The Paired Hydrogel Electrodes are a modification of the M203KEN electrode currently distributed as the Singlet and Triplet Hydrogel Electrodes by Neurovision Medical Products. The Paired Hydrogel Electrode is created by attaching two Singlet M203KEN electrodes by their lead wires to the same DIN plug (shorting the electrodes). The Paired version is designed to provide a single pole of electrophysiological monitoring across a surface too wide to be covered by a single electrode.

AI/ML Overview

Here's an analysis of the provided text regarding the Neurovision Medical Paired Hydrogel Electrode, focusing on acceptance criteria and supporting studies:

This submission is a Special 510(k), indicating a modification to an already cleared device. The focus of the performance testing is typically to demonstrate that the modified device (Paired Hydrogel Electrode) is substantially equivalent to the predicate devices and that the modification does not introduce new questions of safety oreffectiveness, or alter the fundamental scientific technology.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Performed Test/Reported Performance
Material Biocompatibility	Freedom from sensitization	Tested free of Sensitization (ISO 10993: Part 10)
	Freedom from cytotoxicity	Tested free of Cytotoxicity (Agarose Overlay Method)
	Freedom from irritation	Tested free of Irritation (ISO 10993: Part 10)
Physical Performance	Electrode adhesion	Demonstrated equivalence to predicate singlet
	Impedance	Demonstrated equivalence to predicate singlet
Electrophysiological Properties	Electrophysiological properties	Demonstrated equivalence to predicate singlet
Shelf-Life	Shelf-life duration	Demonstrated a 3-year shelf life (ANSI/AAMI EC12:2000)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for performance tests (adhesion, impedance, electrophysiological properties).
- For biocompatibility, it states "Animal testing demonstrated the Biocompatibility," implying animal subjects, but the number is not specified.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal or contracted by the manufacturer. The studies are prospective as they were conducted to support the 510(k) submission for the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This type of device (hydrogel electrode) does not typically involve human-read interpretations or ground truth established by experts in the context of clinical imagery. The performance criteria are technical and measurable (e.g., adhesion strength, electrical impedance, biological reactions).

4. Adjudication Method for the Test Set

Not applicable, as the performance testing involves measurable technical parameters, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not the type of device or study for which an MRMC comparative effectiveness study would be performed. The device is a surface electrode for physiological monitoring, not an imaging or diagnostic AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device itself is hardware (an electrode) that facilitates electrophysiological monitoring, which then requires an EMG unit (compatible device) and human interpretation of the signals. There is no "algorithm only" performance for an electrode.

7. Type of Ground Truth Used

Biocompatibility: In-vitro (cytotoxicity via Agarose Overlay) and in-vivo (irritation and sensitization via animal testing according to ISO 10993).
Physical and Electrophysiological Properties: Measured technical specifications of the device compared against the known performance of the predicate device (Singlet Hydrogel Electrode). The "ground truth" here is the established performance characteristics of the predicate device.
Shelf-Life: Time-dependent measurements demonstrating stability over the claimed 3-year period, adhering to ANSI/AAMI EC12:2000 standards.

8. Sample Size for the Training Set

Not applicable. This is a hardware device (electrode), not a software/AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this hardware device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word is a black line with a heartbeat symbol in the middle, followed by the word "MEDICAL" in smaller, black letters.

Special 510k - Paired Hydrogel Electrode APR - 8 2011

K110138

5. 510K Summarv

In accordance with Title 21 of the Code of Federal Regulations, Part 807 and in particular 21 CFR 8807.92, the following summary of information is provided:

Applicant Information

Christine Vergely Regulatory Affairs Manager Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 PH 805-866-6999 Fax: 413-410-4579 christie@neurovisionmedical.com

Date of Summary:

Device Identification:

Trade or Proprietary Name: Paired Hydrogel Electrode (final name TBD) Common or Usual Name: Hydrogel Surface Electrode Classification Name: Surgical nerve stimulator/locator Device Class: Class II Classification: 8874.1820 ETN Product Code:

Predicate Devices

The Paired Hydrogel Electrodes are substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:
- . M203KEN; Neonatal ECG Electrode (K092744), referred to in this document as the Singlet Hydrogel (K092744)
- 3M Pediatric "Red Dot" hydrogel electrode accessory RLN Systems Nerve Locator/Monitor; . Model A (K902080), superseded by,
- . Neurovision (SE: Surface Electrode) Nerve Locator/Monitor (K954601)

Device Description

Indication for Use

The Paired Hydroget Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.

