(80 days)
Not Found
No
The summary describes a simple electrode modification and does not mention any AI or ML components or capabilities.
No
The device is used for electrophysiological monitoring, which is a diagnostic function, not a therapeutic one.
Yes
The device is used for "evoked electrophysiological monitoring," which involves measuring electrical activity to assess the function of nerves. This process is a form of diagnostic measurement, indicating the health or function of the motor nerves during surgery.
No
The device description clearly describes a physical electrode, which is a hardware component. The performance studies also focus on physical properties like adhesion, impedance, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "evoked electrophysiological monitoring in soft tissue surgeries." This involves measuring electrical signals from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is an electrode designed to be placed on the surface of the body to pick up electrical signals. It does not involve any reagents, test strips, or other components typically associated with in vitro diagnostics.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic tests performed outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the measurement of electrical activity within the body during surgery.
N/A
Intended Use / Indications for Use
The Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.
Product codes
ETN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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 year shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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
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.
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 Device
K042744 | K954601 | K092744 | K902080 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Brand Name | PAIRED HYDROGEL
ELECTRODE | NERVE
LOCATOR/MONITOR
SYSTEM,
MODIFICATION | NEONATAL ECG
ELECTRODES | RED DOT 2269
INFANT
MONITORING
ELECTRODE |
| Description | Surface Electrode for
EMG Monitoring | Neurovision SE (surface
electrode) Nerve/Locator
Monitor | Neonatal ECG Electrode,
M203KEN | Neonatal ECG
Monitoring Electrode |
| Indications for
Use | The Paired Hydrogel
Electrode is used for
evoked
electrophysiological
monitoring in soft
tissue surgeries were
motor nerves are at
risk. | The Neurovision SE is an
electronic device consisting
of a surgical nerve
stimulator and an evoked
EMG monitor with
integrated detecting or
warning capability. This
device is intended for use in
surgical procedures where
motor nerves are at risk to
assist the surgeon in
locating these nerves. | Neonatal ECG Electrodes are
intended for use in pediatric or
neonatal electrocardiographic
procedures where resting
ECG
monitoring is deemed
necessary and is ordered by a
physician.
Such procedures include, in
particular, patient ECG
surveillance and ECG
diagnosis recording. The
Neonatal ECG Electrodes are
applied to the surface of the
body, single use only, and
disposable.
Neonatal ECU electrodes
should be changed every 24
hours. | Neonatal ECG
Monitoring |
| Product Code | ETN | ETN | DRX | DRX |
| Materials and
Design | 2 Comfort Gel A discs
conjoined at DIN plug | Uses FDA approved surface
electrodes | 1 Comfort Gel A disc
terminated at DIN plug. | FDA approved pediatric
ECG/EMG/EKG
hydrogel electrode |
| Bio-
compatibility | Tested free of
Sensitization,
Cytotoxicity and
Irriation | Per approved electrodes | Tested free of Sensitization,
Cytotoxicity and Irriation | FDA approved |
| Compatible
devices | 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 to
Stimulator | 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.
4
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