(323 days)
Not Found
No
The device description and intended use focus on the chemical composition and mechanical action of a wound wash solution. There is no mention of AI or ML in the provided text.
Yes
The device is intended for the cleansing, irrigation, moistening, debridement, and removal of foreign material and debris from wounds, which are actions consistent with therapeutic intervention to promote healing.
No
The device is described as a wound wash and irrigation solution intended for cleansing, irrigation, moistening, debridement, and removal of foreign material and debris from wounds. Its mode of action is mechanical debridement, irrigation, and moistening. These functions are therapeutic and do not involve identifying or diagnosing a disease or condition.
No
The device description clearly states that ELECTROCYN soma is a solution containing purified water and other chemical components, packaged in HDPE bottles. This indicates a physical product, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use of ELECTROCYN soma is for the cleansing, irrigation, moistening, and debridement of wounds and skin. This is a topical application and involves physical action on the wound bed.
- Mode of Action: The primary mode of action is described as mechanical debridement, irrigation, and moistening. This is a physical process, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a solution containing water and a small percentage of hypochlorous acid, sodium hypochlorite, and sodium chloride. These components are used for their cleansing and preservative properties, not for detecting or measuring substances in a biological sample.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is used to manage the wound itself.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. ELECTROCYN soma does not fit this description.
N/A
Intended Use / Indications for Use
Rx Indications:
Under the supervision of a healthcare professional, ELECTROCYN soma is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic wounds including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin and diabetic foot ulcers. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications:
ELECTROCYN soma is intended for OTC use in the management of skin abrasions, minor irritations, cuts, and intact skin.
Product codes
FRO
Device Description
ELECTROCYN soma contains purified water - 99.9%, hypochlorous acid (HOCl) + sodium hypochlorite (NaOCl) + sodium chloride (NaCl) ~ 0.1% and packed in HDPE bottles.
ELECTROCYN soma is a medical devices under category of wound wash and irrigation solution. The solution contains 99.9% purified water and with combined percentage of not more than 0.1% of Hypochlorous acid (HOCl) + Sodium hypochlorite (NaOC1) + sodium chloride (NaCl) which are produced by electrolysis technology with the use of purified water and purified salt.
HOCl acts as preservative for the solution to prevent microbial growth within the solution.
The primary intention of the ELECTROCYN soma solution is for mechanical debridement, irrigation, and moistening. The mechanical action of irrigating and debriding would assist in removing dead, damaged and contaminated tissues on and around the wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the supervision of a healthcare professional, ELECTROCYN soma is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic wounds including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin and diabetic foot ulcers. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
ELECTROCYN soma is intended for OTC use in the management of skin abrasions, minor irritations, cuts, and intact skin.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing
Biocompatibility on ELECTROCYN soma was performed in regards with ISO 10993 Biological Evaluation of Medical Devices, which aim to evaluate the safety and protection of humans from potential biological risk arising from the use of medical device. Biocompatibility test was selected based on Table 2 in Annex A (ISO 10993-1). From the table, under nature of body contact, ELECTROCYN soma falls under the category of surface device. In contact duration category, ELECTROCYN soma falls under B- prolonged (> 24h to 30d).
- Acute Inhalation Toxicity Study of Eectrocyn in Sprague Dawley Rats (OECD Guideline No. 403): No related clinical signs of toxicity and mortality observed. Electrocyn is classified as relatively low acute toxicity.
- Skin Sensitization Study of Electrocyn in Guinea Pigs by Maximization Test (ISO 10993-10: 2013): No gross pathological changes observed in tested animals. Electrocyn is found to be "non-sensitizer" to the skin.
- Acute Ocular Irritation Test of Electrocyn In New Zealand White Rabbits (ISO 10993-10: 2013): No gross pathological changes observed in any tested animals. Electrocyn is concluded as "non-irritant" to the eyes.
- Vaginal irritation Test of Electrocyn in New Zealand White Rabbits (ISO 10993-10: 2013): The irritation index was found to be 0.00 on tested animal. Electrocyn is considered as "non-irritant" to the vagina.
