NICO Myriad

K161307 · Nico Corporation · GEI · Dec 21, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161307
• Device Name: NICO Myriad
• Applicant: Nico Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NICO Myriad™ is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological. Specific neurosurgical indications may include diseases such as the following: - Primary/Secondary Brain Tumors - Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation) - Intraventricular Tumors/Cysts

Device Story

NICO Myriad is a powered surgical system for soft tissue/fluid resection and removal. System comprises a console, foot pedal, and disposable handpieces. Principle of operation: reciprocating inner cannula and stationary outer cannula create a scissoring action; variable suction draws tissue into aperture for cutting and transport to a receptacle. Used in neurosurgical, spinal, and ENT procedures where access is limited. Operated by surgeons under direct visualization (endoscopic, laparoscopic, etc.). Tissue Preservation System (TPS) accessories allow capture of resected tissue for analysis. Device benefits include precise tissue shaving and rapid debulking in minimally invasive settings. Healthcare providers use the system to remove tumors, hematomas, and cysts, directly impacting surgical efficiency and tissue recovery.

Clinical Evidence

No clinical trial data; evidence consists of non-clinical bench testing and clinical literature review. Bench testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), sterility, shelf-life, and simulated use. Clinical evidence includes 1822 case reports (1205 Myriad alone, 617 with BrainPath), 33 peer-reviewed citations, and 12 posters/abstracts documenting successful use in primary/secondary brain tumors, vascular abnormalities, and intraventricular lesions.

Technological Characteristics

Powered electrosurgical cutting/coagulation system. Handpiece: stainless steel cannula, disposable, gamma-sterilized. Console: reusable, provides vacuum and mechanical reciprocation. Connectivity: foot pedal control. Dimensions: various cannula gauges (11G-19G) and lengths (10cm-31.5cm). Software: firmware-controlled console.

Indications for Use

Indicated for resection and removal of soft tissue and fluids under direct visualization (laparoscopic, pelviscopic, endoscopic, percutaneous, open) in limited-access surgical sites, specifically Neurosurgical/Spinal and ENT/Otolaryngological procedures. Includes primary/secondary brain tumors, vascular abnormalities/malformations (hemangiomas, hematoma evacuation), and intraventricular tumors/cysts.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Promex Surgical Cutter (K955168)
• Promex ENT Tissue Removal System (K972865)
• Advantage Drive System (K002523)

Reference Devices

• NICO BrainPath (K150378)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 21, 2016

Nico Corporation Mr. Sean Spence Regulatory Affairs Manager 250 E. 96th Street, Suite 125 Indianapolis, Indiana 46240

Re: K161307

Trade/Device Name: NICO Myriad™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, ERL, HBC Dated: November 11, 2016 Received: November 14, 2016

Dear Mr. Spence:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Jennifer R. Stevenson - A For Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161307

Device Name NICO Myriad

#### Indications for Use (Describe)

The NICO Myriad™ is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological.

Specific neurosurgical indications may include diseases such as the following:

- · Primary/Secondary Brain Tumors
- · Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation)
- · Intraventricular Tumors/Cysts

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for NICO Corporation. The logo consists of the word "NICO" in large, bold, serif letters. Below the word "NICO" is the word "CORPORATION" in smaller, sans-serif letters. The "O" in "NICO" is a filled circle in a golden color with a black outline.

## 4.0 510(K) SUMMARY

# NICO Myriad™

21 CFR §807.92

Date Prepared: 19 December 2016

510(k) Number: K161307

| Submitter: | NICO Corporation<br>250 E. 96th Street, Suite 125<br>Indianapolis, IN 46240 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sean Spence, RAC<br>Regulatory Affairs Manager<br>Office: 317.660.7118 |
| Trade Name: | NICO MyriadTM |
| Common Name: | Electrosurgical, cutting & coagulation & accessories |
| Classification: | 21 CFR §878.4400 (Class II)<br>21 CFR § 874.4250 (Class II) |
| Product Code: | GEI |
| Secondary Product Codes: | ERL, HBC |
| Predicate Devices: | K955168, Promex Surgical Cutter, §878.4400, GEI<br>K972865, Promex ENT Tissue Removal System, §874.4250, ERL<br>K002523, Advantage Drive System, §882.4360, HBC, §878.4820, GEY |

### Device Description

The Myriad is a minimally invasive surgical system designed for the removal of soft tissues and fluids under direct visualization. The technology platform is based on combining a minimally invasive non-heat generating reciprocating inner cannula and a stationary outer cannula with electronically controlled variable suction. The disposable handpiece is capable of precise tissue shaving and rapid tissue debulking.

