Predicate Devices

K071186, K931966, K050194, K091410, K062437

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes disposable needle electrodes for recording electrical activity (EMG/EEG) and injecting botulinum toxin. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on physical characteristics and biocompatibility of the electrodes themselves.

Therapeutic

No.

The device is primarily indicated for recording muscle activity for diagnostic purposes (EMG/EEG) and for injection of Botulinum Toxin while recording muscle activity, which is a diagnostic aid, not a therapeutic treatment itself provided by the device.

Diagnostic

Yes

The device is indicated for "recording muscle activity for Electro-myography (EMG) applications" and "recording muscle activity for Electroencephalography (EEG) applications." These recordings are used to diagnose neuromuscular and neurological conditions, making the device a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like stainless steel cannulas, inner conductors, insulation layers, and lead wires, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the electrodes are for "recording muscle activity for Electro-myography (EMG) applications" and/or "Electroencephalography (EEG) applications." One type is also indicated for "injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications." These are all procedures performed directly on the patient to measure electrical signals from the body.
Device Description: The device description details electrodes designed to be inserted into tissue (subdermal, muscle, nerve) to record electrical signals.
Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body. IVD devices are specifically designed for testing biological samples in a laboratory or clinical setting to provide information about a patient's health status.

The device described is a medical device used for physiological measurement and potentially drug delivery in vivo (within the living body), not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro - myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.

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

IKT, GXZ

Device Description

The BIONEN Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles.

BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.

The BIONEN Disposable Monopolar/Subdermal Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography/Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The BIONEN Disposable Monopolar Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

subdermal, muscle or nerve tissue
muscle

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Electrode preparation and application should be supervised by a qualified healthcare professional.
Use by a licensed physician or technologist under the supervision of a 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)

The non-clinical tests performed are laboratory tests to verify the functionality of the BIONEN Needle Electrodes.
The Concentric Needle Electrode is tested for penetration and friction force according to DIN 13097. The result of testing indicates that the electrodes are as safe, as effective, and perform at least as safely and effectively as the legally marketed device. Ageing tests was performed to verify and ensure the functionality during the shelf life of the product. Quality control tests are performed on every lot: Needle sharpening: visual examination with a microscope camera. Bevel and burrs: visual examination with a microscope camera. Needle continuity: automated process (100% control). Needle pole isolation: automated process (100% control).
The Monopolar/Subdermal needle electrode is tested on 10% of every lot: Needle sharpening: visual examination under microscope. Bevel and burrs: visual examination under microscope. Needle continuity: audible ohmmeter.
Bioburden tests and Dose Audit are performed every 9 months by a third laboratory to verify the microbic load on a sample of the specific batch manufactured. BIONEN has determined its reference value at 100UFC and Bioburden results are always extensively under this value.
The biological safety of the BIONEN Concentric Needle Electrode has been assured through the selection of materials, which demonstrate appropriate levels of biocompatibility. Some tests were selected for the Biological evaluation of Medical Device on the basis of ISO 10993-10 and ISO 10993-5.
Tests performed:

Cytotoxicity - Neutral Red Uptake (ISO 10993-5:2009): Test article treated extract cells were found to be 97% viable. Conclusion: Test sample extract is considered NON-CYTOTOXIC.
Intracutaneous Reactivity (ISO 10993-10: 2009): Test article treated extract were found to have no erythema (Grade 0) or oedema (Grade 0) effects. Conclusion: Test sample extract is considered NON-IRRITANT.
Sensitization test on guinea pig - Delayed contact hypersensitivity - Maximization method (ISO 10993-10: 2009): Test article treated extract were found to have no hypersensitivity effects (Grade 0 erythema). Conclusion: Test sample extract is considered NON-SENSITIZING.
From the tests' results, no adverse effects or sign of sensitization have been detected. The requirements of the test protocol were met. From the results of the non clinical verification test and biocompatibility test, it has been concluded that BIONEN Needle Electrodes fulfill the products' specifications set for the design and are safe and effective needle electrodes comparable to the predicate devices.

