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 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.

AI/ML Overview

The NICO Myriad™ is a powered instrument for resection and removal of soft tissue and fluids. The provided text, a 510(k) summary for the device, does not explicitly define acceptance criteria in a quantitative manner for specific performance metrics. Instead, the study aims to demonstrate substantial equivalence to predicate devices through a combination of non-clinical testing and clinical review, asserting that the device is at least as safe and effective.

Here's an analysis of the provided information:

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

As stated, explicit quantitative acceptance criteria are not provided in the document. The acceptance is determined by "Passed" outcomes for various non-clinical tests and a "Clinical Review" that supports its intended use.

Acceptance Criteria (Implied)	Reported Device Performance
Console & Foot Pedal Packaging Testing	Passed
General Verification Testing including review of specifications	Passed
Console Life Cycle Testing on functionality following repetitive use	Passed
Console Environmental Testing on functionality under environmental extremes	Passed
Firmware Unit Plan, Design, & Verification	Passed
Handpiece Sterility, Packaging, and Shelf Life Testing	Passed
Handpiece 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
Handpiece Life Cycle Testing on functionality following repetitive use	Passed
Handpiece Environmental Testing on functionality under environmental extremes	Passed
Accessories: Replacement Working Channel Adapters Packaging & Shelf Life Testing	Passed
Accessories: Specimen Collector and Filter Element Verification including Sterility, Packaging & Shelf Life	Passed
Accessories: Bending Tool Verification, including Sterility, Packaging, Shelf Life, and Biocompatibility per ISO 10993	Passed
Accessories: 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 evidence supporting specific neurosurgical indications as a subset of general use	Supported by case reports and literature review

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

Non-Clinical Testing: The document does not specify exact sample sizes for each non-clinical test. The tests are general verification, life cycle, and environmental tests, likely conducted on a sufficient number of units to demonstrate compliance.
Clinical Review (Case Reports):
- Sample Size: 1205 case reports for Myriad alone, and 617 case reports for Myriad used in conjunction with NICO BrainPath (totaling 1822 case reports).
- Data Provenance: The document does not explicitly state the country of origin. It mentions "physician feedback on some of their cases in the form of case reports," which suggests these are real-world clinical data. Given the address of NICO Corporation in Indianapolis, Indiana, USA, it's plausible a significant portion, if not all, of these reports originate from the US.
- Retrospective/Prospective: The description "NICO obtains physician feedback on some of their cases in the form of case reports" suggests these are retrospective reports of cases that have already occurred.
Clinical Review (Literature Citations):
- Sample Size: 33 journal citations and 12 posters/abstracts were provided. These represent over 500 clinical uses of the Myriad.
- Data Provenance: Not specified, but likely from various international and domestic sources, as journal articles are often widely published.
- Retrospective/Prospective: Journal articles and abstracts can include both retrospective and prospective study designs.

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)

For the non-clinical tests, the "experts" would be the engineers, technicians, and quality control personnel performing and evaluating the tests according to established standards. Their specific number and qualifications are not detailed.

For the clinical review, the "ground truth" for the case reports would be the clinical outcomes and observations made by the treating physicians. The "experts" are the physicians who submitted the case reports and the authors of the peer-reviewed articles. Their specific number and qualifications (e.g., years of experience, specialty) are not provided in the summary, other than being implied as current clinical users or researchers in neurosurgery and related fields.

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

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in either the non-clinical or clinical review sections.

Non-Clinical: Testing results are typically evaluated against pre-defined specifications by the testing personnel and reviewed by quality management.
Clinical Review: The "ground truth" is derived from individual physician case reports and published literature, which are generally accepted as reported by the authors/clinicians, without an explicit multi-expert adjudication mentioned in this summary. The purpose of this section is to corroborate usage patterns, not to establish a new ground truth for specific diagnoses.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any AI component in this device submission. The NICO Myriad is a surgical instrument, not an AI-powered diagnostic or assistive tool.

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

Not applicable, as the NICO Myriad is a physical surgical instrument and not an algorithm.

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

Non-Clinical Testing: The "ground truth" for these tests is based on established engineering and safety standards (e.g., IEC 60601-1, ISO 10993) and the device's design specifications. Performance is measured against these standards and specifications.
Clinical Review: The "ground truth" for the clinical review is based on:
- Outcomes Data/Physician Observation: from the 1822 case reports, describing the use of the device and its clinical context.
- Published Clinical Literature: (33 citations, 12 abstracts) serving as evidence of existing medical understanding and practice regarding the use of such devices for specific conditions. This supports the claim that the expanded indications are a "subset" of previously cleared general uses.