In addition to the system and handpiece accessories or replacement parts, this submission also covers the Tissue Preservation System (TPS). The TPS is a collection of accessories which attach to the Myriad handpiece to capture resected tissue that would otherwise be discarded in the waste canister. The TPS is comprised of three parts:

- Specimen Collector with filter element which collects tissue;
- Specimen Infusion Valve (SIV) which provides the desired biological environment;
- Specimen Preserver which provides the desired thermal condition ●

These TPS accessories can be arranged in a multitude of ways depending on the desired setup. Refer the handpiece IFU for additional details. The following tables outline the system, components, accessories, and various handpieces sizes.

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Image /page/4/Picture/1 description: The image shows the logo for NICO Corporation. The word "NICO" is written in large, bold, black letters. Below the word "NICO" is the word "CORPORATION" written in smaller, lighter letters. The "O" in NICO is a golden yellow color.

### Table 1: Myriad System Components/Accessories

| Components | |
|-------------------------------------------|--------------------------------------------------------------------|
| Myriad | Console and Foot Pedal |
| | Handpieces (multiple versions) |
| | Console Cart, Canister, Aspiration Line, Nitrogen Line, Power Cord |
| Optional<br>Accessories | Handpiece Bending Tool |
| | Various DISS/Schrader Adapters & N2 Splitter |
| | Replacement Handpiece Endocsope Adapters |
| Tissue<br>Preservation<br>System<br>(TPS) | Specimen Collector with Filter Element |
| | Replacement Filter Element |
| | Specimen Infusion Valve (SIV) |
| | Specimen Preserver |

### Table 2: Current Myriad Handpiece Configurations

| Cannula<br>Diameter | Cannula<br>Length | Description |
|---------------------|-------------------|-------------------------------|
| 19 gauge | 21.5 cm | 19 ga x 21.5 cm (PaediScope®) |
| | 28 cm | 19 ga x 28 cm (Oi®) |
| | 28 cm | 19 ga x 28 cm (Little LOTTA®) |
| 17 gauge | 31.5 cm | 17 ga x 31.5 cm (Decq) |
| 15 gauge | 10 cm | 15 ga x 10 cm (1510) |
| | 13 cm | 15 ga x 13 cm (1513) |
| | 25 cm | 15 ga x 25 cm (MINOP®) |
| | 25 cm | 15 ga x 25 cm (GAAB) |
| | 26.5 cm | 15 ga x 26.5 cm (LOTTA®) |
| 13 gauge | 10 cm | 13 ga x 10 cm (1310) |
| | 13 cm | 13 ga x 13 cm (1313) |
| | 13 cm | 13 ga x 13 cm (Pre-Bent) |
| 11 gauge | 10 cm | 11 ga x 10 cm (1110) |
| | 13 cm | 11 ga x 13 cm (1113) |

## Indication for Use

The NICO Myriad is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological.

Specific neurosurgical indications may include diseases such as the following:

- Primary/Secondary Brain Tumors -
- -Vascular Abnormalities/Malformations (e.g., hemangiomas, cavernomas, and hematoma evacuation)
- Intraventricular Tumors/Cysts -

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Image /page/5/Picture/0 description: The image shows the logo for NICO Corporation. The logo consists of the word "NICO" in large, bold, black letters. Below the word "NICO" is the word "CORPORATION" in smaller, lighter letters. The "O" in "NICO" is a golden color.