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.

K071186, K931966, K050194, K091410, K062437

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

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

0

092973

Image /page/0/Picture/1 description: The image shows the logo for Bionen Medical Devices. The logo features a stylized letter "B" in a bold, sans-serif font, with a smaller, outlined "B" nested within the larger one. Below the "B" symbol, the word "BIONEN" is printed in a simple, sans-serif typeface, followed by the words "medical devices" in a smaller font size.

1 510(k) Summary or 510(k) Statement

Bionen s.a.s Via P. Petrocchi, 42/1 Florence, Italy 50127 P: 39 055 4265945 F: 39 055 412188

Contact: Allison Scott, RAC

Date: September 21, 2010

Trade Name: Disposable Concentric Needle Electrode Disposable Monopolar/Subdermal Needle Electrode Disposable Monopolar Needle Electrode

Common Name: Needle Electrodes

Classification Name: EMG Diagnostic Needle (21 CFR 890.1385, Product Code IKT) Needle Electrode (21 CFR 882.1350, Product Code GXZ)

Predicate Devices:

510(k) Number	Trade or Proprietary or Model Name	Manufacturer
Concentric Needle Electrode
K071186	Neuroline, Disposable Concentric needle
electrode	Ambu A/S
K931966	Needle electrode EMG	Alpine Biomed
(ex Dantec)
Monopolar/Subdermal Needle Electrode
K050194	Subdermal Needle Electrodes, Twisted Pair Needle
Electrodes, Corkscrew (spiral) Needle Electrode	Axon Systems, Inc.
Disposable Monopolar Needle Electrode
K091410	Myobot Needles	Spes Medica
K062437	Disposable Hypodermic Needle Electrode	Technomed Europe

1

Device Description:

The BIONEN Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles.

BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.

The BIONEN Disposable Monopolar/Subdermal Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography/Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

The BIONEN Disposable Monopolar Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.

Indications for Use:

The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electroymyography (EMG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electroymyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.

Technological Characteristics:

BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor that can be of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant. The Electrode has a plastic (NYLON) ergonomic hub.

BIONEN Disposable Monopolar/Subdermal Needle Electrode consists of a formed stainless steel needle with a lead wire attached. The lead wire terminates in a safety connector that cannot be connected to an AC power outlet.

2

BIONEN Disposable Monopolar Needle Electrode consists of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The lead wire terminates in a safety connector that cannot be connected in a AC power outlet.

Substantial Equivalence Discussion:

Compared to the predicate, the subject devices have intended use, similar physical and performance characteristics and are manufactured using similar processes.

