(128 days)
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.
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.
It's characterized by pale yellow colour, no crystallization, no flocculation, bright.
AC Cream - Conductive paste 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. AC Cream - Conductive paste is for external use with recording electrodes only.
AC Cream - Conductive paste 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, Ceteareth-20, Glycerol, Propylene Glycol, Bentonite, Sodium chloride, Potassium chloride, Calcium carbonate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin
The pH range is 6÷8, and Impedance at 10Hz is 120± 25 Ohm.
The mean impedance after 7 days use, considering the worst values detected, is around 480 ± 10 Ohm.
The Conductivity is 20 mS/cm
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 limit temperature
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for AC Cream - Conductive paste:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Set by Standard) | Reported Device Performance (AC Cream - Conductive paste) | Pass/Fail? |
|---|---|---|
| Biocompatibility: | Pass | |
| ISO 10993-5 (Cytotoxicity) | Yes | Pass |
| ISO 10993-10 (Irritation) | Yes | Pass |
| ISO 10993-10 (Skin Sensitization) | Yes | Pass |
| Shelf Life (Accelerated Aging - 3 years): | Pass | |
| Pale yellow color, no flocculation, bright | Exhibits pale yellow color, no flocculation, bright after 84 days (accelerated aging equivalent to 3 years) | Pass |
| Instant Impedance < 2000 Ω (according to ANSI/AAMI EC12:2000/(R)2015) | Max Instant Impedance measured was 144 Ohm (PE Jar) and 118 Ohm (Aluminum tube) after 84 days (accelerated aging equivalent to 3 years) | Pass (Significantly Below Limit) |
| Long-Term Conductivity (7 days): | Pass | |
| DC Offset Voltage < 100 mV (according to ANSI/AAMI EC12:2000/(R)2015) | Complies with limit even after 7 days testing | Pass |
| AC Impedance < 2000 Ohm (according to ANSI/AAMI EC12:2000/(R)2015) | Complies with limit even after 7 days testing | Pass |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The summary describes performance testing for biocompatibility, accelerated aging (shelf life), and long-term conductivity.
- Sample Size: The exact sample size for each test (e.g., number of units tested for aging, number of samples for biocompatibility) is not explicitly stated in the provided text.
- Data Provenance: The document indicates that the performance testing was "conducted on AC Cream - Conductive paste." This implies the testing was performed internally by Spes Medica S.r.l. or by a contract lab on their behalf. There is no information regarding the country of origin of the data or whether the tests were retrospective or prospective since it concerns product qualification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device (electroconductive paste) or the described studies. The studies are bench tests and biocompatibility tests against established standards. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant here. The "ground truth" for these tests is the quantitative measurement against predefined physical and biological acceptance limits from international standards (ISO, ANSI/AAMI).
4. Adjudication method for the test set:
This information is not applicable as the tests performed are objective physical and biological measurements against specific numerical or qualitative (e.g., "no flocculation") criteria. There is no subjective interpretation that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is an electroconductive paste, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical product (conductive paste), not an algorithm or software.
7. The type of ground truth used:
The ground truth used for the performance testing is based on:
- International Standards: ISO 10993-5, ISO 10993-10, and ANSI/AAMI EC12:2000/(R)2015. These standards define the acceptable limits and methodologies for testing biocompatibility and electrical performance parameters for electroconductive media.
- Physical/Chemical Properties: Measured values for color, crystallization, flocculation, brightness, pH, impedance, and conductivity.
