(91 days)
The Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.
The Ambu Neuroline Concentric Needle is a Single Patient EMG Needle Electrode and is used to measure an EMG signal when connected to the EMG equipment through a 5 pins reusable cable. The Electromyogram (EMG) records electrical activity within the muscle. It is used mainly to tell the difference between muscle diseases and nerve diseases. The Ambu Neuroline Concentric Needle is a sterile product.
The provided document is a 510(k) summary for the Ambu Neuroline, Disposable Concentric needle electrode. It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. Instead, it details the non-clinical and biocompatibility tests performed for a traditional medical device (a needle electrode).
Therefore, I cannot populate the table or answer the questions as requested, as the provided input does not describe an AI/ML device or a study with such performance metrics.
However, I can extract the information provided about the non-clinical tests that were performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or reported performance for the device in a table format. It generally states that non-clinical tests were performed to "verify the functionality" and "ensure the functionality during the shelf life." The conclusion is that the device "fulfils the product specifications set for the design."
The non-clinical tests mentioned are:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Penetration and friction force | Verification performed according to DIN 13097. Fulfilled product specifications. |
| Electrical properties | Verification performed. Fulfilled product specifications. |
| Shelf life functionality (Ageing) | Performed to verify and ensure functionality during shelf life. Fulfilled product specifications. |
| Biocompatibility (Cytotoxicity, Hypersensitivity, Intracutaneous, Systemic Injection) | Passed; materials demonstrate appropriate levels of biocompatibility. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The tests are non-clinical, laboratory-based verification tests for a physical device, not a data-driven AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on medical images) is not relevant for these physical device verification tests.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For the physical device tests (penetration, friction, electrical properties, ageing), the "ground truth" would be objective measurements and adherence to established standards (e.g., DIN 13097) and internal product specifications. For biocompatibility, it's based on results from standardized ISO 10993-1 tests (e.g., cell viability, immune response).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Special 510(k) Application - Neuroline, Disposable Concentric needle electrode
510(k) Summary
- 510(k) owner: Ambu A/S JUL 3 0 2007 Baltorpbakken 13 DK-2750 Ballerup Denmark Tel.: +45 72252000 Fax.: +45 72252050 Contact person: Anne Bielefeldt Regulatory Affairs Specialist 2. Preparation date of the 510(k) summary: April 2007 3. Name of device: Device Common name: Disposable Concentric needle electrode Neuroline, Disposable Concentric needle 4. Device Trade name: electrode Electrode, needle, diagnostic electromyography 5. Classification Name: 21 CFR 890.1385 IKT 6. Product Code:
7. Identifies the legally marketed device to which equivalence is claimed
| Manufacturer | Trade Name | 510k number | Product code |
|---|---|---|---|
| Ambu A/S | Neuroline, DisposableConcentric needleelectrode | K973529 | IKT |
| Viasys HealthcareInc. | Medelec Elite Dispos-able Concentric NeedleElectrode | K961013 | IKT |
| Medtronic Inc. | DCNtm DisposableConcentric NeedleElectrode | K931966 | IKT |
-
- Description of device
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The Ambu Neuroline Concentric Needle is a Single Patient EMG Needle Electrode and is used to measure an EMG signal when connected to the EMG equipment through a 5 pins reusable cable. The Electromyogram (EMG) records electrical activity within the muscle. It is used mainly to tell the difference between muscle diseases and nerve diseases. The Ambu Neuroline Concentric Needle is a sterile product.
9. The intended use
Ambu Neuroline Disposable Concentric needle electrodes is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. This is used to assess whether muscle impairment is due to disturbances in the motor neurones, the motor nerve fibres or in the muscle itself. It is used mainly to tell the difference between muscle diseases and nerve diseases.
10.Indications for Use
The Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.
11. Summary of the technoloqical Characteristics
Ambu Neuroline Concentric Needle consists of a cannula made of stainless steel and an inner conductor. In between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction polymer.
12. Brief discussion of the nonclinical tests submitted
The non-clinical tests performed are laboratory tests to verify the functionality of the Ambu Neuroline Disposable Concentric needle electrode. The Ambu Neuroline Disposable Concentric needle electrode is tested for penetration and friction force and electrical properties. The verification of the penetration and the friction force of the needle were performed according to DIN 13097.
Ageing tests are performed to verify and ensure the functionality during the shelf life of the product.
13. Brief discussion of the clinical tests submitted
No clinical tests were performed for the updated version of the Ambu Neuroline Disposable Concetric needle because it has the same intended use and similar characteristics as the currently commercially available Ambu Neuroline Disposable Concentric needle.
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14. Biocompatibility testing - Summary
The biological safety of the Ambu Neuroline Concentric Needle has been assured through the selection of materials, which demonstrate appropriate levels of biocompatibility. Tests were selected on the basis of ISO 10993-1 – Biological evaluation of Medical Device.
The following tests were performed:
- Cytotoxicity assay in vitro -
- Contact hypersensitivity in the guinea pig Maximization study -
- Intracutaneous test in the rabbit -
- Systemic Injection test in the mice -
15. Conclusions drawn from the non clinical and biocompatibility tests
From the results of the non clinical verification test and biocompatibility test, it has been concluded that Ambu Neuroline Disposable Concentric Needle electrode fulfils the product specifications set for the design. It is concluded that Ambu Neuroline Disposable Concentric Needle electrode is a safe and effective Concentric needle electrode and comparable to the predicate devices.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the bird's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2007
Ambu A/S % Ambu Inc. Mr. Sanjay Parikh Technical & Regulatory Affairs Specialists US Agent and FDA Contact 6740 Baymeadow Drive Glen Burnie, MD 21060
Re: K071186
Trade/Device Name: Ambu Neuroline, Disposable Concentric Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic electromyograph needle electrode Regulatory Class: II Product Code: IKT Dated: July 23, 2007 Received: July 24, 2007
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 (OS) 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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Page 2 -- Mr. Sanjay Parikh
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Mark N. Melkerson
Director
7/30/07
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
510(k) Number:
1071186
Device Name: Ambu Neuroline, Disposable Concentric needle electrode
Indications For Use:
The Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
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)
AND/OR
Section D - Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number LC071184
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).