(60 days)
No
The description focuses on the hardware (handheld device, generator) and the control mechanism (bio-impedance feedback) for RF energy delivery. There is no mention of AI, ML, or any learning or adaptive algorithms.
Yes
The device is indicated for use in ENT surgery for "creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis," which directly treats a medical condition.
No
The NEUROMARK™ System is described as a device that applies radiofrequency energy to create lesions in tissue to treat chronic rhinitis. It is used for therapeutic purposes (disrupting nerves) rather than for diagnosing a condition.
No
The device description clearly states that the NEUROMARK™ System comprises a handheld bipolar radiofrequency device (hardware) and a generator (hardware), in addition to software. It is not solely software.
Based on the provided information, the NEUROMARK™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- NEUROMARK™ System Function: The NEUROMARK™ System is a surgical device that uses radiofrequency energy to create lesions in tissue within the body. It is used directly on the patient during a procedure, not on a specimen taken from the patient.
- Intended Use: The intended use is for creating lesions to disrupt nerves in patients with chronic rhinitis, which is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description details a handheld device and a generator that deliver energy to tissue, consistent with a surgical tool.
Therefore, the NEUROMARK™ System falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
Product codes
GEI
Device Description
The NEUROMARK™ System is intended for the application of Radiofrequency energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis.
The NEUROMARK™ Device is a handheld bipolar radiofrequency device which is designed for use in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures along with the NEUROMARK™ Generator.
The NEUROMARK™ System comprises of two key elements which are described in this section:
-
- The NEUROMARK™ Device and
-
- The NEUROMARK™ Generator
The NEUROMARK™ Device is a hand-held single-use bi-polar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar micro electrodes. These electrodes deliver bipolar RF energy while monitoring feedback on the tissue bio-impedance changes allowing for controlled RF energy level delivery. The shaft of the device is pre-shaped for optimal access and delivery to the nasal cavity but is malleable to allow the user to bend or shape the shaft to accommodate variations in anatomy to access the desired treatment area(s). The NEUROMARK™ Device is operated via handle, slider and activation switch. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the end effector array. Using the switch, the user initiates a bio-impedance check, to assesses and confirm contact between the end effector and the treatment area. Once the system contact has been achieved, a subsequent press of the button initiates the RF delivery cycle.
The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator; it includes features to allow compatibility and authentication once connected, via a flexible cable, to the NEUROMARK™ Radiofrequency Generator. The NEUROMARK™ Radiofrequency Generator delivers, monitors and controls RF energy to the device. The generator meets the following requirements: RF operating frequency of 460 – 480 kHz (± 5 kHz); bipolar low power energy delivery and feedback control with low overshoot capabilities.
The NEUROMARK™ Device is intended for single use and provided sterile (EtO). The NEUROMARK™ Radiofrequency Generator is mounted on an ergonomic mobile stand for ease of use. The Graphical User Interface (GUI) provides operational instructions for the procedure; directs user to select nasal cavities for treatment, indicates when the device is apposed and primed to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK™ Radiofrequency Generator works in conjunction with software.
The subject device and predicate device have similar technological characteristics. The primary differences relate to the geometry of the electrode array and the method of controlling power delivery (bioimpedance control for the subject device versus temperature control for the predicate device).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior nasal nerves, nasal cavity
Indicated Patient Age Range
adults (>18 years)
Intended User / Care Setting
otorhinolaryngology (ENT) surgery
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)
- Bench Testing: Dimensional Testing, Deployment/Constrainment Testing, Tensile Testing, Device Integrity Testing, Electrical Continuity and Isolation Testing, Packaging Integrity Testing.
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1: 2018. Tests included Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Irritation, Material Mediated Pyrogenicity, Sensitization.
- Electromagnetic Compatibility Testing: Complies with IEC 60601-1-2.
- Electrical Safety Testing: Complies with IEC 60601-1 and IEC 60601-2-2.
- Characterization of Thermally Affected Zones: Thermal performance assessed using ex-vivo experimentation and computational analysis, comparable with predicate device.
