(30 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a needle electrode for EMG-guided procedures, with no mention of AI or ML capabilities.
No
The device is an EMG needle electrode, used for guiding injections of therapeutic substances (Botulinum Toxin) rather than being a therapeutic device itself.
No
Explanation: The device is an EMG needle electrode used for guided injections in Botulinum Toxin therapy and nerve block procedures. While EMG can be used for diagnostic purposes, this specific device is described as an accessory for therapeutic injections, not for diagnostic signal acquisition or interpretation.
No
The device description clearly states it is a needle electrode made of stainless steel, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Electromyography (EMG) guided injections" for "Botulinum Toxin therapy and nerve block procedures." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a needle electrode used to connect to EMG equipment and deliver injections. This is a medical device used for a therapeutic and diagnostic procedure, not for analyzing a biological sample in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used to facilitate a procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
Electromyography (EMG) guided injections
Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy and nerve block procedures. For single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
IKT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K071185, K001869, K973444, K002992
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
| 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 Electromyograph |
| 21 CFR 890.1385 | |
| 6. Product Code: | IKT |
-
- Identifies the legally marketed device to which equivalence is claimed
| Manufacturer | Trade Name | 510k
number | Product
code |
|---------------------------|----------------------------------------------|----------------|-----------------|
| Ambu A/S | Ambu Neuroline Monopolar needle
electrode | K071185 | GXZ |
| Ambu A/S | Ambu Neuroline Inoject needle
electrode | K001869 | IKT |
| Viasys Healthcare
Inc. | TECA Disposable MyoJect Needle
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
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- Conclusions drawn from the nonclinical, clinical and biocompatibility tests
is per
- 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 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
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