(15 days)
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.
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.
This document describes the NICO TRIOwand, an electrosurgical cutting and coagulation device. The provided text is a 510(k) summary for clearance of a modified version of the device (K162075), comparing it to a previously cleared predicate device (K150993).
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for performance metrics. Instead, the approach is one of demonstrating substantial equivalence to a predicate device. The performance is assessed by repeating nonclinical tests to ensure the modified device (K162075) meets applicable design and performance requirements, as compared to the predicate (K150993).
The "acceptance criteria" are implied to be that the modified device's performance in these nonclinical tests is equivalent to or better than the predicate device and does not raise new questions of safety or effectiveness.
| Performance Characteristic Tested | Implied Acceptance Criteria (relative to Predicate K150993) | Reported Device Performance (K162075) |
|---|---|---|
| Biocompatibility | No new or increased risk (passes ISO 10993-1) | Passes Cytotoxicity, Sensitization, and Irritation tests. |
| Tensile Testing | Meets strength requirements | Results support substantial equivalence. |
| Irrigation/Flush Drip Measurement | Proper drip rate performance | Results support substantial equivalence. |
| Longevity Testing | Maintains function over expected lifetime | Results support substantial equivalence. |
| Usability/Human Factors Analysis | Safe and effective for user interactions | Results support substantial equivalence. |
| Sterility Bioburden | Meets sterility requirements | Results support substantial equivalence. |
| Shelf Life and Packaging Validation | Maintained sterility and device integrity | Results support substantial equivalence. |
| Specification Review & Dimensional Analysis | Conforms to design specifications | Results support substantial equivalence. |
| Product Stability | Maintains function and integrity over time | Results support substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the nonclinical tests.
The data provenance is not explicitly mentioned as retrospective or prospective, nor does it detail the country of origin. However, given that these are nonclinical laboratory tests conducted for a 510(k) submission, they are typically performed in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The tests performed are nonclinical and involve laboratory measurements and comparisons to established standards (e.g., ISO 10993-1) or predicate device performance, not human expert interpretation of data to establish a ground truth as typically seen in in vivo or clinical studies.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment. The listed studies are nonclinical performance tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no MRMC comparative effectiveness study mentioned. The device is an electrosurgical tool, and the studies performed are nonclinical engineering and safety tests, not related to AI or image interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical surgical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it applies to clinical diagnosis or image interpretation is not directly applicable here. For the nonclinical tests:
- Biocompatibility: Ground truth is established by adherence to recognized international standards (ISO 10993-1) and the results of laboratory tests (e.g., observing cell viability, skin reactions).
- Tensile Testing, Irrigation/Flush Drip Measurement, Longevity Testing, Shelf Life, Product Stability, Specification Review: Ground truth is defined by engineering specifications, control samples (predicate device), and established physical/chemical testing methodologies. Performance is compared to these predetermined standards or to the predicate performance.
- Usability/Human Factors Analysis: Ground truth for usability typically involves identifying potential use errors or difficulties based on user interaction protocols and expert review, aiming to ensure safe and effective operation.
8. The sample size for the training set
This information is not applicable and not provided. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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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
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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
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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 125Indianapolis, IN 46240 |
| Primary Contact: | Sean Spence, RACRegulatory Affairs ManagerOffice: 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.
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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 TRIOwandSUBJECT OF THIS SUBMISSION | |
|---|---|---|
| 510(k) # | K150993 | To be determined |
| Intended Use/Indications | Disposable device designed to be used in softtissue surgical procedures that require slow torapid fluid evacuation and low energy outputfor the coagulation of tissue | Same |
| Principles of Use | Catheter-type device which includes fourconnections: 1) bipolar coagulation2) aspiration 3) irrigation drip for electrodes4) irrigation pathway for flushing the surgicalfield. Aspiration lumen used for removal oftissues/fluids from the surgical site. Irrigationdrip lumens constantly bath the electrodes.Additional lumen exists to flush the surgicalfield. | Same |
| FundamentalTechnology | Delivery of bipolar cauterization | Same |
| Device design | Coagulation occurs at/between two individualwire electrodes which are located at the tip ofthe device adjacent to the aspiration lumen.Cavity (or annulus) around each electrodethroughout the length of the device enablesthe continuous flow of saline (drip from bag).Irrigation lumen exists for the manualdelivery of fluids such as saline to the surgicalfield.Sliding valve control over aspiration port onhandle. | Same |
| Cannula StiffeningSleeve | None | Stainless steel (gray) stiffening sleeve addedto proximal portion of mulit-lumen extrusionto 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 LineSpecifics | Larger PVC ID tubing with polycarbonateLuer. | Smaller PVC ID tubing with polycarbonateLuer to help facilitate proper electrode driprate. |
|---|---|---|
| Protective Cap | None | Santoprene cap added to distal tip to protectelectrodes. |
| Slider Mechanismfor AspirationControl | Free moving slider | Free moving slider, with small tab added tolock slider in open position, if desired. |
| Materials | Stainless Steel, Pebax, Polycarbonate | Same + Bayer Makrolon Luer mentionedabove for smaller electrode drip line +Santoprene for protective cap |
| Biocompatible | Externally Communicating Device in DirectContact with Tissue/Bone/Dentin, LimitedDuration. | Same |
| Cross SectionalAnalysis | Total of 4 lumens: 2 for electrodes plusirrigation drip, 1 for aspiration, 1 for surgicalfield irrigation. | Same |
| Diameter (shaft) | 4 mm | Same |
| Lengths | 14 cm (angled shaft) | Same |
| Configuration /System Components | Terminally sterilized, fully disposablecatheter-type device | Same |
| Shippingconfiguration | 5 per box | 2 per box |
| Reusable or SinglePatient Use | Single Patient Use | Same |
| Sterilization | Gamma | Same |
| Handheld/manualoperation andplacement | 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 thehandle | 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.
§ 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.