- Human Factors Evaluations: Complies with IEC 62366, conducted in consideration of FDA Guidance.
- Clinical Study (Early Feasibility): Evaluated usability and procedure logistics on healthy volunteers. Confirmed appropriateness for therapeutic clinical applications, no adverse events.
- Clinical Study (RELIEVE Feasibility Study): Prospective, single-arm (non-randomized), bilateral safety and technical feasibility evaluation.
- Sample Size: Eleven (11) patients.
- Primary Safety Endpoint: Device-related serious adverse events reported up to 1-month post-procedure.
- Results: Successfully completed in all twenty-two (22) nasal cavities (100%), with no serious adverse events or complications. Primary safety endpoint met.
- Primary Technical Feasibility Endpoint: Ability to access the nasal cavity and deliver energy to target treatment areas.
- Results: Access to nasal cavity and delivery of energy to target treatment areas in 22 nasal cavities (100%) completed. Primary technical feasibility endpoint met.
- Additional Evaluations: 100% positive responder rate at 6-months post index (subjects with at least one rTNSS class improvement). Population baseline rTNSS was 8/15, reduced to 4/15 at 6-month follow-up. Discomfort/Pain levels low and resolved immediately post-procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aerin Medical RHIN1 Stylus (K192471)
Reference Device(s)
Polaris RF Ablation System (K181864)
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.
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October 22, 2021
Neurent Medical Kenny Walsh QA/RA Manager 1 Oran Point, Main Street, Oranmore Galway, Galway H91D7X2 Ireland
Re: K212666
Trade/Device Name: Neuromark System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 13, 2021 Received: August 23, 2021
Dear Kenny Walsh:
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
1
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 (OS) 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 mediation-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,
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212666
Device Name NEUROMARK™ System
Indications for Use (Describe)
The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
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/0 description: The image shows the logo for Neurent Medical. The logo features a stylized water droplet shape in dark blue, with a green and light blue curved line inside. To the right of the droplet is the word "NEURENT" in a bold, dark blue font. Below "NEURENT" is the word "MEDICAL" in a smaller, lighter blue font.
510(K) SUMMARY
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Submitter | Neurent Medical |
| 1 Oran Point, Main Street, | |
| Oranmore, Co. Galway | |
| Ireland | |
| Primary Contact Person | Kenny Walsh, |
| Quality & Regulatory Affairs Manager, | |
| Neurent Medical | |
| Phone: +353 91 470720 | |
| Date Prepared | 21 October 2021 |
Device Information
| Proprietary Name | NEUROMARK™ System |
|---|---|
| Common Name | Radiofrequency Probe |
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
| Classification Panel | General and Plastic Surgery |
| Device Class | Class II |
| Product Code | GEI |
| CFR Section | 21 CFR 878.4400 |
| Predicate Device | Aerin Medical RHIN1 Stylus (K192471) |
| Reference Device | Polaris RF Ablation System (K181864) |
Device Description
The NEUROMARK™ System is intended for the application of Radiofrequency energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis.
The NEUROMARK™ Device is a handheld bipolar radiofrequency device which is designed for use in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures along with the NEUROMARK™ Generator.
The NEUROMARK™ System comprises of two key elements which are described in this section:
-
- The NEUROMARK™ Device and
-
- The NEUROMARK™ Generator
The NEUROMARK™ Device is a hand-held single-use bi-polar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End
4
Image /page/4/Picture/0 description: The image shows the logo for Neurent Medical. The logo features a stylized water droplet shape in dark blue, with a green and light blue swirl inside. To the right of the droplet is the word "NEURENT" in a bold, dark blue sans-serif font. Below "NEURENT" is the word "MEDICAL" in a smaller, lighter font.
Effector, consists of an array of bipolar micro electrodes. These electrodes deliver bipolar RF energy while monitoring feedback on the tissue bio-impedance changes allowing for controlled RF energy level delivery. The shaft of the device is pre-shaped for optimal access and delivery to the nasal cavity but is malleable to allow the user to bend or shape the shaft to accommodate variations in anatomy to access the desired treatment area(s). The NEUROMARK™ Device is operated via handle, slider and activation switch. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the end effector array. Using the switch, the user initiates a bio-impedance check, to assesses and confirm contact between the end effector and the treatment area. Once the system contact has been achieved, a subsequent press of the button initiates the RF delivery cycle.
