(56 days)
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.
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 provided text describes a 510(k) summary for the Ambu Neuroline Ground electrode. It is a submission for a medical device seeking clearance based on substantial equivalence to existing legally marketed predicate devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not in the context of clinical performance metrics like sensitivity or specificity. Instead, they refer to the demonstration of substantial equivalence to predicate devices through non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Electrical Functionality: Equivalent electrical characteristics to predicate devices. | Laboratory tests performed to ensure electrical functionality. |
| Mechanical Functionality: Equivalent mechanical characteristics to predicate devices. | Laboratory tests performed to ensure mechanical functionality. |
| Biocompatibility: Device is biocompatible. | Biocompatibility of the electrode has been established. |
| Safety and Effectiveness: As safe and effective as predicate devices. | Concluded that the device has equivalent electrical and mechanical functionality, meets mandatory performance standards, and is as safe and effective as the predicate devices. |
| Aging Test Performance: Maintained performance over time. | Aging tests were performed. |
2. Sample Size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "laboratory tests" and "aging test" but does not quantify the number of electrodes or test cycles used.
- Data Provenance: Not explicitly stated, but the tests are described as "laboratory tests" implying they were conducted in a controlled environment by the manufacturer (Ambu A/S). There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For this type of device and 510(k) submission, "ground truth" is not established by clinical experts in the way it would be for diagnostic algorithms. The ground truth here is derived from the established performance and safety profiles of the predicate devices, against which the new device's engineering and material properties are compared.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There was no clinical study involving human interpretation or adjudication. The non-clinical tests likely involved objective measurements and comparisons to pre-defined engineering specifications or performance metrics of the predicate devices.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This is an electrode device, not an AI or imaging diagnostic tool.
- Effect Size of Human Readers: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (an electrode), not an algorithm or software. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this submission is the established performance and safety characteristics of the legally marketed predicate devices. The new device aims to demonstrate substantial equivalence to these existing devices through comparison of technological characteristics and non-clinical test results. In essence, the predicate devices are the "ground truth" for what is considered safe and effective for this product type.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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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 | Productcode |
|---|---|---|
| Viasys HealthcareNicolet BiomedicalInstruments | Disposable Ground PlateElectrode | GXY |
| Oxford InstrumentsMedicalMedelec Instruments | TECA NCS 2000 DisposableGround Electrode | GXY |
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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.
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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.
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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
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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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§ 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).