Hydrocleanse Antimicrobial Skin and Wound Care Solution

K171727 · Sonoma Pharmaceuticals · FRO · Jul 26, 2017 · SU

Device Facts

• Record ID: K171727
• Device Name: Hydrocleanse Antimicrobial Skin and Wound Care Solution
• Applicant: Sonoma Pharmaceuticals
• Product Code: FRO · SU
• Decision Date: Jul 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Rx Indications for Use: Under the supervision of a healthcare professional, Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and 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 for Use: OTC Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Device Story

Hydrocleanse Antimicrobial Skin and Wound Care Solution is a clear, aqueous, slightly chlorinated solution (pH 4.0-5.8) supplied in PET bottles with a sprayer. It functions via mechanical removal of debris, dirt, and foreign material through fluid irrigation across the wound or device surface. Used in clinical settings under professional supervision or by patients for OTC management of minor skin injuries. The solution moistens and lubricates wound dressings and assists in debridement. It provides a non-sterile, shelf-stable antimicrobial environment for wound management.

Clinical Evidence

Bench testing only. Testing included package integrity, visual inspection, osmolality, pH, and Free Available Chlorine (FAC). Preservative effectiveness (USP <51>) was demonstrated against Proteus mirabilis, Serratia marcescens, MRSA, VRE, and Acinetobacter baumannii. Biocompatibility was evaluated per ISO 10993-1.

Technological Characteristics

Aqueous solution, pH 4.0-5.8. Materials: Polyethylene terephthalate (PET) bottles, polypropylene (PP) screw-top/sprayer. Non-sterile. Mechanism: Mechanical irrigation. Shelf life: 24 months.

Indications for Use

Indicated for cleansing, irrigation, moistening, and debridement of exudating wounds, acute/chronic dermal lesions (stage I-IV pressure ulcers, stasis/diabetic ulcers, post-surgical wounds, 1st/2nd degree burns, abrasions, minor skin irritations, diabetic foot ulcers, ingrown toenails, grafted/donor/exit sites) and moistening/lubricating dressings. OTC use for skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Predicate Devices

• Hydrocleanse Wound Solution (K141012)
• Simple Science Skin and Wound Cleanser (K1600095)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 26, 2017

Sonoma Pharmaceuticals Brian Martin Director of Regulatory Affairs and Ouality Control 1129 N. McDowell Boulevard Petaluma. California 94954

Re: K171727

Trade/Device Name: Hydrocleanse Antimicrobial Skin and Wound Solution Regulatory Class: Unclassified Product Code: FRO Dated: June 8, 2017 Received: June 12, 2017

Dear Brian Martin:

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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image contains the logo for Sonoma Pharmaceuticals. The logo consists of a stylized flower-like design on the left, with the word "Sonoma" in a larger, bolder font to the right. Below "Sonoma" is the word "PHARMACEUTICALS" in a smaller font. The flower-like design is made up of teal and gray shapes.

## 510(k) SUMMARY

The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

#### I. SUBMITTER

Sonoma Pharmaceuticals, Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: [phone] Fax: [phone]

Contact Person: Brian W. Martin, Director of Regulatory Affairs and Quality Control Date Prepared: July 11, 2017

### II. DEVICE

Name of Device: Hydrocleanse Antimicrobial Skin and Wound Care Solution Common or Usual Name: Wound Cleanser Classification Name: Solution, Saline Wound Dressing Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO

#### III. PREDICATE DEVICE

Hydrocleanse Wound Solution manufactured by Sonoma Pharmaceuticals (K141012) Simple Science Skin and Wound Cleanser manufactured by Simple Science (K1600095)

### IV. DEVICE DESCRIPTION

The Hydrocleanse Antimicrobial Skin and Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and device irrigation with a pH range of 4.0 - 5.8. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and sprayer.

### V. INDICATIONS FOR USE

### Rx Indications for Use:

Under the supervision of a healthcare professional, Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and 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

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Image /page/4/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a stylized flower-like symbol on the left, with the word "Sonoma" in a gray sans-serif font to the right. Below "Sonoma" is the word "PHARMACEUTICALS" in a smaller, teal-colored sans-serif font. The flower-like symbol is made up of teal and gray shapes arranged in a circular pattern.

