Predicate Devices

K112435, K110712, K112426, K110422, K031003

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus solely on the physical probes used for electrical stimulation and do not mention any computational or analytical capabilities that would involve AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".

Therapeutic

No
The device aids in nerve identification and assessment during surgery, but it does not treat or cure a disease or condition.

Diagnostic

No.

The device is used to deliver electrical stimulation to tissue and identify nerves, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is composed of physical components such as stainless steel, plastic, cables, and connectors, and is supplied sterile for single use. This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The IOM Stimulator Probes are used during surgery to directly stimulate tissue (nerves and spinal nerve roots) to assess nerve function and identify their location. This is a direct interaction with the patient's body, not a test performed on a sample outside the body.
Intended Use: The intended use clearly states the probes are used "to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function." This is an in vivo (within the living body) application.

Therefore, the IOM Stimulator Probes fall under the category of a surgical instrument used for direct stimulation and monitoring in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identitY nerves and spinal nerve roots and to assess nerve function. 10M Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.

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

ETN

Device Description

IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a 'touch-proof' safety connector(s) on the distal end.

All IOM Stimulator Probes are sterilized by Ethylene Oxide and single use only.

The IOM Stimulator Probes are composed by the part in contact with the patient that is medical grade stainless steels, then there is the handle part and cable in biocompatible plastic; finally the cable has a 'touch-proof' safety connectors.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cranial and peripheral nerves, spinal nerve roots

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeon, surgery

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 testing performed:
Biocompatibility
Ethylene Oxide Sterilization
Dielectric strength
Packaging
Cleaning Room

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.

K112435, K110712, K112426, K110422, K031003

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

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.

Summary

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

November 21, 2014

Giorgio Facco Quality Assurance and Regulatory Affairs Spes Medica s.r.1. Via Europa – Zona Industriale Battipaglia (SA), Italy 84091

Re: K133348

Trade/Device Name: IOM Stimulator Probes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: II Product Code: ETN Dated: October 9, 2014 Received: October 23, 2014

Dear Mr. Facco:

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. Isting 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-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.

1

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Felipe Aquel -S

Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K133348

Device Name IOM Stimulator Probes

Indications for Use (Describe)

IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identitY nerves and spinal nerve roots and to assess nerve function. 10M Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510 (k) Summary of safety and effectiveness

SUBMITTER INFORMATION

A. Company Name:
B. Company Address:
C. Company Phone: Company Fax:
D. Contact Person:

Spes Medica s.r.l. Via Europa - Zona industriale Battipaglia (SA) – Italy 84091 +39 010 39 03 43 +39 010 30 72 345 Giorgio Facco Quality Assurance Spes Medica s.r.l. e-mail: quality@spesmedica.com November 04th 2014

E. Date Summary Prepared:

DEVICE IDENTIFICATION

A. Device name:	IOM Stimulator Probe
B. Trade/Proprietary name:	Stim Probe
C. Classification name:	Surgical nerve stimulator/locator (21 CFR §874.1820)
D. Product code:	ETN

LEGALLY MARKETED DEVICES (PREDICATE DEVICES)

| Predicate device | Device Classification
Name | 510(k) Applicant | 510(k) number |
|-----------------------------------------------------|-------------------------------|-----------------------------------------------------|---------------|
| RHYTHMLINK Monopolar
stimulating instrument | Stimulator Nerve | RHYTHMLINK
INTERNATIONAL, LLC | K112435 |
| Drytouch Suction Stimulator probe | Stimulator Nerve | NEUROVISION MEDICAL
PRODUCTS, INC. | K110712 |
| XIAN FRIENDSHIP MEDICAL nerve
stimulator probes | Stimulator Nerve | XIAN FRIENDSHIP
MEDICAL ELECTRONICS
CO., LTD. | K112426 |
| SURGICAL STIMULATORS | Stimulator Nerve | TECHNOMED EUROPE | K110422 |
| STIMULUS/DISSECTION
INSTRUMENTS, BALL-TIP PROBES | Stimulator Nerve | MEDTRONIC XOMED,
INC | K031003 |

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Image /page/4/Picture/0 description: The image shows a logo for "spes medica". The logo features a stylized globe on the left side, with the company name "spes medica" written in a cursive font to the right of the globe. Below the company name, there is a tagline that reads "the medical accessories source" in a smaller font. The overall design is simple and professional, suggesting a company that is involved in the medical accessories industry.