## Comparison to Predicates

The NICO Myriad is substantially equivalent to the Promex Surgical Cutter (K955168) that is indicated for the removal of tissue during pelviscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited, the Promex ENT Tissue Removal System (K972865) that is indicated for the removal of soft tissue and bone in the ear. nose & throat, and the Advantage Drive System (K002523) that is indicated for removal of soft tissue and bone. All three devices have the same intended use, i.e., they are powered instruments for cutting and removal of tissue and fluids. The specificity provided in the Myriad's indication statement relate to anatomical areas and procedures that are widely understood to present soft tissue or fluid conditions that require removal. The specific neurosurgical indications are supported by a considerable knowledge base of clinical literature that substantiates the inclusion of these specific uses within the previously cleared general use of the Promex Surgical Cutter (refer to Clinical Review section below).

Technologically, the differences between the NICO Myriad and its predicates are that the handpiece in the subject device is a fully disposable single piece compared to a reusable handle and single-use cannula in the predicates. In addition, the subject device has a fixed reciprocation speed, whereas the predicates' reciprocation speeds can vary. These differences do not raise new questions of safety or effectiveness because the functionality and control of the amount of cutting is maintained.

## Technological Characteristics

| | Subject Device<br>NICO Myriad | Predicate Device | | Predicate Device<br>Linvatec/ConMed<br>Advantage Drive System | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Promex<br>Surgical Cutter | Promex ENT<br>Tissue Removal<br>System | | |
| 510(k) | TBD | K955168 | K972865 | K002523 | |
| Device<br>Name | NICO Myriad | Promex Surgical<br>Cutter | Promex ENT<br>Tissue Removal<br>System | Advantage Drive System | |
| Regulation /<br>Code | §878.4400, GEI | SAME | §874.4250, ERL | §882.4360, HBC <br>§878.4820, GEY | |
| Common<br>Name | Electrosurgical, Cutting &<br>Coagulation & Accessories | SAME | Drill, Surgical,<br>Ent (Electric Or<br>Pneumatic)<br>Including<br>Handpiece | Motor, Drill, Electric Motor,<br>Surgical Instrument, Ac-<br>Powered | |
| Intended<br>Use | Powered instrument for cutting and<br>removal of tissue and fluids | SAME | SAME | SAME | |
| | Subject Device<br>NICO Myriad | | Predicate Device | | Predicate Device<br>Linvatec/ConMed<br>Advantage Drive System |
| | | | Promex<br>Surgical Cutter | Promex ENT<br>Tissue Removal<br>System | |
| Indications | The NICO Myriad is a powered<br>instrument consisting of a console,<br>handpieces, and accessories<br>intended to perform resection andunder direct visualization. Types of<br>direct visualization may include<br>laparoscopic, pelviscopic,<br>endoscopic, percutaneous, and open.<br>Applications include those when<br>access to the surgical site is limited,<br>such as Neurosurgical/Spinal and<br>ENT/Otolaryngological.<br>Specific neurosurgical indications<br>may include diseases such as the<br>following:<br>-Primary/Secondary Brain Tumors<br>-Vascular<br>Abnormalities/Malformations (e.g.,<br>hemangiomas, cavernomas, and<br>hematoma evacuation)<br>-Intraventricular Tumors/Cysts | | For the<br>morcellation and<br>removal of tissue<br>during<br>pelviscopic,<br>laparoscopic,<br>percutaneous and<br>open surgical<br>procedures<br>whenever access<br>to the surgical<br>site is limited. | For the removal<br>of soft tissue and<br>bone in the ear,<br>nose & throat. | The Advantage® Turbo Drive<br>System functions as a<br>powered instrument system<br>consisting of handpieces and<br>accessories to perform<br>cutting of soft tissue and<br>bone.<br>The fields of application<br>include Arthroscopic, Foot,<br>Hand, Medial Sternotomy,<br>Neurosurgical, Orthopedic,<br>Otolaryngological,<br>Oral/Maxillofacial,<br>Plastic/Reconstructive and<br>Spinal surgical procedures. |
| Cutting<br>Action /<br>Control | Mechanical / User inputs via Foot<br>Pedal and front panel settings to<br>provide control over the connected<br>handpiece. | | SAME | | SAME |
| Handpiece<br>Design | 1-piece handle/cannula component | | 2-piece, separate handle and<br>cannula/blade | | 2-piece, separate handle and<br>shaver blade components |
| Handpiece<br>Types | Single type, tissue shaver | | SAME | | Multiple blade types,<br>including tissue shavers,<br>drills, burrs, and routers |
| Function | Tissue cutting and removal system<br>via scissoring action between<br>oscillating (reciprocating) inner<br>cannula and stationary outer<br>cannula. Suction draws fluids and<br>tissue into aperture for cutting and<br>carries cut tissue away into<br>downstream receptacle. | | SAME | | Shaver Handpieces:<br>Tissue cutting and removal<br>system via scissoring action<br>between oscillating<br>(rotational) inner cannula and<br>stationary outer cannula.<br>Suction draws fluids and<br>tissue into aperture for<br>cutting and carries cut tissue<br>away into downstream<br>receptacle. |
| Primary<br>System<br>Modes | 1. Suction only<br>2. Suction with fixed oscillation<br>(reciprocating) | | 1. SAME<br>2. Suction with variable oscillation<br>(reciprocating) | | 1. SAME<br>2. Suction with variable<br>oscillation (reciprocating) |
| System | Cutting Speed | Fixed | Variable | | Variable |
| Principle of<br>Operation | Aspiration | Variable | Variable | | Variable |
| | Subject Device<br>NICO Myriad | Predicate Device | | Predicate Device<br>Linvatec/ConMed<br>Advantage Drive System | |
| | | Promex<br>Surgical Cutter | Promex ENT<br>Tissue Removal<br>System | | |
| Suction/<br>Vacuum<br>creation | Vacuum created within console | SAME | | Wall vacuum (i.e., central<br>vacuum supply in hospital) | |
| Use | Console/Foot Pedal = Reusable<br>Capital<br>Handpiece = Fully Disposable | Console/Foot Pedal = SAME<br>Handpiece = 2-piece, reusable handle<br>& single-use cannula | | Console/Foot Pedal = SAME<br>Handpiece = 2-piece,<br>reusable handle & single-use<br>blade | |
| Materials /<br>Biocomp. | Stainless steel Cannula/Blade<br>portion for limited duration<br>( $\u2264$ 24 hours). Demonstrated based<br>on externally communicating device<br>in direct contact with<br>tissue/bone/dentin for a limited<br>duration | SAME | | SAME | |
| Sterility (if<br>applicable) | Gamma (handpiece only) | SAME (blades only) | | Gamma (blades only) | |