- In vitro Cytotoxicity Study of Electrocyn By Agarose Overlay Method (ISO 10993-5: 2009): No reactivity was observed on the fibroblast cells. Electrocyn is 'non-cytotoxic" to the subconfluent monolayer of mouse fibroblast cells.
- In vitro Mammalian Cell Micronucleus Test of Electrocyn In Human Lymphocytes (OECD Guideline No. 487): Electrocyn is non clastogenic and non anuegenic in cultured human lymphocytes in short and long term treatments.
- Acute Oral Toxicity Study of Electrocyn In Sparague Dawley Rats (OECD Guideline No. 423): No clinical signs of toxicity. No gross pathological changes were observed in all tested animals. Electrocyn is classified as relatively low acute toxicity.
- Skin Irritation Test of Electrocyn In New Zealand White Rabbits (ISO 10993-10: 2013): No evidence of irritation of Electrocyn when applied topically on tested animals. Electrocyn is classified as "negligible irritant".
- Intracutaneous Reactivity Test of Electrocyn In New Zealand White Rabbits (ISO 10993-10: 2013): None of the animals revealed skin reactions. Electrocyn is proved as "non-irritant" to the skin.
- Acute Dermal Toxicity Study of Electrocyn In Sprague Dawley (OECD Guideline No. 402): No clinical signs of toxicity and mortality, skin reactions, and gross pathological changes were observed. Electrocyn is classified as relatively low acute toxicity.
- Acute Systemic Toxicity Study of Electrocyn soma In Albino Mice (ISO 10993-11:2017): Electrocyn soma when administered to Swiss Albino Mice through intravenous route at a dose volume of 50 ml/kg body weight did not reveal any systemic toxicity
- Material Mediated Pyrogen Test of Electrocyn soma in New Zealand White Rabbits (USP General Chapter ): Electrocyn soma evaluated for pyrogen test in New Zealand White Rabbits is non-pyrogenic
- Antimicrobial Effectiveness Testing (USP ): Bacteria - NLT 2.0 log reduction from the initial count at 1 day, and no increase from the 14 days to 28 days. Yeast - No increase from the initial calculated count at 12 and 28days.
Non-Clinical Performance Testing
- Composition analysis: Tested on Finished product using Titration method. Result: Comply.
- Bioburden analysis: Tested on Finished product using ISO 11737-1:2018 method. Result: Comply.
- Antimicrobial Efficiency: Tested on Finished product using ASTM E2315 method. Result: Comply.
- Stability Study - Accelerated Aging: Tested on Finished product, 41 bottles using ICH Harmonised Tripartite Guideline - Stability Testing of New Drug Substances and Products Q1A (R2) method. Result: Comply.
- Packaging Validation of Transportation Testing: Tested on 3 cartons with 24 bottles x 500ml Electrocyn soma using ASTM D 276 method. Result: Comply.
Clinical Test Conclusion
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 21, 2022
V3bio Sdn. Bhd % Miriam Walls President and CEO xFDA PO Box 4821 McLean. Virginia 22103
Re: K220286 Trade/Device Name: ELECTROCYN soma Regulatory Class: Unclassified
Product Code: FRO Dated: January 30, 2022 Received: February 1, 2022
Dear Miriam Walls:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220586
Device Name ELECTROCYN soma
Indications for Use (Describe)
Rx Indications:
Under the supervision of a healthcare professional, ELECTROCYN soma is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic wounds including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin and diabetic foot ulcers. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications:
ELECTROCYN soma is intended for OTC use in the management of skin abrasions, minor irritations, cuts, and intact skin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for V3bio. The "V" is black, while the "3" is green. The word "bio" is written in black to the right of the "3". The logo is simple and modern.
510(k) Summary
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
Date of Preparation: November 22, 2022 1.
2. Sponsor Identification
V3bio Sdn. Bhd, No. 18, Jalan Cassia Selatan 3/1, Taman Perindustrian Batu Kawan, 14100 Bandar Cassia, Penang, Malaysia
Contact Person: Shudipta Choudhury Tel: 4-5886993 Email: s.choudhury@y3bio.com
Designated Submission 3.