DEVICE DESCRIPTION

IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a 'touch-proof' safety connector(s) on the distal end.

All IOM Stimulator Probes are sterilized by Ethylene Oxide and single use only.

The IOM Stimulator Probes are composed by the part in contact with the patient that is medical grade stainless steels, then there is the handle part and cable in biocompatible plastic; finally the cable has a 'touch-proof' safety connectors.

INTENDED USE

IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. IOM Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.

5

IOM Stimulator Probes

SUBSTANTIAL EQUIVALENCE

The IOM Stimulator Probes are similar in interials, packaging and other technological characteristics to the predicate devices.

Comparison Chart IOM Stimulator Probes
Predicate
device	510(k)
Applicant	510(k)
number	Intent for use	Tip
Diam.
mm	Shaft
Length
mm*	Material
In contact
with patient	Touch
proof	Bend Angle	Wire Length
cm	Single
Use	Steri
liz.	Ref.
Document
RHYTHMLINK
Monopolar
stimulating
instrument
(Legally
Marketed)	RHYTHMLINK
INTERNATION
AL, LLC	K112435	Rhythmlink
International
Monopolar-
Stimulating
Instruments Is
indicated for
stimulation of cranial
and peripheral motor
nerves for location
and identification
during surgery;
including spinal
nerve roots. The
Rhythmlink
International
Monopolar -
Stimulating
Instruments is sterile
and for single use .	3
2.3
1.6
0.75
Stim
Surface
mm³	100
160	Stainless
steel	YES	NO	150
250	YES	EtO	004_
Section 09
Rhythmlin
k
Drytouch
Suction
Stimulator
probe
(Legally
Marketed)	NEUROVISION
MEDICAL
PRODUCTS,
INC.	K110712	The Suction
Stimulator Probe is a
dedicated manual
surgical instrument
that allows the
surgeon to clear
secretions and test
surgical tissue with
nerve stimulation at
the same time and
with the same
instrument. It is
intended for use only
by a licensed
physician and in
conjunction with the
Neurovision SE
(Nerveäna) Nerve
locator Monitor
System.	2
Stim
Surface
mm³
8	130
260	Stainless
steel	YES	NO	150	YES	EtO	003_
Section 09
Neurovisio
n
XIAN
FRIENDSHIP
MEDICAL
nerve
stimulator
probes
(Legally
Marketed)	XIAN
FRIENDSHIP
MEDICAL
ELECTRONICS
CO., LTD.	K112426	Xian Friendship
Disposable Nerve
Stimulator Probes is
used to perform
localized stimulation
of neural tissue and
to locate, identify
and monitor cranial
motor nerves,
peripheral nerves
and spinal nerve
roots during surgery.	2.3
1.3
0.8
1.2
Stim
Surface
mm³	150÷22
0
80÷150
80÷120
70÷120	Stainless
steel	YES	90° (double
Hook Probe)
100° (double
and triple
Hook Probe)
180° (double
and triple
Hook Probe)	Information
not findable	YES	EtO	006_
Section 09
Xian
Friendship
Medical
Electronics
			Xian Friendship
Disposable Nerve
Stimulator Probes
are sterile (EtO),
single-patient-use
device.	$0.5÷100$
SURGICAL
STIMULATORS
(Legally
Marketed)	TECHNOMED
EUROPE	K110422	The Technomed
Europe Kartush
disposable surgical
stimulators are
indicated for tissue
dissection and
stimulation of cranial
and peripheral motor
nerves for location
and identification
during surgery,
including spinal
nerve roots.	0.5
Stim
Surface
mm3
0.125	38,70,1
00	Stainless
steel	YES	NO	Information
not findable	YES	EtO	005_
Section 09
Technome
d Europe
STIMULUS/DIS
SECTION
INSTRUMENTS
, BALL-TIP
PROBES
(Legally
Marketed)	MEDTRONIC
XOMED, INC	K031003	The Stimulus-
Dissection
Instruments are
indicated for tissue
dissection and
stimulation of cranial
and peripheral motor
nerves for location
and identification
during surgery,
including spinal
nerve roots.	0.5
1.3
1
2.3
Stim
Surface
mm3
$0.125÷12$	/	Stainless
steel	YES	NO	Information
not findable	YES	EtO	002_
Section 09
Medtronic

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IOM Stimulator Probes

*The information about Handle length in not avaible for any models of any predicates device.