| product
characteristics | Needle electrodes | Neuroline, Disposable
Concentric needle
electrode | DCN™ Disposable
Concentric Needle
Electrodes |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| manufacturer | BIONEN s.a.s. | Ambu A/S | Alpine Biomed (ex Dantec) |
| 510K number | K092973 | K071186 | K931966 |
| Device class | Class II | Class II | Class II |
| Product code | IKT | IKT | IKT |
| Device type | Needle electrode | Disposable Concentric
needle
electrode | Electrode, needle,
diagnostic electromyograph |
| Regulation
number | 882.1350
890.1385 | 890.1385 | 890.1385 |
| indications for
use | The BIONEN Disposable
Concentric Needle
electrodes are sterile
electrodes indicated for
recording muscle activity
for Electroymyography
(EMG) applications. The
electrodes are for single
patient use only. | The Neuroline, Disposable
Concentric needle
electrodes are made for
muscle activity recording
for Electromyography
(EMG) applications. The
electrodes are for single
patient use only. | Alpine Biomed Disposable
Needle Electrodes cannot
be re-sterilized and are for
single patient use only. Do
not reuse but discard used
needle electrodes in a
properly marked medical
biohazard sharps container. |
| anatomical sites | subdermal, muscle or nerve
tissue | muscles | subdermal, muscle or nerve
tissue |
| where used
(hospital, home,
ambulance, etc) | Electrode preparation and
application should be
supervised by a qualified
healthcare professional | same | same |
| product
characteristics | Needle electrodes | Neuroline, Disposable
Concentric needle
electrode | DCN™ Disposable
Concentric Needle
Electrodes |
| manufacturer | BIONEN s.a.s. | Ambu A/S | Alpine Biomed (ex Dantec) |
| design | Ergonomic connector and
geometric sharper tip.
Color-coded hub | Ergonomic and Color-coded
hub | Pre-sterilized DCN™
Electrodes have true
ergonomic design and are
always sharp.
Each needle has a matching
colour-coded hub and
package for easy
identification and
reordering.
The hub has a raised bevel
indicator, so you always
know the direction of the
recording surface. The
needle features a coaxial
hub that allows you to
easily connect the needles
into the HUSH™ electrode
cables without orientation.
A wiping contact is used
inside the hub to optimize
the connection throughout
the life of the cable and
reduce oxide build-up. The
cable can withstand a 50 lbs
pull test, so it is made to
last. |
| performance | Tested for penetration
and friction force and
electrical properties
(according to DIN 13097).
Ageing tests are performed
to verify and ensure the
functionality during the
shelf life of the product. | Tested for penetration
and friction force and
electrical properties
(according to DIN 13097).
Ageing tests are performed
to verify and ensure the
functionality during the
shelf life of the product. | Unknown |
| standards met | IEC 60601-1
ISO 10993-1
ISO 10993-10
ISO 10993-5
ISO 11137
UNI EN 11607-1
UNI EN 868-5 | unknown | Unknown |
| | | | |
| product
characteristics | Needle electrodes | Neuroline, Disposable
Concentric needle
electrode | DCN™ Disposable
Concentric Needle
Electrodes |
| manufacturer | BIONEN s.a.s. | Ambu A/S | Alpine Biomed (ex Dantec) |
| materials | Stainless Steel cannula,
Platinum / Stainless Steel
sensor,
Polyethylene (PE) Hub,
Epoxy Insulator,
PELD Plastic protector,
Stainless steel/gold plated
connection | Stainless steel cannula,
Silver sensor,
ABS Hub,
Epoxy Insulator,
Polyethylene (PE) Plastic
protector,
brass/gold plated
connection | Stainless Steel cannula,
Platinum sensor |
| Dimensions | Diameter = 0.45/0.35 mm
L=25-30-35-40-45-50-65mm | Diameter = 0.45/0.35 mm
L=25-30-38-50-75mm | Diameter = 0.30/0.46/0.64
mm
L=25-37-50-75mm |
| Recording area | $0,02 - 0,07mm^2$ | $0,02 - 0,07mm^2$ | $0.019 - 0.07mm^2$ |
| Connector cable | Din 5 poles | Din 5 poles | Din 5 poles |
| biocompatibility | selection of materials,
which demonstrate
appropriate
levels of biocompatibility.
Tests on the basis of ISO
10993-1 | selection of materials,
which demonstrate
appropriate
levels of biocompatibility.
Tests on the basis of ISO
10993-1 | Unknown |
| compatibility
with the
environment
and other
devices | Compatibility is achieved
through the
connecting cable to
EMG/EEG machines or
similar physiological
recording devices. | unknown | Unknown |
| sterility | Gamma irradiation | E-beam | E-Beam. |
| Shelf life | 60 months | 36 months | 36 months |
| electrical safety | The "touch-proof' safety
connector is specifically
designed so that it cannot
be plugged into AC power
outlet and cannot get in
touch with possible
hazardous voltage | unknown | Unknown |
| mechanical
safety | Packaged needle covered
with a needle cover. | Packaged needle covered
with a needle cover. | Packaged needle covered
with a needle cover. |
| chemical safety | Not applicable | Not applicable | Not applicable |
| thermal safety | Not applicable | Not applicable | Not applicable |
| radiation safety | Not applicable | Not applicable | Not applicable |

