Voyager Trajectory Array Guide (V-TAG)

K180854 · Voyager Therapeutics, Inc. · HAW · Jul 23, 2018 · Neurology

Device Facts

• Record ID: K180854
• Device Name: Voyager Trajectory Array Guide (V-TAG)
• Applicant: Voyager Therapeutics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jul 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

V-TAG is a single-use, skull-mounted, rigid trajectory array guide for stereotactic neurosurgery in adults. Device consists of a base (fixed to skull with 4 bone screws), a trajectory guide with 7 channels, handle, center adaptor, imaging cartridge (for gadolinium-based contrast), and reducer. Neurosurgeon aligns V-TAG to a pre-planned trajectory using an image-guided neuronavigational system; once aligned, V-TAG is locked to provide a stable guide for 14-gauge or 16-gauge instruments. MRI confirms alignment before intracranial instrument placement. Used in OR and MRI suites. Benefits include stable, multi-lumen trajectory guidance for precise instrument delivery during minimally invasive procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, intracutaneous toxicity, systemic toxicity, sensitization, pyrogenicity), MRI compatibility (ASTM 2503-13, F2052-14, F2213-06), and integrity testing (dimensional verification, stability, seal integrity, bond/joint strength) at zero time and 1-year accelerated aging.

Technological Characteristics

Single-use, sterile, MR-compatible stereotaxic instrument. Components: Base (4 bone screws), 7-channel Guide, Handle, Center Adaptor, Imaging Cartridge, Reducer. Materials: MR-safe components. Sterilization: 60Co Gamma Irradiation. Standards: ISO 10993 (biocompatibility), ASTM F2503-13, ASTM F2052-14, ASTM F2213-06 (MRI safety).

Indications for Use

Indicated for adult patients undergoing neurological procedures requiring stereotactic guidance, placement, and fixation of surgical instruments, including laser coagulation, biopsies, catheter placement, and electrode placement, performed with preoperative and perioperative MR imaging.

Regulatory Classification

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.

Predicate Devices

• Monteris UFO (K090240)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 [phone] 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:<br>Monteris Medical UFO™ | 510(k) Device:<br>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<br>intended to provide stereotactic<br>guidance, placement and fixation<br>for the operation of instruments or<br>devices during the planning and<br>operation of neurological<br>procedures performed in<br>conjunction with preoperative and<br>(or) perioperative MR or CT<br>imaging. These procedures include<br>laser coagulation, biopsies, catheter<br>placement and electrode<br>procedures. | The V-TAG is intended to assist<br>with stereotactic guidance,<br>placement, and fixation for the<br>operation of surgical instruments<br>or devices during the planning and<br>operation of neurological<br>procedures performed in<br>conjunction with preoperative and<br>perioperative MR imaging. These<br>procedures include laser<br>coagulation, biopsies, catheter<br>placement, and electrode<br>placement procedures. |
| Principal Operator | Neurosurgeon | Neurosurgeon |
| Use Location | MRI Suite and OR | MRI Suite and OR |
| Operating Principle | Stereotactic guiding & fixation<br>device | Stereotactic guiding & fixation<br>device |
| Design Principle | Ball and socket joint on a 3-leg<br>support using 3 bone screws and 9<br>spikes | Ball and socket joint fixed to skull<br>using 4 bone screws |

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| Parameter | Predicate Device:<br>Monteris Medical UFO™ | 510(k) Device:<br>V-TAG™ |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| “Frameless”<br>stereotaxy | Yes | Yes |
| MRI Compatible | Yes | Yes |
| Single use disposable | Yes | Yes |
| Facilitates selection<br>of trajectory | Yes | Yes |
| Provides alignment<br>for neurosurgical<br>device insertion | Yes | Yes |
| Facilitates temporary<br>fixation of<br>neurosurgical device | Yes | Yes |
| Verification of<br>trajectory alignment<br>by MRI | Yes | Yes |
| Range of motion | 15 degrees angular (pre-drilled<br>holes) or 58 degrees angular (no<br>pre-drilled entry hole), 360 degrees<br>rotation | 45 degrees angular, 360 degrees<br>rotation |
| Burr hole size | < 14 mm | < 14 mm |
| Bilateral option | Yes | Yes |
| Multi-lumen spacing | Single lumen | 7 lumens, 2.5 mm spacing |
| Sterilization Method | Ethylene oxide | 60Co Gamma Irradiation |

#### 3.4 Non-Clinical Test 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 equivlence.

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.

The tests conducted, method and overall conclusion is provided in Table 2.

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# Table 5: Summary Nonclinical Test Results

| Test | Test Method | Conclusion |
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility: | | |
| Cytotoxicity:<br>1X MEM Elution<br>(Product and packaging<br>performed according to USP) | ISO 10993-5-Part 5: Tests for<br>In Vitro Cytotoxicity<br><br>In vitro mammalian cell culture<br>test | Non-cytotoxic.<br><br>No evidence of cell lysis or<br>toxicity.<br><br>Grade <2 (mild reactivity) |
| Intracutaneous Toxicity | UNI EN ISO 10993-10-Part<br>10: Tests for Irritation and Skin<br>Sensitization<br><br>0.9 % Sodium Chloride<br>Solution: Sesame Oil, NF<br><br>Intracutaneous injection in<br>rabbits. | No biological response elicited.<br><br>No adverse observations noted<br>throughout the duration of the<br>test.<br><br>Overall mean score was 0.0 for<br>both the sodium chloride and<br>sesame oil test article extracts. |
| Systemic Toxicity: ISO Acute<br>Systemic Injection Test | UNI EN ISO 10993-11-Part<br>11: Tests for Systemic Toxicity<br><br>0.9 % Sodium Chloride<br>Solution: Sesame Oil, NF | Study requirements met.<br><br>No biological response elicited.<br><br>No mortality nor evidence of<br>systemic toxicity. |
| Sensitization | UNI EN ISO 10993-10- Part<br>10: Tests for Irritation and Skin<br>Sensitization<br>ASTM F 720-81 (2002)<br><br>0.9% Sodium Chloride<br>Solution:<br>Sesame Oil, NF | Non-sensitizing.<br><br>Test article extracts showed no<br>evidence of causing delayed<br>dermal contact sensitization in<br>the guinea pig. |
| Material Mediated<br>Pyrogenicity | US, General Chapter <151>,<br>Pyrogen Test 0.9% Sodium<br>Chloride Solution | Test article deemed non-<br>pyrogenic.<br><br>No animal experienced a<br>temperature rise 0.5°C or more<br>above its baseline. |
| Test | Test Method | Conclusion |
| Bench Performance Testing: | | |
| | | |
| MRI Compatibility | ASTM 2503-13<br>ASTM F2052-14<br>ASTM F2213-06<br>Testing was not performed on<br>Center Adaptor or Handle as<br>they are not intended for use in<br>a MR environment. | V-TAG Base, Guide, Imaging<br>Cartridge, and Reducer are MR<br>safe. |
| Integrity Testing- Zero time and 1 year accelerated: | | |
| | | |
| Integrity Testing- Zero Time<br>and 1 year accelerated | Evaluated dimensional<br>verification, device stability,<br>seal integrity of the Image<br>Cartridge, and bond and<br>joint strength for the Image<br>Cartridge, Reducer Handle and<br>tip. | Predetermined test<br>specifications were met for all<br>tests at both time points. |

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