AC Cream - Conductive paste

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December 1, 2021 Spes Medica S.r.l Giorgio Facco Quality Assurance & Regulatory Affairs Via Europa-Zona industriale Battipaglia, 84091 Italy ### Re: K212326 Trade/Device Name: AC Cream - Conductive paste Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: October 18, 2021 Received: November 10, 2021 ### 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. 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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 {1}------------------------------------------------ 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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) K212326 Device Name AC Cream - Conductive paste Indications for Use (Describe) AC Cream - Conductive paste 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) | | |---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt"> <span style="font-family:Wingdings">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size:10pt"> <span style="font-family:Wingdings">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # 510(k) Summary # K212326 | 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: | AC Cream - Conductive paste | | Common or Usual Name: | AC Cream - Conductive paste | | Classification Name: | Media, Electroconductive | | Device Class: | Class II | | Product Code: | GYB | | Classification Regulation: | 882.1275 | | Predicate Device: | SAC2 – Electrode cream<br>510(k) number: K192606 | | Device Description: | AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes<br>as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. | | | It's characterized by pale yellow colour, no crystallization, no flocculation, bright.<br>AC Cream - Conductive paste function is of conductor between the electrode used and the patient's skin and of getting the impedance lower<br>for a better recording of the signal. AC Cream - Conductive paste is for external use with recording electrodes only.<br>AC Cream - Conductive paste is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents<br>and humectants, all in an aqueous solvent. | | | The composition is the following:<br>Water, Ceteareth-20, Glycerol, Propylene Glycol, Bentonite, Sodium chloride, Potassium chloride, Calcium carbonate, Polysorbate 20,<br>Phenoxyethanol, Ethylhexylglycerin | | | The pH range is 6÷8, and Impedance at 10Hz is 120± 25 Ohm.<br>The mean impedance after 7 days use, considering the worst values detected, is around 480 ± 10 Ohm.<br>The Conductivity is 20 mS/cm<br>Shelf life of AC Cream - Conductive paste is 3 years if stored properly in the closed packaging, kept away from the sunlight and within the<br>limit temperature | | Intended Use: | AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes<br>as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. | | Technological Comparison: | AC Cream - Conductive paste is a conductive electrode paste contained in a PE jar or aluminum tube.<br>The characteristics of AC Cream - Conductive paste are substantially equivalent to the predicate device. No new questions of safety or<br>effectiveness are raised.<br>AC Cream - Conductive paste employs the same technological characteristics as the predicate device with just different appearance: the<br>predicate device is a cream instead AC Cream - Conductive paste is a paste. | | | To support the technological comparison the ingredients, pH, impedance, weight and conductivity of the AC Cream - Conductive paste were<br>evaluated internally and compared to the predicate device.<br>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 AC Cream - Conductive paste is higher than the predicate device: the impedance evaluated by Spes Medica is 120 ±<br>25 Ohm. The pH of the AC Cream - Conductive paste is between 6 and 8, lower than the Predicate Device. | | | The predicate device is a cream while the AC Cream - Conductive paste is a paste, the different texture was created just to allow the user to<br>choose what he/she prefers to use during the exam (cream or paste). It's just different way of usability of the product. | | Substantial Equivalence: | AC Cream - Conductive paste is equivalent to the device cleared under K192606 as is presented below in Table. | AC Cream - Conductive paste is provided in a PE jar (25g, 50g 100g, 250g) or in an aluminum tube of 100g. {4}------------------------------------------------ {5}------------------------------------------------ It has been shown in this 510(l) submision that the differences between AC Crean - Conductive paste and the predicate any questions regarding its safety and effectiveness. The AC crean - Conductive paste device as it has the same intended use and similar technological characteristics as the previously cleared predicate devices. | Manufacturer | Spes Medica S.r.l. | Spes Medica S.r.l. | | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | AC Cream - Conductive paste | SAC 2 - Electrode Cream | Discussion Differences | | 510(k) number | K212326 | K192606 | | | Product Code | GYB | GYB | | | Indications for use | AC Cream - Conductive paste is intended for<br>use in clinical and research EEG/EP recordings<br>from humans. It is used with external<br>electrodes as the conductor between the scalp<br>and recessed electrodes to reduce impedance<br>between the electrode surface and the skin | 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<br>the scalp and recessed electrodes to reduce<br>impedance between the electrode surface and<br>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 (Sodium chloride (NaCl) and Potassium<br>chloride (KCl)) | Salts (Sodium chloride (NaCl) and Potassium<br>chloride (KCl)) | Same as predicate device | | Thickening agent | Glycerol,<br>Bentonite, Propylene Glycol | Glycerol,<br>CarboxyMethylCellulose | Equivalent to the predicate.<br>Glycerol is used both for AC Cream – Conductive<br>paste and for predicate device.<br>The other components (Bentonite, Propylene<br>Glycol for AC Cream – Conductive paste and<br>CarboxyMethylCellulose for SAC2) have the same<br>function of thickening agents but for AC Cream<br>the chosen components are not the same as<br>SAC2 because it is wanted a different final<br>texture (AC Cream - conductive paste is less<br>viscous and more sticky). | | | | | The different use of ingredients does not affect<br>the functional characteristics of the product<br>(electroconductive media) | | | | | The different texture, due to the use of different<br>components but with the same function, allows<br>the final user the choice the preferred products<br>according to its needs.