Concentric Needle Electrodes

3

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5

Monopolar/Subdermal Needle Electrodes

product	Needle electrodes	Subdermial Needle Electrodes,
characteristics		Twisted Pair Needle Electrodes,
		Corkscrew (spiral) Needle Electrode
manufacturer	BIONEN s.a.s.	Axon Systems, Inc.
510K number	K092973	K050194
Device class	Class II	Class II
Product code	GXZ	GXZ
Device type	Monopolar/Subdermal Needle electrode	Subdermal Needle electrode
Regulation number	882.1350	882.1350
indications for use	The BIONEN Disposable	Axon Systems' Subdermal Needle
	Monopolar/Subdermal Needle electrodes	Electrodes are intended for use with
	are sterile electrodes indicated for	recording, monitoring and
	recording muscle activity for	stimulation/recording equipment for the
	Electroymyography (EMG) and/or	recording of biopotential signals including
	Electroencephalography (EEG)	electroencephalograph (EEG),
	applications. The electrodes are for	electromyograph (EMG) and nerve
	single patient use only.	potential signals and for stimulation
		during the intraoperative diagnosis of
		acute dysfunction in corticospinal axonal
		conduction.
anatomical sites	subdermal, muscle or nerve tissue	subdermal
where used	Electrode preparation and application	Use by a licensed physician or
(hospital, home,	should be supervised by a qualified	technologist under the supervision of a
ambulance, etc)	healthcare professional.	physician.
design	Ergonomic connector and geometric	Unknown
	sharper tip.
	Color-coded hub
performance	Sharpening; Camera visual	Unknown
	examination with special
	attention to bevel and burrs; Electrical
	continuity and isolation of all
	poles;
standards met	IEC 60601-1	unknown
	ISO 10993-1
	ISO 10993-10
	ISO 10993-5
ISO 11137
	UNI EN 11607-1
	UNI EN 868-5
materials	Stainless Steel / platinum needle	Stainless steel needle
Dimensions	Diameter=0,35mm	Diameter=0,4mm
	L=15-20mm
biocompatibility	selection of materials, which	unknown
	demonstrate appropriate
	levels of biocompatibility. Tests on the
	basis of ISO 10993-1
compatibility with	Compatibility is achieved through the	unknown
the environment and	connecting cable to EMG/EEG machines
other devices	or similar physiological recording devices.
product
characteristics	Needle electrodes	Subdermial Needle Electrodes,
Twisted Pair Needle Electrodes,
Corkscrew (spiral) Needle Electrode
manufacturer	BIONEN s.a.s.	Axon Systems, Inc.
Shelf life	60 months	unknown
electrical safety	The "touch-proof' safety connector is
specifically designed so that it cannot be
plugged into AC power outlet and cannot
get in touch with possible hazardous
voltage	The DIN 42802 "touch-proof' safety
connector is specifically designed so that
it cannot be plugged into AC power outlet
mechanical safety	Packaged needle covered with a
needle cover.	Packaged needle covered with a
needle cover.
chemical safety	Not applicable	Not applicable
thermal safety	Not applicable	Not applicable
radiation safety	Not applicable	Not applicable

.

