(23 days)
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No
The document describes a surgical system for tissue resection and removal, focusing on mechanical and fluid dynamics. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a surgical system for the resection and removal of soft tissue and fluids, which directly treats medical conditions by removing diseased tissue.
No
The device is described as a powered instrument for the resection and removal of soft tissue and fluids, and a minimally invasive surgical system designed for the removal of soft tissues and fluids. Its function is to perform surgical procedures, not to diagnose diseases or conditions.
No
The device description explicitly details hardware components such as a console, handpieces, cannulas, and accessories, including a Tissue Preservation System with physical parts. This indicates it is a physical medical device, not software-only.
Based on the provided text, the NICO Myriad™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "perform resection and removal of soft tissue and fluids under direct visualization." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "minimally invasive surgical system" designed for "removal of soft tissues and fluids." This further reinforces its role in surgical intervention.
- Anatomical Site: The device is used in specific anatomical sites within the body (Neurosurgical/Spinal and ENT/Otolaryngological).
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The NICO Myriad™ does not perform this function. While it has a Tissue Preservation System to collect tissue, this is for potential future analysis, not for the device itself to perform the diagnostic test.
In summary, the NICO Myriad™ is a surgical instrument used for tissue removal within the body, not for performing diagnostic tests on specimens outside the body.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
GEI, ERL, HBC
Device Description
The Myriad 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 disposable handpiece is capable of precise tissue shaving and rapid tissue debulking.
The various handpieces, components, and optional accessories are outlined in tables below. Of note, the system also consists of optional Tissue Preservation System (TPS) accessories. The TPS is a collection of accessories which attach to the Myriad handpiece to capture resected tissue that would otherwise be discarded in the waste canister. The TPS 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
These TPS accessories can be arranged in a multitude of ways depending on the desired setup. Refer the handpiece IFU for additional details.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Neurosurgical/Spinal and ENT/Otolaryngological
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were successfully 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
- Longevity Testing
- Specification Review & Dimensional Analysis
- Usability & Design Validation
- IEC 60601-1 Testing
- Sterility Testing
- Packaging Stability
- Packaging Performance
- Product Stability
- Various Process Validations
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2018
NICO Corporation Sean Spence Regulatory Affairs Manager 250 East 96th Street. Suite 125 Indianapolis, Indiana 46240
Re: K182340
Trade/Device Name: NICO Myriad Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, ERL, HBC Dated: August 27, 2018 Received: August 28, 2018
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name NICO Myriad
Indications for Use (Describe)
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, and hematoma evacuation)
- · Intraventricular Tumors/Cysts
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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/2 description: The image shows the logo for NICO Corporation. The logo is in a serif font, with the letters "N", "I", and "C" in black. The "O" is a circle filled with a golden color. Below the letters is the word "CORPORATION" in a smaller, sans-serif font.
10.0 510(k) SUMMARY
NICO Myriad™
21 CFR §807.92 Date Prepared: 27 August 2018
K182340 510(k) Number:
| 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™ |
| Common/Usual Name | Electrosurgical, cutting & coagulation & accessories |
| Classification | 21 CFR §878.4400 (Class II) |
| Product Code | GEI |
| Secondary Product Codes: | ERL, HBC |
| Predicate Device | K161307 – NICO Myriad |
Device Description
The Myriad 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 disposable handpiece is capable of precise tissue shaving and rapid tissue debulking.
The various handpieces, components, and optional accessories are outlined in tables below. Of note, the system also consists of optional Tissue Preservation System (TPS) accessories. The TPS is a collection of accessories which attach to the Myriad handpiece to capture resected tissue that would otherwise be discarded in the waste canister. The TPS 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 ●
These TPS accessories can be arranged in a multitude of ways depending on the desired setup. Refer the handpiece IFU for additional details. The following tables outline the system, components, accessories, and various handpieces sizes.
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Image /page/4/Picture/2 description: The image shows the logo for NICO Corporation. The logo is in black and gold. The word "NICO" is in large, bold letters, with the "O" being a gold circle. Below the word "NICO" is the word "CORPORATION" in smaller letters.
