SAC2 - Electrode Cream

• K Number: K192606
• Device Name: SAC2 - Electrode Cream
• Manufacturer: Spes Medica S.r.l.
• Date Cleared: 2020-01-17 ( 119 days)
• Product Code: GYB
• Regulation Number: 882.1275

Intended Use

SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.

Device Description

SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. SAC2 is provided in an aluminum tube of 100g. It's characterized by light grey colour, no crystallization, no flocculation, no adverse smell, opaque. SAC2 function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. SAC2 is for external use with recording electrodes only. SAC2 is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium chloride, Phenoxyethanol, Ehylhexylglycerin The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. The Conductivity is 20 mS/cm Shelf life of SAC2 is 3 years if stored properly in the closed aluminum tube kept away from the sunlight.

Predicate Devices

K190050

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and electrical properties of a conductive gel, with no mention of AI or ML algorithms for data processing or analysis.

Therapeutic

No.
The device is described as a conductor for EEG/EP recordings to reduce impedance, not for treating any condition or disease.

Diagnostic

No

The device, SAC2, is described as a conductive gel used with external electrodes to reduce impedance for EEG/EP recordings. Its function is as a conductor, not to diagnose. It simply facilitates the recording of signals; the interpretation of these signals for diagnosis is external to the device itself.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a gel provided in an aluminum tube, composed of various chemical ingredients, and its function is as a conductor. This indicates it is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, SAC2 is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use of SAC2 is to act as a conductor between the scalp and electrodes for EEG/EP recordings. This is a functional role in facilitating the measurement of electrical signals from the body.
• Mechanism of Action: SAC2 works by reducing impedance between the skin and the electrode, improving the quality of the electrical signal recording. It does not analyze or test a sample taken from the body (like blood, urine, or tissue) to provide diagnostic information.
• Device Description: The description focuses on its physical properties and composition as a conductive gel for external application.
• Performance Studies: The performance studies described relate to biocompatibility and the electrical conductivity/impedance of the gel itself, not to the analysis of biological samples.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. SAC2's function is to enable the acquisition of a physiological signal, not to analyze a biological sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.

Product codes

GYB

Device Description

SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. SAC2 is provided in an aluminum tube of 100g. It's characterized by light grey colour, no crystallization, no flocculation, no adverse smell, opaque. SAC2 function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. SAC2 is for external use with recording electrodes only. SAC2 is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium chloride, Phenoxyethanol, Ehylhexylglycerin The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

scalp

Indicated Patient Age Range

Adult and children

Intended User / Care Setting

Neurologists / clinical and research

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

Bench Testing.
Aging test: The aim of this test was to validate the shelf life of 3 years through an accelerated aging procedure according to the ASTM F1980-16 "Standard guide for accelerated aging of sterile barrier system for medical devices"). Pass/fail criteria was fixed at the beginning of the test and all the result of the parameters evaluated (colour, crystallization, flocculation, brightness, pH, impedance) comply according to the pass/fail criteria: SAC2 should be characterized by light grey colour, no crystallization, no flocculation, opaque. Also, the impedance was evaluated and was found out to comply according to the ANSI/AAMIEC12:2000/(R)2015.
Long term conductivity: The aim of this test was to evaluate the electrical performances (in terms of AC Impedance and DC Offset Voltage) of the product SAC2 over time. Pass/fail criteria were set at the beginning of the test according to ANSI/AAMIEC12:2000/(R)2015 : the DC Offset voltage should not exceed 100mV and AC Impedance should not exceed 2000 Ohm. The parameters of AC Impedance and DC Offset Voltage comply according to the ANSI/AAMIEC12:2000/(R)2015 limits even after 7 days testing.
Biocompatibility Testing: Test were conducted in accordance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization). All tests produced conforming results to demonstrate biocompatibility.

Key Metrics

Impedance at 10Hz is 50 ± 10 Ohm.
The Conductivity is 20 mS/cm.
pH range is 8÷10.

Predicate Device(s)

K190050

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.1275 Electroconductive media.

(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.

January 17, 2020

Spes Medica S.r.l. Giorgio Facco Regulatory Affairs and Quality Assurance Via Europa - zona industriale Battipaglia (SA), 84091 Italy

Re: K192606

Trade/Device Name: SAC2 - Electrode Cream Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: September 16, 2019 Received: September 20, 2019

Dear Giorgio 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192606

Device Name SAC2 - Electrode cream

Indications for Use (Describe)

SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.