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Image /page/8/Picture/0 description: The image shows the logo for Spes Medica. The logo features a globe on the left side and the company name "spes medica" on the right side. Below the company name, it says "the medical accessories source" in a smaller font.

IOM Stimulator Probes

IOM Stimulator Probes Comparison

| Spes Medica Product

Name and Drawing	Comparison	Predicate device Photo
Neural stimulator probe
insulated monopolar
Image: Neural stimulator probe insulated monopolar	The materials is the same,
stainless steel, and the probe
diameter is in the same range:
1.2 mm for Spes Medica and
1.5 mm for Predicate Device
(PD). The shaft length is
longer in the PD compared to
Spes Medica. The cable length
is the same 250 cm (PD has
150 cm too). Both the
products as Touch proof
connection . Both products
are sterilized with EtO .	The probe is a monopolar stimulator probe, It is made by
stainless steel AISI 316L, It is insulated with termosrhinkable
tube with an insulating thickness of 0,25 mm (KBM100). The
part in contact with the patient is the tip of the probe (AISI
316L), the diameter is 1,2 mm and the exposure tip (uncoated
surface) is 2 mm . The probe length is 45 mm.
The body of the probe is made by coloured polystyrene, It
contains the connection (Tin soldering) between probe and
lead wire. After the polystyrene there is black
thermosrhinkable (18 mm) tube to protect the cable. The cable
insulation is made by medical PVC (diameter 1,2 mm). The
connector is a coloured T.P. DIN 42802 . The device is EO
sterilized and for only single use	Image: Standard Monopolar Stimulating Probe
Standard Monopolar Stimulating Probe
Rhythmlink
Neural stimulator probe
bipolar hook
Image: Neural stimulator probe bipolar hook	The materials is the same,
stainless steel, and the probe
diameter is 1.2 mm for PD and
0.65 mm for Spes Medica.
The shaft length is longer in
the PD (70÷120mm)
compared to Spes Medica (20
mm). Both the products as
Touch proof connection . Both
products are sterilized with
EtO .	The probe is a bipolar hook stimulator probe, It is made by
Stainless steel AISI 304, It is PTFE insulated with insulating
thikness 0,010-0,015 mm (Duraskin). The part in contact with
the patient are the tips of the probe (AISI 304), the diameter is
0,65 mm and the exposure tip (uncoated surface) is 6 mm with
a radius R 6 mm. The distance between the two probes is 9 mm
(center-center). The probes length are 20 mm. The body of the
probe is made by coloured polystyrene, It contains the
connections (Tin soldering) between probes and lead wires.
After the polystyrene there is black thermosrhinkable (18 mm)
tube to protect the cables. The intertwisted cables insulation is
made by medical PVC (diameter 1,2 mm). The connector is a
coloured T.P. DIN 42802 . The device is EO sterilized and for
only single use	Image: Disposable Double Hook Nerve Stimulator Probe-180 degree
Disposable Double Hook Nerve Stimulator Probe-180 degree
Xian Friendship Medical Electronics
Neural stimulator probe
tripolar hook
Image: Neural stimulator probe tripolar hook	The materials is the same,
stainless steel, and the probe
diameter is 1.2 mm for PD and	The probe is a bipolar hook stimulator probe, It is made by
Stainless steel AISI 304, It is PTFE insulated with insulating
thikness 0,010-0,015 mm (Duraskin). The part in contact with	Image: Disposable Triple Hook Nerve Stimulator Probe-180 degree
Disposable Triple Hook Nerve Stimulator Probe-180 degree
	0.65 mm for Spes Medica.
The shaft length is longer in
the
PD (70÷120mm)
compared to Spes Medica (20
mm). Both the products as
Touch proof connection. Both
products are sterilized with
EtO.	the patient are the tips of the probe (AISI 304), the diameter is
0,65 mm and the exposure tip (uncoated surface) is 6mm with
a radius R 6 mm. The distance between the three probes is 4,5
mm (center-center each). The probes length are 20 mm. The
body of the probe is made by coloured polystyrene, It contains
the connections (Tin soldering) between probes and lead wires.
After the polystyrene there is black thermoshrinkable (18 mm)
tube to protect the cables. The intertwisted cables insulation is
made by medical PVC (diameter 1,2 mm). The connector is a
coloured T.P. DIN 42802. The device is EO sterilized and for
only single use	Xian Friendship Medical Electronics
Neural stimulator probe
monopolar ball	The materials is the same,
stainless steel, and the probe
diameter is 3 mm for PD and
2 mm for Spes Medica. The
shaft length is longer in the
PD (100 mm) compared to
Spes Medica (30 mm). The
cable length is the same 250
cm (PD has 150 cm too). Both
the products as Touch proof
connection. Both products
are sterilized with EtO.	The probe is a monopolar ball stimulator probe, It is made by
