(119 days)
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 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.
The provided text describes the 510(k) summary for the SAC2 - Electrode cream. It does not contain information about a study involving human readers or AI assistance. The performance testing section focuses on bench tests (aging, long-term conductivity) and biocompatibility, not on a clinical effectiveness study with human subjects.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Standard/Methodology |
|---|---|---|
| Aging Test | ASTM F1980-16 | |
| Light grey color | Complies (light grey color) | Visual inspection |
| No crystallization | Complies (no crystallization) | Visual inspection |
| No flocculation | Complies (no flocculation) | Visual inspection |
| Opaque | Complies (opaque) | Visual inspection |
| pH range | 8-10 | Internal testing |
| Impedance at 10Hz | 50 ± 10 Ohm | Internal testing, complies with ANSI/AAMIEC12:2000 |
| Long Term Conductivity Test | ANSI/AAMIEC12:2000/(R)2015 | |
| DC Offset voltage | Does not exceed 100mV (after 7 days testing) | Electrical testing |
| AC Impedance | Does not exceed 2000 Ohm (after 7 days testing) | Electrical testing |
| Biocompatibility | ||
| Cytotoxicity | Passed | ISO 10993-5 |
| Irritation | Passed | ISO 10993-10 |
| Sensitization | Passed | ISO 10993-10 |
2. Sample size used for the test set and the data provenance
Not applicable for this type of product/study. The performance tests described are bench tests on the product itself, not on data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for biocompatibility and bench testing is established through standardized laboratory procedures and instrument readings, not expert consensus.
4. Adjudication method for the test set
Not applicable. Adjudication is typically used in studies involving subjective interpretation (e.g., medical imaging), which is not the case for these performance tests.
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. The document pertains to an electrode cream, not an AI software or system that assists human readers.
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. The device is a physical electrode cream, not an algorithm.
7. The type of ground truth used
The ground truth for the performance tests (aging, long-term conductivity) was established by objective measurements against defined parameters (e.g., color, pH, impedance, DC offset voltage) and the biological responses observed in standardized biocompatibility tests (cytotoxicity, irritation, sensitization). This is based on established industry standards like ASTM F1980-16, ANSI/AAMIEC12:2000, ISO 10993-5, and ISO 10993-10.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As noted above, this device does not involve a training set.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 | DateREV. | 01.16.2020 |
|---|---|---|---|---|---|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (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 FaccoQuality 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 Gel510(k) number: K190050 |
| Device Description: | SAC2 is intended for use in clinical and research EEG/EP recordings from humans. Itis used with external electrodes as the conductor between the scalp and recessedelectrodes 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 adversesmell, opaque.SAC2 function is of conductor between the electrode used and the patient's skin andof getting the impedance lower for a better recording of the signal. SAC2 is forexternal 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, Potassiumchloride, Phenoxyethanol, EhylhexylglycerinThe pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. |
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| SAC2 – Electrode cream | REV. | 2 | DateREV. | 01.16.2020 | |
|---|---|---|---|---|---|
| 510(k) Summary | |||||
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (SA) | Page 2 of 7 | |||
| The Conductivity is 20 mS/cmShelf life of SAC2 is 3 years if stored properly in the closed aluminum tube keptaway from the sunlight. | |||||
| Intended Use: | SAC2 is intended for use in clinical and research EEG/EP recordings from humans. Itis used with external electrodes as the conductor between the scalp and recessedelectrodes 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. Nonew questions of safety or effectiveness are raised.SAC2 employs the same technological characteristics as the predicate device withjust different appearance: the predicate device is a gel instead SAC2 is a cream. | ||||
| To support the technological comparison the ingredients, pH, impedance, weightand conductivity of the SAC2 were evaluated internally and compared to thepredicate device. | |||||
| Both devices are water based with salt as conductive material and with thickeningagents (Glycerin is used for both the products). | |||||
| The impedance of the SAC2 is comparable to the predicate device: the impedanceevaluated by Spes Medica is 50 ± 10 Ohm. The pH of the SAC2 is between 8 and 10higher than the Predicate Device. | |||||
| The predicate device is a gel while the SAC2 is a cream, the different texture wascreated 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 inTable. |
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 | DateREV. | 01.16.2020 |
|---|---|---|---|---|---|
| 510(k) Summary | |||||
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091Battipaglia (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 researchEEG/EP recordings from humans. It is used withexternal electrodes as the conductor between thescalp and recessed electrodes to reduce impedancebetween the electrode surface and the skin | Tech Dots are intended for use in clinical and researchEEG/EP recordings from humans. They are used withexternal electrodes as the conductor between thescalp and recessed electrodes to reduce impedancebetween 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 whichprevent the spread of bacteria whenthe tube is opened. The predicatedevice has a different packaging sopreservatives are not necessary.In both cases the products results tobe biocompatible, so for SAC2 no newquestions of safety oreffectiveness are raised. |
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| SAC2 – Electrode cream | REV. | 2 | DateREV. | 01.16.2020 | |
|---|---|---|---|---|---|
| 510(k) Summary | |||||
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091Battipaglia (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 ofthe predicate device is acid but inboth cases the products results tobe biocompatible, so for SAC2 nonew questions of safety oreffectiveness are raised. |
| Impedance | 50 ± 10 Ohm | 80 ± 10 Ohm | SAC2 has an impedance of 50±10Ohms which is lower than theimpedance of the predicate device.This can be consider as animprovement as lower impedancemeans better signal during recordingand more conductivity.Considering that, no new questions ofsafety or effectiveness are raised. |
| Conductivity | 20mS/cm | 2mS/cm | SAC2 results to have a higher valueof conductivity comparing to thepredicate, this is an advantage(according to the intent of use) as thecream results to be more |
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| SAC2 – Electrode cream | REV. | 2 | DateREV. | 01.16.2020 | |
|---|---|---|---|---|---|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa, Zona Industriale – 84091Battipaglia (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 ofsafety or effectivenessare raised. | |||
| Weight | 100g per tube | $0.14 \pm 0.01$ g per Dot | Different packaging and shapeThe different packaging was madeto give to the users an alternativeway to conduct exams. Thepredicate device is packaged as apre-set quantity for one electrode( $0.14\pm0.001$ g per dot), with SAC2the user can decide itself thequantity to apply with oneelectrode. Considering that, no newquestions of safety or effectivenessare raised. |
| Characteristics | Salt BaseNon-irritatingNon toxic | Salt BaseNon-irritatingNon toxic | Equivalent to predicate device |
| Packaging | Aluminum tube | Aluminum/PET/PE | Different ways of packaging. Bothmaterials are validated. |
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| SAC2 – Electrode cream | REV. | 2 | DateREV. | 01.16.2020 | ||
|---|---|---|---|---|---|---|
| Traditional 510(k) | Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (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, Potassiumchloride, 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
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| SAC2 – Electrode cream | REV. | 2 | DateREV. | 01.16.2020 | |
|---|---|---|---|---|---|
| Spes Medica S.r.l. Via Europa , Zona Industriale – 84091Battipaglia (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.
§ 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).