Who is the manufacturer of DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%?

Century Pharmaceuticals, Inc. filed the 510(k) submission for DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% (K090791).

What is the FDA product code for DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%?

Oculus - Dermacyn (K042729); Anacapa - Anasept Skin and Wound Cleanser (K073547).

Who can help prepare an FDA 510(k) submission like DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%

K090791 · Century Pharmaceuticals, Inc. · FRO · Aug 7, 2009 · SU

Device Facts

Record ID	K090791
Device Name	DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
Applicant	Century Pharmaceuticals, Inc.
Product Code	FRO · SU
Decision Date	Aug 7, 2009
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations. Professional Use: Wound Cleanser intended for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites.

Device Story

Wound Cleanser is an aqueous solution containing 0.0125% (w/v) sodium hypochlorite, with sodium bicarbonate and sodium hydroxide. Used in hospitals, nursing homes, and wound clinics by clinicians, or as an OTC product by patients. Applied topically to mechanically cleanse and debride dirt, debris, and microorganisms from acute and chronic wounds or minor skin irritations. Acts as a preservative solution. Healthcare providers use the cleanser to prepare wound beds for healing; patient benefit includes removal of foreign material and debris to facilitate wound management. Not for injection or use in/near eyes.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by biocompatibility testing (cytotoxicity, sensitization, dermal irritation), stability, and shelf-life testing.

Technological Characteristics

Aqueous solution containing 0.0125% w/v sodium hypochlorite, purified water, sodium bicarbonate, and sodium hydroxide. Shelf-life of 2 years; time-to-use of 3 months. Non-sterile, topical application.

Indications for Use

Indicated for patients with acute or chronic wounds (e.g., pressure ulcers, diabetic foot ulcers, surgical wounds, burns, grafted/donor sites) for mechanical cleansing and debridement, and for OTC use on skin, abrasions, cuts, and minor irritations. Contraindicated for those sensitive to any of the compounds.

Predicate Devices

Oculus - Dermacyn (K042729)
Anacapa - Anasept Skin and Wound Cleanser (K073547)

Related Devices

K150208 — Dakin's Skin and Wound Cleanser · Century Pharmaceuticals, Inc. · Jul 21, 2016
K142592 — CleanSmart Wound Cleanser · Simple Science, LLC · Sep 2, 2015
K113312 — HY-CHLO(TM)WOUND SCRUB · Patrin Pharma · Aug 21, 2012
K252023 — MiraChlor Antimicrobial Wound Solution · Letus Corporation · Mar 25, 2026
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 · Simple Science, LLC · Jun 10, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 510(k) Summary Page 1 of 4 5-Aug-09 AUG 07 2009 Century Pharmaceuticals, Inc. Tel (317) 849-4210 10377 Hague Road Fax (317) 849-4263 Indianapolis, IN 46256 Ross Deardorff - President Official Contact: Wound Cleanser Proprietary or Trade Name: Wound cleanser Common/Usual Name: FRO - Dressing, wound, drug Classification Name/Code: CFR - unclassified - pre-amendment Wound Cleanser Device: Oculus - Dermacyn - K042729 Predicate Devices: Anacapa - Anasept Skin and Wound Cleanser -K073547 ## Device Description: The Wound Cleanser is an aqueous solution of sodium hypochlorite, modified with sodium bicarbonate, used as a solution to mechanically cleanse and debride open wounds. The sodium hypochlorite concentration 0.0125% weight / volume. Sodium hypochlorite is a solution preservative. ## Indications for Use: OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations. Professional Use: Wound Cleanser for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, 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 4 of 8 {1}------------------------------------------------ 510(k) Summary Summary of substantial equivalenc | | Predicate | Predicate | Proposed Wound Cleanser | Features and Performance Characteristics | Predicate Oculus - Dermacyn K042729 | Predicate Anacapa - Anasept K073547 | Proposed Wound Cleanser | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Oculus – Dermacyn K042729 | Anacapa - Anasept K073547 | | Ingredients | Purified Water 99.97%, chloride <200 ppm, chlorate <20ppm, hypochlorous acid hypochlorite < 85 ppm. | Isotonic solution Sodium Hypochlorite | Purified Water Sodium bicarbonate Sodium Hydroxide Sodium Hypochlorite concentration: 0.0125% Weight / volume | | Indications for Use | Intended for moistening and debriding acute and chronic dermal lesions, such as pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin | OTC: Intended for OTC use for mechanical cleansing of dirt and debris from skin abrasions, minor irritations, cuts, exit sites and intact skin | OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations. | Non-clinical Performance Biocompatibility Stability Shelf-life | Results in very low concentration of hypochlorous acid and hypochlorite (85 ppm or 0.0085%) Tested as stated in 510(k) Summary | Tested as stated in 510(k) Summary | Cytotoxicity Sensitization Dermal Irritation Shelf-life- 2 years Time-to-use- 3 months | | | | Professional Use: Intended for professional use for cleansing and removal of foreign materials including micro-organisms and debris from wounds such as Stage I-IV pressure ulcers, diabetic foot ulcers, port-surgical wounds, first and second degree burns, grafted and donor sites. | Professional Use: Wound Cleanser for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites. | Contraindications and Warnings | None | None | Warnings: * For external use only * Not for injection * Not for use in or near the eyes * 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 | | OTC | Prescriptive | OTC | OTC | | | | | | Prescriptive | Not specified | Prescriptive (Professional use) | Prescriptive (Professional use) | | | | | | Environments of use | | Hospitals, nursing homes, wound clinics and pre and post hospitals | Hospitals, nursing homes, wound clinics and pre and post hospitals | | | | | 5 of 8 . {2}------------------------------------------------ 510(k) Summary K090791 3/4 3/4 {3}------------------------------------------------ # 510(k) Summary Page 4 of 4 5-Aug-09 The Wound Cleanser is viewed as substantially equivalent to the predicate devices because: ## Indications - - Identical to predicate Oculus Dermacyn K042729 . - OTC and Professional Use identical to Anacapa Anasept cleanser K073547 . #### Formulation / Technology - - Similar formulation / technology used Oculus Dermacyn K042729 and . Anacapa Anasept cleanser - K073547 ## Materials - - The materials in patient contact are identical to predicate device, Oculus -. Dermacyn - K042729 ## Environment of Use - - Identical to predicate Anacapa Anasept cleanser K073547 . ## Differences - The differences are: - Concentration 0.0125% weight to volume of sodium hypochlorite . Any other differences are not significant between the proposed device and the predicate device and do not introduce any new patient safety issues. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Century Pharmaceuticals, Inc. AUG 0 7 2009 Re: K090791 % ProMedic, Inc. Mr. Paul Dryden 24301 Woodsage Drive Banita Springs, Florida 34134 Trade/Device Name: Wound Cleanser Product Code: FRO Dated: July 30, 2009 Received: August 4, 2009 Dear Mr. Dryden: 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. 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. {5}------------------------------------------------ Page 2 - Mr. Paul Dryden If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # K090791 # Indications for Use Statement Page 1 of 1 510(k) Number: K090791 Device Name: Wound Cleanser Indications for Use: OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations. Professional Use: Wound Cleanser intended for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites. The sodium hypochlorite concentration of 0.0125% weight / volume. | Prescription Use XX | or | Over-the-counter use XX | |-----------------------------|----|-------------------------| | (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Keane (Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices 510(k) Number K090791