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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Voyager Trajectory Array Guide (V-TAG). It details the device's description, indications for use, technological characteristics, and non-clinical test results to demonstrate substantial equivalence to a predicate device.

Based on the provided document, here's a breakdown regarding acceptance criteria and the study that proves the device meets them:

The document focuses on demonstrating substantial equivalence to a predicate device (Monteris UFO, K090240) rather than meeting specific performance metrics for an AI/algorithm-driven device. The V-TAG is a physical, mechanical stereotactic guidance device, not an AI-powered diagnostic or assistive tool in the typical sense that would involve a "test set," "training set," "ground truth experts," or an "MRMC study."

Therefore, many of the requested points regarding AI/algorithm performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this device's regulatory submission and the information provided.

The acceptance criteria here are primarily about safety and performance equivalence to a known, legally marketed device as demonstrated through non-clinical (bench) testing and biocompatibility assessments.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the "Conclusion" stated for each test, indicating that the device met the requirements to demonstrate substantial equivalence. The "reported device performance" is the outcome of these tests.

Test Category	Specific Test	Acceptance Criteria (Implied by Conclusion)	Reported Device Performance (Conclusion)
Biocompatibility	Cytotoxicity: 1X MEM Elution	Non-cytotoxic, no evidence of cell lysis or toxicity, Grade <2 (mild reactivity).	Non-cytotoxic. No evidence of cell lysis or toxicity. Grade <2 (mild reactivity).
	Intracutaneous Toxicity	No biological response elicited; no adverse observations throughout the test duration; overall mean score of 0.0 for sodium chloride and sesame oil test article extracts.	No biological response elicited. No adverse observations noted throughout the duration of the test. Overall mean score was 0.0 for both the sodium chloride and sesame oil test article extracts.
	Systemic Toxicity: ISO Acute Systemic Injection Test	Study requirements met; no biological response elicited; no mortality nor evidence of systemic toxicity.	Study requirements met. No biological response elicited. No mortality nor evidence of systemic toxicity.
	Sensitization	Non-sensitizing; no evidence of causing delayed dermal contact sensitization.	Non-sensitizing. Test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
	Material Mediated Pyrogenicity	Deemed non-pyrogenic; no animal experienced a temperature rise of 0.5°C or more above its baseline.	Test article deemed non-pyrogenic. No animal experienced a temperature rise 0.5°C or more above its baseline.
Bench Performance	MRI Compatibility	Components intended for MR environment (V-TAG Base, Guide, Imaging Cartridge, and Reducer) should be MR safe.	V-TAG Base, Guide, Imaging Cartridge, and Reducer are MR safe.
	Integrity Testing - Zero time and 1-year accelerated	Predetermined test specifications were met for all evaluated parameters (dimensional verification, device stability, seal integrity of Image Cartridge, bond and joint strength for Image Cartridge, Reducer Handle and tip) at both time points.	Predetermined test specifications were met for all tests at both time points.

Since this is a mechanical device, the following points are not applicable (N/A) in the context of this 510(k) submission, as they relate to AI/algorithm performance studies:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. The testing was non-clinical bench testing, not a data-driven algorithm evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. Ground truth for an AI algorithm is not relevant for this mechanical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not an AI algorithm performance study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. Not an AI assistance device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A. For this device, "ground truth" relates to physical properties and material safety, established by standardized test methods (ISO, ASTM, USP) and laboratory findings, not clinical "truth" points for algorithms.

8. The sample size for the training set

N/A. No training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

N/A. No training set.

Summary

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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)

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

3.2 Indication for Use

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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 isintended to provide stereotacticguidance, placement and fixationfor the operation of instruments ordevices during the planning andoperation of neurologicalprocedures performed inconjunction with preoperative and(or) perioperative MR or CTimaging. These procedures includelaser coagulation, biopsies, catheterplacement and electrodeprocedures.	The V-TAG is intended to assistwith stereotactic guidance,placement, and fixation for theoperation of surgical instrumentsor devices during the planning andoperation of neurologicalprocedures performed inconjunction with preoperative andperioperative MR imaging. Theseprocedures include lasercoagulation, biopsies, catheterplacement, and electrodeplacement procedures.
Principal Operator	Neurosurgeon	Neurosurgeon
Use Location	MRI Suite and OR	MRI Suite and OR
Operating Principle	Stereotactic guiding & fixationdevice	Stereotactic guiding & fixationdevice
Design Principle	Ball and socket joint on a 3-legsupport using 3 bone screws and 9spikes	Ball and socket joint fixed to skullusing 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 selectionof trajectory	Yes	Yes
Provides alignmentfor neurosurgicaldevice insertion	Yes	Yes
Facilitates temporaryfixation ofneurosurgical device	Yes	Yes
Verification oftrajectory alignmentby MRI	Yes	Yes
Range of motion	15 degrees angular (pre-drilledholes) or 58 degrees angular (nopre-drilled entry hole), 360 degreesrotation	45 degrees angular, 360 degreesrotation
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:1X MEM Elution(Product and packagingperformed according to USP)	ISO 10993-5-Part 5: Tests forIn Vitro CytotoxicityIn vitro mammalian cell culturetest	Non-cytotoxic.No evidence of cell lysis ortoxicity.Grade <2 (mild reactivity)
Intracutaneous Toxicity	UNI EN ISO 10993-10-Part10: Tests for Irritation and SkinSensitization0.9 % Sodium ChlorideSolution: Sesame Oil, NFIntracutaneous injection inrabbits.	No biological response elicited.No adverse observations notedthroughout the duration of thetest.Overall mean score was 0.0 forboth the sodium chloride andsesame oil test article extracts.
Systemic Toxicity: ISO AcuteSystemic Injection Test	UNI EN ISO 10993-11-Part11: Tests for Systemic Toxicity0.9 % Sodium ChlorideSolution: Sesame Oil, NF	Study requirements met.No biological response elicited.No mortality nor evidence ofsystemic toxicity.
Sensitization	UNI EN ISO 10993-10- Part10: Tests for Irritation and SkinSensitizationASTM F 720-81 (2002)0.9% Sodium ChlorideSolution:Sesame Oil, NF	Non-sensitizing.Test article extracts showed noevidence of causing delayeddermal contact sensitization inthe guinea pig.
Material MediatedPyrogenicity	US, General Chapter <151>,Pyrogen Test 0.9% SodiumChloride Solution	Test article deemed non-pyrogenic.No animal experienced atemperature rise 0.5°C or moreabove its baseline.
Test	Test Method	Conclusion
Bench Performance Testing:

MRI Compatibility	ASTM 2503-13ASTM F2052-14ASTM F2213-06Testing was not performed onCenter Adaptor or Handle asthey are not intended for use ina MR environment.	V-TAG Base, Guide, ImagingCartridge, and Reducer are MRsafe.
Integrity Testing- Zero time and 1 year accelerated:

Integrity Testing- Zero Timeand 1 year accelerated	Evaluated dimensionalverification, device stability,seal integrity of the ImageCartridge, and bond andjoint strength for the ImageCartridge, Reducer Handle andtip.	Predetermined testspecifications were met for alltests at both time points.

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Regulation Number and Section

§ 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).