Myoject Luer Lock Needle Electrode

• K Number: K161430
• Device Name: Myoject Luer Lock Needle Electrode
• Manufacturer: Natus Manufacturing Limited
• Date Cleared: 2017-03-02 ( 283 days)
• Product Code: IKT
• Regulation Number: 890.1385

Intended Use

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, 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 Description

The Myoject™ Luer Lock Needle Electrode is a Disposable Hypodermic Needle Electrode

Predicate Devices

K973444

Reference Devices

K973444

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a disposable needle electrode for EMG and drug delivery, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is used to insert an electrode into a patient to locate a muscle and then inject medication for drug delivery, which constitutes therapy. Additionally, the description "electromyography (EMG)" implies diagnostic use, but the subsequent "inject a medication into that muscle" clearly indicates a therapeutic function.

Diagnostic

Yes

The device is used for electromyography (EMG) and motor unit action potential recording, which are diagnostic procedures to assess the electrical activity of muscles and nerves.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate a physical, disposable hypodermic needle electrode, not a software-only device.

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 that the device is used to insert an electrode into a patient's muscle for EMG and drug injection. This is an in vivo procedure (performed within a living organism).
• Device Description: The description confirms it's a hypodermic needle electrode, designed for direct interaction with the patient's body.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body. IVDs are used to provide information about a physiological state, disease, or congenital abnormality based on the analysis of these in vitro specimens.

Therefore, this device is a medical device used for diagnostic and therapeutic purposes directly on a patient, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, 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.

Product codes

IKT

Device Description

The Myoject™ Luer Lock Needle Electrode is a Disposable Hypodermic Needle Electrode

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

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)

Performance Testing was performed on device characteristics of the Myoject™ Luer Lock Needle Electrodes. This performance testing consisted of:

• Tensile testing
• Coating thickness
• Leak Testing
• Tip geometry grind measurements
• Penetration testing
• Luer Lock Design Verification

Conclusion: All performance testing and bench testing conducted as outlined above demonstrate that the device meets the performance and design specifications. Verification results indicated that Myoject™ Luer Lock Needle Electrodes comply with their predetermined specification and with the applicable Standards.

Biocompatibility Evaluation testing was conducted according to ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012.

• ISO 10993-5:2009 (Cytotoxicity): The extract of the test item was non-cytotoxic to L929 cells.
• ISO 10993-10:2010 (Irritation and Skin Sensitization):
  • Intracutaneous (Intradermal) Reactivity Test in the Rabbit: Polar and non-polar extracts of the test item met the requirements.
  • Local Lymph Node Assay in the Mouse: Polar and non-polar extracts of the test item were considered non-sensitizers.
• ISO 10993-11:2006 (Systemic Toxicity): The test item complies with the standard for both sodium chloride solution and cottonseed oil extracts.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K973444

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them.

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

March 2, 2017

Natus Manufacturing Limited Michael Galvin Manager. Ouality and Regulatory Affairs IDA Business Park Gort, Co. Galway Ireland

Re: K161430

Trade/Device Name: Myoject™ Luer Lock Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: Class II Product Code: IKT Dated: February 9, 2017 Received: February 13, 2017

Dear Mr. Galvin:

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 (reporting of medical device

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -S

• Carlos L. Peña, PhD, MS for 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) K161430

Device Name

Myoject(TM) Luer Lock Needle Electrode

Indications for Use (Describe)

The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, 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.

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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28 February 2017

Natus Manufacturing Limited Traditional 510(k) Myoject™ Luer Lock Needle Electrode

Image /page/3/Picture/3 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are bold. There is a registered trademark symbol to the right of the "s".

Natus Manufacturing Limited, IDA Business Park Gort, Co. Galway 353 091 630043 tel. [phone] fax.

Section 5: 510(k) Summary

| Manufacturer's Name: | Natus Manufacturing Limited
IDA Business Park
Gort, County Galway
Ireland |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Michael Galvin
Manager, Quality and Regulatory Affairs
Natus Manufacturing Limited
IDA Business Park
Gort, County Galway
Ireland |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Summary Date: | 17 May 2016 |
| Trade Names: | Myoject™ Luer Lock 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 |

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28 February 2017

Natus Manufacturing Limited Traditional 510(k) Myoject™ Luer Lock Needle Electrode