6

Disposable Monopolar Needle electrode

product	Disposable Monopolar	Myobot Needle	Disposable Hypodermic
characteristics	Needle electrode		Needle Electrode
manufacturer	BIONEN s.a.s.	Spes Medica	Technomed Europe
510K number	K092973	K091410	K062437
Device class	Class II	Class II	Class II
Product code	IKT	IKT	IKT
Device type	Needle electrode	Needle electrode	Needle electrode
Regulation number	890.1385	890.1385	890.1385
indications for use	The BIONEN Disposable
Monopolar Needle
electrodes are sterile
electrodes indicated for
injection of Botulinum
Toxin while recording
muscle activity with
Electromyography (EMG)
applications. The
electrodes are for single
patient use only.	Recording muscle activity
for Electromyography
(EMG) applications. For
single patient use only.
The disposable
hypodermic needle is
intended to be used for
injection of the Botulinum
Toxin into a muscle, while
recording
electromyography activity.
The electrode has an open
lumen and is designed for
muscle stimulation, motor
unit action, potential
recording and Botulinum
Toxin injection.	The disposable
hypodermic EMG needle
electrode is used for
muscle stimulation, motor
unit action potential
recording and drug
delivery. The motor
nerves are monitored by
detecting EMG activity in
the muscles they
innervate. The drug used
should be Botox Botulinum
Toxin type A.
Note: Technomed Europe
does not supply any drugs
with the Disposable
hypodermic EMG needle
electrodes nor does
Technomed Europe offer
for sale any form of drugs.
anatomical sites	muscle	muscle	muscle
product
characteristics	Disposable Monopolar
Needle electrode	Myobot Needle	Disposable Hypodermic
Needle Electrode
manufacturer	BIONEN s.a.s.	Spes Medica	Technomed Europe
where used
(hospital, home,
ambulance, etc)	Electrode preparation and
application should be
supervised by a qualified
healthcare professional.
The specific Botox® type to
be injected must be
chosen by the physician.	unknown	unknown
design	Ergonomic connector and
geometric sharper tip.
The disposable Monopolar
Needle electrode consists
of a stainless steel cannula
electrically insulated with
a PTFE coating, except for
the lancet point and the
inner surface of the tube.
The coating is to ensure
easy skin penetration and
to ensure electrical
insulation on the entire
cannula, except for the
point. A husk fitting
together with a wire with
connection to an
extension cable has been
attached to the cannula.
This cable will enable the
electrical signal to be
transferred to a
stimulating or recording
device	unknown	The disposable
hypodermic EMG needle
electrode consists of a
stainless steel cannula
electrically insulated with
a PTFE coating, except for
the lancet point and the
inner surface of the tube.
The coating is to ensure
easy skin penetration and
to ensure electrical
insulation on the entire
cannula, except for the
point. A husk fitting
together with a wire with
connection to an
extension cable has been
attached to the cannula.
This cable will enable the
electrical signal to be
transferred to a
stimulating or recording
device.
performance	Sharpening;
Camera visual
examination with special
attention to bevel and
burrs;
Electrical continuity	unknown	unknown
standards met	IEC 60601-1
ISO 10993-1
ISO 10993-10
ISO 10993-5
ISO 11137
UNI EN 11607-1
UNI EN 868-5	unknown	unknown
materials	Stainless Steel cannula,
Polyethylene (PE) Hub,
PELD Plastic protector,
Stainless steel/gold plated	Stainless Steel cannula	Stainless steel cannula,
PTFE coating, lead wire
product
characteristics	Disposable Monopolar
Needle electrode	Myobot Needle	Disposable Hypodermic
Needle Electrode
manufacturer	BIONEN s.a.s.	Spes Medica	Technomed Europe
Dimensions	Diameter=0,50mm
L=20-30-40-50-60mm	Diameter=0,30-0,40-0,45-
0,50-0,55-0,70mm
L=25-37-50-75mm	Diameter=0,30-0,40-0,45-
0,50mm
L=25-37-50-75mm
biocompatibility	Tests on the basis of ISO
10993-1 table 1 made on
the Concentric needle
electrode as the worse
case are considered valid
and extensible to this kind
of device.	unknown	unknown
compatibility with
the environment and
other devices	Compatibility is achieved
through the connecting
cable to EMG machines or
similar physiological
recording devices.	unknown	unknown
sterility	Gamma irradiation	unknown	unknown
Shelf life	60 months	unknown	unknown
electrical safety	The "touch-proof' safety
connector is specifically
designed so that it cannot
be plugged into AC power
outlet and cannot get in
touch with possible
hazardous voltage	unknown	unknown
mechanical safety	Packaged needle covered
with a needle cover.	Packaged needle covered
with a needle cover.	Packaged needle covered
with a needle cover.
chemical safety	Not applicable	Not applicable	Not applicable
thermal safety	Not applicable	Not applicable	Not applicable
radiation safety	Not applicable	Not applicable	Not applicable

:

7

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8

:

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9

Discussion of Nonclinical Tests Submitted:

