(139 days)
Not Found
No
The document describes a radiofrequency surgical system that monitors tissue impedance for controlled energy delivery. While it has software and a user interface, there is no mention or indication of AI, machine learning, or deep learning being used for any function, such as decision-making, pattern recognition, or predictive analytics. The system primarily focuses on physical energy delivery and feedback mechanisms rather than intelligent processing.
Yes
The device is used to create radiofrequency lesions to disrupt posterior nasal nerves, which is a therapeutic intervention for chronic rhinitis.
No
Explanation: The device description states that the NEUROMARK System is used for the "creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves" and "application of Radiofrequency (RF) energy to create lesions in mucosal tissue." This indicates a therapeutic function, not a diagnostic one. While it monitors feedback on tissue bioimpedance changes, this is for controlling energy delivery during the therapeutic procedure, not for diagnosing a condition.
No
The NEUROMARK System is clearly described as consisting of hardware components (NEUROMARK Device and NEUROMARK Radiofrequency (RF) Console) that physically interact with the patient and deliver energy. While the Console includes software, the device as a whole is not software-only.
No.
The device is used to create lesions in mucosal tissue using radiofrequency energy, which is a direct therapeutic intervention on the patient's body rather than an in vitro examination of specimens derived from the human body.
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 (comma separated list FDA assigned to the subject device)
GEI
Device Description
The NEUROMARK System is intended for the application of Radiofrequency (RF) 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 System is composed of the NEUROMARK Device and the NEUROMARK Radiofrequency (RF) Console.
The NEUROMARK Device is a hand-held, single-use, bipolar 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 electrodes that deliver RF energy while monitoring feedback on tissue bioimpedance changes allowing for controlled RF energy delivery. The shaft of the device is pre-shaped to aid access and delivery to the nasal cavity but is malleable to allow the user to bend or shape it to accommodate variations in anatomy to access the desired treatment area. The NEUROMARK Device is operated via handle, slider and activation button. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the End Effector. Using the activation button, the user initiates a bio-impedance check to assess and confirm contact between the End Effector and the treatment area. Once the System confirms contact has been achieved, a subsequent press of the activation button initiates the RF energy delivery cycle. The NEUROMARK Device is intended for single use and provided sterile (EO).
The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console only and is connected via a flexible interface cable.
The NEUROMARK Console delivers, monitors and controls RF energy to the Device. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure, directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software.
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
Not Found
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)
Performance testing of the NEUROMARK System consisted of design verification testing, usability testing, biocompatibility, software, and electrical and thermal safety testing to support the device modifications listed above. All testing passed and showed that the device meets design specifications, performs as intended, and performs the same as the predicate.
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.
NEUROMARK® System [K222032]
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.
FDA 510(k) Clearance Letter - NEUROMARK System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 29, 2025
Neurent Medical Ltd.
Fay Dalton
Senior Regulatory Affairs Specialist
No. 1 Oranpoint, Main Street
Oranmore
Galway, N/A H91D7X2
Ireland
Re: K250048
Trade/Device Name: NEUROMARK System (NMK00301)
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories
Regulatory Class: Class II
Product Code: GEI
Dated: May 1, 2025
Received: May 1, 2025
Dear Fay Dalton:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K250048 - Fay Dalton
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K250048 - Fay Dalton
Page 3
Sincerely,
Joyce C. Lin -S
for 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 Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250048
Device Name
NEUROMARK System (NMK00301)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
Neurent Medical
Page 1 of 2
510(k) Summary
Date Prepared: January 8, 2025
Submitter Information: Neurent Medical
1 Oranpoint, Main Street
Oranmore, Co. Galway, H91 D7X2
Ireland
Establishment Registration: 3016813690
Contact Information: Fay Dalton
Senior Regulatory Affairs Specialist
Neurent Medical
+353 85 7289921
fay@neurentmedical.com
Device Information:
| Field | Value |
|---|---|
| Trade Name | NEUROMARK® System |
| Common Name | Radiofrequency Probe |
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
| Product Code | GEI |
| Classification | Class II |
| Regulation Number | 21 CFR 878.4400 |
| Predicate Device | NEUROMARK® System [K222032] |
Device Description:
The NEUROMARK System is intended for the application of Radiofrequency (RF) 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 System is composed of the NEUROMARK Device and the NEUROMARK Radiofrequency (RF) Console.
The NEUROMARK Device is a hand-held, single-use, bipolar 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 electrodes that deliver RF energy while monitoring feedback on tissue bioimpedance changes allowing for controlled RF energy delivery. The shaft of the device is pre-shaped to aid access and delivery to the nasal cavity but is malleable to allow the user to bend or shape it to accommodate variations in anatomy to access the desired treatment area. The NEUROMARK Device is operated via handle, slider and activation button. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the End Effector. Using the activation button, the user initiates a bio-impedance check to assess and confirm contact between the End Effector and the treatment area. Once the System confirms contact has been achieved, a subsequent press of the activation button initiates the RF energy delivery cycle. The NEUROMARK Device is intended for single use and provided sterile (EO).
The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console only and is connected via a flexible interface cable.
The NEUROMARK Console delivers, monitors and controls RF energy to the Device. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure, directs the user to select nasal cavities for treatment, indicates when the device is in contact with
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Neurent Medical
Page 2 of 2
tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software.
Indication 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.
Technological Characteristics:
The NEUROMARK System (subject device) has the same intended use, indications for use and fundamental scientific technology as the predicate NEUROMARK System [K222032].
The subject device has the same technological characteristics (i.e., principle of operation, anatomical location of use, design configuration, functionality, energy type, standard medical grade materials, biocompatibility, feedback control, thermal lesion characteristics, electrical and thermal safety, performance specifications, shelf-life, and sterilization) as the predicate device.
The treatment tip of the subject device has fewer leaflets and minor changes in material from that of the predicate device. The shaft of the subject device has minor changes in material and dimensions from that of the predicate device. The subject device activation button, slider, connector, interface cable, and sterile barrier packaging configuration were modified for simplicity.
Performance Data:
Performance testing of the NEUROMARK System consisted of design verification testing, usability testing, biocompatibility, software, and electrical and thermal safety testing to support the device modifications listed above. All testing passed and showed that the device meets design specifications, performs as intended, and performs the same as the predicate.
Substantial Equivalence:
The NEUROMARK System has the same intended use, indications for use and fundamental scientific technology as the predicate device. Evaluation of the impact of the device modifications was completed. The minor changes made to the subject device do not raise different questions of safety and effectiveness. Performance testing was completed to ensure the subject device meets intended use, product specifications, and performs the same as the predicate device. The NEUROMARK System is substantially equivalent to the predicate device.
Conclusion:
In conclusion, the intended use, indications for use and fundamental technological characteristics are the same as the predicate device. Performance testing has demonstrated that the device is as safe and effective and that its performance is substantially equivalent to the predicate device.