Miriam Walls (Primary Contact Person)
xFDA - FDA Consulting for Drugs, Biologics and Medical Devices
PO Box 4821 McLean, Virginia 22103-4821 Phone: 703-966-1100 Email: mwall@xfda.com
4. Subject Device
Name of Device: ELECTROCYN soma Common Name: Wound Cleanser Classification Name: Dressing, Wound, Drug Class: Unclassified, Pre-amendment status Product Code: FRO
Identification of Predicate Device510(k) Number: ട്.
K172622 - Sonoma Pharmaceuticals, Inc. Name of Device: Microcyn Antimicrobial Skin and Wound Cleanser Common or Usual Name: Wound Cleanser Classification Name: Solution, Saline Wound Dressing Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO
4
Device Description 6.
ELECTROCYN soma contains purified water - 99.9%, hypochlorous acid (HOCl) + sodium hypochlorite (NaOCl) + sodium chloride (NaCl) ~ 0.1% and packed in HDPE bottles.
Product Overview
ELECTROCYN soma is a medical devices under category of wound wash and irrigation solution. The solution contains 99.9% purified water and with combined percentage of not more than 0.1% of Hypochlorous acid (HOCl) + Sodium hypochlorite (NaOC1) + sodium chloride (NaCl) which are produced by electrolysis technology with the use of purified water and purified salt.
HOCl acts as preservative for the solution to prevent microbial growth within the solution.
Mode of Action
The primary intention of the ELECTROCYN soma solution is for mechanical debridement, irrigation, and moistening. The mechanical action of irrigating and debriding would assist in removing dead, damaged and contaminated tissues on and around the wound.
Product Range
| Name as Per Device Label | Product Description |
|---|---|
| Electrocyn soma | Electrocyn soma, 100 mL spray mist |
| Electrocyn soma | Electrocyn soma, 250 mL, spray mist |
| Electrocyn soma | Electrocyn soma, 250 mL, cap closure |
| Electrocyn soma | Electrocyn soma, 500 mL, cap closure |
Summary of Packaging Material and Configuration
| Product Description | Bottle Type | Stopper | Capping Type | Packaging Box*
*single bottle box |
|-----------------------------------------|----------------------|---------------|--------------|--------------------------------------|
| Electrocyn soma,
100 mL spray mist | 100mL HDPE
Bottle | Not Available | Spray Mist | Available |
| Electrocyn soma,
250 mL, spray mist | 250mL HDPE
Bottle | Not Available | Spray Mist | Not Available |
| Electrocyn soma,
250 mL, cap closure | 250mL HDPE
Bottle | Available | Cap Closure | Not Available |
| Electrocyn soma,
500 mL, cap closure | 500mL HDPE
Bottle | Available | Cap closure | Not Available |
7. Indications For Use
5
Rx Indications:
Under the supervision of a healthcare professional, ELECTROCYN soma is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic wounds including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin and diabetic foot ulcers. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications:
ELECTROCYN soma is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
| Item | Proposed Device | Predicate Device (K172622) | Comparison |
|---|---|---|---|
| Product name | ELECTROCYN soma | Microcyn | |
| Antimicrobial Skin and Wound | |||
| Cleanser | |||
| Product code | FRO | FRO | Same |
| Prescription (Rx)/Over the | |||
| Counter (OTC) | OTC and Rx | OTC and Rx | Same |
