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.

The various handpieces, components, and optional accessories are outlined in tables below. Of note, the system also consists of optional Tissue Preservation System (TPS) accessories. 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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NICO Myriad device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with predefined metrics.

Therefore, the document does not contain the information required to answer the questions about acceptance criteria and the study proving the device meets them in the context of an AI/ML medical device. Specifically:

Acceptance Criteria Table and Reported Performance: The document does not define specific performance metrics (e.g., sensitivity, specificity, AUC) for the device. Instead, it focuses on demonstrating that design changes do not raise new questions of safety or effectiveness compared to the predicate device.
Sample Size and Data Provenance (Test Set): This information is not applicable as there is no mention of a clinical "test set" being used to evaluate performance against specific metrics like an AI/ML model would require. The testing described is primarily non-clinical (e.g., biocompatibility, longevity, IEC 60601-1 testing).
Number of Experts and Qualifications (Ground Truth): Not applicable, as there's no mention of expert-established ground truth for a test set.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Study: Not applicable. This type of study is common for evaluating the impact of AI on human reader performance, which isn't the focus of this 510(k) summary.
Standalone Performance: Not applicable. The NICO Myriad is an electrosurgical device, not an AI algorithm.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable. The device is not an AI/ML model.
How Ground Truth for Training Set was Established: Not applicable.

Summary of what is in the document:

The document outlines the NICO Myriad's substantial equivalence to a predicate device (K161307). The new submission (K182340) addresses changes such as:

New contract manufacturer
Design enhancements/process improvements (e.g., electronic components, bonding methods, adhesives)
Capital equipment changes
Packaging changes
Additional handpiece offering (11 ga x 13 cm Pre-Bent handpiece)
Labeling updates

The non-clinical testing performed to support substantial equivalence includes:

Biocompatibility per ISO 10993-1
Longevity Testing
Specification Review & Dimensional Analysis
Usability & Design Validation
IEC 60601-1 Testing
Sterility Testing
Packaging Stability and Performance
Product Stability
Various Process Validations

The conclusion is that these changes "do not raise new questions of safety or effectiveness," indicating that the device "is as safe, as effective, and performs as well as or better than the legally marketed predicate Myriad." This is the typical standard for a 510(k) clearance, which differs significantly from the type of performance evaluation required for AI/ML-based medical devices.

Summary

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September 20, 2018

NICO Corporation Sean Spence Regulatory Affairs Manager 250 East 96th Street. Suite 125 Indianapolis, Indiana 46240

Re: K182340

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: August 27, 2018 Received: August 28, 2018

Dear Sean 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,

David Krause -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

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.

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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:

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Image /page/3/Picture/2 description: The image shows the logo for NICO Corporation. The logo is in a serif font, with the letters "N", "I", and "C" in black. The "O" is a circle filled with a golden color. Below the letters is the word "CORPORATION" in a smaller, sans-serif font.

10.0 510(k) SUMMARY

NICO Myriad™

21 CFR §807.92 Date Prepared: 27 August 2018

K182340 510(k) Number:

Submitter/Manufacturer	NICO Corporation250 E. 96th Street, Suite 125Indianapolis, IN 46240
Primary Contact:	Sean Spence, RACRegulatory Affairs ManagerOffice: 317.660.7118
Trade Name	NICO Myriad™
Common/Usual Name	Electrosurgical, cutting & coagulation & accessories
Classification	21 CFR §878.4400 (Class II)
Product Code	GEI
Secondary Product Codes:	ERL, HBC
Predicate Device	K161307 – NICO Myriad

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 ●

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/2 description: The image shows the logo for NICO Corporation. The logo is in black and gold. The word "NICO" is in large, bold letters, with the "O" being a gold circle. Below the word "NICO" is the word "CORPORATION" in smaller letters.

Table 1: Myriad System Components/Accessories

Components
Myriad	Console and Foot Pedal
	Handpieces (multiple versions)
	Console Cart, Aspiration Line, Nitrogen Line/Instrument Air Line, Power Cord, Canister (single-use)
OptionalAccessories	Handpiece Bending Tool
	Various DISS/Schrader Adapters & N2 Splitter
	Replacement Handpiece Endoscope Adapters
TissuePreservationSystem(TPS)	Specimen Collector with Filter Element – Clamshell or Scoop
	Replacement Filter Element – Clamshell or Scoop
	Specimen Infusion Valve (SIV) - 0.50 mm or 0.76 mm Metering Line
	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 1313)
11 gauge	10 cm	11 ga x 10 cm (1110)
	13 cm	11 ga x 13 cm (1113)
	13 cm	11 ga x 13 cm (Pre-Bent 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/2 description: The image shows the logo for NICO Corporation. The logo consists of the word "NICO" in a serif font, with the "O" being a filled-in circle. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font.

Comparison to Predicate

The NICO Myriad is substantially equivalent to the NICO Myriad cleared under K161307. The subject iteration of the device and the predicate device are both used for resection and removal of soft tissue and fluids under direct visualization. Changes to the subject device include being assembled by a new contract manufacturer, design enhancements/process improvements, capital equipment changes, packaging changes, additional handpiece offering, and labeling updates. These modified attributes when evaluated individually, or collectively, do not raise new questions of safety or effectiveness.

