Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns, and grafted and donor sites.

Dakin's Skin and Wound Cleanser is intended for cleansing of minor lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.

Device Description

The Dakin's Skin and Wound Cleanser, Sodium Hypochlorite 0.125% is an aqueous, clear, colorless solution with mild chlorine odor, modified with sodium bicarbonate, used as a solution to cleanse and debride wounds. Sodium hypochlorite is used as a solution preservative, and sodium bicarbonate is used as a pH modifier.

Dakin's Skin and Wound Cleanser is packaged in amber HDPE (High Density PolyEthylene) bottles and induction sealed caps. A permanently affixed label, lot number and expiration date will be on each bottle of the Dakin's Skin and Wound Cleanser.

AI/ML Overview

The provided document is a 510(k) premarket notification decision letter and summary for a medical device called "Dakin's Skin and Wound Cleanser." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria and detailed study results typical for novel devices or significant modifications.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about training and test sets, expert adjudication, MRMC studies, or standalone algorithm performance.

Here's why and what information is present:

Lack of Acceptance Criteria and Performance Data: The 510(k) process focuses on demonstrating substantial equivalence to a predicate device. This typically involves performance testing (e.g., biocompatibility, stability, shelf-life, antimicrobial effectiveness) to show the new device performs as intended and is as safe and effective as the predicate, but it doesn't involve establishing and meeting clinical performance acceptance criteria in the same way a PMA (Premarket Approval) submission for a novel device would.
The "Study" Mentioned: The document mentions a "Preclinical Wound Healing Study in Yucatan miniature swine" (page 6). This is a preclinical animal study, not a human clinical trial. Its purpose was to show that "Daily treatment of the abraded site with either Dakin's Skin and Wound Cleanser or Predicate did not inhibit the healing process when compared with untreated sites." This is a comparative study against the predicate and a control, aimed at showing non-inferiority in terms of healing inhibition in a preclinical model, not establishing clinical effectiveness or meeting specific performance metrics with human data.
No Information on AI/Algorithm Performance: The device is a "Dakin's Skin and Wound Cleanser," which is a topical solution (sodium hypochlorite). It is not an AI-powered diagnostic or therapeutic device. Therefore, questions regarding MRMC studies, standalone algorithm performance, training/test sets for AI, expert adjudication for ground truth of an AI model, and data provenance related to AI model development are not applicable to this device or document.

Summary of what can be extracted from the document:

Device Name: Dakin's Skin and Wound Cleanser
Predicate Device: Patrin Pharma, Inc. – Hy-Chlo Wound Solution (K113312)
Indications for Use (similar for both proposed and predicate):
- OTC: Cleansing of minor cuts, lacerations, abrasions, minor wounds, and removal of foreign objects.
- Professional Use: Cleansing of acute, chronic, and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second-degree burns, and grafted and donor sites.
Non-clinical Performance Testing (mentioned on page 6):
- Biocompatibility (Cytotoxicity, Sensitization, Dermal Irritation)
- Preclinical Wound Healing Study in Yucatan miniature swine
- Antimicrobial (preservative testing) - meets USP <51> criteria for antimicrobial effectiveness.

In conclusion, this document is a regulatory approval notice for a topical wound cleanser based on substantial equivalence to an existing product, not a study report for an AI device or a device requiring complex clinical performance acceptance criteria and human clinical trials as per your prompt's questions.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection.

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

July 21, 2016

Century Pharmaceuticals, Inc. Mr. Stephen Deardorff Vice President 10377 Hague Road Indianapolis, IN 46256

Re: K150208

Trade/Device Name: Dakin's Skin and Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: June 2, 2016 Received: June 8, 2016

Dear Mr. Deardorff:

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 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.

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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

for

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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Indications for Use

510(k) Number (if known) K150208

Device Name Dakin's Skin and Wound Cleanser

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K150208

Device Name Dakin's Skin and Wound Cleanser

Indications for Use (Describe)

Dakin's Skin and Wound Cleanser is intended for cleansing of minor lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary Page 1 of 4 19-Jul-16

Century Pharmaceuticals, Inc.10377 Hague RoadIndianapolis, IN 46256	Tel (317) 849-4210Fax (317) 849-4263
Official Contact:	Stephen Deardorff – Vice President
Proprietary or Trade Name:	Dakin's Skin and Wound Cleanser
Common/Usual Name:	Wound cleanser
Classification Name/Code:	FRO - DRESSING, WOUND, DRUG
Device:	Dakin's Skin and Wound Cleanser, Quarter Strength 0.125%
Predicate Device:	Patrin Pharma, Inc. – Hy-Chlo Wound Solution – K113312

Device Description:

Indications for Use:

OTC: Dakin's Skin and Wound Cleanser is intended for cleansing of minor cuts, minor

lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.