stainless steel AISI 316L, It is insulated with thermoshrinkable
tube with an insulating thickness 0,25 mm (KBM100). The part
in contact with the patient is the tip of the probe (AISI 316L),
the diameter is 1,7 mm, the ball (exposure tip - uncoated
surface) has a diameter of 2 mm. The probe length is 30 mm.
The body of the probe is made by coloured polystyrene, It
contains the connection (Tin soldering) between probe and lead
wire. After the polystyrene there is black
thermoshrinkable (18 mm) tube to protect the cable. The cable
insulation is made by medical PVC (diameter 1,2 mm). The
connector is a coloured T.P. DIN 42802.
The device is EO sterilized and for only single use	Disposable Ball Tip Direct Nerve Stimulator Probe
Xian Friendship Medical Electronics
Neural stimulator probe
monopolar ball	The materials is the same,
stainless steel, and the probe
diameter is 3 mm for PD and
2 mm for Spes Medica. The
shaft length is longer in the
PD (100 mm) compared to
Spes Medica (45 mm). The
cable length is the same 250
cm (PD has 150 cm too). Both	The probe is a monopolar ball stimulator probe, It is made by
stainless steel AISI 316L, It is insulated with thermoshrinkable
tube with an insulating thickness 0,25 mm (KBM100). The part
in contact with the patient is the tip of the probe (AISI 316L),
the diameter is 1,7 mm, the ball (exposure tip - uncoated
surface) has a diameter of 2 mm. The probe length is 45 mm.
The body of the probe is made by coloured polystyrene, It
contains the connection (Tin soldering) between probe and lead
wire. After the polystyrene there is black
thermoshrinkable	Disposable Ball Tip Direct Nerve Stimulator Probe
	the products as Touch proof
connection . Both products
are sterilized with EtO .	thermosrhinkable (18 mm) tube to protect the cable. The cable
insulation is made by medical PVC (diameter 1,2 mm). The
connector is a coloured T.P. DIN 42802 . The device is EO
sterilized and for only single use
Neural stimulator probe
bipolar balls
Image: [Neural stimulator probe bipolar balls]	The materials is the same,
stainless steel, and the probe
diameter is the same for PD
and Spes Medica (2 mm). The
shaft length is longer in the
PD ( $70\div120$ mm) compared to
Spes Medica (30 mm).
Both the products as Touch
proof connection . Both
products are sterilized with
EtO .	The probe is a bipolar balls stimulator probe, It is made by
stainless steel AISI 316L, It is insulated with termosrhinkable
tube with an insulating thickness 0,25 mm (KBM100). The part
in contact with the patient is the tip of the probe (AISI 316L),
the diameter is 1,7 mm, the balls (exposure tips - uncoated
surfaces) have a diameter of 2 mm . The distance between the
two probes is 6,5 mm (center-center). The probe length is 30
mm.
The body of the probe is made by coloured polystyrene, It
contains the connection (Tin soldering) between probe and
lead wire. After the polystyrene there is black
thermosrhinkable (18 mm) tube to protect the cables. The
cable insulation is made by medical PVC (diameter 1,2 mm).
The connector is a coloured T.P. DIN 42802 .
The device is EO sterilized and for only single use	Image: [Disposable Double Ball Tip Direct Nerve Stimulator Probe]
Xian Friendship Medical Electronics
Neural stimulator probe
bipolar concentric
Image: [Neural stimulator probe bipolar concentric]	The materials is the same,
stainless steel, and the probe
diameter is 0.8 mm for PD and
0.32 mm for Spes Medica
The shaft length is longer in
the PD ( $80\div150$ mm)
compared to Spes Medica (45	The probe is a bipolar concentric stimulator probe, It is made
by stainless steel AISI 304 canula with internal sensor in
stainless steel AISI 304, It is insulated with PTFE with an
insulating thickness 0,010-0,015 mm (Duraskin). The part in
contact with the patient is AISI 304, the diameter of canula is
1,5 mm, the sensor tip has a diameter of 0,32 mm and a
length of 0.3 mm. The probe length is 45mm.	Image: [Disposable Concentric Direct Nerve Stimulator Probe]
Xian Friendship Medical Electronics
	mm).
Both the products as Touch
proof connection . Both
products are sterilized with
EtO .	The body of the probe is made by coloured polystyrene, It
contains the connection (Tin soldering) between probe and
lead wire. After the polystyrene there is black
thermosrhinkable (18 mm) tube to protect the cables. The
cable insulation is made by medical PVC (diameter 1,2 mm).
The connector is a coloured T.P. DIN 42802.
The device is EO sterilized and for only single use	Image: Xian Friendship Medical Electronics
		Xian Friendship Medical Electronics
Image: Neural stimulator probe bipolar minifork	The materials is the same,
stainless steel, and the probe
diameter is 1.3 mm for PD and
0.65 mm for Spes Medica.

