Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical needle electrode for EMG and drug delivery, with no mention of AI/ML capabilities or related data analysis.

Therapeutic

Yes

The device is designed to facilitate the injection of medication into a muscle, which is a therapeutic intervention, as well as for muscle stimulation and recording, which can be part of a diagnostic or therapeutic procedure.

Diagnostic

Yes

The device is used in electromyography (EMG) to locate a particular muscle and record EMG activity, which are diagnostic purposes for assessing muscle and nerve health.

SaMD (Software as a Medical Device)

No

The device description clearly indicates a physical needle electrode with a lead wire, designed for insertion into a patient and drug delivery, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "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." This involves direct interaction with the patient's body for diagnostic (EMG) and therapeutic (drug injection) purposes.
Device Description: The description reinforces this by stating it's used in "EMG applications to record EMG activity while allowing injection of medication."
IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to provide information about a person's health.

This device is used in vivo (within the living body) for both diagnostic (EMG) and therapeutic (drug delivery) purposes, which is not the definition of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

IKT

Device Description

The Allergan Botox Needle Electrode is used in EMG applications to record EMG activity while allowing injection of medication. The Allergan Botox Needle Electrode is a sterile, disposable, monopolar needle electrode with attached lead wire. The needle shaft is insulated so the needle records signals received only from the tip. The needle hub is designed to allow for precise manipulation of the electrode.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

muscle

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician

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)

Nonclinical performance data includes: Dimensional measurement of Needle Electrode – Needle Length (Pass, Substantially Equivalent to Predicate), Dimensional measurement of Needle Electrode - Needle Diameter with and without coating (Pass, Substantially Equivalent to Predicate), Device Continuity measurement (Pass, Substantially Equivalent to Predicate), Biocompatibility Evaluation (Pass, Substantially Equivalent to Predicate), Tensile testing (Pass, Substantially Equivalent to Predicate), Penetration testing (Pass, Substantially Equivalent to Predicate), Leak Testing (Pass, Substantially Equivalent to Predicate), Tip geometry measurements (Pass, Substantially Equivalent to Predicate), and Luer Lock Design (Pass, Substantially Equivalent to Predicate).

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.

K973444

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.

K161430

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

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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);

1

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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
IDA Business Park
Gort, County Galway
Ireland |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Martha Kennedy
Senior Regulatory Affairs Specialist
Natus Manufacturing Limited
IDA Business Park
Gort, County Galway
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
reference device has an almost identical indication for use and is
technologically very similar to that of the proposed device. The
device is being referenced to demonstrate that the proposed device
is consistent with current technology. |

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natus.

| | Natus Manufacturing Limited
Traditional 510(k)
Allergan Botox Needle Electrode |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Allergan Botox Needle Electrode is used in EMG applications
to record EMG activity while allowing injection of medication.
The Allergan Botox Needle Electrode is a sterile, disposable,
monopolar needle electrode with attached lead wire. The needle
shaft is insulated so the needle records signals received only from
the tip. The needle hub is designed to allow for precise
manipulation of the electrode. |
| 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. |
| Comparison: | Table 5A compares the Allergan Botox Needle Electrode to the
predicate device with respect to indications for use, principles of
operation, technological characteristics, materials, and
performance testing. The comparison of the devices provides more
detailed information regarding the basis for the determination of
substantial equivalence. The subject device does not raise any new
issues of safety or effectiveness based on the similarities to the
predicate device. |

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Table 5A: Substantial Equivalence Comparison Table

