NICO Myriad NOVUS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 13, 2019 NICO Corporation Sean Spence Regulatory Affairs Manager 250 East 96th Street. Suite 125 Indianapolis, Indiana 46240 Re: K191599 Trade/Device Name: NICO Myriad NOVUS Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, ERL, HBC, FST, HBI Dated: June 14, 2019 Received: June 17, 2019 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 {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191599 Device Name NICO Myriad NOVUS #### Indications for Use (Describe) The NICO Myriad NOVUS 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 with or without magnification (e.g., loupes or microscope). Types of direct visualization may include laparoscopic, pelviscopic, percutaneous, and open. Applications include those when access to the 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/CH) - Intraventricular Tumors/Cysts The Myriad-LX illumination accessories are intended for use with the Myriad-LX light source for delivery of light to the surgical field to enhance visualization of tissue. The NICO Automated Preservation System accessories are intended for use with the Myriad for collection and preservation of resected tissue. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | |-------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### 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/1 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 golden circle. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font. 21 CFR \$80' Date Prepared: 14 June 2019 | Submitter/Manufacturer | NICO Corporation<br>250 E. 96th Street, Suite 125<br>Indianapolis, IN 46240 | |--------------------------|-----------------------------------------------------------------------------| | Primary Contact: | Sean Spence, RAC<br>Regulatory Affairs Manager<br>Office: 317.660.7118 | | Trade Name | NICO Myriad NOVUS™ | | Common/Usual Name | Electrosurgical, cutting & coagulation & accessories | | Classification | 21 CFR §878.4400 (Class II) | | Product Code | GEI | | Secondary Product Codes: | ERL, HBC, FST, HBI | | Predicate Device | K182340 - NICO Myriad | ## Device Description The NICO Myriad NOVUS 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 handpiece is capable of precise tissue shaving and rapid tissue debulking. The NICO Automated Preservation System™ is a group of accessories for collection and preservation of resected tissue, it 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 ● For standard handpieces, the Myriad-LX™ high intensity light source, handpiece sleeve, and illumination fiber combine to deliver illumination to the surgical field to aid in visualization. The various handpieces, components, and accessories are outlined in tables below. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for NICO Corporation. The word "NICO" is written in a bold, serif font, with the "O" in a golden color. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font. #### Table 1: Myriad Components/Accessories | Components | | |----------------------------------------------------|---------------------------------------------------------------------------| | NICO Myriad<br>NOVUS | Myriad NOVUS Console and Foot Pedal | | | Myriad-LX Light Source | | | Cart, Aspiration Line, Nitrogen/Instrument Air Line, Power Cord, Canister | | | Myriad Handpieces (multiple versions) | | | Myriad-LX Handpiece Sleeve (multiple sizes) | | | Myriad-LX Illumination Fiber | | Automated<br>Preservation<br>System<br>Accessories | 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 | | Optional /<br>Replacement<br>Accessories | Handpiece Bending Tool | | | Various DISS/Schrader Adapters & N2 Splitter | | | Replacement Handpiece Endoscope Adapters | Table 2: Myriad Standard Handpieces | CANNULA<br>DIAMETER | CANNULA<br>LENGTH | DESCRIPTION | |---------------------|-------------------|---------------| | 15 gauge | 10 cm | 1510 | | 15 gauge | 13 cm | 1513 | | 13 gauge | 10 cm | 1310 | | 13 gauge | 13 cm | 1313 | | 13 gauge | 13 cm | Pre-Bent 1313 | | 11 gauge | 10 cm | 1110 | | 11 gauge | 13 cm | 1113 | | 11 gauge | 13 cm | Pre-Bent 1113 | Table 3: Myriad Working-Channel Handpieces | CANNULA<br>DIAMETER | CANNULA<br>LENGTH | DESCRIPTION | |---------------------|-------------------|--------------------------| | 19 gauge | 21.5 cm | Aesculap PaediScope® | | 19 gauge | 28 cm | Karl Storz Oi HandyPro® | | 19 gauge | 28 cm | Karl Storz Little LOTTA® | | 17 gauge | 31.5 cm | Karl Storz Decq | | 15 gauge | 25 cm | Aesculap MINOP® & InVent | | 15 gauge | 25 cm | Karl Storz GAAB | | 15 gauge | 26.5 cm | Karl Storz LOTTA® | ## Indication for Use The NICO Myriad NOVUS 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 - {5}------------------------------------------------ Image /page/5/Picture/1 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 in a golden color. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font. - Vascular Abnormalities/Malformations (e.g., hemangiomas, cavernomas, and hematoma evacuation/ICH) - Intraventricular Tumors/Cysts - The Myriad-LX illumination accessories are intended for use with the Myriad-LX light source for delivery of light to the surgical field to enhance visualization of tissue. The NICO Automated Preservation System accessories are intended for use with the Myriad for collection and preservation of resected tissue. # Comparison to Predicate The NICO Myriad NOVUS is substantially equivalent to the NICO Myriad cleared under K182340. The Subject 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 the addition of illumination and a console software update. 