The following table compares the subject and predicate devices, including technological characteristics.

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Image /page/6/Picture/0 description: The image shows the logo for NICO Corporation. The logo is in black and gold. The word "NICO" is in large, bold, black letters. Below the word "NICO" is the word "CORPORATION" in smaller, thinner, black letters. The "O" in "NICO" is gold.

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Image /page/7/Picture/0 description: The image shows the logo for NICO Corporation. The logo consists of the word "NICO" in large, bold, sans-serif font. The "O" in "NICO" is stylized as a filled circle in a golden color. Below the word "NICO" is the word "CORPORATION" in a smaller, lighter font.

## Non-Clinical Testing

The following non-clinical testing was performed:

| Description | Result |
|-------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Console & Foot Pedal | |
| Console/Foot Pedal Packaging Testing | Passed |
| General Verification Testing including review of specifications | Passed |
| Console Life Cycle Testing on functionality during/following repetitive use | Passed |
| Console Environmental Testing on functionality under environmental extremes | Passed |
| Firmware Unit Plan, Design, & Verification | Passed |
| Handpieces | |
| Sterility, Packaging, and Shelf Life Testing | Passed |
| Biocompatibility per ISO 10993 (Cyto, Sensi, Irri, Pyro, Hemo) | Passed |
| Simulated Use of system and ability to cut surrogate materials/tissue while using handpieces bent to maximum allowable angle | Passed |
| Endoscope Compatibility on functionality with applicable commercially available endoscopes | Passed |
| Physical Characteristics Verification on material selection, fabrication methods, and multiple bonds/joint/weld evaluations | Passed |
| Life Cycle Testing on functionality during/following repetitive use | Passed |
| Environmental Testing on functionality under environmental extremes | Passed |
| Accessories | |
| Replacement Working Channel Adapters Packaging & Shelf Life Testing | Passed |
| Specimen Collector and Filter Element Verification including Sterility, Packaging & Shelf Life | Passed |
| Bending Tool Verification, including Sterility, Packaging, Shelf Life, and Biocompatibility per ISO 10993 (Cyto, Sensi, Irri, Pyro, Hemo) | Passed |
| Specimen Infusion Valve Verification including Sterility, Packaging, & Shelf Life Testing | Passed |
| NICO Myriad System | |
| Usability | Passed |
| IEC 60601-1 General Electrical Safety Testing | Passed |
| IEC 60601-1-2 EMC Testing | Passed |

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Image /page/8/Picture/0 description: The image shows the logo for NICO Corporation. The logo is in black and white, except for the "O" in NICO, which is a golden color. The word "CORPORATION" is written in smaller letters below the word NICO.