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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| Image: Globe logo | SAC2 – Electrode cream | REV. | 2 | Date
REV. | 01.16.2020 |
|--------------------|------------------------------------------------------------------------------|----------------|---|--------------|------------|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091
Battipaglia (SA) | 510(k) Summary | | | |
| | | | | Page 1 of 7 | |

510(k) Summary

| Manufacturer's Name: | Spes Medica S.r.l.
via Europa (Zona Ind.le), 84091 Battipaglia (SA) - Italy |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Giorgio Facco
Quality Assurance and Regulatory Affairs |
| Telephone Number: | 0039 0828 614191 |
| Fax Number: | 0039 0828 341788 |
| Trade Names: | SAC2 - Electrode cream |
| Common or Usual Name: | Media, Electroconductive |
| Classification Name: | Electroconductive Media |
| Device Class: | Class II |
| Product Code: | GYB |
| Classification Regulation: | 882.1275 |
| Predicate Device: | Tech Dots – Adhesive and Conductive Gel
510(k) number: K190050 |
| Device Description: | SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It
is used with external electrodes as the conductor between the scalp and recessed
electrodes to reduce impedance between the electrode surface and the skin.
SAC2 is provided in an aluminum tube of 100g.
It's characterized by light grey colour, no crystallization, no flocculation, no adverse
smell, opaque.
SAC2 function is of conductor between the electrode used and the patient's skin and
of getting the impedance lower for a better recording of the signal. SAC2 is for
external use with recording electrodes only.
SAC2 is made of powders, Potassium Chloride and Sodium Chloride as conductors,
combined with thickening agents and humectants, all in an aqueous solvent.
The composition is the following:
Water, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium
chloride, Phenoxyethanol, Ehylhexylglycerin
The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. |

4

| | SAC2 – Electrode cream | REV. | 2 | Date
REV. | 01.16.2020 |
|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---|--------------|------------|
| | | 510(k) Summary | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091
Battipaglia (SA) | | | Page 2 of 7 | |
| The Conductivity is 20 mS/cm
Shelf life of SAC2 is 3 years if stored properly in the closed aluminum tube kept
away from the sunlight. | | | | | |
| Intended Use: | SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It
is used with external electrodes as the conductor between the scalp and recessed
electrodes to reduce impedance between the electrode surface and the skin. | | | | |
| Technological Comparison: | SAC2 is a conductive electrode cream contained in an aluminum tube.
The characteristics of SAC2 are substantially equivalent to the predicate device. No
new questions of safety or effectiveness are raised.
SAC2 employs the same technological characteristics as the predicate device with
just different appearance: the predicate device is a gel instead SAC2 is a cream. | | | | |
| | To support the technological comparison the ingredients, pH, impedance, weight
and conductivity of the SAC2 were evaluated internally and compared to the
predicate device. | | | | |
| | Both devices are water based with salt as conductive material and with thickening
agents (Glycerin is used for both the products). | | | | |
| | The impedance of the SAC2 is comparable to the predicate device: the impedance
evaluated by Spes Medica is 50 ± 10 Ohm. The pH of the SAC2 is between 8 and 10
higher than the Predicate Device. | | | | |
| | The predicate device is a gel while the SAC2 is a cream, the different texture was
created just to allow the user to choose what he/she prefers to use during the exam
(cream or gel). It's just different way of usability of the product. | | | | |
| Substantial Equivalence: | SAC2 is equivalent to the device cleared under K190050 as is presented below in
Table. | | | | |

lt has been shown in this 510(k) submission that the differences between SAC2 and the predicate device Tech Dots do not raise any questions regarding its safety and effectiveness. The SAC2 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.

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| Image: Globe logo | SAC2 – Electrode cream | REV. | 2 | Date
REV. | 01.16.2020 |
|--------------------|-----------------------------------------------------------------------------|------|---|--------------|------------|
| 510(k) Summary | | | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091
Battipaglia (SA) | | | Page 3 of 7 | |

