Who is the manufacturer of NICO TRIOwand?

Nico Corporation filed the 510(k) submission for NICO TRIOwand (K150993).

What is the FDA product code for NICO TRIOwand?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for NICO TRIOwand?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NICO TRIOwand?

Kirwan Bipolar Suction Coagulator (K960455); SilverGlide Non-Stick Bipolar Forceps (K992931).

Who can help prepare an FDA 510(k) submission like NICO TRIOwand?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NICO TRIOwand

K150993 · Nico Corporation · GEI · Apr 23, 2015 · General, Plastic Surgery

Device Facts

Record ID	K150993
Device Name	NICO TRIOwand
Applicant	Nico Corporation
Product Code	GEI · General, Plastic Surgery
Decision Date	Apr 23, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

Intended Use

Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue.

Device Story

NICO TRIOwand is a surgeon-controlled, disposable catheter-type device for soft tissue surgery. It connects to third-party electrosurgical generators to deliver bipolar coagulation via two stationary insulated electrodes. The device features four lumens: two for electrode irrigation drip, one for aspiration, and one for surgical field irrigation. Aspiration is managed via a sliding valve on the handle. Used in clinical settings, the device allows surgeons to simultaneously coagulate tissue, evacuate fluids, and flush the surgical site. By combining these functions into a single instrument, it simplifies surgical workflows, potentially reducing procedure time and improving visibility in the surgical field.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1), tensile testing, electrical safety (IEC 60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), ex-vivo animal study, longevity testing, usability/human factors analysis, design validation/simulated use, sterility validation, and shelf-life/packaging validation.

Technological Characteristics

Catheter-type device with 4 lumens. Materials: PEBAX, stainless steel (direct contact); Tygon, polycarbonate, ABS, PC/ABS, silicone, Dymax glue (indirect). Bipolar electrosurgical energy source. 4mm diameter, 14cm length, 30-degree pre-bent shaft. Sliding valve aspiration control. Terminally sterilized via Gamma radiation. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.

Indications for Use

Indicated for soft tissue surgical procedures requiring fluid evacuation and low energy coagulation.

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

Kirwan Bipolar Suction Coagulator (K960455)
SilverGlide Non-Stick Bipolar Forceps (K992931)

Related Devices

K162075 — NICO TRIOwand · Nico Corporation · Aug 11, 2016
K201637 — Aurora Evacuator +Coag · Rebound Therapeutics · Aug 12, 2020
K965241 — BIPOLAR SUCTION COAGULATOR · Kirwan Surgical Products, Inc. · Feb 28, 1997
K203745 — AURORA Evacuator +Coag · Rebound Therapeutics · Dec 2, 2021
K091223 — VALLEYLAB SUCTION COAGULATOR, MODEL E3305 · Covidien LP · Sep 11, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or clothing. The profiles are arranged in a way that creates a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 23, 2015 NICO Corporation Mr. Jay Dittman Quality and Regulatory Director 250 East 96th Street, Suite 125 Indianapolis, Indiana 46240 Re: K150993 Trade/Device Name: NICO TRIOwand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 8, 2015 Received: April 15, 2015 Dear Mr. Dittman: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ forth in 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" (21CFR 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 -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150993 Device Name NICO TRIOwand Indications for Use (Describe) Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue. Type of Use (*Select one or both, as applicable*)X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### 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}------------------------------------------------ # 5.0 510(K) SUMMARY # NICO TRIOwand 21 CFR §807.92 Date Prepared: 06 March 2015 510(k) Number: _ | Submitter/Manufacturer | NICO Corporation 250 E. 96th Street, Suite 125 Indianapolis, IN 46240 | |------------------------|----------------------------------------------------------------------------------------------| | Primary Contact: | Jay Dittman Quality and Regulatory Director Office: 317.660.7118 | | Trade Name | NICO TRIOwand | | Common/Usual Name | Electrosurgical, cutting & coagulation & accessories | | Classification | 21 CFR §878.4400 (Class II) | | Product Code | GEI | | Predicate Devices | Kirwan Bipolar Suction Coagulator; K960455 SilverGlide Non-Stick Bipolar Forceps; K992931 | ### Device Description The NICO TRIOwand is a surgeon controlled device that enables the delivery of bipolar coagulation via third-party electrosurgical generators. Coagulation occurs between two stationary insulated electrodes which are continuously drip irrigated during use. Second, the TRIOwand provides user controlled delivery of aspiration/vacuum for the evacuation of fluids from the surgical site. Third, the TRIOwand provides the user the ability to deliver irrigation for flushing the surgical field. This submission covers a single configuration of the device: - . NICO TRIOwand - 4mm diameter, 14cm length, pre-bent (~30°) The direct patient contacting materials consist of PEBAX® and stainless steel. The indirect contacting materials are Tygon®, polycarbonate, ABS, PC/ABS, silicone, and Dymax glue. #### Intended Use Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for NICO Corporation. The logo is in a sans-serif font, with the letters N, I, and C in black and the letter O in gold. Below the word NICO is the word CORPORATION in a smaller font, also in black. The logo is simple and modern. # Comparison to Predicates The NICO TRIOwand is substantially equivalent to the combination of Kirwan's Bipolar Suction Coagulator (K960455) and Stryker's SilverGlide Non-Stick Bipolar Forceps (K992931). The subject device and the Kirwan device are both used for soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue. The Stryker SilverGlide predicate is also intended for electrocautery, as well as grasping and manipulation of tissue. The TRIOwand is not designed for grasping or manipulation of tissue, and this additional feature of the Stryker predicate is not critical to the primary electrocautery function of subject device. ## Technological Characteristics The following table compares the subject device and predicate devices. | Feature | NICO TRIOwand | Kirwan Bipolar Suction Coagulator | Stryker SilverGlide Non-Stick Bipolar Forceps | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) # | TBD | K960455 | K992931 | | Intended Use/ Indications | Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue. | The Bipolar Suction Coagulator is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e. neurosurgery, endoscopic, sinusoidal | Intended to facilitate grasping and manipulation of soft tissue and blood vessels and provide electrocautery in surgical procedures. | | Principles of Use | Catheter-type device which includes four connections: 1) bipolar coagulation 2) aspiration 3) irrigation drip for electrodes 4) irrigation pathway for flushing the surgical field. Aspiration lumen used for removal of tissues/fluids from the surgical site. Irrigation drip lumens constantly bath the electrodes. Additional lumen exists to irrigate the surgical field. | Catheter-type device which includes two connections: 1) bipolar coagulation 2) aspiration. Aspiration occurs through center lumen of device for the removal of tissues/fluids from the surgical site. Coagulation occurs at/between two tubular coaxial electrodes which are located at the tip of the device adjacent to the aspiration lumen. | Forceps-type device which includes two connections: 1) Bipolar coagulation 2) Irrigation drip for electrodes. Irrigation drip lumens constantly bathe electrodes. | | Fundamental Technology | Delivery of bipolar cauterization | Identical | Identical | | Feature | NICO TRIOwand | Kirwan Bipolar Suction Coagulator | Stryker SilverGlide Non-Stick Bipolar Forceps | | Design | Coagulation occurs at/between two individual wire electrodes which are located at the tip of the device adjacent to the aspiration lumen. Cavity (or annulus) around each electrode throughout the length of the device enables the continuous flow of saline (drip from bag). Irrigation lumen exists for the manual delivery of fluids such as saline to the surgical field. Sliding valve control over aspiration port on handle | Coagulation occurs at/between two tubular coaxial electrodes which are located at the tip of the device adjacent to the aspiration lumen. No means for continuous flow of saline at/around electrodes No lumen or means of delivery of fluids No sliding valve, aspiration controlled via extent of fingertip coverage over aspiration port | Coagulation occurs at/between the tips of the forceps as they are squeezed within proximity of one another. Lumens within handle of forceps enable the continuous flow of saline (drip from bag). No means of delivering irrigation to clear the surgical field No aspiration capabilities | | Materials | Stainless Steel, Pebax, Polycarbonate | Unknown | Stainless Steel | | Biocomp. | Externally Communicating Device in Direct Contact with Tissue/Bone/Dentin, Limited Duration - Demonstrated | Identical | Identical | | Cross Sectional Analysis | Total of 4 lumens: 2 for electrodes/irrigation drip, 1 for aspiration, 1 for surgical site irrigation | Total of 1 lumen for aspiration | Forceps configuration with a small lumen contained within one of the forceps for delivery of saline drip. | | Shaft (dia.) | 4 mm | 5.5 mm | NA – no diameter (Forceps) | | Lengths | 1) 14 cm (angled shaft) | 1) 14.2 cm (angled tip) | 1) 19cm 2) 22cm 3) 25cm | | Config./ Components | Terminally sterilized, single- use catheter-like device | Identical | Reprocessed, reusable forceps-type device | | Shipping | 5 per box | Identical | 1 per box | | Usage | Single Patient Use | Identical | Reusable device | | Sterilization | Gamma | Identical | Onsite steam sterilization | | Handheld/ manual operation and placement | Yes | Identical | Identical | | Placement | Via scope or unaided | Identical | Identical | | Handle | ~14cm | ~7cm | No defined handle, forceps- style device | | Aspiration | Fingertip controlled w/ the aid of a "slider" component which moves over a slot | Fingertip controlled via slot which is occluded to produce aspiration | NA – no aspiration | #### Table 1: Technological Characteristic Comparison {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for NICO Corporation. The letters "N," "I," and "C" are in black, and the "O" is in gold. The word "CORPORATION" is written in smaller, black letters below the letters "NICO." ## Table 1: Technological Characteristic Comparison (continued) {6}------------------------------------------------ Image /page/6/Picture/0 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. The TRIOwand has the same fundamental technology as the predicate devices – they all deliver bipolar energy for the purpose of coagulation of tissue. Like the Kirwan predicate, the TRIOwand enables the delivery of aspiration for evacuation of fluids. Like the secondary predicate, the TRIOwand enables the delivery of irrigation drip to the electrodes. The technological 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 combined characteristics of the subject device as compared to the predicates. ## Nonclinical Testing The following tests were performed and demonstrate that the subject device met applicable design and performance requirements, and supports a determination of substantial equivalence: - Biocompatibility per ISO 10993-1 . - o Cytotoxicity. Sensitization, and Irritation - Tensile Testing - General Electrical Safety Testing per IEC 60601-1 ● - EMC Testing per IEC 60601-1-2 ● - High Frequency Surgical Equipment Testing per IEC 60601-2-2 - Ex-Vivo Animal Study for Comparison to Predicates - Predicate Device Testing for Comparison to Predicates - Longevity Testing - Usability/Human Factors Analysis - Design Validation/Simulated Use ● - Sterility Validation - . Shelf Life and Packaging Validation ## Conclusion The subject device and the two predicate devices are equivalent in terms of intended use and technological considerations. Risk assessments, biocompatibility, electrical safety, bench testing. design validation, and compliance with recognized standards have demonstrated that any differences do not raise new questions of safety or effectiveness. Therefore, the conclusion drawn from the nonclinical activities demonstrate that the NICO TRIOwand is as safe, as effective, and performs as well as or better than the legally marketed predicate Kirwan and Stryker devices.