Technological Characteristics of Device in Relation to Predicate Devices

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Image /page/1/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word "neurovision" are two horizontal lines with a heartbeat symbol in between them, followed by the word "MEDICAL" in smaller, black letters.

Special 510k – Paired Hydrogel Electrode

510(k) number	Subject DeviceK042744	K954601	K092744	K902080
Brand Name	PAIRED HYDROGELELECTRODE	NERVELOCATOR/MONITORSYSTEM,MODIFICATION	NEONATAL ECGELECTRODES	RED DOT 2269INFANTMONITORINGELECTRODE
Description	Surface Electrode forEMG Monitoring	Neurovision SE (surfaceelectrode) Nerve/LocatorMonitor	Neonatal ECG Electrode,M203KEN	Neonatal ECGMonitoring Electrode
Indications forUse	The Paired HydrogelElectrode is used forevokedelectrophysiologicalmonitoring in softtissue surgeries weremotor nerves are atrisk.	The Neurovision SE is anelectronic device consistingof a surgical nervestimulator and an evokedEMG monitor withintegrated detecting orwarning capability. Thisdevice is intended for use insurgical procedures wheremotor nerves are at risk toassist the surgeon inlocating these nerves.	Neonatal ECG Electrodes areintended for use in pediatric orneonatal electrocardiographicprocedures where restingECGmonitoring is deemednecessary and is ordered by aphysician.Such procedures include, inparticular, patient ECGsurveillance and ECGdiagnosis recording. TheNeonatal ECG Electrodes areapplied to the surface of thebody, single use only, anddisposable.Neonatal ECU electrodesshould be changed every 24hours.	Neonatal ECGMonitoring
Product Code	ETN	ETN	DRX	DRX
Materials andDesign	2 Comfort Gel A discsconjoined at DIN plug	Uses FDA approved surfaceelectrodes	1 Comfort Gel A discterminated at DIN plug.	FDA approved pediatricECG/EMG/EKGhydrogel electrode
Bio-compatibility	Tested free ofSensitization,Cytotoxicity andIrriation	Per approved electrodes	Tested free of Sensitization,Cytotoxicity and Irriation	FDA approved
Compatibledevices	EMG units	EMG units	EMG units	ECG, EKG, EMG units
Shelf-Life	3 years	N/A	3 years	N/A
Sterility	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Attachment toStimulator	DIN connector	DIN connector	DIN connector	Snap lead wire

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Image /page/2/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word "neurovision" are two horizontal lines with a small waveform between them, followed by the word "MEDICAL" in smaller, bold, black letters.

Special 510k - Paired Hydrogel Electrode

Performance Testing

Performance testing of the electrode adhesion, impedance, and electrophysiological properties demonstrated equivalence between the paired hydrogel electrode and the predicate singlet.

Animal testing demonstrated the Biocompatibility of the materials and was conducted according to ISO 10993: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation. Cytoxicity testing was according to the Agarose Overlay Method.

Shelf life testing was according to ANSI/AAMI EC12:2000 : Disposable ECG Electrodes and demonstrated a 3 vear shelf life.

(End of 510(k) Summary)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged along the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Neurovision Medical Products, Inc. c/o Ms. Christine Vergély Regulatory Affairs Manager 2225 Sperry Ave., Suite 1000 Ventura, CA 93003

Re: K110138

Trade/Device Name: Paired Hydrogel Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: March 14, 2011 Received: March 16, 2011

APR - 8 2011

Dear Ms. Vergély:

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. 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.

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Page 2 - Ms. Christine Vergély

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ruhlin mf

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Below the word "neurovision" are two horizontal lines with a small EKG waveform between them, followed by the word "MEDICAL" in smaller, bold, black letters.

Special 510k - Paired Hydrogel Electrode

Indications for Use

4. Indications for Use:

Device Name: Paired Hydrogel Electrode

The Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Model Hyman

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number K110138

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.