Professional Use: Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns, and grafted and donor sites.

Patient Population: Patients with acute or chronic wounds.

Environment of Use: Hospitals, nursing homes, wound clinics and pre and post hospitals

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K150208 Page 2 of 4

510(k) Summary

Summary of substantial equivalence

	Predicate	Proposed
	Patrin Pharma – Hy-Chlo	Dakin's Skin and Wound Cleanser,Quarter Strength 0.125%
	K113312
Indications for Use	OTC: Hy-chlo Wound Solution is intended for removalof foreign objects such as dirt, for cleansing of minorcuts, lacerations, abrasions and wounds.Professional Use: Hy-chlo Wound Solution is intendedto be used under the supervision of healthcareprofessional in cleansing of acute, chronic and/or openwounds such as Stage I-IV pressure ulcers, diabetic footand leg ulcers, surgical wounds, first and second degreeburns and grafted and donor sites.	OTC: Dakin's Skin and Wound Cleanser is intended forcleansing of minor cuts, minor lacerations, minorabrasions and minor wounds, and for removal of foreignobjects such as dirt and debris.Professional Use: Dakin's Skin and Wound Cleanser isintended for cleansing of acute, chronic and openwounds such as stage I-IV pressure ulcers, diabetic footand leg ulcers, surgical wounds, first and second degreeburns, and grafted and donor sites.
OTC	OTC	OTC
	Prescriptive (Professional use)	Prescriptive (Professional use)
Prescriptive
Environments of use	Attended healthcare setting such as acute and non-acutecare hospitals, nursing homes, surgery centers,emergency rooms and wound clinics.	Hospitals, nursing homes, wound clinics and pre andpost hospitals

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K150208
Page 3 of 4

510(k) Summary

	PredicatePatrin Pharma – Hy-ChloK113312	ProposedDakin's Skin and Wound Cleanser,Quarter Strength 0.125%
Ingredients	Purified WaterSodium bicarbonateSodium HydroxideSodium Hypochlorite concentration:0.125% weight/volume	Purified WaterSodium bicarbonateSodium HydroxideSodium Hypochlorite concentration:0.125% weight/volume
Non-clinical PerformanceBiocompatibility	Tested as stated in 510(k) Summary	CytotoxicitySensitizationDermal Irritation
Preclinical Wound HealingStudy in Yucatanminiature swine	Daily treatment did not inhibit the healing process when compared with untreated sites.	Daily treatment of the abraded site with either Dakin's Skin and Wound Cleanser or Predicate did not inhibit the healing process when compared with untreated sites.
Antimicrobial(preservative testing)	S. aureus, E.Coli, P. aeruginosa, C. albicans, S.aureus (MRSA), A. Brasiliensis, mold and yeast.	Multi-microbial challenge testing meets the criteria in the USP <51> Antimicrobial Effectiveness Testing
Contraindications andWarnings	Warnings:	Warnings:
	For external use only Keep out of reach of children If swallowed, contact Poison Center or seek immediate medical attention If redness, irritation, swelling or pain appears or increases, contact doctor immediately Do not use if sensitive to chlorine	For external use only Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases. Do not use if sensitive to any of the compounds Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

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510(k) Summary Page 4 of 4 19-Jul-16

The Dakin's Skin and Wound Cleanser, Quarter Strength 0.125% is viewed as substantially equivalent to the predicate device because:

Indications

. Identical to predicate - Patrin Pharma - Hy-Chlo - K113312

Formulation / Technology

Similar formulation / technology used to predicate Patrin Pharma Hy-Chlo . - K113312

Materials

The materials in patient contact are identical to predicate device, Patrin Pharma . – Hy-Chlo – K113312

Environment of Use

Identical to predicate Patrin Pharma– Hy-Chlo K113312 .

Differences

No significant differences between the proposed device and the predicate device, and do ● not introduce any new patient safety issues.

Regulation Number and Section

N/A