| Indications for use | Rx Indications: | ||
| Under the supervision of a healthcare | |||
| professional, ELECTROCYN soma is | |||
| intended for the cleansing, irrigation, | |||
| moistening, debridement and removal | |||
| of foreign material and debris from | |||
| exudating wounds, acute and chronic | |||
| wounds including stage I-IV pressure | |||
| ulcers, stasis ulcers, diabetic ulcers, | |||
| post-surgical wounds, first- and second- | |||
| degree burns, abrasions, minor | |||
| irritations of the skin and diabetic foot | |||
| ulcers. It is also intended for use to | |||
| moisten and lubricate wound dressings | |||
| and for use with devices intended to | |||
| irrigate wounds. | |||
| OTC Indications: | |||
| ELECTROCYN soma is intended for | |||
| OTC use in the management of skin | |||
| abrasions, lacerations, minor | |||
| irritations, cuts, and intact skin. | Rx Indications: | ||
| Under the supervision of a | |||
| healthcare professional, | |||
| Microcyn™ Antimicrobial Skin | |||
| and Wound Cleanser is intended | |||
| for the cleansing, irrigation, | |||
| moistening, debridement and | |||
| removal of foreign material | |||
| including debris from exudating | |||
| wounds, acute and chronic dermal | |||
| lesions including stage I-IV | |||
| pressure ulcers, stasis ulcers, | |||
| diabetic ulcers, post-surgical | |||
| wounds, firstand second-degree | |||
| burns, abrasions, minor irritations | |||
| of the skin, diabetic foot ulcers, | |||
| ingrown toe nails, grafted/donor | |||
| sites and exit sites. It is also | |||
| intended for use to moisten and | |||
| lubricate wound dressings and for | |||
| use with devices intended to | |||
| irrigate wounds. | |||
| OTC Indications: | |||
| Microcyn ™ Antimicrobial Skin | |||
| and Wound Cleanser is intended | |||
| for OTC use in the management | |||
| of skin abrasions, lacerations, | |||
| minor irritations, cuts, and intact | |||
| skin. | Same | ||
| Technology | Ingredients: Water, Sodium | ||
| Chloride, Hypochlorous Acid, | |||
| Sodium Hypochlorite | Ingredients: Water, | ||
| Sodium Chloride, | |||
| Hypochlorous Acid, | |||
| Sodium Hypochlorite | Same | ||
| Sterility Claim | Non-Sterile | Non-Sterile | Same |
Substantially Equivalent (SE) Comparison 8.
6
| Item | Proposed Device | Predicate Device (K172622) | Comparison |
|---|---|---|---|
| Mechanism of Action | Dirt debris and foreign material are | ||
| mechanically removed by the action | |||
| of the fluid moving across the wound | |||
| or device. | Dirt debris and foreign material are | ||
| mechanically removed by the action | |||
| of the fluid moving across the wound | |||
| or device. | Same | ||
| Delivery System | Aqueous Solution | Aqueous Solution | Same |
9. Non-Clinical Testing
Biocompatibility Testing
Biocompatibility on ELECTROCYN soma was performed in regards with ISO 10993 Biological Evaluation of Medical Devices, which aim to evaluate the safety and protection of humans from potential biological risk arising from the use of medical device. Biocompatibility test was selected based on Table 2 in Annex A (ISO 10993-1). From the table, under nature of body contact, ELECTROCYN soma falls under the category of surface device. In contact duration category, ELECTROCYN soma falls under B- prolonged (> 24h to 30d).