## Clinical Review

In addition to the non-clinical testing, data on the current clinical usage of the Myriad was provided (i.e., peer reviewed journal articles and case report surveys) to support the added specificity. These citations, along with the post-market surveillance, show that intracranial tumors, vascular abnormalities or malformations, and intraventricular tumors/cysts are a known subset of the previously cleared general use to cut and remove soft tissue and fluids. This body of evidence reflects existing understanding by the medical community that the more specific use is a subset of the general use.

The types of procedures and surgeries identified in the Myriad's indication statement relate to anatomical areas that are widely understood to present soft tissue or fluid conditions that require removal. Since NICO began commercially distributing the Myriad system, the company focus has been in neurosurgery, thus most of the data are within that specialty. As part of continuous improvement and post-market surveillance, NICO obtains physician feedback on some of their cases in the form of case reports. These case reports were obtained directly on the Myriad (n = 1205) and when the Myriad is used in conjunction with the complimentary NICO BrainPath (n = 617) access device (K150378). These 1822 case reports predominantly included uses for primary/secondary brain tumors, vascular clot removal/hemorrhage (i.e., ICH), and cysts. In addition, 33 citations and 12 posters/abstracts were provided to corroborate the case report usage patterns. These citations represent over 500 clinical uses of the Myriad for primary/secondary brain tumors - , vascular abnormalities/malformations34 (e.g., hemangiomas, cavernomas, and hematoma evacuation), and intraventricular tumors/cysts , among other less common uses. The footnoted items are examples of those specific uses. For the latest bibliography contact NICO Clinical Affairs or refer to www.niconeuro.com.

In sum, these specific examples of uses for cutting and removal of soft tissue and fluids identified in the subject Myriad's indications statement are understood by the medical community to represent a subset of the surgical procedures for which a device such as the Myriad can be used.

## Conclusion

Based upon a comparison of the intended use, technological characteristics, non-clinical performance testing, and clinical review, the subject NICO Myriad is substantially equivalent to the predicates. These data show that the differences do not raise different questions of safety or effectiveness and that the subject device is at least as safe and effective as the predicates.

¹ Labib M, Young RL, Rovin RA, Day JD, Eliyas JK, Bailes JE. The safety and efficacy of diffusion tensor imaging (DTT)- guided Transulcal radial tubular corridors to subcortical neoplasms: A multicenter study. Abstract presented at: 2015 Congress of Neurological Surgeons Annual Meeting; September 26-30, 2015; New Orleans, LA

² Kassam AB, Labib MA, Bafaquh M, et al. Part II: an evaluation of an integrated systems approach using diffusion-weighted, image-guided, Exoscopic-assisted, transulcal radial corridors. Innovative Neurosurg. 2015; 3(1-2): 25-33.

³ Labib MA, Shah M, Kassam AB, et al. The Safety and Feasibility of Image-Guided Transulcul Hematoma Evacuation: A Multicenter Study, [Published online ahead of print June 17, 2016] Neurosurgery. 2016. DOI: 10.1227/NEU.000000000001316.

⁴ Bauer AM, Rasmuseen, PS, Bain, MD. Initial Single-Center Technical Experience With the BrainPath System for Acute Intracerebral Hemorrhage Evacuation. [Published online ahead of print May 28, 2016] Operative Neurosurgery 2016. DOI: 10.1227/NEU.0000000001258. 3 Eliyas JK, Glynn R, Kulwin CG, et al. Minimally Invasive Transsucal Resection of Intraventricular Lesions Through a

Tubular Retractor System: Multicentric Experience and Results. World Neurosurg. 2016;90:556-64.