The Ambu Neuroline Disposable Inoject needle electrode is a Single Patient needle electrode for Electromyography (EMG) guided injections. The needle electrode is designed for Botulinum Toxin therapy and nerve block procedures. The Ambu Neuroline Disposable Inoject needle is manufactured in different lengths and diameters. The Ambu Neuroline Disposable Inoject needle is connected to the EMG equipment through a touch proof connector with a pre-attached cable. The Ambu Neuroline Disposable Inoject needle electrode is a sterile product. Ambu Neuroline Disposable Inoject needle electrodes consist of a coated needle made from stainless steel. The Ambu Neuroline Disposable Inoject needle electrode is used with a reference electrode and a ground electrode.

AI/ML Overview

Here's an analysis of the provided text regarding the Ambu Neuroline Disposable Inoject Needle Electrode (K093825), focusing on acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or a direct measurement of "device performance" in terms of clinical outcomes or specific numerical metrics. Instead, the justification for clearance relies on substantial equivalence to predicate devices and verification of functionality through non-clinical testing.

Given the information, the acceptance criteria are implicitly tied to meeting product specifications and demonstrating safety and effectiveness comparable to predicate devices. The reported "performance" is that it meets these implicit criteria.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Verification (Non-clinical)	The device was tested for: - Penetration force - Friction force - Electrical properties - Mechanical properties These tests reportedly verified the functionality and fulfilled product specifications. (Conclusion from non-clinical tests stated that the device fulfills product specifications set for the design.)
Biocompatibility	The device passed the following tests based on ISO 10993-1: - Cytotoxicity assay in vitro - Contact hypersensitivity in the guinea pig Maximization study - Intracutaneous test in the rabbit - Systemic Injection test in the mice This ensures biological safety and appropriate levels of biocompatibility.
Safety and Effectiveness (Relative to Predicate Devices)	Concluded to be a safe and effective Inoject needle electrode and comparable to the predicate devices based on non-clinical verification and biocompatibility tests. (This is the overarching conclusion required for 510(k) clearance via substantial equivalence).
Maintenance of Functionality over Shelf Life (Aging)	Aging tests were performed to verify and ensure the functionality during the shelf life of the product.
Intended Use and Indications for Use Match Predicate	The device has the same intended use and similar characteristics as the currently commercially available Ambu Neuroline Disposable Inoject needle electrode (K001869, assuming this is the primary predicate) and other predicate devices (K071185, K973444, K002992). The intended use is "Electromyography (EMG) guided injections" and indications for use are "EMG Needle Electrode designed for Botulinum Toxin therapy and nerve block procedures. For single patient use only."

Regarding the study proving the device meets acceptance criteria:

The provided document describes a submission for a 510(k) premarket notification, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving de novo clinical efficacy through a standalone study.

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

Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set. The submission relies on non-clinical laboratory tests for functional verification and biocompatibility tests. The sample sizes for these specific lab tests (e.g., number of needles tested for penetration force, number of animals in biocompatibility studies) are not provided in this summary.
Data Provenance: The data provenance for the non-clinical and biocompatibility tests would be internal laboratory studies conducted by Ambu A/S. The document does not specify a country of origin for the non-clinical data, but Ambu A/S is based in Denmark. These were retrospective studies in the sense that they were performed to support the 510(k) submission.

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

Not applicable. For this type of submission (510(k) for an EMG needle electrode), ground truth is not established by a panel of clinical experts in the context of diagnostic agreement. The "ground truth" for the non-clinical tests would be the pre-defined product specifications and international standards (e.g., ISO 10993-1 for biocompatibility). Compliance with these objective criteria is assessed by engineers and laboratory personnel, not clinical experts for ground truth establishment.

4. Adjudication method for the test set

Not applicable. There was no clinical adjudication process described, as no clinical test set requiring expert interpretation was conducted. The "adjudication" for non-clinical tests is against pre-defined performance specifications.

