(56 days)
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No
The description focuses on the physical and electrical properties of a ground electrode for neurophysiological examination, with no mention of AI or ML.
No
The device is used to ensure electrical potential for neurophysiological examination, not to treat a condition or disease.
No
This device is described as a ground electrode used to ensure consistent electrical potential during neurophysiological examinations. It does not state that it processes or interprets data to diagnose a condition, but rather facilitates the measurement process.
No
The device description explicitly states it is a multi-layer construction containing physical components like hydrogel, conductive film, and a lead wire, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ensuring the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves." This describes a device used during a physiological measurement on a patient, not a test performed in vitro (outside the body) on a sample of human origin.
- Device Description: The description reinforces its use in a neurophysiological examination, involving a hydrogel, conductive film, and lead wire, all components consistent with a surface electrode used for electrical signal detection on the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Ambu Neuroline Ground electrode is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Ambu Neuroline Ground electrode is to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves. The electrode is for single patient use only.
Ground electrode for standard neurophysiological examinations.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Ambu Neuroline Ground electrode should only be used by or on the order of a physician.
Ambu Neuroline Ground electrode is used to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination.
Ambu Neuroline Ground electrode is provided non-sterile. Ambu Neuroline Ground electrode is a single patient use disposable device.
Ambu Neuroline Ground electrode is a multi-layer construction containing a hydrogel, a conductive film and a lead wire.
The electrode is a multi-layer construction consisting of Hydrogel, conducting film, non-wowen backing material and lead wire with 1,5 mm touch proof connector.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Used by or on the order of a physician.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests performed are laboratory tests to ensure the electrical and mechanical functionality of the electrode. No clinical tests are performed. Aging test of Ambu Neuroline Ground electrode and comparison test to predicate devices have been performed. From the results it has been concluded that Ambu Neuroline Ground electrode has equivalent electrical and mechanical functionality as the predicate device. The device meets mandatory performance standards. The biocompatibility of the electrode has been established.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
0
AUG 4 - 2005
510(k) Summary
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- 510(k) owner: Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark Tel.: +45 72252000 Fax.: +45 72252050 Contact person: Poul Ottosen Corporate Quality Manager 1. June 2005 Preparation date of the 510(k) summary: 2. Name of device: Ground Electrode Device Common name: Disposable Ground Plate Electrode Disposable Ground Electrode Device Trade name: Ambu Neuroline Ground Classification Name: Electrode, Cutaneous. 21 CFR 882.1320 Product Code: GXY
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- Identifies the legally marketed device to which equivalence is claimed
| Manufacturer | Trade Name | Product
code |
|--------------------------------------------------------|----------------------------------------------|-----------------|
| Viasys Healthcare
Nicolet Biomedical
Instruments | Disposable Ground Plate
Electrode | GXY |
| Oxford Instruments
Medical
Medelec Instruments | TECA NCS 2000 Disposable
Ground Electrode | GXY |
1
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- Description of device
Ambu Neuroline Ground electrode should only be used by or on the order of a physician.
- Description of device
Ambu Neuroline Ground electrode is used to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination.
Ambu Neuroline Ground electrode is provided non-sterile. Ambu Neuroline Ground electrode is a single patient use disposable device.
Ambu Neuroline Ground electrode is a multi-layer construction containing a hydrogel, a conductive film and a lead wire.
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- The intended use Ground electrode for standard neurophysiological examinations.
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- Summary of the technological Characteristics
The technological characteristics of the Ambu Neuroline Ground electrode are identical to the predicate devices.
The electrode is a multi-layer construction consisting of Hydrogel, conducting film, non-wowen backing material and lead wire with 1,5 mm touch proof connector.
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- Brief discussion of the nonclinical tests submitted The non-clinical tests performed are laboratory tests to ensure the electrical and mechanical functionality of the electrode
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- Brief discussion of the clinical tests submitted No clinical tests are performed
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- Conclusions drawn from the nonclinical and clinical tests Aging test of Ambu Neuroline Ground electrode and comparison test to predicate devices have been performed. From the results it has been concluded that Ambu Neuroline Ground electrode has equivalent electrical and mechanical functionality as the predicate device. The device meets mandatory performance standards. The biocompatibility of the electrode has been established. It is concluded that Ambu Neuroline Ground electrode is as safe and effective as the predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
AUG 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sanjay Parikh Technical and Regulatory Affairs Ambu Inc. 6740 Baymeadow Drive Glen Burnie, Maryland 21060
Re: K051529
Trade/Device Name: Ambu Neuroline Ground Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: July 13, 2005 Received: July 18, 2005
Dear Mr. Parikh:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Ko51529 510(k) Number (if known):
Ambu Neuroline Ground Device Name: Indications For Use:
The intended use of Ambu Neuroline Ground electrode is to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves. The electrode is for single patient use only.
× Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styet Alurd
(Division Sign-Off)
I i vision of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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