(88 days)
Not Found
No
The summary describes a surgical system for tissue removal and fluid aspiration, focusing on mechanical and illumination components. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended for the resection, removal, and collection of soft tissue and fluids, which is a surgical tool, not a therapeutic device.
No
This device is described as a surgical system for the resection and removal of soft tissue and fluids ("resection and removal of soft tissue and fluids"). It also mentions "collection and preservation of resected tissue" and "delivery of light to the surgical field to enhance visualization of tissue." These are all therapeutic or supportive functions, not diagnostic ones.
No
The device description explicitly details hardware components such as a console, handpieces, cannulas, suction mechanisms, a light source, and accessories for tissue collection and preservation. The performance studies also include testing of physical characteristics like tensile strength, illumination, longevity, and thermal properties, indicating a hardware-based device.
Based on the provided text, the NICO Myriad NOVUS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument for the resection and removal of soft tissue and fluids within the body under direct visualization. This is an in vivo procedure.
- Device Description: The description details a surgical system with handpieces, suction, and illumination for use during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body to provide information about a patient's health status, which is the core function of an IVD. The tissue collection system is for preserving resected tissue, not for diagnostic testing of that tissue by the device itself.
Therefore, the NICO Myriad NOVUS is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NICO Myriad NOVUS is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization with or without magnification (e.g., loupes or microscope). Types of direct visualization may include laparoscopic, pelviscopic, percutaneous, and open. Applications include those when access to the is limited, such as Neurosurgical/ Spinal and ENT/Otolaryngological. Specific neurosurgical indications may include diseases such as the following:
- Primary/Secondary Brain Tumors
- Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation/CH)
- Intraventricular Tumors/Cysts
The Myriad-LX illumination accessories are intended for use with the Myriad-LX light source for delivery of light to the surgical field to enhance visualization of tissue.
The NICO Automated Preservation System accessories are intended for use with the Myriad for collection and preservation of resected tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI, ERL, HBC, FST, HBI
Device Description
The NICO Myriad NOVUS is a minimally invasive surgical system designed for the removal of soft tissues and fluids under direct visualization. The technology platform is based on combining a minimally invasive non-heat generating reciprocating inner cannula and a stationary outer cannula with electronically controlled variable suction. The handpiece is capable of precise tissue shaving and rapid tissue debulking.
The NICO Automated Preservation System™ is a group of accessories for collection and preservation of resected tissue, it is comprised of three parts:
- Specimen Collector with filter element which collects tissue; ●
- Specimen Infusion Valve (SIV) which provides the desired biological environment; ●
- Specimen Preserver which provides the desired thermal condition ●
For standard handpieces, the Myriad-LX™ high intensity light source, handpiece sleeve, and illumination fiber combine to deliver illumination to the surgical field to aid in visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurosurgical/ Spinal and ENT/Otolaryngological.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 successfully repeated/completed to demonstrate that the subject device met all applicable design and performance requirements, and supports a determination of substantial equivalence:
- Biocompatibility per ISO 10993-1
- Specification Review & Dimensional Analysis
- Tensile Testing
- Illumination Characteristics
- Longevity
- Thermal Characteristics
- . Product Stability
- Sterility Testing/Adoption
- Packaging Stability
- Packaging Performance
- Software Project Plan
- Software Design Architecture
- General Console Verification
- Software Unit Testing ●
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 Myriad NOVUS is as safe, as effective, and performs as well as or better than the legally marketed predicate Myriad.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 13, 2019
NICO Corporation Sean Spence Regulatory Affairs Manager 250 East 96th Street. Suite 125 Indianapolis, Indiana 46240
Re: K191599
Trade/Device Name: NICO Myriad NOVUS Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, ERL, HBC, FST, HBI Dated: June 14, 2019 Received: June 17, 2019
Dear Sean 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191599
Device Name NICO Myriad NOVUS
Indications for Use (Describe)
The NICO Myriad NOVUS is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization with or without magnification (e.g., loupes or microscope). Types of direct visualization may include laparoscopic, pelviscopic, percutaneous, and open. Applications include those when access to the is limited, such as Neurosurgical/ Spinal and ENT/Otolaryngological. Specific neurosurgical indications may include diseases such as the following:
- Primary/Secondary Brain Tumors
- Vascular Abnormalities/Malformations (e.g., hemangiomas, and hematoma evacuation/CH)
- Intraventricular Tumors/Cysts
The Myriad-LX illumination accessories are intended for use with the Myriad-LX light source for delivery of light to the surgical field to enhance visualization of tissue.
The NICO Automated Preservation System accessories are intended for use with the Myriad for collection and preservation of resected tissue.
Type of Use (Select one or both, as applicable)
| 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/1 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 golden circle. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font.