Year	2017	20 Nov 1997 (original submission date)	Discussion of Differences
Manufacturer	Natus Manufacturing Limited	TECA Corporation
3 Campus Drive
Pleasantville
New York 10570
Trade Name	Allergan Botox Needle Electrode	Teca Myoject Disposable Needle
Electrode
510(k) number	Unknown	K973444
Product Code	IKT	IKT
Labelling	Packaging Labels	Packaging Labels
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	The disposable hypodermic monopolar
needles are for SINGLE USE ONLY
in electromyography (EMG) in
situations wherein it is desired to insert
an electrode, in the form of a probe.	Identical other than product
name
Year	2017	20 Nov 1997 (original submission date)	Discussion of Differences
Manufacturer	Natus Manufacturing Limited	TECA Corporation
3 Campus Drive
Pleasantville
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
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.	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.
Physical
Characteristics	Monopolar Needle	Monopolar Needle	Same
Connector	Single Contact Touch Proof DIN42
802	Single Contact Touch Proof DIN42
802	Same
Material of Needle	Stainless 304	Stainless 304	Same
Needle Size (mm)	Needle Diameter:
0.41	Needle Diameter:
0.30
0.41
0.46	The only diameter of the
proposed device is identical to
one of the predicate variants
Year	2017	20 Nov 1997 (original submission date)	Discussion of Differences
Manufacturer	Natus Manufacturing Limited	TECA Corporation
3 Campus Drive
Pleasantville
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
0.71
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
(Replacement material used to mould the needle hub is now Polypropylene (Exxonmobil) Escorene PP9074 MED	Luer Slip
(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
3 Campus Drive
Pleasantville
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:
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
3 Campus Drive
Pleasantville
New York 10570	Therefore, the physician will
have the necessary
information required to
properly evaluate the state of
the muscle before and after
injections using the Allergan
Botox Needle Electrode.
Therefore the difference does
not raise any new issues of
safety or effectiveness.
Trade Name	Allergan Botox Needle Electrode	Teca Myoject Disposable Needle
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
1.5mm touch proof	14 or 26 inches terminated in a 2mm
or touchproof plug
Year	2017	20 Nov 1997 (original submission date)	Discussion of Differences
Manufacturer	Natus Manufacturing Limited	TECA Corporation
3 Campus Drive
Pleasantville
New York 10570	the cable are minor and do not
raise new issues of safety and
effectiveness, the cable still
serves the same function as
the predicate device. In
addition, these changes do not
interfere with the diagnostic
functioning of the device.
Trade Name	Allergan Botox Needle Electrode	Teca Myoject Disposable Needle
Electrode
510(k) number	Unknown	K973444
Product Code	IKT	IKT
Sterilization	Supplied sterilized gamma irradiated	Supplied sterilized gamma irradiated
Protective Sheath	Polypropylene Escorene PP9074
MED (Exxon Mobil)	Polyethylene	Minor difference:
The function of the protective
sheath is to protect the sharp
needle tip in packaging and
also provide safety to user
when handling the device
before and after use. The
material for this device has
changed compared to the
predicate device.
Year	2017	20 Nov 1997 (original submission date)	Discussion of Differences
Manufacturer	Natus Manufacturing Limited	TECA Corporation
3 Campus Drive
Pleasantville
New York 10570	Review of MSDS sheet and
biocompatibility and bench
tested have demonstrated the
difference does not raise any
new issues of safety or
effectiveness.
Trade Name	Allergan Botox Needle Electrode	Teca Myoject Disposable Needle
Electrode
510(k) number	Unknown	K973444
Product Code	IKT	IKT
Protective Pouch	Tyvek/Mylar	Tyvek/Mylar
Tip geometry	Trocar Point
15 degree bevel	Lancet Point
			Same
			Both Lancet and Trocar
geometries are routinely used
by needle manufacturers in
the Medical Industry. PMS
feedback indicates that Trocar
point is currently the preferred
geometry for this type of
needle.
			Change resulted from
modifications to the Myoject
Needle tip geometry enabling
improvements to the Myoject
tip sharpness. Bench testing
Year	2017	20 Nov 1997 (original submission date)	Discussion of Differences
Manufacturer	Natus Manufacturing Limited	TECA Corporation
3 Campus Drive
Pleasantville
New York 10570
Trade Name	Allergan Botox Needle Electrode	Teca Myoject Disposable Needle
Electrode
510(k) number	Unknown	K973444
Product Code	IKT	IKT
			conducted has demonstrated
the difference does not raise
any new issues of safety or
effectiveness.
Sterility Assurance
Level (SAL)	10-6	10-6	SAL remains the same.

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natus.

