(8 days)
Not Found
No
The description focuses on mechanical and electrical functions (coagulation, aspiration, irrigation) and material composition. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is described as a surgical tool for fluid evacuation and tissue coagulation, which are procedural steps rather than therapeutic outcomes themselves.
No
The device description clearly states its functions are coagulation, aspiration/vacuum, and irrigation, all of which are treatment-oriented actions, not diagnostic.
No
The device description clearly outlines a physical, disposable surgical instrument with electrodes, aspiration, and irrigation capabilities, made of various materials like PEBAX and stainless steel. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of tissue." This describes a surgical tool used during a procedure on a patient's body.
- Device Description: The description details a device that performs bipolar coagulation, aspiration/vacuum, and irrigation at the surgical site. These are all actions performed directly on or within the patient's body during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status. This device does not perform any such analysis of specimens.
- Anatomical Site: The anatomical site is "soft tissue," indicating direct interaction with the patient's body.
- Intended User / Care Setting: The intended user is a "surgeon" in "surgical procedures," further reinforcing its use in a surgical setting on a patient.
The device is a surgical instrument used for coagulation, aspiration, and irrigation during soft tissue procedures, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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 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:
- Bipolar coagulation
- 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
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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.