Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical surgical device for tissue removal and fluid aspiration, with no mention of AI/ML, image processing, or data analysis that would typically indicate the presence of such technology.

Therapeutic

No.
The device is described as a surgical system used for tissue resection and removal, making it an operative device rather than a therapeutic one. It facilitates the removal of diseased tissue but does not directly treat the disease itself.

Diagnostic

No

The device description clearly states its purpose is for "resection and removal of soft tissue and fluids," and it is referred to as a "powered instrument." Its function is to remove tissue and fluids from the body, not to diagnose conditions. While the device may be used during procedures for diagnosed conditions (e.g., brain tumors), it does not perform any diagnostic function itself.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a console, handpieces, accessories, and a Tissue Preservation System with physical parts like a specimen collector, infusion valve, and preserver. The performance studies also detail testing of hardware aspects like packaging, electrical safety, and simulated use with surrogate materials.

IVD (In Vitro Diagnostic)

Based on the provided information, the NICO Myriad™ is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "perform resection and removal of soft tissue and fluids under direct visualization." This describes a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
Device Description: The description details a surgical system with handpieces and accessories for tissue removal. While it includes a Tissue Preservation System (TPS) to capture resected tissue, the primary function is the surgical removal itself, not the analysis of the tissue for diagnostic purposes.
Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, tissue, urine, etc.) to provide diagnostic information about a patient's condition.
Performance Studies: The performance studies focus on the safety and efficacy of the surgical system in removing tissue and fluids, not on the accuracy or reliability of diagnostic results.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The NICO Myriad™ is a surgical tool used for tissue removal during procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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, 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

Product codes (comma separated list FDA assigned to the subject device)

GEI, ERL, HBC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Neurosurgical/Spinal, ENT/Otolaryngological, Brain

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

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

Clinical Review:
Data on the current clinical usage of the Myriad was provided (peer reviewed journal articles and case report surveys) to support the added specificity.

Case reports obtained directly on the Myriad: n = 1205
Case reports when the Myriad is used in conjunction with the complimentary NICO BrainPath (K150378) access device: n = 617
Total case reports: 1822, predominantly included uses for primary/secondary brain tumors, vascular clot removal/hemorrhage (i.e., ICH), and cysts.
33 citations and 12 posters/abstracts were provided, representing over 500 clinical uses of the Myriad for primary/secondary brain tumors, vascular abnormalities/malformations (e.g., hemangiomas, cavernomas, and hematoma evacuation), and intraventricular tumors/cysts.

Key results: Non-clinical testing passed all specified items. Clinical review from case reports and literature corroborates the specific neurosurgical indications as a subset of the previously cleared general use, showing safety and effectiveness.

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.

K955168, Promex Surgical Cutter, K972865, Promex ENT Tissue Removal System, K002523, Advantage Drive System

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.

K150378

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

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.

Summary

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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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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4.0 510(K) SUMMARY

NICO Myriad™

21 CFR §807.92

Date Prepared: 19 December 2016

510(k) Number: K161307

| Submitter: | NICO Corporation
250 E. 96th Street, Suite 125
Indianapolis, IN 46240 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sean Spence, RAC
Regulatory Affairs Manager
Office: 317.660.7118 |
| Trade Name: | NICO MyriadTM |
| Common Name: | Electrosurgical, cutting & coagulation & accessories |
| Classification: | 21 CFR §878.4400 (Class II)
21 CFR § 874.4250 (Class II) |
| Product Code: | GEI |
| Secondary Product Codes: | ERL, HBC |
| Predicate Devices: | K955168, Promex Surgical Cutter, §878.4400, GEI
K972865, Promex ENT Tissue Removal System, §874.4250, ERL
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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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
Accessories	Handpiece Bending Tool
	Various DISS/Schrader Adapters & N2 Splitter
	Replacement Handpiece Endocsope Adapters
Tissue
Preservation
System
(TPS)	Specimen Collector with Filter Element
	Replacement Filter Element
	Specimen Infusion Valve (SIV)
	Specimen Preserver

Table 2: Current Myriad Handpiece Configurations

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

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