The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator; it includes features to allow compatibility and authentication once connected, via a flexible cable, to the NEUROMARK™ Radiofrequency Generator. The NEUROMARK™ Radiofrequency Generator delivers, monitors and controls RF energy to the device. The generator meets the following requirements: RF operating frequency of 460 – 480 kHz (± 5 kHz); bipolar low power energy delivery and feedback control with low overshoot capabilities.
The NEUROMARK™ Device is intended for single use and provided sterile (EtO). The NEUROMARK™ Radiofrequency Generator is mounted on an ergonomic mobile stand for ease of use. The Graphical User Interface (GUI) provides operational instructions for the procedure; directs user to select nasal cavities for treatment, indicates when the device is apposed and primed to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK™ Radiofrequency Generator works in conjunction with software.
The subject device and predicate device have similar technological characteristics. The primary differences relate to the geometry of the electrode array and the method of controlling power delivery (bioimpedance control for the subject device versus temperature control for the predicate device).
Indications for Use
The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
Comparison of Technological Characteristics with Predicate Device
Application of radiofrequency energy to create lesions in tissue by coagulation necrosis is the technological principle for both the subject and predicate devices. This is based on the use of a surface contacting electrode array device, connected to an RF generator to apply RF energy to mucosal tissue. At a high level, the NEUROMARK™ and the predicate have the following same technological elements:
- Class II; GEI; 21 CFR 878.4400; Electrosurgical, Cutting & Coagulation & Accessories. .
- Single use and sterile device (EtO). .
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Image /page/5/Picture/0 description: The image shows the logo for Neurent Medical. The logo features a stylized water droplet design in shades of blue and green on the left. To the right of the droplet is the company name, "NEURENT," in bold, dark blue capital letters, with the word "MEDICAL" in a smaller, lighter blue font underneath.
- Device design comprises a handle, malleable shaft and treatment tip with bipolar electrodes, . radiofrequency generator.
- . Device materials are standard medical grade materials of animal origin or nanotechnology.
- . Device inserted via the nostrils - target location is the nasal cavity in the area of the posterior nasal nerves.
- Energy delivery:
- -Same energy type (bi-polar RF energy).
- Same energy operating range. -
- Same energy delivery contact site. -
- Same energy delivery mechanism (via a surface contacting electrode array). -
Performance Data Summary
The following performance data was completed to substantial equivalence determination.
- . Bench Testing was completed to ensure that the device design is capable of meeting performance specifications, thereby ensuring the safety and effectiveness of the device. Bench Testing included:
- Dimensional Testing O
- Deployment/Constrainment Testing O
- Tensile Testing O
- Device Integrity Testing O
- Electrical Continuity and Isolation Testing O
- Packaging Integrity Testing O
- Biocompatibility Testing .
The biocompatibility evaluation for the NEUROMARK™ System was conducted in accordance with ISO 10993-1: 2018 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' (FDA Recognition Number 2-258) and in consideration of FDA Guidance document 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
The testing conducted included the following tests:
- O Cytotoxicity
- Acute Systemic Toxicity O
- Intracutaneous Irritation O
- Material Mediated Pyrogenicity O
- Sensitization O
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Image /page/6/Picture/0 description: The image shows the logo for Neurent Medical. The logo features a stylized water droplet design in shades of blue and green on the left. To the right of the droplet is the company name, "NEURENT," in a bold, dark blue sans-serif font, with the word "MEDICAL" in a smaller, lighter blue font directly underneath.
The NEUROMARK™ System is categorized as an externally communicating device in limited contact (≤ 24 hours) with tissues of patients.