Classification Panel:	Neurology
Predicate Device:	K973444 Teca Myoject Disposable Needle Electrode
Device Description:	The Myoject™ Luer Lock Needle Electrode is a Disposable
Hypodermic Needle Electrode
Intended Use:	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, 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:	The Myoject™ Luer Lock Needle Electrode employ the same
technological characteristics as the predicate device.
Nonclinical Tests:	Tensile testing Coating thickness Leak Testing Tip geometry measurements Penetration testing Luer Lock Design
Substantial
Equivalence:	The Myoject™ Luer Lock Needle Electrode is equivalent to the device cleared under K973444

It has been shown in this 510(k) submission that the differences between the Myoject™ Luer Lock and the predicate device do not raise any questions regarding its safety and effectiveness. The Myoject™ Luer Lock Needle electrode device is substantially equivalent to the predicate device as it has the same intended use and similar technological characteristics as the previously cleared predicate devices. The Myoject™ Luer Lock Needle Electrode, as designed and manufactured is determined to be substantially equivalent to the referenced predicate devices.

Substantial Equivalence Comparison Table.

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Table 5A: Substantial Equivalence Comparison Table

| Year | 2016 | 20 Nov 1997 (original submission
date) | Discussion of Differences |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Natus Manufacturing Limited | TECA Corporation
3 Campus Drive
Pleasantville
New York 10570 | Minor changes to the labelling include change of legal manufacturer name, address and branding. In addition the new device labelling incorporates warnings and harmonized symbols. However, these changes do not raise questions of safety and effectiveness as they provide additional information to the user for the safe and effective use of the device. |
| Trade Name | Myoject™ Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| Labelling | Packaging Labels | Packaging Labels | |
| Intended Use | 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 | 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, into a patient to | |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| | | | |
| | Manufacturer | Natus Manufacturing Limited | TECA Corporation |
| | 3 Campus Drive | | |
| | Pleasantville | | |
| | New York 10570 | | |
| Trade Name | | | |
| | Myoject™ Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | | | |
| | K161430 | 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. | 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.

Note: TECA Corp. does not supply
any drugs with needle electrodes nor
does TECA Corp. offer for sale any
form of drugs. | can be included in labeling.
The needles are sold on their
own as a medical device and
are not specifically designated
for use with a specific drug.
Therefore, this statement is
not appropriate for the IFU. |
| Physical
Characteristics | Monopolar Needle | Monopolar Needle | Same |
| Connector | Single Contact Touch Proof DIN42
802 | Single Contact Touch Proof DIN42
802 | Same |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation
3 Campus Drive
Pleasantville
New York 10570 | |
| Trade Name | Myoject™ Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| Material of Needle | Stainless 304 | Stainless 304 | Same |
| Needle Size (mm) | Needle Diameter:
0.30
0.41
0.46
0.51
0.71 | Needle Diameter:
0.30
0.41
0.46
0.51
0.71 | Same
The dimensions relate to needle diameter |
| Needle Coating material | PTFE (Xylan 8820 G4075) | PTFE (Ultralon R-605/T-5) | This change resulted from the
Accessories development
Department's request to
reduce the initial penetration
force and mitigate against the
obsolescence of the Ultralon
coating. This change does not
raise questions of safety and
effectiveness as the needle
coating material remains as
PTFE however just the |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation
3 Campus Drive
Pleasantville
New York 10570 | |
| Trade Name | Myoject™ Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| | | | formulation has changed to
reduce the initial penetration
force to aid easier insertion of
the needle. As a result, this
reduces patient discomfort
when performing EMG
examinations. |
| Hub | Luer Lock/Slip | Luer Slip | This change originated from
market place demand for the
needles to fit a Luer Lock
Syringe. The Luer Lock
needle locks into place and as
a result is more likely to be
seepage free. Therefore, this
reduces the risk of medication
accidentally leaking from the
syringe and possibly causing
harm to the patient and user.
This does not affect the safety |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation
3 Campus Drive
Pleasantville
New York 10570 | and effectiveness of the
device as the overall function
of the device remains
unchanged, the Luer lock
simply adds an additional
safety mechanism to the
device. |
| Trade Name | MyojectTM Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| Hub Material | Polypropylene (Exxonmobil)
Escorene PP9074 MED | Polycarbonate | The material for this device
has changed compared to the
predicate device, however
comparison with the predicate
device demonstrates the
material performance is
equivalent and they are both
variants of polymer materials.
There is an insignificant |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation
3 Campus Drive
Pleasantville
New York 10570 | |
| Trade Name | Myoject™ Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | materials; as a result product
performance, safety and
effectiveness are not affected.
In addition, Biocompatibility
testing demonstrates there are
no new concerns of safety or
effectiveness. |
| Needle grind angle | 10-16 degrees conical | 10-20 degrees conical | The grind angles have similar
specifications; the slight
change in the upper range of
the grind angle is not a
significant change and
therefore does not raise new
concerns of safety and
effectiveness. The change
does not alter the diagnostic
effects of the device. |
| Recording area
(sqmm) | .19(mm≤) fine and then increases to
.89(mm≤) depending on needle size | 0.25 | There are some differences in
recording areas which vary
depending on needle size |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation
3 Campus Drive
Pleasantville
New York 10570 | |
| Trade Name | Myoject™ Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| | | | which does not affect the
safety and effectiveness of the
device; as there are no
changes to the diagnostic
effects of the device. |
| Length (mm) | 25, 37, 50, 75 | 25, 37, 50, 75, 100 | The 100mm version of the
Teca Myoject needle (MJT-
10022) (22G) is no longer
offered. All other needle sizes
are available. This does not
raise new concerns of safety
and effectiveness as no
changes have been made to
the devices, the 100mm
version has just been made
obsolete. |
| Connecting lead | Myoject: 770±10mm, Form 'ST'
moulded 1.5mm touch proof. Cable
Length "30" (76cm), terminating in | 14 or 26 inches terminated in a 2mm
or touchproof plug | For this device the cable has
been increased in length to aid
ease of use when performing
EMG examinations. The |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation
3 Campus Drive
Pleasantville
New York 10570 | |
| Trade Name | MyojectTM Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | |
| | 1.5mm female touchproof
connector. | | changes to 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. |
| Sterilization | Supplied sterilized gamma irradiated | Supplied sterilized gamma irradiated | Same |
| Protective Sheath | Polypropylene Escorene PP9074
MED (Exxon Mobil) | Polyethylene | 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 |
| Year | 2016 | 20 Nov 1997 (original submission date) | Discussion of Differences |
| Manufacturer | Natus Manufacturing Limited | TECA Corporation
3 Campus Drive
Pleasantville
New York 10570 | |
| Trade Name | MyojectTM Luer Lock Needle
Electrodes | Teca Myoject Disposable Needle
Electrode | |
| 510(k) number | K161430 | K973444 | |
| Product Code | IKT | IKT | changed compared to the
predicate device, however
comparison with the predicate
device demonstrates the
material performance is
equivalent and they are both
variants of polymer materials.
There is an insignificant
difference between both
materials; as a result product
performance, safety and
effectiveness are not affected. |
| Protective Pouch | Tyvek/Mylar | Tyvek/Mylar | Same |