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 Myriad<br>K182340 | NICO Myriad<br>K19XXXX | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) # | K182340 | To be determined | | Intended Use | Powered instrument for cutting and removal of<br>tissue and fluids. | SAME | | Indications for Use | The NICO Myriad is a powered instrument<br>consisting of a console, handpieces, and<br>accessories intended to perform resection and<br>removal of soft tissue and fluids under direct<br>visualization. Types of direct visualization may<br>include laparoscopic, pelviscopic, endoscopic,<br>percutaneous, and open. Applications include those<br>when access to the surgical site is limited, such as<br>Neurosurgical/Spinal and ENT/Otolaryngological.<br>Specific neurosurgical indications may include<br>diseases such as the following:<br>• Primary/Secondary Brain Tumors<br>• Vascular Abnormalities/Malformations (e.g.,<br>hemangiomas, cavernomas, and hematoma<br>evacuation)<br>• Intraventricular Tumors/Cysts | The NICO Myriad NOVUS is a powered<br>instrument consisting of a console, handpieces, and<br>accessories intended to perform resection and<br>removal of soft tissue and fluids under direct<br>visualization with or without magnification (e.g.,<br>loupes or microscope). Types of direct<br>visualization may include laparoscopic,<br>pelviscopic, endoscopic, percutaneous, and open.<br>Applications include those when access to the<br>surgical site is limited, such as<br>Neurosurgical/Spinal and ENT/Otolaryngological.<br>Specific neurosurgical indications may include<br>diseases such as the following:<br>-Primary/Secondary Brain Tumors<br>- Vascular Abnormalities/Malformations (e.g.,<br>hemangiomas, cavernomas, and hematoma<br>evacuation/ICH)<br>-Intraventricular Tumors/Cysts<br>The Myriad-LX illumination accessories are<br>intended for use with the Myriad-LX light source<br>for delivery of light to the surgical field to enhance<br>visualization of tissue.<br>The NICO Automated Preservation System<br>accessories are intended for use with the Myriad | | | NICO Myriad<br>K182340 | NICO Myriad<br>K19XXXX | | Principles of Use | User inputs via Foot Pedal and console settings to provide control over the connected handpiece to cut and remove tissues and fluids. The high-speed reciprocating cannula with electronically controlled variable suction in a disposable handpiece is capable of precise tissue shaving and rapid tissue debulking. The system modes include 'suction-only' or 'suction-with-cutting.' | SAME | | Fundamental<br>Technology | A powered instrument consisting of a console, foot pedal, handpieces, and various accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Tissue cutting and removal 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 | | Console | Brand Name - NICO Myriad<br>Gray Anodized Aluminum Accents with Painted Blue Shell | Brand Name – NICO Myriad NOVUS<br>Blue Anodized Aluminum Accents with Painted Gray Shell | | Console Software | Ver 1.50 | Ver 1.52 ( <i>1.51 never released</i> )<br>- Administrative updates to code structure<br>- Update to handpiece motor stopping algorithm | | Cart | Existing Cart | Similar - with Modifications to accommodate Myriad-LX Light Source | | Light Source | None | Myriad-LX Light Source | | Handpieces | See Tables 2/3 Above | SAME | | Accessories | NICO Automated Preservation System<br>Optional / Replacement Accessories | SAME<br>SAME<br>Myriad-LX Illumination Accessories | | Packaging<br>Configurations | Packaged per Device Type | SAME<br>Procedure Pack/Tray Configurations | | Biocompatibility | Demonstrated based on externally communicating device in direct contact with tissue/bone/dentin for a limited duration | SAME | | Labeling | Console Operator's Manual<br>Handpiece IFU | SAME<br>Handpiece IFU – Minor Changes<br>Illumination IFU - new<br>APS IFU - extracted from handpiece IFU | | Sterility | Gamma (handpiece and certain accessories) | SAME | ## Table 3: Technological Characteristic Comparison {6}------------------------------------------------ NICO CORPORATION The Myriad NOVUS has the same principles of use and fundamental technology as the predicate. 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. {7}------------------------------------------------ Image /page/7/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, thinner, black letters. The "O" in "NICO" is a golden color. # Nonclinical Testing The following tests were successfully repeated/completed to demonstrate that the subject device met all applicable design and performance requirements, and supports a determination of substantial equivalence: - Biocompatibility per ISO 10993-1 - Specification Review & Dimensional Analysis - Tensile Testing - Illumination Characteristics - Longevity - Thermal Characteristics - . Product Stability - Sterility Testing/Adoption - Packaging Stability - Packaging Performance - Software Project Plan - Software Design Architecture - General Console Verification - Software Unit Testing ● # 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 NOVUS is as safe, as effective, and performs as well as or better than the legally marketed predicate Myriad.