← Product Code FRO · K160095

# Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (K160095)

_Simple Science, LLC · FRO · Jun 10, 2016 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K160095

## Device Facts

- **Applicant:** Simple Science, LLC
- **Product Code:** FRO
- **Decision Date:** Jun 10, 2016
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

For Over-the-Counter Use: For management of minor skin abrasions, minor irritations, minor urritations, minor cuts, minor burns and intact skin Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and second- degree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

## Device Story

Simple Science Antimicrobial Wound & Skin Cleanser is a clear, hypotonic, topical solution containing ionized water, sodium chloride, hypochlorous acid, and hypochlorite ion. Used for cleansing, irrigating, and debriding dermal wounds; also moistens/lubricates absorbent dressings. Mechanism of action is mechanical fluid flow across the wound site to remove debris and foreign objects. Contains hypochlorous acid as an antimicrobial preservative to inhibit microbial growth in the liquid. Supplied in PET bottles with spray inserts. Used in clinical or home settings by professionals or patients. Output is the physical cleansing of the wound site, aiding in debris removal and infection control.

## Clinical Evidence

Bench testing only. Biocompatibility studies (cytotoxicity, sensitization, irritation) per ISO 10993. Preservative effectiveness testing per USP <51> demonstrated inhibition of various microorganisms including MRSA, VRE, E. coli, and P. aeruginosa. Stability studies confirm 12-month shelf life.

## Technological Characteristics

Hypotonic solution; ingredients: ionized water (99.927%), sodium chloride (0.06%), hypochlorous acid (0.011%), hypochlorite ion (0.002%). Form factor: PET bottles (2-23 oz) with spray caps. Antimicrobial preservative mechanism. Manufactured under cGMP guidelines.

## Predicate Devices

- CleanSmart™ Wound Cleanser ([K142592](/device/K142592.md))
- Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel ([K150799](/device/K150799.md))
- Anasept™ Animicrobial Skin and Wound Cleanser ([K073547](/device/K073547.md))

## 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

June 10, 2016

Simple Science LLC Eoin Croke CTO 5555W 78th St., Suite M Edina, MN 55439

Re: K160095

Trade/Device Name: Simple Science Antimicrobial Wound & Skin Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: May 9, 2016 Received: May 13, 2016

Dear Eoin Croke:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K160095

#### Device Name

Simple Science Antimicrobial Wound & Skin Cleanser

Indications for Use (Describe)

For Over-the-Counter Use: For management of minor skin abrasions, minor irritations, minor urritations, minor cuts, minor burns and intact skin

Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and second- degree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summarv

## 1. Submitter's Name and Address Simple Science, LLC. 5555 W 78th St STE M Edina, MN 55439

#### 2. Submitter's Contact Person

Eoin Croke (612) 367-4540 eoin.croke@simplesciencellc.com

#### 3. Date of 510(k) Summary Preparation: 23rd December 2015

23rd December 2015

- 4. Device Name (Proprietary) Simple Science Antimicrobial Wound & Skin Cleanser
- 5. Common Name Wound Dressing Solution
- 6. Classification Name Wound Dressing, Drug
- 7. Device Class Unclassified
- 8. Device Code FRO

#### 9. Legally Marketed Device for substantial equivalence comparison:

Simple Science Antimicrobial Wound & Skin Cleanser is substantially equivalent to the following cleared predicate devices:

- 1) CleanSmart™ Wound Cleanser (OTC and Professional use) manufactured by Simple Science LLC, cleared for distribution under 510(k) K142592 (Sept-2ªd-2015)
- 2) Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel manufactured by Innovacyn, Inc, cleared for distribution under K150799 (Nov-19th-2015)
- 3) Anasept™ Animicrobial Skin and Wound Cleanser, manufactured by Anacapa™ Technologies, Inc., cleared for distribution under K073547 (April-23rd-2008)

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#### 10. Description of Device

Simple Science Antimicrobial Wound & Skin Cleanser is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Simple Science Antimicrobial Wound & Skin Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). Simple Science Antimicrobial Wound & Skin will be supplied in Polyethylene terephthalate (PET) bottles of various volumes (2 oz, 8 oz, 16 oz, 23 oz) with spray inserts / caps.

## 11. Intended Use of Device

Simple Science Antimicrobial Wound & Skin Cleanser is intended for over-the-counter (OTC) and professional use as follows:

For Over-the-Counter Use: For management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, minor burns and intact skin.

Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and seconddegree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

These indications are similar to that of the predicate devices.

## 12. Device Technological Characteristics

Simple Science Antimicrobial Wound & Skin Cleanser is a clear hypotonic solution to aid in the removal of debris and foreign material from the application site. This is accomplished through the flow of the solution moving across the application site with or without the assistance of a suitable wound dressing. Simple Science Antimicrobial Wound & Skin Cleanser solution contains hypochlorous acid, a known antimicrobial preservative, which is shown to inhibit the growth of microorganisms such as Candida albicans, Aspergillus brasiliensis, acinetobacter albumin, Vancomycinresistant Enterococcus (VRE), Escherichia coli, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Methicillin-resistant Staphylococcus aureus (MRSA) in the liguid. Simple Science Antimicrobial Wound & Skin Cleanser is manufactured under Good Manufacturing Practices (GMP) guidelines

A comparison of technological characteristics between the subject and predicate devices is provided in the attached

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### 13. Manufacturing

Simple Science Antimicrobial Wound & Skin Cleanser will be manufactured under the guidelines of current Good Manufacturing Practices (cGMPs) and according to the established manufacturing, quality, and product specifications. Process validations have been completed for this device, and filling process parameters have been qualified. Manufacturing controls have been established and implemented to address the identified risk factors based on the criticality of the failure mode. Established cGMPs will assure the device manufactured by Simple Science, LLC. Meets all the established specifications prior to release, and is substantially equivalent to its predicates.

## 14. Performance Testing

Simple Science Antimicrobial Wound & Skin Cleanser has been subjected to ISO 10993 biocompatibility studies (cytotoxicity, sensitization, irritation) to demonstrate that the device is as safe and as effective as its predicate devices. The preservative effectiveness has been supported by USP <51> testing. Additionally, Test results have demonstrated preservative effectiveness 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). The results of the stability study demonstrate that the product is stable and effective for the entire shelf life of 12Months.

## 15. Substantial equivalence conclusion

Simple Science Antimicrobial Wound & Skin Cleanser is similar in function and has the same intended use as the predicate devices CleanSmart™ Wound Cleanser, 510(k) K142596, Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel; K150799, Anasept™ Animicrobial Skin and Wound Cleanser, K073547, The safety evaluation meets the requirements as detailed by USP and ISO.

On the basis of the information presented in this 510(k) submission, Simple Science, LLC. concludes a) that Simple Science Antimicrobial Wound & Skin Cleanser is substantially equivalent to the predicate devices, as it has the same intended use as the predicates; and b) demonstrates that the device is at least as safe and as effective as the legally marketed predicate devices.

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**Source:** [https://fda.innolitics.com/device/K160095](https://fda.innolitics.com/device/K160095)

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