PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM

{0}------------------------------------------------ Premier Brands of America Inc. Saline Wound Wash K090848 # 510(k) SUMMARY JUN 17 2009 #### SALINE WOUND WASH # 1. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared. Premier Brands of America Inc. 120 Pearl St. Mount Vernon, NY 10550 (718) 325-3000 Telephone No .: Facsimile No .: (718) 325-1050 Contact Person: # Mack Cauthen mcauthen@premier-brands.com May 26, 2009 . Date Prepared: #### 2. Name of Device and Name/Address of Sponsor Premier Saline Wound Wash Premier Brands of America Inc. 120 Pearl St. Mount Vernon, NY 10550 #### 3. Name of Device Proprietary: Premier Sterile Saline Wound Cleanser Classification Name: Lavage, Jet (21 CFR 880.5475) Product Code: FQH # 4. Classification of Device: 2 #### 5. Description Saline Wound Wash is a multi-use, isotonic, sterile saline solution packaged in a bag-in-can aerosol system. Actuation of the device (product can) delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15, AHCPR, US Department of Health and Human Services). The mechanical action of isotonic saline solution moving across the wound aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudates, and other extraneous matter. No preservatives are added since the finished device #### CONFIDENTIAL 1 {1}------------------------------------------------ Premier Brands of America Inc. Saline Wound Wash K090848 page 2/3 is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements (Sterilization of health care products - Requirements for validation and routine control - radiation sterilization). Saline Wound Wash passes the USP<71> Sterility Test. Saline Wound Wash is an Rx and OTC device and will only be labeled for use in wounds. #### 6. Predicate Device OTC: Wound Wash Saline; Blairex Laboratories, Inc. (K083355) Dermacyn™ Wound Dressing (K041161) RX: Sterile Saline (K082330) # 7. Intended Use/Indication for Use Indications for Rx (Prescription) Use: Saline Wound Wash is intended for use by or under the direction of a professional health care provider in moistening and lubricating absorbent wound dressings, cleansing and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts abrasions and minor burns. Indications for Over the Counter (OTC) Use: Saline Wound Wash is intended for use in moistening and lubricating absorbent wound dressings and for cleansing minor wounds, scrapes and minor burns. If redness, swelling or bleeding continues please seek the help of a nurse, nurses aid, doctor or other medical professional. #### 8. Technological Characteristics Saline Wound Wash is an aerosol bag-in-can system. The propellant, compressed air, is charged into the container between bag and the can creating a means to dispense the contents of the bag, isotonic sterile saline solution. The bag is a 4-Laver laminate system including a sandwiched polyethylene layer establishing an impermeable barrier between the propellant (compressed air) and the bag contents (sterile isotonic saline). The isotonic saline solution is in contact with either a polyethylene or polypropylene layer. Saline Wound Wash is a clear, colorless 0.9% sodium chloride solution prepared from sodium Chloride, USP, and purified water. USP. After filling and pressurizing, the device is sterilized by gamma irradiation. The product is tested against established specifications and meets USP sterility requirements. #### CONFIDENTIAL 2 {2}------------------------------------------------ Premier Brands of America Inc. Saline Wound Wash . . 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Ko9o8ye ge 3/3 # 9. Substantial Equivalence Saline Wound Wash is as safe and effective as the predicate devices. Saline Wound Wash has the same intended uses, technological characteristics, and basic principles of operation as its predicate devices and raises no new issues of safety or effectiveness. Thus Saline Wound Wash is substantially equivalent to the predicate devices. . 3 {3}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem. Public Health Service JUN 17 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Premier Brands of America. Incorporated % Mr. Mack Cauthen Manager, Quality and Regulatory Affairs 120 Pearl Street Mount Vernon, New York 10550 Re: K090848 Trade/Device Name: Saline Wound Wash Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: II Product Code: FQH, FRO Dated: May 26, 2009 Received: June 3, 2009 Dear Mr. Cauthen: - 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 {4}------------------------------------------------ # Page 2-Mr. Mack Cauthen 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 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. Ror Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K090848 # Indications for Use 510(k) Number (if known): K090848 Device Name: Saline Wound Wash Indications for Prescription (Rx) Use: Saline Wound Wash is intended for use by or under the direction of a professional health care provider in moistening and lubricating absorbent wound dressings, cleansing and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts abrasions and minor burns. Indications for Over the Counter (OTC) Use: Saline Wound Wash is intended for use in moistening and lubricating absorbent wound dressings and for cleansing minor wounds, scrapes and minor burns. If redness, swelling or bleeding continues please seek the help of a nurse, nurses aid, doctor or other medical professional. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Daniel Krone for MVM (Division Sign-Off) Division of Surgical, Orthopedic, Concurrence of CDRH, Office of Device Evaluation of Surgical, OFfices 510(k) Number K090846 Page 1 of 1