21 CFR $80' Date Prepared: 14 June 2019
| Submitter/Manufacturer | NICO Corporation
250 E. 96th Street, Suite 125
Indianapolis, IN 46240 |
|--------------------------|-----------------------------------------------------------------------------|
| Primary Contact: | Sean Spence, RAC
Regulatory Affairs Manager
Office: 317.660.7118 |
| Trade Name | NICO Myriad NOVUS™ |
| Common/Usual Name | Electrosurgical, cutting & coagulation & accessories |
| Classification | 21 CFR §878.4400 (Class II) |
| Product Code | GEI |
| Secondary Product Codes: | ERL, HBC, FST, HBI |
| Predicate Device | K182340 - NICO Myriad |
Device Description
The NICO Myriad NOVUS is a minimally invasive surgical system designed for the removal of soft tissues and fluids under direct visualization. The technology platform is based on combining a minimally invasive non-heat generating reciprocating inner cannula and a stationary outer cannula with electronically controlled variable suction. The handpiece is capable of precise tissue shaving and rapid tissue debulking.
The NICO Automated Preservation System™ is a group of accessories for collection and preservation of resected tissue, it is comprised of three parts:
- Specimen Collector with filter element which collects tissue; ●
- Specimen Infusion Valve (SIV) which provides the desired biological environment; ●
- Specimen Preserver which provides the desired thermal condition ●
For standard handpieces, the Myriad-LX™ high intensity light source, handpiece sleeve, and illumination fiber combine to deliver illumination to the surgical field to aid in visualization.
The various handpieces, components, and accessories are outlined in tables below.
4
Image /page/4/Picture/1 description: The image shows the logo for NICO Corporation. The word "NICO" is written in a bold, serif font, with the "O" in a golden color. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font.
Table 1: Myriad Components/Accessories
| Components | |
|---|---|
| NICO Myriad | |
| NOVUS | Myriad NOVUS Console and Foot Pedal |
| Myriad-LX Light Source | |
| Cart, Aspiration Line, Nitrogen/Instrument Air Line, Power Cord, Canister | |
| Myriad Handpieces (multiple versions) | |
| Myriad-LX Handpiece Sleeve (multiple sizes) | |
| Myriad-LX Illumination Fiber | |
| Automated | |
| Preservation | |
| System | |
| Accessories | Specimen Collector with Filter Element – Clamshell or Scoop |
| Replacement Filter Element - Clamshell or Scoop | |
| Specimen Infusion Valve (SIV) - 0.50 mm or 0.76 mm Metering Line | |
| Specimen Preserver | |
| Optional / | |
| Replacement | |
| Accessories | Handpiece Bending Tool |
| Various DISS/Schrader Adapters & N2 Splitter | |
| Replacement Handpiece Endoscope Adapters |
Table 2: Myriad Standard Handpieces
| CANNULA
DIAMETER | CANNULA
LENGTH | DESCRIPTION |
|---------------------|-------------------|---------------|
| 15 gauge | 10 cm | 1510 |
| 15 gauge | 13 cm | 1513 |
| 13 gauge | 10 cm | 1310 |
| 13 gauge | 13 cm | 1313 |
| 13 gauge | 13 cm | Pre-Bent 1313 |
| 11 gauge | 10 cm | 1110 |
| 11 gauge | 13 cm | 1113 |
| 11 gauge | 13 cm | Pre-Bent 1113 |
Table 3: Myriad Working-Channel Handpieces
| CANNULA
DIAMETER | CANNULA
LENGTH | DESCRIPTION |
|---------------------|-------------------|--------------------------|
| 19 gauge | 21.5 cm | Aesculap PaediScope® |
| 19 gauge | 28 cm | Karl Storz Oi HandyPro® |
| 19 gauge | 28 cm | Karl Storz Little LOTTA® |
| 17 gauge | 31.5 cm | Karl Storz Decq |
| 15 gauge | 25 cm | Aesculap MINOP® & InVent |
| 15 gauge | 25 cm | Karl Storz GAAB |
| 15 gauge | 26.5 cm | Karl Storz LOTTA® |
Indication for Use
The NICO Myriad NOVUS is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological.
Specific neurosurgical indications may include diseases such as the following:
- Primary/Secondary Brain Tumors -
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Image /page/5/Picture/1 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.
- Vascular Abnormalities/Malformations (e.g., hemangiomas, cavernomas, and hematoma evacuation/ICH)
- Intraventricular Tumors/Cysts -
The Myriad-LX illumination accessories are intended for use with the Myriad-LX light source for delivery of light to the surgical field to enhance visualization of tissue.
The NICO Automated Preservation System accessories are intended for use with the Myriad for collection and preservation of resected tissue.
Comparison to Predicate
The NICO Myriad NOVUS is substantially equivalent to the NICO Myriad cleared under K182340. The Subject Device and the Predicate device are both used for resection and removal of soft tissue and fluids under direct visualization. Changes to the Subject Device include the addition of illumination and a console software update. These modified attributes when evaluated individually, or collectively, do not raise new questions of safety or effectiveness.
