The Neuroline, Disposable Monopolar needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.

Device Description

The Ambu Neuroline Disposable Monopolar needle electrode is a Single Patient EMG needle electrode and is used to measure an EMG signal when connected to the EMG equipment. The Ambu Neuroline Disposable Monopolar needle is manufactured in different lengths and diameters. The Ambu Neuroline Disposable Monopolar needle is connected to the EMG equipment through a 1.5 mm touch proof connector according to DIN 42 802 either with a pre-attached cable or as a non-cable version to be used with Ambu's reusable cable for the Ambu Neuroline Monopolar. The Ambu Neuroline Disposable Monopolar needle electrode is a sterile product.

AI/ML Overview

The provided text describes a 510(k) application for a medical device (Neuroline Disposable Monopolar needle electrode) seeking substantial equivalence to existing devices. It details the device's characteristics, intended use, and the non-clinical tests performed. However, it explicitly states that no clinical tests were performed for this updated version of the device. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria cannot be fully extracted from the provided text as it pertains to a clinical efficacy study.

Based on the provided text, the device's acceptance criteria and "proof" are based on non-clinical performance verification and biocompatibility testing, and by demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance	Evidence Source
Functionality	Penetration force (according to DIN 13097)	Verified	Non-clinical tests
	Friction force (according to DIN 13097)	Verified	Non-clinical tests
	Electrical properties	Verified	Non-clinical tests
	Sharpness (according to DIN 13097)	Verified	Non-clinical tests
Durability/Shelf Life	Ageing tests	Verified functionality during shelf life	Non-clinical tests
Biocompatibility	Cytotoxicity assay in vitro	Passed	Biocompatibility tests (ISO 10993-1)
	Contact hypersensitivity (guinea pig Maximization study)	Passed	Biocompatibility tests (ISO 10993-1)
	Intracutaneous test (rabbit)	Passed	Biocompatibility tests (ISO 10993-1)
	Systemic Injection test (mice)	Passed	Biocompatibility tests (ISO 10993-1)

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a series of non-clinical laboratory tests and biocompatibility tests. The document explicitly states: "The non-clinical tests performed are laboratory tests to verify the functionality of the Ambu Neuroline Disposable Monopolar needle electrode. The Ambu Neuroline Disposable Monopolar needle electrode is tested for penetration force, friction force and electrical properties. The verification of the sharpness and the friction of the needle was performed according to DIN 13097. Ageing tests are performed to verify and ensure the functionality during the shelf life of the product." and "The biological safety of the Ambu Neuroline Disposable Monopolar needle electrode 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."

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The description refers to "laboratory tests" and "biocompatibility tests" but does not provide specific sample quantities for the tested units or animals.
Data provenance: The tests were performed in a laboratory setting, likely by the manufacturer (Ambu A/S). The specific country of origin for the raw data is not explicitly stated, but the manufacturer is based in Denmark. These are non-clinical, prospective tests, meaning they were conducted specifically for this regulatory submission to evaluate the device's performance against predefined standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable / not provided for this submission. The "ground truth" here is objective measurement against engineering specifications and biological safety standards (e.g., DIN 13097 for mechanical properties, ISO 10993-1 for biocompatibility). These do not typically involve human expert consensus for "ground truth" in the way a clinical diagnostic study would. The acceptance criteria were based on predefined engineering and biocompatibility standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable / not provided. Adjudication methods are typically used in clinical studies where human interpretation or a "gold standard" is debated. For non-clinical lab tests against objective standards, the test results (e.g., force measurements) either pass or fail the specified limit.

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:

No. The document explicitly states: "No clinical tests were performed for the updated version of the Ambu Neuroline Disposable Monopolar needle because it has the same intended use and similar characteristics as the currently commercially available Ambu Neuroline Disposable Monopolar needle electrode." This is a needle electrode, not an AI-powered diagnostic device, so an MRMC study with AI assistance is irrelevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

No. This is a hardware medical device (a needle electrode), not a software algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical tests involved objective measurements against established engineering standards (e.g., DIN 13097) and biological safety standards (ISO 10993-1). For example, for "penetration force," the ground truth is a specific force value that the needle must not exceed. For biocompatibility, it's the passing of established in vitro and in vivo biological assays.

