Allergan Botox Needle Electrode
Device Facts
| Record ID | K173815 |
|---|---|
| Device Name | Allergan Botox Needle Electrode |
| Applicant | Natus Manufacturing Limited |
| Product Code | IKT · Physical Medicine |
| Decision Date | Jun 29, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.1385 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Allergan Botox Needle Electrode are for SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
Device Story
Sterile, disposable, monopolar needle electrode with attached lead wire; used in EMG applications to record muscle activity and deliver medication. Physician inserts needle into patient to locate target muscle; uses needle for stimulation and motor unit action potential recording; injects drug through needle lumen once location is confirmed. Used in clinical settings by physicians. Device features insulated shaft for tip-only signal recording and Luer lock/slip hub for syringe attachment. Benefits include precise muscle localization and integrated drug delivery in a single procedure.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including dimensional measurements, device continuity, tensile strength, penetration force, leak testing, tip geometry compliance (BS EN ISO 7864), and Luer lock/slip design compliance (ISO 594-1 & 594-2). Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, irritation, sensitivity, hemolysis).
Technological Characteristics
Monopolar needle electrode; 304 stainless steel; PTFE coating (Xylon 8820 G4075); polypropylene hub (Exxonmobil Escorene PP9074 MED); 1.5mm touch-proof DIN 42 802 connector; trocar point with 15-degree bevel; gamma-sterilized; single-use; disposable.
Indications for Use
Indicated for use in patients requiring electromyography (EMG) for muscle localization and subsequent drug delivery via the needle lumen. For single 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
- Teca Myoject Disposable Needle Electrode (K973444)
Reference Devices
- Myoject Luer Lock Needle Electrodes (K161430)
Submission Summary (Full Text)
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June 29, 2018
Natus Manufacturing Limited Martha Kennedy Senior Regulatory Affairs Specialist IDA Business Park Gort, County Galway Ireland
Re: K173815
Trade/Device Name: Allergan Botox Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: Class II Product Code: IKT Dated: May 28, 2018 Received: May 30, 2018
Dear Martha Kennedy:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
## Jay R. Gupta -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K173815
Device Name Allergan Botox Needle Electrode
#### Indications for Use (Describe)
The Allergan Botox Needle Electrode are for SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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# natus.
Natus Manufacturing Limited Traditional 510(k) Allergan Botox Needle Electrode
### Section 5: 510(k) Summary
| Manufacturer's Name: | Natus Manufacturing Limited<br>IDA Business Park<br>Gort, County Galway<br>Ireland |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Martha Kennedy<br>Senior Regulatory Affairs Specialist<br>Natus Manufacturing Limited<br>IDA Business Park<br>Gort, County Galway<br>Ireland |
| Telephone Number: | +353-(0)91-647433 |
| Fax Number: | +353-(0)91-630050 |
| Summary Date: | 27 June 2018 |
| Trade Names: | Allergan Botox Needle Electrode |
| Common or Usual Name: | Electrode, Needle, Diagnostic Electromyograph |
| Classification Name : | Diagnostic Electromyograph Needle Electrode |
| Device Class: | Class II |
| Product Code: | IKT |
| Classification Regulation: | 21.CFR.890.1385 |
| Classification Panel: | Neurology |
| Predicate Device: | K973444 Teca Myoject Disposable Needle Electrode |
| Reference Device: | K161430, MyojectTM Luer Lock Needle Electrodes. This<br>reference device has an almost identical indication for use and is<br>technologically very similar to that of the proposed device. The<br>device is being referenced to demonstrate that the proposed device<br>is consistent with current technology. |
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# natus.
| | Natus Manufacturing Limited<br>Traditional 510(k)<br>Allergan Botox Needle Electrode |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Allergan Botox Needle Electrode is used in EMG applications<br>to record EMG activity while allowing injection of medication.<br>The Allergan Botox Needle Electrode is a sterile, disposable,<br>monopolar needle electrode with attached lead wire. The needle<br>shaft is insulated so the needle records signals received only from<br>the tip. The needle hub is designed to allow for precise<br>manipulation of the electrode. |
| Indications for Use: | The Allergan Botox Needle Electrode are for SINGLE USE ONLY<br>in electromyography (EMG) in situations wherein it is desired to<br>insert an electrode, in the form of a probe, into a patient to locate a<br>particular muscle and then inject a medication into that muscle.<br>The hypodermic needle with an open lumen is designed for muscle<br>stimulation, motor unit action potential recording and drug<br>delivery. Once the physician is satisfied with the location, he/she<br>injects a drug therein via the lumen of the needle. |
| Comparison: | Table 5A compares the Allergan Botox Needle Electrode to the<br>predicate device with respect to indications for use, principles of<br>operation, technological characteristics, materials, and<br>performance testing. The comparison of the devices provides more<br>detailed information regarding the basis for the determination of<br>substantial equivalence. The subject device does not raise any new<br>issues of safety or effectiveness based on the similarities to the<br>predicate device. |
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Image /page/5/Picture/0 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are closely spaced together. There is a registered trademark symbol to the right of the "s".
