(323 days)
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.
ELECTROCYN soma contains purified water - 99.9%, hypochlorous acid (HOCl) + sodium hypochlorite (NaOCl) + sodium chloride (NaCl) ~ 0.1% and packed in HDPE bottles.
The provided text is a 510(k) summary for the device ELECTROCYN soma. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. The document includes non-clinical testing results but explicitly states that no clinical studies were included in the submission. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in ground truth.
Specifically, the document focuses on demonstrating that ELECTROCYN soma is substantially equivalent to Microcyn Antimicrobial Skin and Wound Cleanser (K172622) based on product code, Rx/OTC classification, indications for use, technology, sterility claim, mechanism of action, and delivery system, all of which are stated as "Same."
The non-clinical testing section details biocompatibility and performance tests conducted to evaluate the device's safety and effectiveness, but these are not presented as meeting specific clinical acceptance criteria or used to establish performance metrics in the way clinical studies would.
Missing Information:
- Table of Acceptance Criteria and Reported Device Performance: This information is not present as no clinical studies were performed. The document lists "non-clinical performance testing" with "TEST PERFORMED," "DEVICE DESCRIPTION/SAMPLE SIZE," "TEST METHOD/APPLICABLE STANDARDS," and "SPECIFICATION COMPLIANCE." All results are listed as "Comply," but these are for engineering/performance specifications (e.g., composition, bioburden, antimicrobial efficiency, stability, packaging validation), not clinical performance or acceptance criteria in terms of diagnostic accuracy or clinical outcomes.
- Sample size used for the test set and the data provenance: Not applicable as no clinical studies were conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical studies were conducted.
- Adjudication method: Not applicable as no clinical studies were conducted.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable as no clinical studies were conducted.
- Standalone (algorithm only) performance: Not applicable as this is a medical device (wound cleanser/irrigation solution), not an AI algorithm.
- Type of ground truth used: Not applicable as no clinical studies were conducted.
- Sample size for the training set: Not applicable as no AI algorithm is involved and no clinical training sets are mentioned.
- How the ground truth for the training set was established: Not applicable as no AI algorithm is involved and no clinical training sets are mentioned.
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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
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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,
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
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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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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
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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 HDPEBottle | Not Available | Spray Mist | Available |
| Electrocyn soma,250 mL, spray mist | 250mL HDPEBottle | Not Available | Spray Mist | Not Available |
| Electrocyn soma,250 mL, cap closure | 250mL HDPEBottle | Available | Cap Closure | Not Available |
| Electrocyn soma,500 mL, cap closure | 500mL HDPEBottle | Available | Cap closure | Not Available |
7. Indications For Use
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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 | MicrocynAntimicrobial Skin and WoundCleanser | |
| Product code | FRO | FRO | Same |
| Prescription (Rx)/Over theCounter (OTC) | OTC and Rx | OTC and Rx | Same |
| Indications for use | Rx Indications:Under the supervision of a healthcareprofessional, ELECTROCYN soma isintended for the cleansing, irrigation,moistening, debridement and removalof foreign material and debris fromexudating wounds, acute and chronicwounds including stage I-IV pressureulcers, stasis ulcers, diabetic ulcers,post-surgical wounds, first- and second-degree burns, abrasions, minorirritations of the skin and diabetic footulcers. It is also intended for use tomoisten and lubricate wound dressingsand for use with devices intended toirrigate wounds.OTC Indications:ELECTROCYN soma is intended forOTC use in the management of skinabrasions, lacerations, minorirritations, cuts, and intact skin. | Rx Indications:Under the supervision of ahealthcare professional,Microcyn™ Antimicrobial Skinand Wound Cleanser is intendedfor the cleansing, irrigation,moistening, debridement andremoval of foreign materialincluding debris from exudatingwounds, acute and chronic dermallesions including stage I-IVpressure ulcers, stasis ulcers,diabetic ulcers, post-surgicalwounds, firstand second-degreeburns, abrasions, minor irritationsof the skin, diabetic foot ulcers,ingrown toe nails, grafted/donorsites and exit sites. It is alsointended for use to moisten andlubricate wound dressings and foruse with devices intended toirrigate wounds.OTC Indications:Microcyn ™ Antimicrobial Skinand Wound Cleanser is intendedfor OTC use in the managementof skin abrasions, lacerations,minor irritations, cuts, and intactskin. | Same |
| Technology | Ingredients: Water, SodiumChloride, 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.