Both the products as Touch
proof connection . Both
products are sterilized with
EtO . | The probe is a bipolar minifork stimulator probe, It is made by
stainless steel AISI 304, It is insulated with PTFE with an
insulating thickness0,010-0,015 mm (Duraskin). The diameter
are 0,65 mm, the exposure tips (uncoated surface) have a
length of 2 mm . The distance between the two probes is 1,5
mm (center-center). The probe length is 30 mm.
The body of the probe is made by coloured polystyrene, It
contains the connection (Tin soldering) between probe and
lead wire. After the polystyrene there is black
thermosrhinkable (18 mm) tube to protect the cables. The
cable insulation is made by medical PVC (diameter 1,2 mm).
The connector is a coloured T.P. DIN 42802
The device is EO sterilized and for only single use | Image: Kartush Side-by-Side Bipolar Stimulator Probe

Medtronic |

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Image /page/9/Picture/0 description: The image shows a logo for "spes medica, the medical accessories source". The logo includes a stylized globe on the left side. The text is in a serif font and is slightly stylized.

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Image /page/10/Picture/0 description: The image shows the logo for Spes Medica. The logo features a globe on the left side and the words "spes medica" on the right side. Below the words is the phrase "the medical accessories source" in a smaller font.

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Image /page/11/Picture/0 description: The image shows the logo for Spes Medica. The logo consists of a globe on the left and the words "spes medica" on the right. Below the words is the phrase "the medical accessories source".

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Image /page/12/Picture/2 description: The image shows a logo for "spes medica". The logo features a globe on the left side and the company name on the right side. Below the company name is the text "the medical accessories source".

Neural stimulator probe insulated monopolar
Specification	Proposed Spes Medical Probe	Rhythmlink – Standard Monopolar
Stimulating Probe
Stimulating Surface Area (mm2)	7.5 mm²	4.7 mm²
Tip Diameter (mm)	1.2 mm	0.75 mm
Shaft Length (mm)	45 mm	100 mm
Lead Length (mm)	250 cm	250 cm and 150 cm
Bend Angle (degrees)	0°	0°
Discussion	The differences between the two devices are shaft length and tip diameter.
Shaft is insulated and the length is only an ease of use. The tip diameter is
bigger in Spes Medica device, the stimulating area is larger than the PD,
this doesn't change in dangerous way current densities. So these two
differences not affect the safety and effectiveness as compared to the
predicate.

Neural stimulator probe bipolar hook
Specification	Proposed Spes Medical Probe	Xian Friendship Medical Electronics –
Disposable Double Hook Nerve
Stimulator Probe
Stimulating Surface Area (mm2)	30.6 mm2	37.7 mm2
Tip Diameter (mm)	0.65 mm	1.2 mm
Shaft Length (mm)	20 mm	70-120 mm
Lead Length (mm)	250 cm	Information not available
Bend Angle (degrees)	180°	180°
Discussion	The differences between the two devices are shaft length and tip diameter.
Shaft is insulated and the length is only an ease of use. The tip diameter is
bigger in PD, but the stimulating area doesn't change in dangerous way
current densities. So these two differences not affect the safety and
effectiveness as compared to the predicate.

