SAC2 - Electrode Cream

K192606 · Spes Medica Srl · GYB · Jan 17, 2020 · Neurology

Device Facts

• Record ID: K192606
• Device Name: SAC2 - Electrode Cream
• Applicant: Spes Medica Srl
• Product Code: GYB · Neurology
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2
• Attributes: Pediatric

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 Story

SAC2 is an electroconductive cream used in clinical and research EEG/EP recordings. It acts as a conductive interface between the patient's scalp and external recording electrodes to reduce impedance and improve signal quality. The cream is composed of water, talc, celite, glycerol, carboxymethylcellulose, sodium chloride, potassium chloride, phenoxyethanol, and ethylhexylglycerin. It is supplied in 100g aluminum tubes. The device is applied topically to intact skin by neurologists or trained clinical staff. By lowering skin-electrode impedance, the cream facilitates better signal acquisition for electrophysiological monitoring. It is a non-invasive, single-use, non-sterile product.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included accelerated aging (ASTM F1980-16) to validate a 3-year shelf life, and electrical performance testing (AC impedance and DC offset) per ANSI/AAMI EC12:2000/(R)2015. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed cytotoxicity, irritation, and sensitization safety.

Technological Characteristics

Electroconductive cream; aqueous solvent base with NaCl and KCl conductors, thickening agents (CarboxyMethylCellulose, Glycerol), and preservatives (Phenoxyethanol, Ethylhexylglycerin). pH 8-10; impedance 50 ± 10 Ohm at 10Hz; conductivity 20 mS/cm. Non-sterile, single-use. Packaged in 100g aluminum tubes. Complies with ANSI/AAMI EC12:2000/(R)2015 for electrical performance.

Indications for Use

Indicated for use in clinical and research EEG/EP recordings in adults and children. Used as a conductive medium between scalp and external electrodes to reduce impedance.

Regulatory Classification

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.

Predicate Devices

• Tech Dots – Adhesive and Conductive Gel (K190050)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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

{2}------------------------------------------------

## 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the

time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

# 510(k) Summary

| Manufacturer's Name: | Spes Medica S.r.l.<br>via Europa (Zona Ind.le), 84091 Battipaglia (SA) - Italy |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Giorgio Facco<br>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<br>510(k) number: K190050 |
| Device Description: | SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It<br>is used with external electrodes as the conductor between the scalp and recessed<br>electrodes to reduce impedance between the electrode surface and the skin.<br>SAC2 is provided in an aluminum tube of 100g.<br>It's characterized by light grey colour, no crystallization, no flocculation, no adverse<br>smell, opaque.<br>SAC2 function is of conductor between the electrode used and the patient's skin and<br>of getting the impedance lower for a better recording of the signal. SAC2 is for<br>external use with recording electrodes only.<br>SAC2 is made of powders, Potassium Chloride and Sodium Chloride as conductors,<br>combined with thickening agents and humectants, all in an aqueous solvent.<br>The composition is the following:<br>Water, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium<br>chloride, Phenoxyethanol, Ehylhexylglycerin<br>The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. |

{4}------------------------------------------------

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

{5}------------------------------------------------

| Image: Globe logo | SAC2 – Electrode cream | REV. | 2 | Date<br>REV. | 01.16.2020 |
|--------------------|-----------------------------------------------------------------------------|------|---|--------------|------------|
| 510(k) Summary | | | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091<br>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<br>EEG/EP recordings from humans. It is used with<br>external electrodes as the conductor between the<br>scalp and recessed electrodes to reduce impedance<br>between the electrode surface and the skin | Tech Dots are intended for use in clinical and research<br>EEG/EP recordings from humans. They are used with<br>external electrodes as the conductor between the<br>scalp and recessed electrodes to reduce impedance<br>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<br>prevent the spread of bacteria when<br>the tube is opened. The predicate<br>device has a different packaging so<br>preservatives are not necessary.<br>In both cases the products results to<br>be biocompatible, so for SAC2 no new<br>questions of safety or<br>effectiveness are raised. |

{6}------------------------------------------------

| | SAC2 – Electrode cream | REV. | 2 | Date<br>REV. | 01.16.2020 |
|--------------------|-----------------------------------------------------------------------------|----------------|---|--------------|------------|
| | | 510(k) Summary | | | |
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091<br>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<br>the predicate device is acid but in<br>both cases the products results to<br>be biocompatible, so for SAC2 no<br>new questions of safety or<br>effectiveness are raised. |
| Impedance | 50 ± 10 Ohm | 80 ± 10 Ohm | SAC2 has an impedance of 50±10<br>Ohms which is lower than the<br>impedance of the predicate device.<br>This can be consider as an<br>improvement as lower impedance<br>means better signal during recording<br>and more conductivity.<br>Considering that, no new questions of<br>safety or effectiveness are raised. |
| Conductivity | 20mS/cm | 2mS/cm | SAC2 results to have a higher value<br>of conductivity comparing to the<br>predicate, this is an advantage<br>(according to the intent of use) as the<br>cream results to be more |

{7}------------------------------------------------

| | SAC2 – Electrode cream | REV. | 2 | Date<br>REV. | 01.16.2020 |
|--------------------|-----------------------------------------------------------------------------|------|----------------|--------------|------------|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091<br>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.<br>Considering that, no new questions of<br>safety or effectiveness<br>are raised. |
| Weight | 100g per tube | $0.14 \pm 0.01$ g per Dot | Different packaging and shape<br>The different packaging was made<br>to give to the users an alternative<br>way to conduct exams. The<br>predicate device is packaged as a<br>pre-set quantity for one electrode<br>( $0.14\pm0.001$ g per dot), with SAC2<br>the user can decide itself the<br>quantity to apply with one<br>electrode. Considering that, no new<br>questions of safety or effectiveness<br>are raised. |
| Characteristics | Salt Base<br>Non-irritating<br>Non toxic | Salt Base<br>Non-irritating<br>Non toxic | Equivalent to predicate device |
| Packaging | Aluminum tube | Aluminum/PET/PE | Different ways of packaging. Both<br>materials are validated. |

{8}------------------------------------------------

| | SAC2 – Electrode cream | | REV. | 2 | Date<br>REV. | 01.16.2020 |
|--------------------|------------------------------------------------------------------------------|--|----------------|---|--------------|------------|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091<br>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,<br>CarboxyMethylCellulose, Sodium chloride, Potassium<br>chloride, Phenoxyethanol, Ethylhexylglycerin |

Contact duration: >24h, <30days

#### Performance Testing-Bench Testing

Performance Testing was performed on device characteristics of Spes Medica SAC2. This performance mechanical testing consisted of

- 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.

Spes Medica SAC2 are tested internally for pH, impedance on a regular basis

{9}------------------------------------------------

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

## Conclusion

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