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 for Use:

OTC Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

| Submitter/<br>Holder | Proposed Device:<br>Hydrocleanse Antimicrobial<br>Skin and Wound Care Solution<br>Sonoma Pharmaceuticals, Inc. | Predicate Device: K141012<br>Hydrocleanse Skin and Wound<br>Care Solution<br>Sonoma Pharmaceuticals, Inc. | Predicate Device:<br>K1600095<br>Simple Science Skin and<br>Wound Cleanser Simple<br>Science, LLC |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for<br>Use | Rx Indications:<br>Under the supervision of a<br>healthcare professional,<br>Hydrocleanse™ Antimicrobial Skin<br>and Wound Care Solution is<br>intended for the cleansing, irrigation,<br>moistening, debridement and<br>removal of foreign material and<br>debris from exudating wounds, acute<br>and chronic dermal lesions including<br>stage I-IV pressure ulcers, stasis<br>ulcers, diabetic ulcers, post-surgical<br>wounds, first- and second-degree<br>burns, abrasions, minor irritations of<br>the skin, diabetic foot ulcers,<br>ingrown toe nails, grafted/donor sites<br>and exit sites. It is also intended for<br>use to moisten and lubricate wound<br>dressings and for use with devices<br>intended to irrigate wounds.<br>OTC Indications:<br>OTC Hydrocleanse™ Antimicrobial<br>Skin and Wound Care Solution is<br>intended for OTC use in the<br>management of skin abrasions,<br>lacerations, minor irritations, cuts,<br>and intact skin. | Rx Indications:<br>Under the supervision of a healthcare<br>professional, Hydrocleanse™ Solution<br>is intended for the cleansing, irrigation,<br>moistening, debridement and removal<br>of foreign material including<br>microorganisms and debris from<br>exudating wounds, acute and chronic<br>dermal lesions including stage I-IV<br>pressure ulcers, stasis ulcers, diabetic<br>ulcers, post-surgical wounds, first- and<br>second-degree burns, abrasions, minor<br>irritations of the skin, diabetic foot<br>ulcers, ingrown toe nails, grafted/donor<br>sites and exit sites. It is also intended<br>for the irrigation, moistening and<br>lubricating of wound dressings as well<br>as device irrigation.<br>OTC Indications:<br>Hydrocleanse™ Solution is intended<br>for OTC use in the management of skin<br>abrasions, lacerations, minor irritations,<br>cuts, and intact skin. | Rx Indications:<br>For management of wounds<br>such as Stage I-IV pressure<br>ulcers, partial and full thickness<br>wounds, diabetic foot and leg<br>ulcers, post-surgical wounds,<br>first-and second degree burns,<br>grafted and donor sites, and<br>minor irritations of the skin in<br>addition to moistening and<br>lubricating absorbent wound<br>dressings.<br>OTC Indications:<br>For management of minor skin<br>abrasions, minor lacerations,<br>minor irritations, minor cuts,<br>minor burns and intact skin. |
| Sterility<br>Claim | Non-sterile | Same | Same |
| Mechanism<br>of Action | Dirt debris and foreign material are<br>mechanically removed by the action<br>of the fluid moving across the wound<br>or device. | Same | Same |
| Delivery<br>System | Aqueous Solution | Same | Same |
| Shelf Life | 24 months | Same | 12 months |

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Image /page/5/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a circular design on the left and the company name on the right. The circular design is made up of several curved shapes in shades of gray and teal, arranged to form a flower-like pattern. The company name "Sonoma" is written in a gray sans-serif font, with the word "PHARMACEUTICALS" written in a smaller teal font underneath.

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility Testing

The biocompatibility evaluation for the Hydrocleanse Antimicrobial Skin and Wound Care Solution was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

## Bench Testing

The following tests were performed to support the performance of Hydrocleanse Antimicrobial Skin and Wound Care Solution: package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC). USP <51> testing was used to support preservative effectiveness within the solution while on the shelf, used against the following bacteria in solution, Proteus mirabilis (ATCC- 25933), Serratia marcescens (ATCC-8100), antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA) (ATCC-43300), Vancomycin-resistant Enterococcus faecalis (VRE) (ATCC-700221), and Acinetobacter baumannii (ATCC 19606).

### VIII. CONCLUSION

Hydrocleanse Antimicrobial Skin and Wound Care Solution is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Hydrocleanse Wound Solution manufactured by Sonoma Pharmaceuticals, Inc. (K141012) and Simple Science Antimicrobial Skin and Wound Cleanser manufactured by Simple Science (K1600095). Therefore, the Hydrocleanse Antimicrobial Skin and Wound Care Solution is substantially equivalent to the predicate devices.