8. The sample size for the training set:

Not applicable / not provided. As no clinical studies were performed and this is a hardware device (not an AI algorithm), there is no concept of a "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established:

Not applicable / not provided. (See point 8).

Summary

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Revised Summary

Special 510(k) Application - Neuroline Disposable Monopolar needle electrode

K071185

510(k) Summary

MAY 3 0 2007

1. 510(k) owner: Ambu A/S Baltorpbakken 13 DK-2750 Ballerup Denmark Tel.: +45 72252000 Fax.: +45 72252050
  Contact person: Anne Bielefeldt Regulatory Affairs Specialist
1. Preparation date of the 510(k) summary: April 2007

3. Name of device:Device Common name:	Disposable Monopolar needle electrode
4. Device Trade name:	Neuroline, Disposable Monopolar needleelectrode
5. Classification Name:	Electrode, needle.21 CFR 882.1350
6. Product Code:	GXZ

7. Identifies the legally marketed device to which equivalence is claimed

Manufacturer	Trade Name	Product code
Ambu A/S	Neuroline, DisposableMonopolar needle electrode	GXZ
Viasys Healthcare Inc.	Medelec Elite DisposableConcentric Needle Electrode	IKT

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8. Description of device

The Ambu Neuroline Disposable Monopolar needle is connected to the EMG equipment through a 1.5 mm touch proof connector according to DIN 42 802 either with a pre-attached cable or as a non-cable version to be used with Ambu's reusable cable for the Ambu Neuroline Monopolar. The Ambu Neuroline Disposable Monopolar needle electrode is a sterile product.

9. The intended use

Ambu Neuroline Disposable Monopolar 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. Indication for Use

The Neuroline, Disposable Monopolar needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.

11. Summary of the technological Characteristics

Ambu Neuroline Disposable Monopolar needle electrodes consist of a solid needle made from stainless steel coated with a low friction polymer. The Ambu Neuroline Disposable Monopolar needle electrode is used with a reference electrode and a ground electrode.

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 Monopolar needle electrode. The Ambu Neuroline Disposable Monopolar needle electrode is tested for penetration force, friction force and electrical properties. The verification of the sharpness and the friction of the needle was 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

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No clinical tests were performed for the updated version of the Ambu Neuroline Disposable Monopolar needle because it has the same intended use and similar characteristics as the currently commercially available Ambu Neuroline Disposable Monopolar needle electrode.

14. Biocompatibility testing

The biological safety of the Ambu Neuroline Disposable Monopolar needle electrode 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 and passed:

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 nonclinical, clinical and biocompatibility tests

From the results of the non clinical verification test and biocompatibility test, it has been concluded that Ambu Neuroline Disposable Monopolar Needle electrode fulfils the product specifications set for the design. It is concluded that Ambu Neuroline Disposable Monopolar Needle electrode is a safe and effective Monopolar needle electrode and comparable to the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ambu Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs 6470 Baymeadow Drive Glen Burnie, Maryland 21060

MAY 3 0 2007

Re: K071185

Trade/Device Name: Neuroline, Disposable Monopolar needle electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: Class II Product Code: GXZ Dated: April 26, 2007 Received: April 30, 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 (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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Page 2 - Mr. Parikh

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin mailtoning your and equivalence of your device to a legally premaired 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 If you desire specific daries in your as the regulation of the regulation entitled, Connact the Office of Companisemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on your roopemer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

for P.D.

Mark N. Melkerson

N.D. 5/25/07

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Application - Neuroline, Disposable Monopolar needle electrode

Indications for Use

510(k) Number: K071185

Device Name: Ambu Neuroline, Disposable Monopolar needle electrode

Indications For Use:

The Neuroline, Disposable Monopolar 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)

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)

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Section D - Page 1 of __ 1 ____

Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).