The non-clinical tests performed are laboratory tests to verify the functionality of the BIONEN Needle Electrodes. The following standards were applied during testing:

IEC 60601-1:2005	UNI EN 868-5:2002
UNI EN ISO 10993-1	UNI EN 556-1:200
UNI EN ISO 10993-10	ASTM F1980-07
UNI EN ISO 10993-5	ASTM F2054-00
UNI EN ISO 11137-1	DIN 58953-6
UNI EN ISO 11137-2	ASTM F1929-98
UNI EN ISO 11137-3	ASTM F1886-98
DIN 13097:2009	ISO 11607-1

The Concentric Needle Electrode is tested for penetration and friction force according to DIN 13097. The result of testing indicates that the electrodes are as safe, as effective, and perform at least as safely and effectively as the legally marketed device.

Ageing tests was performed to verify and ensure the functionality during the shelf life of the product.

Quality control tests are performed on every lot:

Needle sharpening: visual examination with a microscope camera �
. Bevel and burrs: visual examination with a microscope camera
Needle continuity: automated process (100% control) .
Needle pole isolation: automated process (100% control) �

The Monopolar/Subdermal needle electrode is tested on 10% of every lot:

� Needle sharpening: visual examination under microscope
Bevel and burrs: visual examination under microscope .
Needle continuity: audible ohmmeter .

Bioburden tests and Dose Audit are performed every 9 months by a third laboratory to verify the microbic load on a sample of the specific batch manufactured.

BIONEN has determined its reference value at 100UFC and Bioburden results are always extensively under this value.

The biological safety of the BIONEN Concentric Needle Electrode has been assured through the selection of materials, which demonstrate appropriate levels of biocompatibility.

10

Some tests were selected for the Biological evaluation of Medical Device on the basis of ISO 10993-10 and ISO 10993-5. The following tests were performed:

| Test | Report
number | Standard | Result | Conclusion |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Cytotoxicity -
Neutral Red Uptake | 408/10 &
Addendum
May 3,
2010 | ISO 10993-5
:2009 | Test article treated
extract cells were found
to be 97% viable | Test sample extract
is considered
NON-CYTOTOXIC |
| Intracutaneous
Reactivity | 281/10 | ISO 10993-
10: 2009 | Test article treated
extract were found to
have no erythema
(Grade 0) or oedema
(Grade 0) effects | Test sample extract
is considered
NON-IRRITANT |
| Sensitization test
on guinea pig -
Delayed contact
hypersensitivity -
Maximization
method | 1653 A-10 &
Addendum
September
30, 2010 | ISO 10993-
10: 2009 | Test article treated
extract were found to
have no
hypersensitivity effects
(Grade 0 erythema) | Test sample extract
is considered
NON- SENSITIZING |

From the tests' results, no adverse effects or sign of sensitization have been detected. The requirements of the test protocol were met.

From the results of the non clinical verification test and biocompatibility test, it has been concluded that BIONEN Needle Electrodes fulfill the products' specifications set for the design and are safe and effective needle electrodes comparable to the predicate devices.

11

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

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

Bionen SAS c/o Ms. Allison Scott Anson Group, LLC 11460 N. Meridian St., Ste 150 Carmel, IN 46032

DCT - 7 2010

Re: K092973

Trade/Device Name: Disposable Concentric Needle Electrode

Disposable Monopolar/Subdermal Needle Electrode Disposable Monopolar Needle Electrode

Regulation Number: 21 CFR 890.1385 Regulation Name: EMG Diagnostic Needle Regulatory Class: Class II Product Code: IKT, GXZ Dated: September 22, 2010 Received: September 24, 2010

Dear Ms. Scott:

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.

12

Page 2 - Ms. Allison Scott

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 nut . 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.

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/ucm1118001/pp.flast 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Malvina B. Evdelman M.D Director Division of Ophthalmic, Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

13

Indications for Use

510(k) Number (if known): H 09297 3

Device Name: BIONEN Needle Electrodes

Indications for Use:

The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro - myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.

The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Noll

(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K092973