Technological Characteristics
The following table compares the subject device and predicate device.
| | NICO Myriad
K182340 | NICO Myriad
K19XXXX |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K182340 | To be determined |
| Intended Use | Powered instrument for cutting and removal of
tissue and fluids. | SAME |
| Indications for Use | The NICO Myriad is a powered instrument
consisting of a console, handpieces, and
accessories intended to perform resection and
removal of soft tissue and fluids under direct
visualization. Types of direct visualization may
include laparoscopic, pelviscopic, endoscopic,
percutaneous, and open. Applications include those
when access to the surgical site is limited, such as
Neurosurgical/Spinal and ENT/Otolaryngological.
Specific neurosurgical indications may include
diseases such as the following:
• Primary/Secondary Brain Tumors
• Vascular Abnormalities/Malformations (e.g.,
hemangiomas, cavernomas, and hematoma
evacuation)
• Intraventricular Tumors/Cysts | The NICO Myriad NOVUS is a powered
instrument consisting of a console, handpieces, and
accessories intended to perform resection and
removal of soft tissue and fluids under direct
visualization with or without magnification (e.g.,
loupes or microscope). Types of direct
visualization may include laparoscopic,
pelviscopic, endoscopic, percutaneous, and open.
Applications include those when access to the
surgical site is limited, such as
Neurosurgical/Spinal and ENT/Otolaryngological.
Specific neurosurgical indications may include
diseases such as the following:
-Primary/Secondary Brain Tumors
- Vascular Abnormalities/Malformations (e.g.,
hemangiomas, cavernomas, and hematoma
evacuation/ICH)
-Intraventricular Tumors/Cysts
The Myriad-LX illumination accessories are
intended for use with the Myriad-LX light source
for delivery of light to the surgical field to enhance
visualization of tissue.
The NICO Automated Preservation System
accessories are intended for use with the Myriad |
| | NICO Myriad
K182340 | NICO Myriad
K19XXXX |
| Principles of Use | User inputs via Foot Pedal and console settings to provide control over the connected handpiece to cut and remove tissues and fluids. The high-speed reciprocating cannula with electronically controlled variable suction in a disposable handpiece is capable of precise tissue shaving and rapid tissue debulking. The system modes include 'suction-only' or 'suction-with-cutting.' | SAME |
| Fundamental
Technology | A powered instrument consisting of a console, foot pedal, handpieces, and various accessories intended to perform resection and removal of soft tissue and fluids under direct visualization. Tissue cutting and removal via scissoring action between oscillating (reciprocating) inner cannula and stationary outer cannula. Suction draws fluids and tissue into aperture for cutting and carries cut tissue away into downstream receptacle. | SAME |
| Console | Brand Name - NICO Myriad
Gray Anodized Aluminum Accents with Painted Blue Shell | Brand Name – NICO Myriad NOVUS
Blue Anodized Aluminum Accents with Painted Gray Shell |
| Console Software | Ver 1.50 | Ver 1.52 ( 1.51 never released ) - Administrative updates to code structure
- Update to handpiece motor stopping algorithm |
| Cart | Existing Cart | Similar - with Modifications to accommodate Myriad-LX Light Source |
| Light Source | None | Myriad-LX Light Source |
| Handpieces | See Tables 2/3 Above | SAME |
| Accessories | NICO Automated Preservation System
Optional / Replacement Accessories | SAME
SAME
Myriad-LX Illumination Accessories |
| Packaging
Configurations | Packaged per Device Type | SAME
Procedure Pack/Tray Configurations |
| Biocompatibility | Demonstrated based on externally communicating device in direct contact with tissue/bone/dentin for a limited duration | SAME |
| Labeling | Console Operator's Manual
Handpiece IFU | SAME
Handpiece IFU – Minor Changes
Illumination IFU - new
APS IFU - extracted from handpiece IFU |
| Sterility | Gamma (handpiece and certain accessories) | SAME |
Table 3: Technological Characteristic Comparison
6
NICO
CORPORATION
The Myriad NOVUS has the same principles of use and fundamental technology as the predicate. 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.
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Nonclinical Testing
The following tests were successfully repeated/completed to demonstrate that the subject device met all applicable design and performance requirements, and supports a determination of substantial equivalence:
- Biocompatibility per ISO 10993-1
- Specification Review & Dimensional Analysis
- Tensile Testing
- Illumination Characteristics
- Longevity
- Thermal Characteristics
- . Product Stability
- Sterility Testing/Adoption
- Packaging Stability
- Packaging Performance
- Software Project Plan
- Software Design Architecture
- General Console Verification
- Software Unit Testing ●
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 Myriad NOVUS is as safe, as effective, and performs as well as or better than the legally marketed predicate Myriad.