8. The sample size for the training set:
This information is not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The device's formulation was likely developed through R&D, but this is not a "training set" in the context of typical AI device submissions.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" in the AI/ML context for this device. The formulation and properties were established through product development, material science principles, and internal quality control, with the goal of meeting the performance requirements eventually tested against the standards mentioned above.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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. 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
{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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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}------------------------------------------------
510(k) Summary
K212326
| Manufacturer's Name: | Spes Medica S.r.l.via Europa (Zona Ind.le), 84091 Battipaglia (SA) – Italy |
|---|---|
| Official Correspondent: | Giorgio FaccoQuality 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 cream510(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 electrodesas 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.AC Cream - Conductive paste function is of conductor between the electrode used and the patient's skin and of getting the impedance lowerfor a better recording of the signal. AC Cream - Conductive paste is for external use with recording electrodes only.AC Cream - Conductive paste is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agentsand humectants, all in an aqueous solvent. | |
| The composition is the following:Water, Ceteareth-20, Glycerol, Propylene Glycol, Bentonite, Sodium chloride, Potassium chloride, Calcium carbonate, Polysorbate 20,Phenoxyethanol, Ethylhexylglycerin | |
| The pH range is 6÷8, and Impedance at 10Hz is 120± 25 Ohm.The mean impedance after 7 days use, considering the worst values detected, is around 480 ± 10 Ohm.The Conductivity is 20 mS/cmShelf life of AC Cream - Conductive paste is 3 years if stored properly in the closed packaging, kept away from the sunlight and within thelimit 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 electrodesas 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.The characteristics of AC Cream - Conductive paste are substantially equivalent to the predicate device. No new questions of safety oreffectiveness are raised.AC Cream - Conductive paste employs the same technological characteristics as the predicate device with just different appearance: thepredicate 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 wereevaluated 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 AC Cream - Conductive paste is higher than the predicate device: the impedance evaluated by Spes Medica is 120 ±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 tochoose 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 foruse in clinical and research EEG/EP recordingsfrom humans. It is used with externalelectrodes as the conductor between the scalpand recessed electrodes to reduce impedancebetween the electrode surface and the skin | SAC2 is intended for use in clinical and researchEEG/EP recordings from humans. It is used withexternal electrodes as the conductor betweenthe scalp and recessed electrodes to reduceimpedance between the electrode surface andthe 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 Potassiumchloride (KCl)) | Salts (Sodium chloride (NaCl) and Potassiumchloride (KCl)) | Same as predicate device |
| Thickening agent | Glycerol,Bentonite, Propylene Glycol | Glycerol,CarboxyMethylCellulose | Equivalent to the predicate.Glycerol is used both for AC Cream – Conductivepaste and for predicate device.The other components (Bentonite, PropyleneGlycol for AC Cream – Conductive paste andCarboxyMethylCellulose for SAC2) have the samefunction of thickening agents but for AC Creamthe chosen components are not the same asSAC2 because it is wanted a different finaltexture (AC Cream - conductive paste is lessviscous and more sticky). |
| The different use of ingredients does not affectthe functional characteristics of the product(electroconductive media) | |||
| The different texture, due to the use of differentcomponents but with the same function, allowsthe final user the choice the preferred productsaccording to its needs.No new questions of safety or effectiveness areraised. | |||
| Preservative | Phenoxyethanol, Ethylhexylglycerin | Phenoxyethanol, Ethylhexylglycerin | Same as predicate device |
| The ingredients are different but have the samefunction. | |||
| Opacifying | Calcium carbonate | Talc, Celite | Not the same ingredients have been used as it iswanted a less opaque and pale yellow (AC Cream– conductive paste) paste. The predicate device isgray colored and more opaque. |
| The different use of ingredients does not alterthe functional characteristics of the product(electroconductive media) but act only on theaesthetic aspect (color and opacity). Also in thiscase the final user can choose the preferredproducts 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 finalformulation (6 - 8, neutral) is different from thepH of SAC2 final formulation (8 - 10, basic) due |
| to the different components and differentpercentage of components.The measured pH of the final product is anintrinsic characteristic of the paste but is notrelevant considering the functionality of theproduct.The functionality and effectiveness are notaffected by pH.The functionality of the product is given by thesalts ("conductive material") present in bothproducts.Furthermore, the skin has a good tolerance forboth the pH, also according to the positivebiocompatibility testsConsidering the lines above, no new questionabout safety and effectiveness of the subjectdevice are raised | |||
| Impedance | 120 ± 25 Ohm | 50 ± 10 Ohm | AC Cream - Conductive paste has a higherimpedance, but no new question of safety oreffectiveness are raised as the AC Cream -Conductive paste impedance is lower than themaximum limit of 2000 Ω according to theANSI/AAMI EC12:2000/(R)2015 |
| Conductivity | 20mS/cm | 20mS/cm | Same as predicate device |
| Characteristics | Salt BaseNon-irritatingNon toxic | Salt BaseNon-irritatingNon toxic | Same as predicate device |
| Weight | 100g per tube25g, 50g, 100g, 250 g per jar | 100g per tube | No differences for the tube.The different packaging (jar) was made to give tothe users an alternative way of use according toits needs. Considering that, no new questions ofsafety or effectiveness are raised. |
| Packaging | Aluminum tubePE jar | Aluminum tube | No differences for the tube.AC Cream - Conductive paste can also bepackaged in a jar, this is a further change for the |
| user to choose the packaging according to itsneeds. 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,Bentonite, Sodium chloride, Potassium chloride,Calcium carbonate, Polysorbate 20, Phenoxyethanol,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 instantimpedance after 0 | Mean instantimpedance after 28 | Mean instantimpedance after 56 | Mean instantimpedance after 84 days |
|---|---|---|---|---|
| ------------------- | ----------------------------------- | ------------------------------------ | ------------------------------------ | ----------------------------------------- |
{9}------------------------------------------------
| days of shelf life(accelerating aging) | days of shelf life(accelerating aging) | days of shelf life(accelerating aging) | of shelf life (acceleratingaging) | |
|---|---|---|---|---|
| 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.
§ 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).