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Image /page/6/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are bold and evenly spaced. A registered trademark symbol is located to the right of the letter "s".

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Image /page/7/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are evenly spaced and the word is horizontally oriented. A small registration mark is located to the right of the letter "s".

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Image /page/8/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are bold and evenly spaced. A registered trademark symbol is located to the right of the letter "s".

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Image /page/9/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are bold and slightly rounded. A small registration mark is located to the right of the "s".

10

Image /page/10/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are bold and slightly rounded. A small registration mark is located to the right of the "s".

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Image /page/11/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are evenly spaced and the word is horizontally oriented. A small registration mark is located to the right of the letter "s".

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Image /page/12/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are evenly spaced and the word is horizontally oriented. A small registration mark is located to the right of the letter "s".

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Image /page/13/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are bold and evenly spaced. A registered trademark symbol is located to the right of the letter "s".

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Image /page/14/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are all lowercase and connected to each other. There is a registered trademark symbol to the right of the letter "s".

Year	2016	20 Nov 1997 (original submission date)	Discussion of Differences
Manufacturer	Natus Manufacturing Limited	TECA Corporation
3 Campus Drive
Pleasantville
New York 10570
Trade Name	MyojectTM Luer Lock Needle
Electrodes	Teca Myoject Disposable Needle
Electrode
510(k) number	K161430	K973444
Product Code	IKT	IKT

Year	2016	20 Nov 1997 (original submission date)	Discussion of Differences
Manufacturer	Natus Manufacturing Limited	TECA Corporation
3 Campus Drive
Pleasantville
New York 10570
Trade Name	Myoject Luer Lock Needle
Electrode	Teca Myoject Disposable Needle
Electrode
510(k) number	K161430	K973444
Product Code	IKT	IKT
Tip geometry	Trocar Point

15 degree bevel | Lancet Point | Both Lancet and Trocar
geometries are routinely used by
needle manufacturers in the
medical device industry. Trocar
point is the preferred geometry for
the range of needles to meet |