-
Electromagnetic Compatibility Testing (IEC 60601-1-2)
Electromagnetic Compatibility Testing was conducted on the NEUROMARK™ System. The NEUROMARK™ System complies with the IEC 60601-1-2 standard for Electromagnetic Compatibility. -
Electrical Safety Testing (IEC 60601-1, IEC 60601-2-2) ●
Electrical Safety Testing was conducted on the NEUROMARK™ System. The NEUROMARK™ System complies with the IEC 60601-1 and IEC 60601-2-2 standards for Electrical Safety. -
. Characterization of Thermally Affected Zones
Thermal performance was assessed using ex-vivo experimentation and supported by computational analysis. Thermal performance of the NEUROMARK™ System was comparable with the predicate device. -
. Human Factors Evaluations
Human Factors Evaluations was conducted on the NEUROMARK™ System. The NEUROMARK™ System complies with the IEC 62366 and the evaluations were conducted in consideration of FDA Guidance document "Applying Human Factors and Usability Engineering to Medical Devices".
An early feasibility Clinical Study was conducted to evaluate the NEUROMARK System's usability and procedure logistics on healthy volunteers. The successful completion of the study, including device delivery, deployment and positioning of the device under endoscopic guidance, with no adverse events, confirms the appropriateness of the NEUROMARK™ System for therapeutic clinical applications.
- . Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for the NEUROMARK System was considered as a "major" level of concern since a failure could result in serious injury.
Clinical Tests
Clinical testing of the NEUROMARK™ System included a feasibility study. The RELIEVE feasibility study is a safety and technical feasibility study of eleven (11) patients (RELIEVE Study).
The RELIEVE study is a prospective, single-arm (non-randomized), bilateral safety and technical feasibility evaluation of the NEUROMARK™ System in patients with chronic rhinitis. Eleven (11) adults (>18 vears) with chronic rhinitis. (allergic or nonallergic) presenting with rhinorrhoea and/or congestion symptoms (≥2 reflected Total Nasal Symptom Score sub-scale) were enrolled. The
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Image /page/7/Picture/0 description: The image shows the logo for Neurent Medical. The logo consists of a stylized water droplet shape in dark blue, with a green and light blue curved line inside. To the right of the droplet is the word "NEURENT" in a bold, dark blue font. Below "NEURENT" is the word "MEDICAL" in a smaller, lighter blue font.
device was used to create radiofrequency (RF) lesions to disrupt posterior nasal nerves. The study was conducted in the United States under an IRB approved study.
Primary Safety Endpoint:
Safety was assessed based on device-related serious adverse events reported up to 1-month postprocedure.
Primary Technical Feasibility Endpoint:
Technical feasibility was assessed based on the ability of the NEUROMARK™ System to access the naval cavity and deliver energy to the target treatment areas.
Safety Results:
The procedure was successfully completed in all twenty-two (22) nasal cavities (100%) of patients, with no serious adverse events or complications. The primary safety endpoint was met.
Technical Feasibility Results:
Access to the nasal cavity and delivery of energy to the target treatment areas in 22 nasal cavities (100%) was completed. The primary technical feasibility endpoint was met.
Additional Evaluations:
The procedure was well tolerated with a 100% positive responder rate at 6-months post index (subjects with at least one rTNSS class improvement). Population baseline rTNSS (total nasal symptom score) was 8/15. At the 6-month follow up, population rTNSS had reduced to 4/15.
Discomfort and/or Pain levels were low and resolved immediately post procedure.
Summary:
This study provides initial data that the NEUROMARK™ procedure is safe and technically feasible. Additional evaluations indicate that the procedure is well tolerated and results in similar improvement in symptoms to that of the predicate.
Conclusion
The NEUROMARK™ System has been shown to be substantially equivalent to the predicate device based on Indications for Use, Principles of Operation and Technological Characteristics. The nonclinical data and thermal safety data support substantial equivalence of the NEUROMARK™ System with the predicate device and the software verification and validation demonstrate that the NEUROMARK™ System should perform as intended in the specified use conditions. The clinical data provides additional confirmation of safety reporting no adverse events and indicates similar symptomatic improvement. The NEUROMARK™ System is as safe, as effective, and performs as well as the predicate device that is currently marketed for the same intended use.