8. The sample size for the training set

Not applicable, as this is a surgical device and not an AI/machine learning model that requires a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161307

Device Name NICO Myriad

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 Corporation250 E. 96th Street, Suite 125Indianapolis, IN 46240
Contact Person:	Sean Spence, RACRegulatory Affairs ManagerOffice: 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, GEIK972865, Promex ENT Tissue Removal System, §874.4250, ERLK002523, Advantage Drive System, §882.4360, HBC, §878.4820, GEY

Device Description

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 ●

{4}------------------------------------------------

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
OptionalAccessories	Handpiece Bending Tool
	Various DISS/Schrader Adapters & N2 Splitter
	Replacement Handpiece Endocsope Adapters
TissuePreservationSystem(TPS)	Specimen Collector with Filter Element
	Replacement Filter Element
	Specimen Infusion Valve (SIV)
	Specimen Preserver

Table 2: Current Myriad Handpiece Configurations

CannulaDiameter	CannulaLength	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 -

{5}------------------------------------------------

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 DeviceNICO Myriad	Predicate Device		Predicate DeviceLinvatec/ConMedAdvantage Drive System
		PromexSurgical Cutter	Promex ENTTissue RemovalSystem
510(k)	TBD	K955168	K972865	K002523
DeviceName	NICO Myriad	Promex SurgicalCutter	Promex ENTTissue RemovalSystem	Advantage Drive System
Regulation /Code	§878.4400, GEI	SAME	§874.4250, ERL	§882.4360, HBC §878.4820, GEY
CommonName	Electrosurgical, Cutting &Coagulation & Accessories	SAME	Drill, Surgical,Ent (Electric OrPneumatic)IncludingHandpiece	Motor, Drill, Electric Motor,Surgical Instrument, Ac-Powered
IntendedUse	Powered instrument for cutting andremoval of tissue and fluids	SAME	SAME	SAME
	Subject DeviceNICO Myriad		Predicate Device		Predicate DeviceLinvatec/ConMedAdvantage Drive System
			PromexSurgical Cutter	Promex ENTTissue RemovalSystem
Indications	The NICO Myriad is a poweredinstrument consisting of a console,handpieces, and accessoriesintended to perform resection andunder direct visualization. Types ofdirect visualization may includelaparoscopic, pelviscopic,endoscopic, percutaneous, and open.Applications include those whenaccess to the surgical site is limited,such as Neurosurgical/Spinal andENT/Otolaryngological.Specific neurosurgical indicationsmay include diseases such as thefollowing:-Primary/Secondary Brain Tumors-VascularAbnormalities/Malformations (e.g.,hemangiomas, cavernomas, andhematoma evacuation)-Intraventricular Tumors/Cysts		For themorcellation andremoval of tissueduringpelviscopic,laparoscopic,percutaneous andopen surgicalprocedureswhenever accessto the surgicalsite is limited.	For the removalof soft tissue andbone in the ear,nose & throat.	The Advantage® Turbo DriveSystem functions as apowered instrument systemconsisting of handpieces andaccessories to performcutting of soft tissue andbone.The fields of applicationinclude Arthroscopic, Foot,Hand, Medial Sternotomy,Neurosurgical, Orthopedic,Otolaryngological,Oral/Maxillofacial,Plastic/Reconstructive andSpinal surgical procedures.
CuttingAction /Control	Mechanical / User inputs via FootPedal and front panel settings toprovide control over the connectedhandpiece.		SAME		SAME
HandpieceDesign	1-piece handle/cannula component		2-piece, separate handle andcannula/blade		2-piece, separate handle andshaver blade components
HandpieceTypes	Single type, tissue shaver		SAME		Multiple blade types,including tissue shavers,drills, burrs, and routers
Function	Tissue cutting and removal systemvia scissoring action betweenoscillating (reciprocating) innercannula and stationary outercannula. Suction draws fluids andtissue into aperture for cutting andcarries cut tissue away intodownstream receptacle.		SAME		Shaver Handpieces:Tissue cutting and removalsystem via scissoring actionbetween oscillating(rotational) inner cannula andstationary outer cannula.Suction draws fluids andtissue into aperture forcutting and carries cut tissueaway into downstreamreceptacle.
PrimarySystemModes	1. Suction only2. Suction with fixed oscillation(reciprocating)		1. SAME2. Suction with variable oscillation(reciprocating)		1. SAME2. Suction with variableoscillation (reciprocating)
System	Cutting Speed	Fixed	Variable		Variable
Principle ofOperation	Aspiration	Variable	Variable		Variable
	Subject DeviceNICO Myriad	Predicate Device		Predicate DeviceLinvatec/ConMedAdvantage Drive System
		PromexSurgical Cutter	Promex ENTTissue RemovalSystem
Suction/Vacuumcreation	Vacuum created within console	SAME		Wall vacuum (i.e., centralvacuum supply in hospital)
Use	Console/Foot Pedal = ReusableCapitalHandpiece = Fully Disposable	Console/Foot Pedal = SAMEHandpiece = 2-piece, reusable handle& single-use cannula		Console/Foot Pedal = SAMEHandpiece = 2-piece,reusable handle & single-useblade
Materials /Biocomp.	Stainless steel Cannula/Bladeportion for limited duration( $\u2264$ 24 hours). Demonstrated basedon externally communicating devicein direct contact withtissue/bone/dentin for a limitedduration	SAME		SAME
Sterility (ifapplicable)	Gamma (handpiece only)	SAME (blades only)		Gamma (blades only)

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

{6}------------------------------------------------

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.

{7}------------------------------------------------

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

{8}------------------------------------------------

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.

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.