Table 1: Myriad System Components/Accessories
Components | |
---|---|
Myriad | Console and Foot Pedal |
Handpieces (multiple versions) | |
Console Cart, Aspiration Line, Nitrogen Line/Instrument Air Line, Power Cord, Canister (single-use) | |
Optional | |
Accessories | Handpiece Bending Tool |
Various DISS/Schrader Adapters & N2 Splitter | |
Replacement Handpiece Endoscope Adapters | |
Tissue | |
Preservation | |
System | |
(TPS) | 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 |
Table 2: Current Myriad Handpiece Configurations
| Cannula
Diameter | Cannula
Length | Description |
|---------------------|-------------------|-------------------------------|
| 19 gauge | 21.5 cm | 19 ga x 21.5 cm (PaediScope®) |
| | 28 cm | 19 ga x 28 cm (Oi®) |
| | 28 cm | 19 ga x 28 cm (Little LOTTA®) |
| 17 gauge | 31.5 cm | 17 ga x 31.5 cm (Decq) |
| 15 gauge | 10 cm | 15 ga x 10 cm (1510) |
| | 13 cm | 15 ga x 13 cm (1513) |
| | 25 cm | 15 ga x 25 cm (MINOP®) |
| | 25 cm | 15 ga x 25 cm (GAAB) |
| | 26.5 cm | 15 ga x 26.5 cm (LOTTA®) |
| 13 gauge | 10 cm | 13 ga x 10 cm (1310) |
| | 13 cm | 13 ga x 13 cm (1313) |
| | 13 cm | 13 ga x 13 cm (Pre-Bent 1313) |
| 11 gauge | 10 cm | 11 ga x 10 cm (1110) |
| | 13 cm | 11 ga x 13 cm (1113) |
| | 13 cm | 11 ga x 13 cm (Pre-Bent 1113) |
Indication 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, 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 -
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Image /page/5/Picture/2 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. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font.
Comparison to Predicate
The NICO Myriad is substantially equivalent to the NICO Myriad cleared under K161307. The subject iteration of the 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 being assembled by a new contract manufacturer, design enhancements/process improvements, capital equipment changes, packaging changes, additional handpiece offering, and labeling updates. 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
K161307 | NICO Myriad
K18XXXX |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) #
Intended Use/
Indications | 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 | To be determined
SAME |
| 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 |
| | NICO Myriad | NICO Myriad |
| | K161307 | K18XXXX |
| 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 |
| Contract
Manufacturer | *differences from predicate identified in right
column | New Contract Manufacturer |
| Design
Enhancements /
Process Changes | *differences from predicate identified in right
column | - Equivalent electronic components
- Console pneumatic/Teflon tape usage
- Change in bonding method for inner cannula
to plastic components - Adhesive changes
- Manufacturing Fixtures
- Laser etching
- Foot pedal cable strain relief
- Console overlay updates to accommodate
UDI direct-part-marking requirement |
| Adjustments to
Prints during
manufacturing
transfer | *differences from predicate identified in right
column | - More detail on cannula prints - Several injection molded parts were re-
tooled requiring print adjustments - Gasket print now has the material listed and
a defined dimension for outer diameter - Luer Hub added new overall length
- Assembly, Split Cable print has additional
notes and details regarding the overall length - Dimensional changes to re-tooled injection
molded plastic components |
| Packaging | *differences from predicate identified in right
column | - Thicker polypropylene portion of Tyvek
header bag - Dimensional changes to handpiece
corrugated box, heavier corrugated material - Dimensional changes to handpiece tray |
| Handpieces | *differences from predicate identified in right
column | Added 11 ga x 13 cm Pre-Bent handpiece |
| Biocompatibility /
Materials | Demonstrated based on externally
communicating device in direct contact with
tissue/bone/dentin for a limited duration | SAME |
| Labeling | *differences from predicate identified in right
column | - Console/foot pedal updates to accommodate
UDI direct-part-marking requirement - Operator's Manual updates to align with
International version and identify information
on updated rear overlay - Handpiece IFU updates to list new factory
pre-bent 1113 handpiece offering |
| Sterility of Sterile
Components | Gamma (handpiece and certain accessories) | SAME |
Table 3: Technological Characteristic Comparison
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Image /page/6/Picture/2 description: The image shows the logo for NICO Corporation. The logo is in black and gold. The word "NICO" is in black, and the word "CORPORATION" is in a smaller font size below the word "NICO".
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Image /page/7/Picture/2 description: The image shows the logo for NICO Corporation. The logo is in a serif font, with the letters "N", "I", and "C" in black. The "O" is a circle with a black outline and a yellow fill. Below the letters is the word "CORPORATION" in a smaller, sans-serif font.
The Myriad 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 successfully 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
- Longevity Testing ●
- Specification Review & Dimensional Analysis ●
- Usability & Design Validation
- IEC 60601-1 Testing
- Sterility Testing
- . Packaging Stability
- Packaging Performance
- Product Stability ●
- Various Process Validations .
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 is as safe, as effective, and performs as well as or better than the legally marketed predicate Myriad.