27 June 2018

Natus Manufacturing Limited Traditional 510(k) Allergan Botox Needle Electrode

Nonclinical Performance Data:

| Test | Test Method
Summary | Proposed Device
Botox needle | K973444
Predicate
Device Teca
Myoject
Disposable
Needle
Electrode | Conclusion |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------|
| Dimensional
measurement of
Needle Electrode –
Needle Length | Verification of
the Needle
length using
Digital Vernier
Caliper in metric
unit
Acceptance
Criteria:
Needle length
should be 37.0 ±
1.5mm. | Pass | Pass | Conclusion:
Substantially
Equivalent to
Predicate |
| Dimensional
measurement of
Needle Electrode -
Needle Diameter
with and without
coating | Verification of
the Needle
diameter
without PTFE
coating using
Digital
Micrometer in
metric unit.
Verify the
Needle diameter
with PTFE
coating using | Pass | Pass | Conclusion:
Substantially
Equivalent to
Predicate |
| | Digital
Micrometer in
metric unit.
Acceptance
Criteria:
The diameter of
the Needle
(without PTFE
coat) Electrode
should be of 27
Gauge (0.40±
0.1mm).
The diameter of
the Needle with
PTFE coating
should be
between 0.420
to 0.456 mm. | | | |
| Device Continuity
measurement | Verify the
resistance
between needle
tip to 1.5mm
touch proof
connector end
using a Digital
Multimeter in
resistance mode.
Record the
measurement. | Pass | Pass | Conclusion:
Substantially
Equivalent to
Predicate |
| | Acceptance
criteria:
The resistance
between needle
tip to the
standard 1.5mm
connector end
should be less
than 1.5Ω to
allow the
biopotential
signals | | | |
| Biocompatibility
Evaluation | Biocompatibility
testing per ISO
10993-1. The
Needle
Electrode is an
Invasive
Electrode,
classified per
ISO 10993-
1:2009 as
external
communicating
device in limited
(≤ 24 hours)
contact with
tissue. Annex A
defines that the
following
evaluation tests
need to be
considered
cytotoxicity
(ISO 10993-5) | Pass | Pass | Conclusion:
Substantially
Equivalent to
Predicate |
| | (ISO 10993-10)
and irritation
sensitivity (ISO
10993-10) and
Blood
Compatibility
Hemolysis Test
(ISO 10993-4). | | | |
| Tensile testing | Needle to Wire
Crimp Pull Test.
Acceptance
Criteria:
$>/=22N$ | Pass | Pass | Conclusion:
Substantially
Equivalent to
Predicate |
| Penetration testing | Verify that the
needle
consistently
produces the
comparative
sharpness and
frictional force.
Acceptance
Criteria:
Comparative
data | Pass | Pass | Conclusion:
Substantially
Equivalent to
Predicate |
| Leak Testing | Using the
Digital Multi-
meter, measure
the resistance | Pass | Pass | Conclusion: |
| | across the
needle (probe on
the PTFE
coating)

Acceptance
criteria:
The resistance
of the needle
should be
greater than
$10MΩ$ . | | | Substantially
Equivalent to
Predicate |
| Tip geometry
measurements | Verify BS EN
ISO 7864
certificate for
the tip geometry
of the needle
electrode.

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Natus Manufacturing Limited Traditional 510(k) Allergan Botox Needle Electrode

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Natus Manufacturing Limited Traditional 510(k) Allergan Botox Needle Electrode

| certificates for
Luer lock and
Luer slip fit
syringes for
Botox
Hypodermic
Injection Needle
Electrode.

Acceptance
Criteria:

The Luer lock
and Luer slip fit
syringes should
be conform to
ISO 594-1 &
594-2 standard. | | Substantially
Equivalent to
Predicate |

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--	---------------------------------------------

It has been demonstrated in this 510(k) submission that the differences between the Allergan Botox Needle Electrode and the predicate device do not raise any questions regarding its safety and effectiveness. Natus completed a number of non-clinical performance tests to demonstrate that the device is as safe and effective as the predicate device and that substantial equivalence to the predicate device that is subject to this 510(k) submission can be claimed. The Allergan Botox Needle Electrode meets all the requirements for overall design, sterilization and biocompatibility confirming that the design output meets the design inputs and specifications for the device.

The Allergan Botox Needle Electrode passed all the testing in accordance with internal requirements, national standards, and international standards shown in the table above to support substantial equivalence of the subject device.

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| Statement of
Substantial Equivalence: | The Allergan Botox Needle Electrode is determined to be
substantially equivalent to the device cleared under K973444 as is
presented above in Table 5A Substantial Equivalence Comparison
Table. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Allergan Botox Needle Electrode is determined to be
substantially equivalent to the predicate device as it has the same
intended use and similar technological characteristics as the
previously cleared predicate devices. The Allergan Botox Needle
Electrode is determined to be substantially equivalent to the
predicate device. |