(15 days)
Not Found
No
The summary describes a mechanical and electrical device for surgical procedures with no mention of AI or ML capabilities.
No.
The device is used for surgical procedures like fluid evacuation and tissue coagulation, not for diagnosing, curing, mitigating, treating, or preventing disease, which are criteria for a therapeutic device.
No
The device is designed for surgical procedures involving fluid evacuation and tissue coagulation, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, disposable surgical instrument with electrodes, aspiration, and irrigation capabilities, made of various materials like PEBA, stainless steel, PVC, etc. 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 delivers bipolar coagulation, aspiration, and irrigation directly to the surgical site. These are all actions performed in vivo (within the living body).
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used on specimens taken from the human body to provide diagnostic information. This device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The NICO TRIOwand 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 tissue.
Product codes (comma separated list FDA assigned to the subject device)
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 PEBA and stainless steel. The indirect contacting materials are PVC, TPV, polycarbonate, ABS, PC/ABS, silicone, and 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 controlled device, 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 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
- Cytotoxicity, Sensitization, and Irritation
- Tensile Testing
- Predicate Device Testing Addendum (Irrigation/Flush Drip Measurement)
- Longevity Testing
- Usability/Human Factors Analysis
- Sterility Bioburden Addendum
- Shelf Life and Packaging Validation
- Specification Review & Dimensional Analysis
- Product Stability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a staff with three intertwined snakes and a pair of wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2016
NICO Corporation Mr. Sean Spence Regulatory Affairs Manager 250 East 96th Street, Suite 125 Indianapolis, Indiana 46240
Re: K162075
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: July 26, 2016 Received: July 27, 2016
Dear Mr. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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 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.
Christopher J. Ronk -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) K162075
Device Name NICO TRIOwand
Indications for Use (Describe)
The NICO TRIOwand 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 tissue.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Residential Use (Part 61 CFR 301 Subpart D) |
|---|
| □ Commercial Use (61 CFR 301.45-8) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 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.
10.0 510(k) SUMMARY
NICO TRIOwand™
21 CFR §807.92 Date Prepared: 26 July 2016
510(k) Number:
| NICO Corporation | |
|---|---|
| Submitter/Manufacturer | 250 E. 96th Street, Suite 125 |
| Indianapolis, IN 46240 | |
| Primary Contact: | Sean Spence, RAC |
| Regulatory Affairs Manager | |
| 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 Device | K150993 – NICO TRIOwand |
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 PEBA and stainless steel. The indirect contacting materials are PVC, TPV, polycarbonate, ABS, PC/ABS, silicone, and glue.
Intended Use
The NICO TRIOwand 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 tissue.
4
Comparison to Predicate
The NICO TRIOwand is substantially equivalent to the NICO TRIOwand cleared under K150993. The subject iteration of the device and the predicate 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 design changes include the addition of a stiffening sleeve, a smaller diameter drip line, a protective cap, and the ability to lock the slider in place.
Technological Characteristics
The following table compares the subject device and predicate device.
| | NICO TRIOwand
(Bipolar Aspirating Wand (BAW)) | NICO TRIOwand
SUBJECT OF THIS SUBMISSION |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K150993 | To be determined |
| 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 | Same |
| 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 flush the surgical
field. | Same |
| Fundamental
Technology | Delivery of bipolar cauterization | Same |
| Device 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. | Same |
| Cannula Stiffening
Sleeve | None | Stainless steel (gray) stiffening sleeve added
to proximal portion of mulit-lumen extrusion
to provide additional rigidity |
Table 1: Technological Characteristic Comparison
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Image /page/5/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 yellow circle with a black outline. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font.
| Electrode Drip Line
Specifics | Larger PVC ID tubing with polycarbonate
Luer. | Smaller PVC ID tubing with polycarbonate
Luer to help facilitate proper electrode drip
rate. |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protective Cap | None | Santoprene cap added to distal tip to protect
electrodes. |
| Slider Mechanism
for Aspiration
Control | Free moving slider | Free moving slider, with small tab added to
lock slider in open position, if desired. |
| Materials | Stainless Steel, Pebax, Polycarbonate | Same + Bayer Makrolon Luer mentioned
above for smaller electrode drip line +
Santoprene for protective cap |
| Biocompatible | Externally Communicating Device in Direct
Contact with Tissue/Bone/Dentin, Limited
Duration. | Same |
| Cross Sectional
Analysis | Total of 4 lumens: 2 for electrodes plus
irrigation drip, 1 for aspiration, 1 for surgical
field irrigation. | Same |
| Diameter (shaft) | 4 mm | Same |
| Lengths | 14 cm (angled shaft) | Same |
| Configuration /
System Components | Terminally sterilized, fully disposable
catheter-type device | Same |
| Shipping
configuration | 5 per box | 2 per box |
| Reusable or Single
Patient Use | Single Patient Use | Same |
| Sterilization | Gamma | Same |
| Handheld/manual
operation and
placement | Yes | Same |
| Device Placement | Via scope or unaided | Same |
| Handle | ~14 cm length handle | Same |
| Aspiration | Fingertip controlled w/ the aid of a "slider"
component which moves over a slot in the
handle | Same |
The TRIOwand 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 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
- o Cytotoxicity, Sensitization, and Irritation
- Tensile Testing
- Predicate Device Testing Addendum (Irrigation/Flush Drip Measurement) ●
- . Longevity Testing
- Usability/Human Factors Analysis
- Sterility Bioburden Addendum ●
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Image /page/6/Picture/0 description: The image shows the logo for NICO Corporation. The letters "NICO" are in a bold, sans-serif font, with the "O" being a circle that is split in half with the left half being black and the right half being gold. Below the letters "NICO" is the word "CORPORATION" in a smaller, sans-serif font.
- Shelf Life and Packaging Validation ●
- Specification Review & Dimensional Analysis .
- Product Stability ●
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 TRIOwand is as safe, as effective, and performs as well as or better than the legally marketed predicate TRIOwand.