Technological Characteristics

The following table compares the subject device and predicate device.

	NICO MyriadK161307	NICO MyriadK18XXXX
510(k) #Intended Use/Indications	The NICO Myriad™ is a powered instrumentconsisting of a console, handpieces, andaccessories intended to perform resection andremoval of soft tissue and fluids under directvisualization. Types of direct visualizationmay include laparoscopic, pelviscopic,endoscopic, percutaneous, and open.Applications include those when access to thesurgical site is limited, such asNeurosurgical/Spinal andENT/Otolaryngological.Specific neurosurgical indications mayinclude diseases such as the following:• Primary/Secondary Brain Tumors• Vascular Abnormalities/Malformations(e.g., hemangiomas, cavernomas, andhematoma evacuation)• Intraventricular Tumors/Cysts	To be determinedSAME
Principles of Use	User inputs via Foot Pedal and consolesettings to provide control over the connectedhandpiece to cut and remove tissues andfluids. The high-speed reciprocating cannulawith electronically controlled variable suctionin a disposable handpiece is capable ofprecise tissue shaving and rapid tissuedebulking. The system modes include 'suctiononly' or 'suction with cutting.'	SAME
	NICO Myriad	NICO Myriad
	K161307	K18XXXX
FundamentalTechnology	A powered instrument consisting of a console,foot pedal, handpieces, and variousaccessories intended to perform resection andremoval of soft tissue and fluids under directvisualization. Tissue cutting and removal viascissoring action between oscillating(reciprocating) inner cannula and stationaryouter cannula. Suction draws fluids and tissueinto aperture for cutting and carries cut tissueaway into downstream receptacle.	SAME
ContractManufacturer	*differences from predicate identified in rightcolumn	New Contract Manufacturer
DesignEnhancements /Process Changes	*differences from predicate identified in rightcolumn	- Equivalent electronic components- Console pneumatic/Teflon tape usage- Change in bonding method for inner cannulato plastic components- Adhesive changes- Manufacturing Fixtures- Laser etching- Foot pedal cable strain relief- Console overlay updates to accommodateUDI direct-part-marking requirement
Adjustments toPrints duringmanufacturingtransfer	*differences from predicate identified in rightcolumn	- More detail on cannula prints- Several injection molded parts were re-tooled requiring print adjustments- Gasket print now has the material listed anda defined dimension for outer diameter- Luer Hub added new overall length- Assembly, Split Cable print has additionalnotes and details regarding the overall length- Dimensional changes to re-tooled injectionmolded plastic components
Packaging	*differences from predicate identified in rightcolumn	- Thicker polypropylene portion of Tyvekheader bag- Dimensional changes to handpiececorrugated box, heavier corrugated material- Dimensional changes to handpiece tray
Handpieces	*differences from predicate identified in rightcolumn	Added 11 ga x 13 cm Pre-Bent handpiece
Biocompatibility /Materials	Demonstrated based on externallycommunicating device in direct contact withtissue/bone/dentin for a limited duration	SAME
Labeling	*differences from predicate identified in rightcolumn	- Console/foot pedal updates to accommodateUDI direct-part-marking requirement- Operator's Manual updates to align withInternational version and identify informationon updated rear overlay- Handpiece IFU updates to list new factorypre-bent 1113 handpiece offering
Sterility of SterileComponents	Gamma (handpiece and certain accessories)	SAME

Table 3: Technological Characteristic Comparison

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Image /page/6/Picture/2 description: The image shows the logo for NICO Corporation. The logo is in black and gold. The word "NICO" is in black, and the word "CORPORATION" is in a smaller font size below the word "NICO".

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Image /page/7/Picture/2 description: The image shows the logo for NICO Corporation. The logo is in a serif font, with the letters "N", "I", and "C" in black. The "O" is a circle with a black outline and a yellow fill. Below the letters is the word "CORPORATION" in a smaller, sans-serif font.

The Myriad has the same fundamental technology as the predicate device. The technological and design differences do not raise new questions of safety or effectiveness and where applicable the nonclinical testing provides adequate means to assess the effects of the subject device as compared to the predicate.

Nonclinical Testing

The following tests were successfully repeated to demonstrate that the proposed modifications met applicable design and performance requirements, and supports a determination of substantial equivalence:

Biocompatibility per ISO 10993-1
Longevity Testing ●
Specification Review & Dimensional Analysis ●
Usability & Design Validation
IEC 60601-1 Testing
Sterility Testing
. Packaging Stability
Packaging Performance
Product Stability ●
Various Process Validations .

Conclusion

The subject device and the predicate are equivalent in terms of intended use and technological considerations. Risk assessments and testing activities have demonstrated that the design differences do not raise new questions of safety or effectiveness. Therefore, the conclusion drawn from these activities is that the NICO Myriad is as safe, as effective, and performs as well as or better than the legally marketed predicate Myriad.

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.