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. An MRMC comparative effectiveness study was not performed. This device is a passive medical instrument (a needle electrode), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

No. This device is a physical medical instrument, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

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

For the non-clinical tests (penetration force, friction force, electrical, mechanical properties): The ground truth is the pre-defined engineering specifications and performance requirements for the device.
For the biocompatibility tests: The ground truth is established by international standards (ISO 10993-1) and the specific biological endpoints measured in the in vitro and in vivo assays (e.g., cell viability for cytotoxicity, skin reaction for hypersensitivity).

8. The sample size for the training set

Not applicable. As this is not an AI/machine learning device, there is no "training set" in the computational sense. The device's design is based on established engineering principles and prior iterations of similar devices.

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

Not applicable. As there is no training set. The design and manufacturing process are validated against the product specifications and regulatory standards.

Summary

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K093825

1. 510(k) owner:	Ambu A/S
	Baltorpbakken 13
	DK-2750 Ballerup
	Denmark
	Tel.: +45 72252000
	Fax.: +45 72252050
	JAN 1 3 2010
Contact person:	Anne Bielefeldt
	Regulatory Affairs Specialist
2. Preparation date of the 510(k) summary:	November 2009
3. Device Common name:	Neuroline Single Patient, Hypodermic Needle Electrode
4. Device Trade name:	Ambu ® Neuroline Disposable Inoject needle electrode
5. Classification Name:	Electrode, Needle, Diagnostic Electromyograph21 CFR 890.1385
6. Product Code:	IKT

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

Manufacturer	Trade Name	510knumber	Productcode
Ambu A/S	Ambu Neuroline Monopolar needleelectrode	K071185	GXZ
Ambu A/S	Ambu Neuroline Inoject needleelectrode	K001869	IKT
Viasys HealthcareInc.	TECA Disposable MyoJect NeedleElectrodes	K973444	IKT
Alpine Biomed	Bo-Ject Needles	K002992	IKT

8. Description of device

ﺗﺒ

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The Ambu Neuroline Disposable Inoject needle is manufactured in different lengths and diameters.

The Ambu Neuroline Disposable Inoject needle is connected to the EMG equipment through a touch proof connector with a pre-attached cable.

The Ambu Neuroline Disposable Inoject needle electrode is a sterile product.

9. The intended use

Electromyography (EMG) guided injections

10. Indication for use

Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy and nerve block procedures. For single patient use only.

11. Summary of the technological Characteristics

Ambu Neuroline Disposable Inoject needle electrodes consist of a coated needle made from stainless steel. The Ambu Neuroline Disposable Inoject needle electrode is used with a reference electrode and a ground electrode.

12. Brief djscussion of the nonclinical tests submitted

The non-clinical tests performed are laboratory tests to verify the functionality of the Ambu Neuroline Disposable Inoject needle electrode. The Ambu Neuroline Disposable Inoject needle electrode is tested for penetration force and friction force, electrical properties and mechanical properties.

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 Inoject needle because it has the same intended use and similar characteristics as the currently commercially available Ambu Neuroline Disposable Inoject needle electrode.

14. Biocompatibility testing

The biological safety of the Ambu Neuroline Disposable Inoject 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

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1. Conclusions drawn from the nonclinical, clinical and biocompatibility tests
  is per

From the results of the non clinical verification test and biocompatibility test, it has been concluded that Ambu Neuroline Disposable Inoject Needle electrode fulfils the product specifications set for the design.

It is concluded that Ambu Neuroline Disposable Inoject Needle electrode is a safe and effective Inoject 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 Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ambu, Inc. c/o Mr. Sanjay Parikh Vice President Operations, US Agent 6740 Baymeadow Drive Glen Burnie, MD 21060

JAN 1 8 2010

Re: K093825

Trade/Device Name: Ambu® Neuroline Disposable Inoject Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: II Product Code: IKT Dated: December 11, 2009 Received: December 14, 2009

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 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); 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.

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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely, yours,

Kesia Alexander for

Malvina B. Eydelman, M.D. 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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Indications for Use

510(k) Number: K093825

Device Name: Ambu® Neuroline Disposable Inoject Needle Electrode

Indications For Use: Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy and nerve block procedures. 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)

Division Sign-Off)

· Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K093825
510(k) Number

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Regulation Number and Section

§ 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).