Neural stimulator probe tripolar hook
Specification	Proposed Spes Medical Probe	Xian Friendship Medical Electronics –
Disposable Triple Hook Nerve
Stimulator Probe
Stimulating Surface Area (mm²)	30.6 mm²	37.7 mm²
Tip Diameter (mm)	0.65 mm	1.2 mm
Shaft Length (mm)	20 mm	70-120 mm
Lead Length (mm)	250 cm	Information not avaible
Bend Angle (degrees)	180°	180°
Discussion	The differences between the two devices are shaft length and tip diameter.
Shaft is insulated and the length has only an ease of use. The tip diameter is
bigger in PD device, stimulating area is smaller than the PD, but the
stimulating area doesn't change in dangerous way current densities.
So these two differences not affect the safety and effectiveness as
compared to the predicate.

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Image /page/13/Picture/2 description: The image shows the logo for "spes medica". The logo consists of a globe on the left and the company name on the right. Below the company name is the tagline "the medical accessories source".

Neural stimulator probe monopolar ball
Specification	Proposed Spes Medical Probe	Xian Friendship Medical Electronics -
Disposable Ball Tip Direct Nerve
Stimulator Probe
Stimulating Surface Area (mm2)	50.2 mm2	66 mm2
Tip Diameter (mm)	2 mm	2.3 mm
Shaft Length (mm)	30 mm and 45 mm	70-150 mm
Lead Length (mm)	250 cm	Information not available
Bend Angle (degrees)	0°	0°
Discussion	The differences between the two devices are shaft length and tip diameter.
Shaft is insulated and the length has only an ease of use. The tip diameter is
bigger in Spes Medica device stimulating area is smaller than the PD, but
the stimulating area doesn't change in dangerous way current densities.
So these two differences not affect the safety and effectiveness as
compared to the predicate

Neural stimulator probe bipolar balls
Specification	Proposed Spes Medical Probe	Xian Friendship Medical Electronics –
Disposable Double Ball Tip Direct
Nerve Stimulator Probe
Stimulating Surface Area (mm²)	51 mm²	51 mm²
Tip Diameter (mm)	2 mm	2 mm
Shaft Length (mm)	30 mm	70-150 mm
Lead Length (mm)	250 cm	Information not available
Bend Angle (degrees)	0°	0°

Neural stimulator probe bipolar concentric
Specification	Proposed Spes Medical Probe	Xian Friendship Medical Electronics –
Disposable Concentric Direct Nerve
Stimulator Probe
Stimulating Surface Area (mm²)	211 mm²	201-377 mm²
Tip Diameter (mm)	1.5 mm	0.8 mm
Shaft Length (mm)	45 mm	80-150 mm
Lead Length (mm)	250 mm	Information not available
Bend Angle (degrees)	0°	0°
Discussion	The differences between the two devices are shaft length and tip diameter.
Shaft is insulated and the length has only an ease of use. The tip diameter is
bigger in Spes Medica device and shaft length is bigger in the PD. At the
end the Spes Medica stimulating area is in the range of the PD stimulating
area. So these two differences not affect the safety and effectiveness as
compared to the predicate.

Neural stimulator probe bipolar minifork
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Specification	Proposed Spes Medical Probe
	Medtronic – Kartush Side-by-Side

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Image /page/14/Picture/2 description: The image shows the logo for Spes Medica. The logo features a globe on the left side and the company name "spes medica" on the right side. Below the company name, it says "the medical accessories source" in a smaller font.

		Bipolar Stimulator Probe
Stimulating Surface Area (mm2)	9.4 mm2	8 mm2
Tip Diameter (mm)	1.5 mm	1.3 mm
Shaft Length (mm)	45 mm	Information not avaible
Lead Length (mm)	250 mm	Information not avaible
Bend Angle (degrees)	0°	0°
Discussion	The differences between the two devices is the tip diameter that is bigger in Spes Medica device. At the end the stimulating area for the two devices is larger than the PD, this doesn't change in dangerous way the current. So this difference not affect the safety and effectiveness as compared to the predicate.

Nonclinical testing performed
Biocompatibility
Ethylene Oxide Sterilization
Dielectric strength
Packaging
Cleaning Room

CONCLUSION

Comparing these tables and each Spes Medica IOM Stimulator Probes models with PD models we can say that the safety and effectiveness of our device as compared to legally marketed predicate devices. The conclusion of Spes Medica s.r.l. is that the IOM Stimulator Probes are safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness.