(8 days)
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 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.
This document describes the NICO TRIOwand, an electrosurgical device. The information provided heavily focuses on regulatory aspects, comparisons to predicate devices, and a list of nonclinical tests performed. It does not contain the specific acceptance criteria or detailed results of a study that prove the device meets these criteria in the format requested.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert involvement, or ground truth as this information is not present in the provided text.
The document states that "The following tests were performed and demonstrate that the subject device met applicable design and performance requirements, and supports a determination of substantial equivalence." However, it only lists the types of tests, not the detailed acceptance criteria for each test or the specific results that satisfied those criteria.
For example, it lists "Ex-Vivo Animal Study for Comparison to Predicates" but does not provide details on the study design, sample size, or results. Similarly, "Design Validation/Simulated Use" is mentioned, but without any specifics on the validation metrics or outcomes.
In summary, the provided text lacks the detailed scientific study results and acceptance criteria breakdown necessary to complete the requested table and answer many of the specific questions.
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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
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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
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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)
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5.0 510(K) SUMMARY
NICO TRIOwand
21 CFR §807.92 Date Prepared: 06 March 2015
510(k) Number: _
| Submitter/Manufacturer | NICO Corporation250 E. 96th Street, Suite 125Indianapolis, IN 46240 |
|---|---|
| Primary Contact: | Jay DittmanQuality and Regulatory DirectorOffice: 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; K960455SilverGlide 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.
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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 SuctionCoagulator | Stryker SilverGlideNon-Stick Bipolar Forceps |
|---|---|---|---|
| 510(k) # | TBD | K960455 | K992931 |
| Intended Use/Indications | Disposable device designed tobe used in soft tissue surgicalprocedures that require slowto rapid fluid evacuation andlow energy output for thecoagulation of tissue. | The Bipolar SuctionCoagulator is a disposabledevice, designed to be used insoft tissue surgical proceduresthat require slow to rapid fluidevacuation and low energyoutput for the coagulation ofthe tissue i.e. neurosurgery,endoscopic, sinusoidal | Intended to facilitate graspingand manipulation of softtissue and blood vessels andprovide electrocautery insurgical procedures. |
| Principles ofUse | Catheter-type device whichincludes four connections: 1)bipolar coagulation 2)aspiration 3) irrigation dripfor electrodes 4) irrigationpathway for flushing thesurgical field. Aspirationlumen used for removal oftissues/fluids from thesurgical site. Irrigation driplumens constantly bath theelectrodes. Additional lumenexists to irrigate the surgicalfield. | Catheter-type device whichincludes two connections: 1)bipolar coagulation 2)aspiration. Aspiration occursthrough center lumen ofdevice for the removal oftissues/fluids from thesurgical site. Coagulationoccurs at/between two tubularcoaxial electrodes which arelocated at the tip of the deviceadjacent to the aspirationlumen. | Forceps-type device whichincludes two connections:1) Bipolar coagulation2) Irrigation drip forelectrodes. Irrigation driplumens constantly batheelectrodes. |
| FundamentalTechnology | Delivery of bipolarcauterization | Identical | Identical |
| Feature | NICO TRIOwand | Kirwan Bipolar Suction Coagulator | Stryker SilverGlide Non-Stick Bipolar Forceps |
| Design | Coagulation occursat/between two individualwire electrodes which arelocated at the tip of the deviceadjacent to the aspirationlumen.Cavity (or annulus) aroundeach electrode throughout thelength of the device enablesthe continuous flow of saline(drip from bag).Irrigation lumen exists for themanual delivery of fluids suchas saline to the surgical field.Sliding valve control overaspiration port on handle | Coagulation occursat/between two tubularcoaxial electrodes which arelocated at the tip of the deviceadjacent to the aspirationlumen.No means for continuous flowof saline at/around electrodesNo lumen or means ofdelivery of fluidsNo sliding valve, aspirationcontrolled via extent offingertip coverage overaspiration port | Coagulation occursat/between the tips of theforceps as they are squeezedwithin proximity of oneanother.Lumens within handle offorceps enable the continuousflow of saline (drip from bag).No means of deliveringirrigation to clear the surgicalfieldNo aspiration capabilities |
| Materials | Stainless Steel, Pebax,Polycarbonate | Unknown | Stainless Steel |
| Biocomp. | Externally CommunicatingDevice in Direct Contact withTissue/Bone/Dentin, LimitedDuration - Demonstrated | Identical | Identical |
| CrossSectionalAnalysis | Total of 4 lumens: 2 forelectrodes/irrigation drip, 1for aspiration, 1 for surgicalsite irrigation | Total of 1 lumen foraspiration | Forceps configuration with asmall lumen contained withinone of the forceps for deliveryof 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) 19cm2) 22cm3) 25cm |
| Config./Components | Terminally sterilized, single-use catheter-like device | Identical | Reprocessed, reusableforceps-type device |
| Shipping | 5 per box | Identical | 1 per box |
| Usage | Single Patient Use | Identical | Reusable device |
| Sterilization | Gamma | Identical | Onsite steam sterilization |
| Handheld/manualoperation andplacement | Yes | Identical | Identical |
| Placement | Via scope or unaided | Identical | Identical |
| Handle | ~14cm | ~7cm | No defined handle, forceps-style device |
| Aspiration | Fingertip controlled w/ the aidof a "slider" componentwhich moves over a slot | Fingertip controlled via slotwhich is occluded to produceaspiration | NA – no aspiration |
Table 1: Technological Characteristic Comparison
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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)
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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.
§ 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.