ZEROWET SPLASHIELD

{0}------------------------------------------------ K 974288 JAN 2 9 1998 ## 510(k) Summary Submitted by-Zerowet, Inc. PO Box 4375 Palos Verdes Peninsula, CA 90274 (310) 544-1600 Phone (310) 544-4411 FAX Contact person-Keith Stamler, MD Date-November 10, 1997 Trade name-Zerowet Splashield Common name-Same Classification name-Irrigation syringe-Accessory Predicate legally marketed device-Zerowet Splashield (sterile) The device of the current submission is an unsterilized styrene bell-shaped unit, with a 19g nozzle integrated in the stem which attaches to the end of a syringe. The intended use is as attached to the end of an irrigation syringe, during wound irrigation, to protect the user from (a) needlesticks (by eliminating the use of a needle), and (b) bloody splash during this procedure. The only difference between the current device and the predicate device is the sterility level. Whereas the predicate device is marketed as a gamma-radiation-sterilized device, the current device is to be marketed as a clean, but unsterilized device. This is in response to requests from: (1) some end users (hospitals/physicians) who feel that an unsterilized Zerowet Splashield is adequate to irrigate a traumatic, already contaminated wound, (2) some end users (hospitals/physicians) who prefer a sterile product, but who wish to use in-house EtO sterilization facilities to sterilize the Zerowet Splashield as a component of a wound repair tray, and (3) independent kit packers who would like to include the unsterilized Zerowet Splashield as a component part of a disposable wound prep/repair tray, to be sterilized by a method of their choosing (either EtO or radiation), to then be marketed to end users (hospitals/physicians). It is felt that there is no substantial difference in the integrity or performance of the Zerowet Splashield between the following four formats: 1) as a radiation sterilized device (as currently permitted by FDA), 2) as an unsterilized device, to be used as such, 3) as an unsterilized device, to be sterilized by the end user using in-house EtO. 4) as an unsterilized device, to be sterilized by a kit packer using EtO or radiation. {1}------------------------------------------------ Although there is no body of literature comparing the use of sterilized versus unsterilized wound irrigation components, it is felt that there is no reasonable likelihood that the use of unsterilized components (as in the present submission) would adversely impact wound healing, wound infection rates, or general patient care. This is based on requests from a number of end users who are themselves specialists in the field of emergency wound care, who would prefer to use the Zerowet Splashield in an unsterilized format and feel that sterilization of this component for irrigation of a traumatic, contaminated wound is unnecessary. Additionally, it is felt that sterilization by the end user or kit assembler using standard EtO or radiation protocols would not adversely affect the integrity or performance of this device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures or profiles, stacked on top of each other, with flowing lines suggesting movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 9 1998 Keith Stamler, MD President ZeroWet®, Incorporated P.O. Box 4375 Palos Verdes Peninsula, California 90274 Re : K974288 Trade Name: ZeroWet Splashield Regulatory Class: I Product Code: KYZ Dated: November 10, 1997 Received: November 14, 1997 Dear Dr. Stamler: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does {3}------------------------------------------------ Page 2 - Dr. Stamler not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Ulat Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | Page_ | of | |-------|----| |-------|----| 40003 510(k) Number (if known): K 974288 Device Name: Zerowet Splashield Indications For Use: . Allery Pre "The Zerowet Splashield is intended for use as an accessory to an irrigation syringe. It is intended to be attached to the end of said syringe during wound irrigation, in place of the commonly used needle, thereby eliminating the use of a needle during this procedure. Additionally, the Zerower Splashield protects the user from contaminated (bloody) fluid splashing back during wound irrigation." (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Patucia Cucendi (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number X974288 Prescription Use ✓ (Per 21 CFR 801.109) OR Over-The-Counter Use__ (Optional Format 1-2-96)