Table 5A: Substantial Equivalence Comparison Table
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Natus Manufacturing Limited | TECA Corporation<br>3 Campus Drive<br>Pleasantville<br>New York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle<br>Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Labelling | Packaging Labels | Packaging Labels | |
| Indications for Use | The Allergan Botox Needle<br>Electrode are for SINGLE USE<br>ONLY in electromyography (EMG)<br>in situations wherein it is desired to<br>insert an electrode, in the form of a | The disposable hypodermic monopolar<br>needles are for SINGLE USE ONLY<br>in electromyography (EMG) in<br>situations wherein it is desired to insert<br>an electrode, in the form of a probe. | Identical other than product<br>name |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation<br>3 Campus Drive<br>Pleasantville<br>New York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| | probe, into a patient to locate a<br>particular muscle and then inject a<br>medication into that muscle. The<br>hypodermic needle with an open<br>lumen is designed for muscle<br>stimulation, motor unit action<br>potential recording and drug<br>delivery. Once the physician is<br>satisfied with the location, he/she<br>injects a drug therein via the lumen<br>of the needle. | into a patient to locate a particular<br>muscle and then inject a medication<br>into that muscle. The hypodermic<br>needle with an open lumen is designed<br>for muscle stimulation, motor unit<br>action potential recording and drug<br>delivery. Once the physician is<br>satisfied with the location, he/she<br>injects a drug therein via the lumen of<br>the needle. | |
| Physical<br>Characteristics | Monopolar Needle | Monopolar Needle | Same |
| Connector | Single Contact Touch Proof DIN42<br>802 | Single Contact Touch Proof DIN42<br>802 | Same |
| Material of Needle | Stainless 304 | Stainless 304 | Same |
| Needle Size (mm) | Needle Diameter:<br>0.41 | Needle Diameter:<br>0.30<br>0.41<br>0.46 | The only diameter of the<br>proposed device is identical to<br>one of the predicate variants |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation<br>3 Campus Drive<br>Pleasantville<br>New York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Needle Coating material | PTFE (Xylon 8820 G4075) | 0.51<br>0.71<br>PTFE (Ultralon R-605/T-5) | Review of MSDS sheet and biocompatibility and bench tested have demonstrated the difference does not raise any new issues of safety or effectiveness. |
| Hub | Luer Lock/Slip<br>(Replacement material used to mould the needle hub is now Polypropylene (Exxonmobil) Escorene PP9074 MED | Luer Slip<br>(Original material used to mould the needle hub was Polypropylene (Himont - Legacy company of Lyondell Basell Industries) Pro-Fax 6329 | Review of MSDS sheet and biocompatibility and bench tested have demonstrated the difference does not raise any new issues of safety or effectiveness. |
| Hub Material | Polypropylene (Exxonmobil) Escorene PP9074 MED | Polycarbonate | Review of MSDS sheet and biocompatibility and bench tested have demonstrated the difference does not raise any new issues of safety or effectiveness. |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation<br>3 Campus Drive<br>Pleasantville<br>New York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | new issues of safety or effectiveness. |
| Needle grind angle | 10-16 degrees conical | 10-20 degrees conical | The specification of the proposed device falls within the original specification associated with the predicate device therefore the difference does not raise any new issues of safety or effectiveness. The change does not alter the diagnostic effects of the device |
| Recording area (sqmm) | 0.33 | 0.25 | Slight difference:<br>It is demonstrated in the proposed 510(k) that changes in recording area do not adversely affect the recording properties of the device. |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation<br>3 Campus Drive<br>Pleasantville<br>New York 10570 | Therefore, the physician will<br>have the necessary<br>information required to<br>properly evaluate the state of<br>the muscle before and after<br>injections using the Allergan<br>Botox Needle Electrode.<br>Therefore the difference does<br>not raise any new issues of<br>safety or effectiveness. |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle<br>Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Length (mm) | 37 | 25, 37, 50, 75, 100 | |
| Connecting lead | 655 ±13mm, Form 'ST' moulded<br>1.5mm touch proof | 14 or 26 inches terminated in a 2mm<br>or touchproof plug | |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation<br>3 Campus Drive<br>Pleasantville<br>New York 10570 | the cable are minor and do not<br>raise new issues of safety and<br>effectiveness, the cable still<br>serves the same function as<br>the predicate device. In<br>addition, these changes do not<br>interfere with the diagnostic<br>functioning of the device. |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle<br>Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Sterilization | Supplied sterilized gamma irradiated | Supplied sterilized gamma irradiated | |
| Protective Sheath | Polypropylene Escorene PP9074<br>MED (Exxon Mobil) | Polyethylene | Minor difference:<br>The function of the protective<br>sheath is to protect the sharp<br>needle tip in packaging and<br>also provide safety to user<br>when handling the device<br>before and after use. The<br>material for this device has<br>changed compared to the<br>predicate device. |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation<br>3 Campus Drive<br>Pleasantville<br>New York 10570 | Review of MSDS sheet and<br>biocompatibility and bench<br>tested have demonstrated the<br>difference does not raise any<br>new issues of safety or<br>effectiveness. |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle<br>Electrode | |
| 510(k) number | Unknown | K973444 | |
| Product Code | IKT | IKT | |
| Protective Pouch | Tyvek/Mylar | Tyvek/Mylar | |
| Tip geometry | Trocar Point<br>15 degree bevel | Lancet Point | |
| | | | Same |
| | | | Both Lancet and Trocar<br>geometries are routinely used<br>by needle manufacturers in<br>the Medical Industry. PMS<br>feedback indicates that Trocar<br>point is currently the preferred<br>geometry for this type of<br>needle. |
| | | | Change resulted from<br>modifications to the Myoject<br>Needle tip geometry enabling<br>improvements to the Myoject<br>tip sharpness. Bench testing |
| Year | 2017 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation<br>3 Campus Drive<br>Pleasantville<br>New York 10570 | |
| Trade Name | Allergan Botox Needle Electrode | Teca Myoject Disposable Needle<br>Electrode | |
| 510(k) number | Unknown | K973444…