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| Item | Proposed Device | Predicate Device (K172622) | Comparison |
|---|---|---|---|
| Mechanism of Action | Dirt debris and foreign material aremechanically removed by the actionof the fluid moving across the woundor device. | Dirt debris and foreign material aremechanically removed by the actionof the fluid moving across the woundor 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 ofEectrocyn in Sprague Dawley Rats | OECD GuidelineNo. 403 | No related clinical signs of toxicity and mortalityobserved. Electrocyn is classified as relatively low acutetoxicity. |
| Skin Sensitization Study ofElectrocyn in Guinea Pigs byMaximization Test | ISO 10993-10: 2013 | No gross pathological changes observed in testedanimals. Electrocyn is found to be "non-sensitizer" tothe skin. |
| Acute Ocular Irritation Test ofElectrocyn In New Zealand WhiteRabbits | ISO 10993-10: 2013 | No gross pathological changes observed in any testedanimals. Electrocyn is concluded as "non-irritant" to theeyes. |
| Vaginal irritation Test ofElectrocyn in New Zealand WhiteRabbits | ISO 10993-10: 2013 | The irritation index was found to be 0.00 on testedanimal. Electrocyn is considered as "non-irritant" to thevagina. |
| In vitro Cytotoxicity Study ofElectrocyn By Agarose OverlayMethod | ISO 10993-5: 2009 | No reactivity was observed on the fibroblast cells.Electrocyn is 'non-cytotoxic" to the subconfluentmonolayer of mouse fibroblast cells. |
| In vitro Mammalian CellMicronucleus Test of Electrocyn InHuman Lymphocytes | OECD GuidelineNo. 487 | Electrocyn is non clastogenic and non anuegenic incultured human lymphocytes in short and long termtreatments. |
| Acute Oral Toxicity Study ofElectrocyn In Sparague DawleyRats | OECD GuidelineNo. 423 | No clinical signs of toxicity. No gross pathologicalchanges were observed in all tested animals. Electrocynis classified as relatively low acute toxicity. |
| Skin Irritation Test of Electrocyn InNew Zealand White Rabbits | ISO 10993-10: 2013 | No evidence of irritation of Electrocyn when appliedtopically on tested animals. Electrocyn is classified as"negligible irritant". |
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| REPORT TITLE | REFERENCE | RESULT |
|---|---|---|
| Intracutaneous Reactivity Test ofElectrocyn In New Zealand WhiteRabbits | ISO 10993-10: 2013 | None of the animals revealed skin reactions. Electrocynis proved as "non-irritant" to the skin. |
| Acute Dermal Toxicity Study ofElectrocyn In Sprague Dawley | OECD GuidelineNo. 402 | No clinical signs of toxicity and mortality, skinreactions, and gross pathological changes wereobserved. Electrocyn is classified as relatively low acutetoxicity. |
| Acute Systemic Toxicity Study ofElectrocyn soma In Albino Mice | ISO 10993-11:2017 | Electrocyn soma when administered to Swiss AlbinoMice through intravenous route at a dose volume of 50ml/kg body weight did not reveal any systemic toxicity |
| Material Mediated Pyrogen Test ofElectrocyn soma in New ZealandWhite Rabbits | USP GeneralChapter <151> | Electrocyn soma evaluated for pyrogen test in NewZealand White Rabbits is non-pyrogenic |
| Antimicrobial EffectivenessTesting | USP <51> | Bacteria - NLT 2.0 log reduction from the initial countat 1 day, and no increase from the 14 days to 28 days.Yeast - No increase from the initial calculated count at12 and 28days. |
Non-Clinical Performance Testing
| TEST PERFORMED | DEVICE DESCRIPTION/SAMPLE SIZE | TEST METHOD/ APPLICABLESTANDARDS | SPECIFICATIONCOMPLIANCE |
|---|---|---|---|
| 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 TripartiteGuideline - Stability Testing ofNew Drug Substances andProducts Q1A (R2) | Comply |
| 5. Packaging Validation ofTransportation Testing | 3 cartons with 24 bottles x500ml 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.
N/A