(22 days)
No
The summary describes electrodes for recording physiological signals (EEG, EP, etc.) and mentions standard electrical and mechanical performance testing. There is no mention of AI, ML, algorithms for signal processing beyond basic recording, or any training/test data sets typically associated with AI/ML development. The focus is on the physical characteristics and MR/CT compatibility of the electrodes themselves.
No
The device is used for recording bioelectrical signals (EEG, EP) for diagnostic purposes, not for treating a disease or condition.
Yes
Explanation: The device is intended for recording physiological signals like EEG and evoked potentials, which are used to diagnose medical conditions.
No
The device description explicitly details physical components (electrodes, cables) and mentions bench testing for mechanical design, electrical safety, and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for recording physiological signals (EEG, EP) from the patient's body surface. This is a direct measurement of electrical activity within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as surface electrodes for monitoring physiological data signals. This aligns with in-vivo measurements, not in-vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in-vitro diagnostics.
In-vitro diagnostics involve testing samples outside of the body to gain information about a patient's health. This device is used to record electrical signals from the patient's body.
N/A
Intended Use / Indications for Use
The Grass MR Conditional/CT Cup Electrodes and Arrays are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording.
This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Grass® MR Conditional/CT Cup Electrodes are for surface monitoring EEG, electromyogenic and physiologic data signals commonly recorded on the chest, extremities, head and faces of patients. Grass® MR Conditional/CT Array Cup Electrodes are also used in electrocardiography, evoked potentials, and polysomnography. The Grass® MR Conditional/CT Array Cup Electrodes are MR conditional/CT. The included extension cables are MR/CT Unsafe.
The Operating Principle and technological characteristics of the Grass MR Conditional Cup Electrodes are identical to the predicate device (K171102), with a few dimensional and material modifications that have been assessed to be equivalent to the predicate and therefore do not affect the fundamental scientific technology, safety, or effectiveness of the device (reference Substantial Equivalence of Technological Characteristics table, below). The test methods were identical to those used to assess the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT
Anatomical Site
patient's skin, including but not limited to, the head (scalp).
Indicated Patient Age Range
2 Years and Older.
Intended User / Care Setting
professional use only and should be used in compliance with accepted industry standards.
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)
Electrical Safety: The Grass® MR Conditional/CT Cup Electrodes was verified for performance in accordance with the following standard: IEC 60601-1 Edition 3.2 2020-08 Clause 8.5.2.3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Packaging and Handling Verification: The packaged Natus Grass® MR Conditional/CT Cup Electrodes components have successfully passed packaging and handling verification per ASTM D4169.
Performance Testing – Bench Verification & Validation: The Natus Grass® MR Conditional/CT Cup Electrodes has successfully passed performance verification and validation in accordance with internal requirements and specifications at the system level. The Bench testing verification and validation was performed to confirm device meets the functional and performance characteristics.
Additionally, Natus Grass® MR Conditional/CT have been tested internally and met defined acceptance criteria. The tests included:
- Functional Test
- Mechanical design Test
- Electrical Safety Test
- Biocompatibility Test
- Packaging
- FDA Guidance for Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway
Results indicate that the Grass® MR Conditional/CT Cup Electrodes system complies with its predetermined specifications and the applicable.
Non-Clinical Testing: The MR safety and performance equivalency of the Natus Grass® MR Conditional/CT Electrodes were determined using the same test methodology as the predicate device, summarized below:
- Worst-case device configuration was established through feasibility testing.
- The established worst-case configuration of the finished device was tested to the applicable ASTM standards:
- RF-Induced Heating
- MR Image Artifact
- Magnetically Induced Torque
- Magnetically Induced Displacement Force
All MR testing was performed by an accredited MR testing laboratory on behalf of Natus Medicals. In summary, the non-clinical testing concluded that the Natus Grass® MR Conditional/CT Electrodes demonstrated equivalent functionality, safety, and effectiveness as the predicate device.
Clinical Tests: No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2).
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.
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
August 29, 2024
Natus Manufacturing Limited % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K242346
Trade/Device Name: Grass® MR Conditional/CT Cup Electrodes, Single and Array Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: August 7, 2024 Received: August 7, 2024
Dear Prithul Bom:
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.
1
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" (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 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-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 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.
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-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.
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Grass® MR Conditional/CT Cup Electrodes Single
Grass® MR Conditional/CT Cup Electrodes, Array
ndications for Use (Describe)
The Grass MR Conditional/CT Cup Electrodes and Arrays are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording.
This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.
Intended Patient Population:2 Years and Older.
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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510K Summary
Preparation date: August 7, 2024
Applicant:
Address: Natus Manufacturing Limited, IDA Business Park Gort, Co. Galway, Ireland Contact Person: Sanjay Mehta, Director, Global Regulatory Affairs Natus Manufacturing Limited Tel.: (905) 829-5300 Fax .: (905) 829-5304 E-mail: sanjay.mehta(@natus.com
Device:
Proprietary Name: Grass® MR Conditional/CT Cup Electrodes ,Single, Grass® MR Conditional/CT Cup Electrodes, Array Classification Name: Cutaneous Electrode Regulation Number: 21 CFR 882.1320 Product code: GXY Device Class: II,
Predicate Device:
510K Number: K172503 MR Conditional Cup Electrode, MR Conditional Webb Electrode
Reference Device:
510K Number: K171102 Ives MR Conditional Cup Electrode
Indications for Use:
The Grass MR Conditional/CT Cup Electrodes and Arrays are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording.
This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.
5
Device Description:
Overview: Grass® MR Conditional/CT Cup Electrodes
Grass® MR Conditional/CT Cup Electrodes are for surface monitoring EEG, electromyogenic and physiologic data signals commonly recorded on the chest, extremities, head and faces of patients. Grass® MR Conditional/CT Array Cup Electrodes are also used in electrocardiography, evoked potentials, and polysomnography. The Grass® MR Conditional/CT Array Cup Electrodes are MR conditional/CT. The included extension cables are MR/CT Unsafe.
Operating Principle of the Grass® MR Conditional/CT Cup Electrodes
The Operating Principle and technological characteristics of the Grass MR Conditional Cup Electrodes are identical to the predicate device (K171102), with a few dimensional and material modifications that have been assessed to be equivalent to the predicate and therefore do not affect the fundamental scientific technology, safety, or effectiveness of the device (reference Substantial Equivalence of Technological Characteristics table, below). The test methods were identical to those used to assess the predicate device.
System Setup Overview
Use a cotton tip applicator to apply a small amount of skin prep gel such as NuPrep® to the site of the electrode application scrubbing gently.
Fill the electrode cup with a conductive paste or gel such as Ten20®. Do not overfill the cup. Excessive amount of paste or gel can result in asymmetric signals.
Fix the cup to the patient with a small amount of pressure.
Use a small pre-cut gauze square or piece of paper tape to help secure the cup electrode to the application site.
Check that clear, strong signals are being transmitted.
When ready to remove the electrode cup, carefully remove gauze square or tape and remove any gel or paste with soap and water.
After use, discard the electrodes.
Device-patient interaction Accessories List:
Cup Electrodes are applied on the patient's skin, including but not limited to, the head (scalp). Only the cup portion of the Grass MR/CT Conditional Electrodes, which has contact with the patient (see the portion highlighted in green in Figure 2), is categorized as B - Prolonged (>24
6
hours but