K Number

Device Name

CleanSmart Wound Cleanser

Manufacturer

SIMPLE SCIENCE, LLC

Date Cleared

2015-09-02

(352 days)

Product Code

FRO

Regulation Number

N/A

Intended Use

Over-the-Counter Use: For management of minor skin abrasions, minor irritations, minor cuts, 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 Description

CleanSmart™ Wound 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. CleanSmart™ Wound Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). CleanSmart™ Wound Cleanser will be supplied in Polyethylene terephthalate (PET) bottles of various volumes (2 oz, 8 oz, 16 oz, 23 oz) with spray inserts / caps.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K113693, K133542, K090206, K093697

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition and mechanical action of a wound cleansing solution, with no mention of AI or ML technologies.

Therapeutic

Yes.
The device is intended for the management of wounds and skin conditions, which aligns with the definition of a therapeutic device as something used to treat or alleviate a disease or condition.

Diagnostic

No
The device is a wound cleanser for management and cleansing, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "clear hypotonic solution topically applied to skin and wound areas" and lists chemical ingredients and packaging (bottles with spray inserts/caps), indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the management and cleansing of skin and wounds. This involves topical application to the body surface.
Device Description: The device is a solution applied topically for cleansing, irrigating, and debriding wounds. Its mechanism of action is mechanical (fluid movement).
Lack of In Vitro Testing: The description of performance studies focuses on biocompatibility, preservative effectiveness against bacteria in solution, and stability. There is no mention of testing biological samples (like blood, urine, tissue) in vitro to diagnose a condition or provide information about a physiological state.

IVD devices are used to examine specimens taken from the human body in vitro to provide information for diagnosis, monitoring, or screening. This device is applied to the body for wound management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FRO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin and wound areas

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-Counter (OTC) and professional use.

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)

CleanSmart™ Wound 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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113693, K133542, K090206, K093697

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

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

September 2, 2015

Simple Science, LLC Mr. Eoin Croke CTO 5555 West 78th Street Suite M Edina, Minnesota 55439

Re: K142592

Trade/Device Name: CleanSmart (TM) Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: August 20, 2015 Received: August 27, 2015

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

Indications for Use

510(k) Number (if known) K142592

Device Name ClcanSmart™ Wound Cleanser

Indications for Use (Describe)

Over-the-Counter Use:

For management of minor skin abrasions, minor irritations, minor cuts, 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K142592 510(k) Summary (r4)

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: 1st September 2015

1. Device Name (Proprietary) CleanSmart™ Wound Cleanser
1. Common Name Wound was Solution
1. Classification Name Wound Dressing, Drug
1. Device Class Unclassified
1. Device Code FRO

9. Legally Marketed Device for substantial equivalence comparison:

CleanSmart™ Wound Cleanser is substantially equivalent to the following cleared predicate devices:

1. Nixall™ Wound and Skin Care (OTC and Professional use) manufactured by Seriously Clean LTD, cleared for distribution under 510(k) K113693 (11/12/2012)
1. Puracyn Plus™ Skin and Wound Care (OTC and Professional use) manufactured by Innovacyn, Inc, cleared for distribution under 510(k) K133542 (28/4/2014)
1. Oculus Puracyn™ Skin and Wound Cleanser with Preservatives manufactured by Oculus Innovative Sciences Inc., cleared for distribution under 510(k) K090206 (02/06/2009)
1. Vashe® Wound Therapy Solution (OTC use) manufactured by PuriCore, Inc. cleared for distribution under 510(k) K093697 (13/04/2010)

10. Description of Device

11. Intended Use of Device

CleanSmart™ Wound Cleanser is intended for over-the-counter (OTC) and professional use as follows:

o 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 second-degree 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

CleanSmart™ Wound 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. CleanSmart™ Wound Cleanser solution contains a preservative that inhibits the growth of microorganisms within the solution. CleanSmart™ Wound Cleanser is manufactured under Good Manufacturing Practices (GMP) guidelines.

13. Manufacturing

CleanSmart™ Wound 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

15. Substantial equivalence conclusion

As discussed in this 510(k) submission, CleanSmart™ Wound Cleanser is similar in function and has the same intended use as the predicate devices Nixall™ Wound and Skin Care, 510(k) K113693, Puracyn Plus™ Skin and Wound Care, 510(k) K133542, Puracyn™ Skin and Wound Cleanser with Preservatives, 510(k) K090206, and Vashe® Wound Therapy Solution. 510(k) K093697. 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 CleanSmart™ Wound 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.