical trajectories into the head. An image-guided 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
preoperative and perioperative MR imaging
Anatomical Site
Neurological procedures (head)
Indicated Patient Age Range
adults
Intended User / Care Setting
Principal Operator: Neurosurgeon
Use Location: MRI Suite and OR
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 non-clinical tests performed were prospectively identified to show substantial equivalence to the predicate device. All testing was conducted on the subject device. All biocompatibility testing was in compliance with the FDA GLP regulations (21 CFR 58). The device passed all tests that were conducted indicating substantial equivalence. Thus, the non-clinical performance data demonstrate that the V-TAG performs as indicated in the Instructions for Use, and is substantially equivalent and performs as well as the predicate device that is marketed for the same intended use.
Summary Nonclinical Test Results:
- Biocompatibility:
- Cytotoxicity: ISO 10993-5-Part 5: Tests for In Vitro Cytotoxicity, In vitro mammalian cell culture test. Conclusion: Non-cytotoxic. No evidence of cell lysis or toxicity. Grade , Pyrogen Test 0.9% Sodium Chloride Solution. Conclusion: Test article deemed non-pyrogenic. No animal experienced a temperature rise 0.5 degrees C or more above its baseline.
- Bench Performance Testing:
- MRI Compatibility: ASTM 2503-13, ASTM F2052-14, ASTM F2213-06. Testing was not performed on Center Adaptor or Handle as they are not intended for use in a MR environment. Conclusion: V-TAG Base, Guide, Imaging Cartridge, and Reducer are MR safe.
- Integrity Testing- Zero time and 1 year accelerated: Evaluated dimensional verification, device stability, seal integrity of the Image Cartridge, and bond and joint strength for the Image Cartridge, Reducer Handle and tip. Conclusion: Predetermined test specifications were met for all tests at both time points.
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
§ 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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features an abstract design of a human figure. The FDA logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 23, 2018
Voyager Therapeutics, Inc. Lynn Bayless Director, Regulatory Affairs 75 Sidney Street Cambridge, Massachusetts 02139
Re: K180854
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: June 20, 2018 Received: June 21, 2018
Dear Lynn Bayless:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Valerie A. Flournoy -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180854
Device Name Voyager Trajectory Array Guide (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) |
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510(K) SUMMARY 3
SUBMITTER:
CONTACT PERSON: DATE PREPARED: DEVICE TRADE NAME: COMMON NAME: CLASSIFICATION NAME: CFR CITATION: PRODUCT CODE: PREDICATE DEVICE:
Voyager Therapeutics, Inc 75 Sidney Street Cambridge, MA 02139 USA (857) 259-5340 Lynn E. Bayless, MS, RAC June 12, 2018 V-TAGTM Stereotaxic instrument Stereotaxic instrument 882.4560 HAW Monteris UFO (K090240)
3.1 Device Description
The V-TAG™ device is a single-use, skull-mounted, rigid trajectory array guide used in stereotactic surgical procedures in adults. The V-TAG can be manipulated to provide a wide range of surgical trajectories into the head. An image-guided 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. 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.
3.2 Indication 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.
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3.3 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 guide 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. Table 1 demonstrates substantial equivalence of the V-TAG to the predicate device.
Table 4: Substantial Equivalence: V-TAG to the Predicate Device (Monteris Medical-UFO™)
| Parameter | Predicate Device:
Monteris Medical UFO™ | 510(k) Device:
V-TAG™ |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K090240 | - |
| Product | Monteris Medical UFO | Voyager Trajectory Array Guide |
| Manufacturer | Monteris Medical, Inc. | Voyager Therapeutics, Inc. |
| Indication for use | The Monteris Medical UFO is
intended to provide stereotactic
guidance, placement and fixation
for the operation of instruments or
devices during the planning and
operation of neurological
procedures performed in
conjunction with preoperative and
(or) perioperative MR or CT
imaging. These procedures include
laser coagulation, biopsies, catheter
placement and electrode
procedures. | 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. |
| Principal Operator | Neurosurgeon | Neurosurgeon |
| Use Location | MRI Suite and OR | MRI Suite and OR |
| Operating Principle | Stereotactic guiding & fixation
device | Stereotactic guiding & fixation
device |
| Design Principle | Ball and socket joint on a 3-leg
support using 3 bone screws and 9
spikes | Ball and socket joint fixed to skull
using 4 bone screws |
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| Parameter | Predicate Device:
Monteris Medical UFO™ | 510(k) Device:
V-TAG™ |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| “Frameless”
stereotaxy | Yes | Yes |
| MRI Compatible | Yes | Yes |
| Single use disposable | Yes | Yes |
| Facilitates selection
of trajectory | Yes | Yes |
| Provides alignment
for neurosurgical
device insertion | Yes | Yes |
| Facilitates temporary
fixation of
neurosurgical device | Yes | Yes |
| Verification of
trajectory alignment
by MRI | Yes | Yes |
| Range of motion | 15 degrees angular (pre-drilled
holes) or 58 degrees angular (no
pre-drilled entry hole), 360 degrees
rotation | 45 degrees angular, 360 degrees
rotation |
| Burr hole size | ,
Pyrogen Test 0.9% Sodium
Chloride Solution | Test article deemed non-
pyrogenic.
No animal experienced a
temperature rise 0.5°C or more
above its baseline. |
| Test | Test Method | Conclusion |
| Bench Performance Testing: | | |
| | | |
| MRI Compatibility | ASTM 2503-13
ASTM F2052-14
ASTM F2213-06
Testing was not performed on
Center Adaptor or Handle as
they are not intended for use in
a MR environment. | V-TAG Base, Guide, Imaging
Cartridge, and Reducer are MR
safe. |
| Integrity Testing- Zero time and 1 year accelerated: | | |
| | | |
| Integrity Testing- Zero Time
and 1 year accelerated | Evaluated dimensional
verification, device stability,
seal integrity of the Image
Cartridge, and bond and
joint strength for the Image
Cartridge, Reducer Handle and
tip. | Predetermined test
specifications were met for all
tests at both time points. |
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