AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE

K093825 · Ambu A/S · IKT · Jan 13, 2010 · Physical Medicine

Device Facts

Record IDK093825
Device NameAMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
ApplicantAmbu A/S
Product CodeIKT · Physical Medicine
Decision DateJan 13, 2010
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 890.1385
Device ClassClass 2

Intended Use

Electromyography (EMG) guided injections

Device Story

Ambu Neuroline Disposable Inoject needle electrode is a sterile, single-patient-use device for EMG-guided injections. It consists of a stainless steel needle connected to EMG equipment via a touch-proof connector and pre-attached cable. Used by clinicians during Botulinum Toxin therapy and nerve block procedures to facilitate precise needle placement via EMG guidance. The device functions as an electrode to detect electrical signals, aiding the physician in identifying target muscle or nerve sites. It is used in clinical settings; output is displayed on external EMG equipment to inform clinical decision-making regarding injection placement.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical laboratory testing, including penetration force, friction force, electrical properties, mechanical properties, and shelf-life aging tests. Biocompatibility was verified via ISO 10993-1 testing, including cytotoxicity, contact hypersensitivity, intracutaneous, and systemic injection assays.

Technological Characteristics

Coated stainless steel needle electrode; touch-proof connector with pre-attached cable; used with external reference and ground electrodes. Biocompatibility per ISO 10993-1. Sterile, single-patient-use.

Indications for Use

Indicated for patients requiring Botulinum Toxin therapy or nerve block procedures. For single patient use only.

Regulatory Classification

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).

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 <sup>®</sup> Neuroline Disposable Inoject needle electrode | | 5. Classification Name: | Electrode, Needle, Diagnostic Electromyograph<br>21 CFR 890.1385 | | 6. Product Code: | IKT | - 7. Identifies the legally marketed device to which equivalence is claimed | Manufacturer | Trade Name | 510k<br>number | Product<br>code | |---------------------------|----------------------------------------------|----------------|-----------------| | Ambu A/S | Ambu Neuroline Monopolar needle<br>electrode | K071185 | GXZ | | Ambu A/S | Ambu Neuroline Inoject needle<br>electrode | K001869 | IKT | | Viasys Healthcare<br>Inc. | TECA Disposable MyoJect Needle<br>Electrodes | K973444 | IKT | | Alpine Biomed | Bo-Ject Needles | K002992 | IKT | # 8. Description of device ﺗﺒ 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. {1}------------------------------------------------ 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 ・・ {2}------------------------------------------------ - 15. 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. {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ # 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 Page 1 of 1 - 1
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%