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Image /page/15/Picture/0 description: The image shows the word "natus" in a teal sans-serif font. The letters are evenly spaced and the word is centered in the image. A registered trademark symbol is located to the right of the letter "s".

| Sterility Assurance
Level (SAL) | 10 minus 6 | 10 minus 6 | This change resulted from
modifications to the needle tip
geometry enabling improvements
to the needle tip sharpness. This
change does not result in new
issues related to safety and
effectiveness; as it increases tip
sharpness which reduces the
initial penetration force which
reduces patient discomfort. This is
an improved feature to the device
which ultimately functions the
same as the predicate device. The
diagnostic capabilities of the
device are unaffected. |
|------------------------------------|------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Same |

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Image /page/16/Picture/0 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are rounded. There is a small registered trademark symbol to the bottom right of the letter "s".

Summary of Performance Testing-Biocompatibility

Myoject™ Luer Lock Needle Electrodes are Invasive Electrodes, classified per ISO 10993-1:2009 as external communicating devices in limited (≤ 24 hours) contact with tissue. Annex A defines that the following evaluation tests need to be considered cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation sensitivity (ISO 10993-10).

The Biocompatibility Evaluation testing summarized below was conducted on the Myoject™ Luer Lock Needle Electrodes to demonstrate compliance of these materials to the following standards:

• . ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
• ISO 10993-11:2006 ● Biological evaluation of medical devices -- Part 11: Test for Systemic Toxicity
• . ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

International Standard BS EN ISO 10993-5: (2009) Biological Evaluation of Medical Devices- Part 5: Tests for in vitro Cytotoxicity

The extract of the test item was non-cytotoxic to L929 cells under the conditions of this test.

ISO 10993-10:2010

Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization Section 6.4 Intracutaneous (Intradermal) Reactivity Test

Intracutaneous (Intradermal) Reactivity Test in the Rabbit

The average reaction to the polar test item extract was considered not to be greater than the average reaction for the corresponding control at any observation period.

The average reaction to the non-polar test item extract was considered not to be greater than the average reaction for the corresponding control at any observation period.

Polar and non-polar extracts of the test item meet the requirements of ISO 10993-10: 2010 Intracutaneous (Intradermal) Reactivity Test in the Rabbit.

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ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

Local Lymph Node Assay in the Mouse - Polar and Non-Polar Extracts

A Polar extract of the test item was considered to be a non-sensitizer under the conditions of the test.

The non-polar extract of the test item was considered to be a non-sensitizer under the conditions of the test.

The polar positive control and non-polar positive control each gave a Stimulation Index of greater than 3.

ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Test for Systemic Toxicitv

The results are summarizes as follows: 0.9% sodium chloride solution test item extract: PASS Cottonseed oil test item extract: PASS The test item complies with ISO 10993-11: 2006, Systemic Toxicity Test in the Mouse.

Performance Testing-Bench Testing

Performance Testing was performed on device characteristics of the Myoject™ Luer Lock Needle Electrodes. This performance testing consisted of

• Tensile testing ●
• Coating thickness .
• Leak Testing ●
• Tip geometry grind measurements ●
• Penetration testing
• Luer Lock Design Verification ●

Conclusion

All performance testing and bench testing conducted as outlined above demonstrate that the device meets the performance and design specifications.

Verification results indicated that Myoject™ Luer Lock Needle Electrodes comply with their predetermined specification and with the applicable Standards detailed below:

18

• . 21 CFR 820.75 Quality System Regulation - Process Validation
• ISO 2859-1:1999 Sampling Procedures For Inspection By Attributes Part 1: Sampling . Schemes Indexed By Acceptance Quality Limit (AQL) For Lot-By-Lot Inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
• . ISO 10993-1:2009 Biological Evaluation of medical devices Part 1: Evaluation and testing
• . ISO 10993-5:2009 Biological Evaluation of medical devices Part : Tests for in vitro cytotoxicity
• ASTM F 1980 07-2011 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices

Verification activities were conducted to establish the performance and safety characteristics of the Myoject 100 Luer Lock Needle Electrodes. The results of these activities demonstrate that the Myoject™ Luer Lock Needle Electrodes are safe and effective when used in accordance with the intended use, labelling and Instructions for Use.

Therefore, the Myoject™ Luer Lock Needle Electrodes are considered substantially equivalent to the predicate device Teca™ Myoject Disposable Needle Electrodes.