NICO Myriad

K182340 · Nico Corporation · GEI · Sep 20, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K182340
• Device Name: NICO Myriad
• Applicant: Nico Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 20, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NICO Myriad is a minimally invasive surgical system for soft tissue/fluid resection. System comprises a console, foot pedal, and disposable handpieces. Principle of operation: high-speed reciprocating inner cannula and stationary outer cannula perform scissoring action; electronically controlled variable suction draws tissue into aperture for cutting and transport to waste canister. Optional Tissue Preservation System (TPS) accessories (specimen collector, infusion valve, preserver) allow capture of resected tissue for analysis. Used in OR settings by surgeons (neurosurgical, ENT). Surgeon controls cutting/suction via foot pedal and console settings. Device enables precise tissue shaving and rapid debulking in limited-access surgical sites, potentially improving surgical outcomes by facilitating tissue removal and preservation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), longevity testing, specification/dimensional analysis, usability/design validation, IEC 60601-1 electrical safety, sterility, and packaging stability/performance testing.

Technological Characteristics

Powered electrosurgical cutting/coagulation system. Components: console, foot pedal, disposable handpieces (11-19 gauge), and optional tissue preservation accessories. Cutting mechanism: reciprocating inner cannula vs. stationary outer cannula. Energy: pneumatic/electric. Sterilization: Gamma radiation. Connectivity: console-based with foot pedal interface. Materials: biocompatible for direct tissue/bone contact.

Indications for Use

Indicated for resection and removal of soft tissue and fluids under direct visualization (laparoscopic, pelviscopic, endoscopic, percutaneous, open) in patients requiring limited-access surgery, including neurosurgical/spinal and ENT/otolaryngological procedures such as primary/secondary brain tumors, vascular abnormalities/malformations (hemangiomas, hematoma evacuation), and intraventricular tumors/cysts.

Regulatory Classification

Identification

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

Predicate Devices

• NICO Myriad (K161307)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

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) | <span style="font-size: 16px;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 16px;">☐</span> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 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™ |
| 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

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 ●

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) |
| Optional<br>Accessories | Handpiece Bending Tool |
| | Various DISS/Schrader Adapters & N2 Splitter |
| | Replacement Handpiece Endoscope Adapters |
| Tissue<br>Preservation<br>System<br>(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

| Cannula<br>Diameter | Cannula<br>Length | Description |
|---------------------|-------------------|-------------------------------|
| 19 gauge | 21.5 cm | 19 ga x 21.5 cm (PaediScope®) |
| | 28 cm | 19 ga x 28 cm (Oi®) |
| | 28 cm | 19 ga x 28 cm (Little LOTTA®) |
| 17 gauge | 31.5 cm | 17 ga x 31.5 cm (Decq) |
| 15 gauge | 10 cm | 15 ga x 10 cm (1510) |
| | 13 cm | 15 ga x 13 cm (1513) |
| | 25 cm | 15 ga x 25 cm (MINOP®) |
| | 25 cm | 15 ga x 25 cm (GAAB) |
| | 26.5 cm | 15 ga x 26.5 cm (LOTTA®) |
| 13 gauge | 10 cm | 13 ga x 10 cm (1310) |
| | 13 cm | 13 ga x 13 cm (1313) |
| | 13 cm | 13 ga x 13 cm (Pre-Bent 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 Myriad<br>K161307 | NICO Myriad<br>K18XXXX |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) #<br>Intended Use/<br>Indications | 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<br>may include laparoscopic, pelviscopic,<br>endoscopic, percutaneous, and open.<br>Applications include those when access to the<br>surgical site is limited, such as<br>Neurosurgical/Spinal and<br>ENT/Otolaryngological.<br><br>Specific neurosurgical indications may<br>include diseases such as the following:<br>• Primary/Secondary Brain Tumors<br>• Vascular Abnormalities/Malformations<br>(e.g., hemangiomas, cavernomas, and<br>hematoma evacuation)<br>• Intraventricular Tumors/Cysts | To be determined<br>SAME |
| Principles of Use | User inputs via Foot Pedal and console<br>settings to provide control over the connected<br>handpiece to cut and remove tissues and<br>fluids. The high-speed reciprocating cannula<br>with electronically controlled variable suction<br>in a disposable handpiece is capable of<br>precise tissue shaving and rapid tissue<br>debulking. The system modes include 'suction<br>only' or 'suction with cutting.' | SAME |
| | NICO Myriad | NICO Myriad |
| | K161307 | K18XXXX |
| Fundamental<br>Technology | A powered instrument consisting of a console,<br>foot pedal, handpieces, and various<br>accessories intended to perform resection and<br>removal of soft tissue and fluids under direct<br>visualization. Tissue cutting and removal via<br>scissoring action between oscillating<br>(reciprocating) inner cannula and stationary<br>outer cannula. Suction draws fluids and tissue<br>into aperture for cutting and carries cut tissue<br>away into downstream receptacle. | SAME |
| Contract<br>Manufacturer | *differences from predicate identified in right<br>column | New Contract Manufacturer |
| Design<br>Enhancements /<br>Process Changes | *differences from predicate identified in right<br>column | - Equivalent electronic components<br>- Console pneumatic/Teflon tape usage<br>- Change in bonding method for inner cannula<br>to plastic components<br>- Adhesive changes<br>- Manufacturing Fixtures<br>- Laser etching<br>- Foot pedal cable strain relief<br>- Console overlay updates to accommodate<br>UDI direct-part-marking requirement |
| Adjustments to<br>Prints during<br>manufacturing<br>transfer | *differences from predicate identified in right<br>column | - More detail on cannula prints<br>- Several injection molded parts were re-<br>tooled requiring print adjustments<br>- Gasket print now has the material listed and<br>a defined dimension for outer diameter<br>- Luer Hub added new overall length<br>- Assembly, Split Cable print has additional<br>notes and details regarding the overall length<br>- Dimensional changes to re-tooled injection<br>molded plastic components |
| Packaging | *differences from predicate identified in right<br>column | - Thicker polypropylene portion of Tyvek<br>header bag<br>- Dimensional changes to handpiece<br>corrugated box, heavier corrugated material<br>- Dimensional changes to handpiece tray |
| Handpieces | *differences from predicate identified in right<br>column | Added 11 ga x 13 cm Pre-Bent handpiece |
| Biocompatibility /<br>Materials | Demonstrated based on externally<br>communicating device in direct contact with<br>tissue/bone/dentin for a limited duration | SAME |
| Labeling | *differences from predicate identified in right<br>column | - Console/foot pedal updates to accommodate<br>UDI direct-part-marking requirement<br>- Operator's Manual updates to align with<br>International version and identify information<br>on updated rear overlay<br>- Handpiece IFU updates to list new factory<br>pre-bent 1113 handpiece offering |
| Sterility of Sterile<br>Components | 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.