| REPORT TITLE | REFERENCE | RESULT |
|---|---|---|
| Acute Inhalation Toxicity Study of | ||
| Eectrocyn in Sprague Dawley Rats | OECD Guideline | |
| No. 403 | No related clinical signs of toxicity and mortality | |
| observed. Electrocyn is classified as relatively low acute | ||
| toxicity. | ||
| Skin Sensitization Study of | ||
| Electrocyn in Guinea Pigs by | ||
| Maximization Test | ISO 10993-10: 2013 | No gross pathological changes observed in tested |
| animals. Electrocyn is found to be "non-sensitizer" to | ||
| the skin. | ||
| Acute Ocular Irritation Test of | ||
| Electrocyn In New Zealand White | ||
| Rabbits | ISO 10993-10: 2013 | No gross pathological changes observed in any tested |
| animals. Electrocyn is concluded as "non-irritant" to the | ||
| eyes. | ||
| Vaginal irritation Test of | ||
| Electrocyn in New Zealand White | ||
| Rabbits | ISO 10993-10: 2013 | The irritation index was found to be 0.00 on tested |
| animal. Electrocyn is considered as "non-irritant" to the | ||
| vagina. | ||
| In vitro Cytotoxicity Study of | ||
| Electrocyn By Agarose Overlay | ||
| Method | ISO 10993-5: 2009 | No reactivity was observed on the fibroblast cells. |
| Electrocyn is 'non-cytotoxic" to the subconfluent | ||
| monolayer of mouse fibroblast cells. | ||
| In vitro Mammalian Cell | ||
| Micronucleus Test of Electrocyn In | ||
| Human Lymphocytes | OECD Guideline | |
| No. 487 | Electrocyn is non clastogenic and non anuegenic in | |
| cultured human lymphocytes in short and long term | ||
| treatments. | ||
| Acute Oral Toxicity Study of | ||
| Electrocyn In Sparague Dawley | ||
| Rats | OECD Guideline | |
| No. 423 | No clinical signs of toxicity. No gross pathological | |
| changes were observed in all tested animals. Electrocyn | ||
| is classified as relatively low acute toxicity. | ||
| Skin Irritation Test of Electrocyn In | ||
| New Zealand White Rabbits | ISO 10993-10: 2013 | No evidence of irritation of Electrocyn when applied |
| topically on tested animals. Electrocyn is classified as | ||
| "negligible irritant". |
7
| REPORT TITLE | REFERENCE | RESULT |
|---|---|---|
| Intracutaneous Reactivity Test of | ||
| Electrocyn In New Zealand White | ||
| Rabbits | ISO 10993-10: 2013 | None of the animals revealed skin reactions. Electrocyn |
| is proved as "non-irritant" to the skin. | ||
| Acute Dermal Toxicity Study of | ||
| Electrocyn In Sprague Dawley | OECD Guideline | |
| No. 402 | No clinical signs of toxicity and mortality, skin | |
| reactions, and gross pathological changes were | ||
| observed. Electrocyn is classified as relatively low acute | ||
| toxicity. | ||
| Acute Systemic Toxicity Study of | ||
| Electrocyn soma In Albino Mice | ISO 10993-11:2017 | Electrocyn soma when administered to Swiss Albino |
| Mice through intravenous route at a dose volume of 50 | ||
| ml/kg body weight did not reveal any systemic toxicity | ||
| Material Mediated Pyrogen Test of | ||
| Electrocyn soma in New Zealand | ||
| White Rabbits | USP General | |
| Chapter | Electrocyn soma evaluated for pyrogen test in New | |
| Zealand White Rabbits is non-pyrogenic | ||
| Antimicrobial Effectiveness | ||
| Testing | USP | Bacteria - NLT 2.0 log reduction from the initial count |
| at 1 day, and no increase from the 14 days to 28 days. | ||
| Yeast - No increase from the initial calculated count at | ||
| 12 and 28days. |
Non-Clinical Performance Testing
| TEST PERFORMED | DEVICE DESCRIPTION/
SAMPLE SIZE | TEST METHOD/ APPLICABLE
STANDARDS | SPECIFICATION
COMPLIANCE |
|------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------|
| 1. Composition analysis | Finished product | Titration | Comply |
| 2. Bioburden analysis | Finished product | ISO 11737-1:2018 | Comply |
| 3. Antimicrobial Efficiency | Finished product | ASTM E2315 | Comply |
| 4. Stability Study - Accelerated Aging | Finished product,
41 bottles | ICH Harmonised Tripartite
Guideline - Stability Testing of
New Drug Substances and
Products Q1A (R2) | Comply |
| 5. Packaging Validation of
Transportation Testing | 3 cartons with 24 bottles x
500ml Electrocyn soma | ASTM D 276 | Comply |
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
ELECTROCYN soma is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Microcyn Antimicrobial Skin and Wound Cleanser manufactured by Sonoma Pharmaceuticals, Inc (K172622). Therefore, the ELECTROCYN soma is substantially equivalent to the predicate device.