<br>No new questions of safety or effectiveness are<br>raised. | | Preservative | Phenoxyethanol, Ethylhexylglycerin | Phenoxyethanol, Ethylhexylglycerin | Same as predicate device | | | | | The ingredients are different but have the same<br>function. | | Opacifying | Calcium carbonate | Talc, Celite | Not the same ingredients have been used as it is<br>wanted a less opaque and pale yellow (AC Cream<br>– conductive paste) paste. The predicate device is<br>gray colored and more opaque. | | | | | The different use of ingredients does not alter<br>the functional characteristics of the product<br>(electroconductive media) but act only on the<br>aesthetic aspect (color and opacity). Also in this<br>case the final user can choose the preferred<br>products according to its needs. | | 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 | | 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 | $6÷8$ | $8÷10$ | The pH of AC Cream – Conductive cream final<br>formulation (6 - 8, neutral) is different from the<br>pH of SAC2 final formulation (8 - 10, basic) due | | | | | to the different components and different<br>percentage of components.<br>The measured pH of the final product is an<br>intrinsic characteristic of the paste but is not<br>relevant considering the functionality of the<br>product.<br>The functionality and effectiveness are not<br>affected by pH.<br>The functionality of the product is given by the<br>salts ("conductive material") present in both<br>products.<br>Furthermore, the skin has a good tolerance for<br>both the pH, also according to the positive<br>biocompatibility tests<br>Considering the lines above, no new question<br>about safety and effectiveness of the subject<br>device are raised | | Impedance | 120 ± 25 Ohm | 50 ± 10 Ohm | AC Cream - Conductive paste has a higher<br>impedance, but no new question of safety or<br>effectiveness are raised as the AC Cream -<br>Conductive paste impedance is lower than the<br>maximum limit of 2000 Ω according to the<br>ANSI/AAMI EC12:2000/(R)2015 | | Conductivity | 20mS/cm | 20mS/cm | Same as predicate device | | Characteristics | Salt Base<br>Non-irritating<br>Non toxic | Salt Base<br>Non-irritating<br>Non toxic | Same as predicate device | | Weight | 100g per tube<br>25g, 50g, 100g, 250 g per jar | 100g per tube | No differences for the tube.<br>The different packaging (jar) was made to give to<br>the users an alternative way of use according to<br>its needs. Considering that, no new questions of<br>safety or effectiveness are raised. | | Packaging | Aluminum tube<br>PE jar | Aluminum tube | No differences for the tube.<br>AC Cream - Conductive paste can also be<br>packaged in a jar, this is a further change for the | | | | | user to choose the packaging according to its<br>needs. Anyway, both materials are validated. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ### Summary of Performance Testing-Biocompatibility Spes Medica AC Cream - Conductive paste is no invasively Francation testing summarized below was conducted on AC Cream - Conductive paste to demonstrate compliance of this product to the following standards: - . ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytoxicity, - . 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 | | | Paste | Y | N | N | Water, Ceteareth-20, Glycerol, Propylene Glycol,<br>Bentonite, Sodium chloride, Potassium chloride,<br>Calcium carbonate, Polysorbate 20, Phenoxyethanol,<br>Ethylhexylglycerin | Contact duration: >24h, <30days ### Performance Testing - Bench Testing Performance Testing was performed on device characteristics of Spes - This performance mechanical testing consisted of - Aging test . The aim of this test was to validate the shell the of 3 years through according to the ASTM F1980-16 "Standard guide for acceler ted aging of sterile barrier system for medical devices"). Pass/fail criteria was fixed at the beginning of the parameters evaluated (colour, crystallization, floculation, brightness, pH, impedance) comply according to the pass/fail criteria: AC Cream - Conductive paste should be characterized by pale yellow colour, no floculation, bright. Also, the instant impedance was evaluated for the whole shelf life (accelerating aging) of the product and was found out to cording to the ANSI/AAMIEC12:2000/(R)2015. Results in the table below: | Primary packaging | Mean instant<br>impedance after 0 | Mean instant<br>impedance after 28 | Mean instant<br>impedance after 56 | Mean instant<br>impedance after 84 days | |-------------------|-----------------------------------|------------------------------------|------------------------------------|-----------------------------------------| |-------------------|-----------------------------------|------------------------------------|------------------------------------|-----------------------------------------| {9}------------------------------------------------ | | days of shelf life<br>(accelerating aging) | days of shelf life<br>(accelerating aging) | days of shelf life<br>(accelerating aging) | of shelf life (accelerating<br>aging) | |---------------|--------------------------------------------|--------------------------------------------|--------------------------------------------|---------------------------------------| | PE jar | 101 Ohm | 108 Ohm | 126 Ohm | 144 Ohm | | Aluminum tube | 104 Ohm | 118 Ohm | 101 Ohm | 108 Ohm | #### Long term conductivity . The aim of this test was to evaluate the electrical performance and DC Offset Voltage) of the product AC Cream - Conductive paste ver time. Pass/fail criteria were set at the beginning of the test according to ANS/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 ANS/AAMIEC12:2000/(R)2015 limits even after 7 days testing. Spes Medica AC Cream - Conductive paste is tested internally for pH, impedance on a regular basis ### Performance Testing - Clinical Testing The subject device AC Cream – Conductive paste does not need clinical testing has been made. ### Conclusion All performance testing conducted as outlined above demonstrate that the performance and design specifications. The device is as safe, as effective, and is substantially equivalent to the legally marketed device.