Manufacturer	Spes Medica S.r.l.	Spes Medica S.r.l.
Trade Name	SAC 2	Tech Dots
510(k) number	New Device	K190050	Discussion Differences
Product Code	GYB	GYB
Indications for use	SAC2 is intended for use in clinical and research
EEG/EP recordings from humans. It is used with
external electrodes as the conductor between the
scalp and recessed electrodes to reduce impedance
between the electrode surface and the skin	Tech Dots are intended for use in clinical and research
EEG/EP recordings from humans. They are used with
external electrodes as the conductor between the
scalp and recessed electrodes to reduce impedance
between the electrode surface and the skin	Same as predicate device
Regulation Name	Media, Electroconductive	Media, Electroconductive	Same as predicate device
Regulation Number	882.1275	882.1275	Same as predicate device
Environment of use	Electrophysiological	Electrophysiological	Same as predicate device
Intended user	Neurologists	Neurologists	Same as predicate device
Target patient	Adult and children	Adult and children	Same as predicate device
Where used	Topically on intact skin	Topically on intact skin	Same as predicate device
Conductive material	Salts (NaCl and KCI)	Salt (NaCl)	Same as predicate device
Thickening agent	CarboxyMethylCellulose, Glycerol	Sodium Acrylates Copolymers, Glycerin	Equivalent to predicate device
Sterilization method	Provide non sterile	Provide non sterile	Same as predicate device
Shelf-life	3 years	3 years	Same as predicate device
Chemical Safety	No OSHA PEL	No OSHA PEL	Same as predicate device
Preservative	Phenoxyethanol, Ethylhexylglycerin	No preservative	SAC2 contains preservatives which
prevent the spread of bacteria when
the tube is opened. The predicate
device has a different packaging so
preservatives are not necessary.
In both cases the products results to
be biocompatible, so for SAC2 no new
questions of safety or
effectiveness are raised.

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| | SAC2 – Electrode cream | REV. | 2 | Date
REV. | 01.16.2020 |
|--------------------|-----------------------------------------------------------------------------|----------------|---|--------------|------------|
| | | 510(k) Summary | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091
Battipaglia (SA) | | | Page 4 of 7 | |

Manufacturer	Spes Medica S.r.l.	Spes Medica S.r.l.
Trade Name	SAC 2	Tech Dots	Discussion Differences
510(k) number	New Device	K190050
Product Code	GYB	GYB
Biocompatibility	Test in accordance with ISO 10993	Test in accordance with ISO 10993	Same as predicate device
Cytotoxicity	Yes	Yes	Same as predicate device
Irritation	Yes	Yes	Same as predicate device
Sensitization	Yes	Yes	Same as predicate device
Single Use	Yes	Yes	Same as predicate device
pH range	8÷10	4÷5	The pH of SAC2 is basic, the pH of
the predicate device is acid but in
both cases the products results to
be biocompatible, so for SAC2 no
new questions of safety or
effectiveness are raised.
Impedance	50 ± 10 Ohm	80 ± 10 Ohm	SAC2 has an impedance of 50±10
Ohms which is lower than the
impedance of the predicate device.
This can be consider as an
improvement as lower impedance
means better signal during recording
and more conductivity.
Considering that, no new questions of
safety or effectiveness are raised.
Conductivity	20mS/cm	2mS/cm	SAC2 results to have a higher value
of conductivity comparing to the
predicate, this is an advantage
(according to the intent of use) as the
cream results to be more

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| | SAC2 – Electrode cream | REV. | 2 | Date
REV. | 01.16.2020 |
|--------------------|-----------------------------------------------------------------------------|------|----------------|--------------|------------|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091
Battipaglia (SA) | REV. | 510(k) Summary | | |
| | | | Page 5 of 7 | | |

Manufacturer	Spes Medica S.r.l.	Spes Medica S.r.l.
Trade Name	SAC 2	Tech Dots
510(k) number	New Device	K190050	Discussion Differences
Product Code	GYB	GYB
			conductive than the predicate device.
Considering that, no new questions of
safety or effectiveness
are raised.
Weight	100g per tube	$0.14 \pm 0.01$ g per Dot	Different packaging and shape
The different packaging was made
to give to the users an alternative
way to conduct exams. The
predicate device is packaged as a
pre-set quantity for one electrode
( $0.14\pm0.001$ g per dot), with SAC2
the user can decide itself the
quantity to apply with one
electrode. Considering that, no new
questions of safety or effectiveness
are raised.
Characteristics	Salt Base
Non-irritating
Non toxic	Salt Base
Non-irritating
Non toxic	Equivalent to predicate device
Packaging	Aluminum tube	Aluminum/PET/PE	Different ways of packaging. Both
materials are validated.

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| | SAC2 – Electrode cream | | REV. | 2 | Date
REV. | 01.16.2020 |
|--------------------|------------------------------------------------------------------------------|--|----------------|---|--------------|------------|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091
Battipaglia (SA) | | 510(k) Summary | | | |
| | Page 6 of 7 | | | | | |

Summary of Performance Testing-Biocompatibility

Spes Medica SAC2 is no invasive product, the Biocompatibility Evaluation testing summarized below was conducted on SAC2 to demonstrate compliance of this product to the following standards:

• ●
• ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

Component Name	Type of contact			Material
	Skin	Blood	Tissue
Cream	Y	N	N	Water, Talc, Celite, Glycerol,
CarboxyMethylCellulose, Sodium chloride, Potassium
chloride, Phenoxyethanol, Ethylhexylglycerin

Contact duration: >24h,