Y2K2 ENTERNAL TUBE FLUID FILTER

{0}------------------------------------------------ ## NOV - 1 2005 ## 510(k) SUMMARY INFORMATION | APPLICANT NAME: | Moss Medical Products, Inc. | |-----------------------|------------------------------------------------------------------------------| | ADDRESS: | 4049 NY 150<br>West Sand Lake, New York 12196 | | PHONE: | 518-674-0904 | | FAX: | 914-684-1464 | | E-MAIL: | mosstube@mossmed.com | | ACTIVITY OF APPLICANT | Initial Distributor | | CONTACT PERSON: | GERALD MOSS, Ph.D., M.D. | | ADDRESS: | 1 Reynal Road<br>White Plains, New York 10605 | | PHONE: | 914-997-0392 | | FAX: | 914-684-1464 | | E-MAIL: | gerald_moss@mossmed.com | | NAME OF DEVICE | | | TRADE NAME: | Y2K2 Enteral Tube Fluid Filter | | COMMON NAME: | In-Line Filter | | CLASSIFICATION NAME: | {21 CFR 876.5980}<br>{Tubes, Gastrointestinal (and accessories) | | PRODUCT CODE: | {KNT} | | MANUFACTURER: | Filtertek, Inc.<br>P.O. Box 310<br>11411 Price Road<br>Hebron, IL 60034-0310 | | PREDICATE DEVICES: | Pall PharmAssure Capsule Filter (K943127 | I will maintain records to support a claim (TL, 15 to 127) Cobe Cardiovascular Pre-bypass Filter (K850139) INDICATIONS FOR USE: The device will filter fluids to be delivered into a feeding tube to remove potentially obstructing particulates. TECHNICAL CHARACTERISTICS: The proposed and predicate devices are of essentially the same size, construction, and function. They are made of comparable (Re: Pall) or identical (Re: Cobe Cardiovascular) inert biomaterials. The Y2K2 Enteral In-Line Filter differs in having a larger pore size, to remove coarse (but not fine) particulates from enterally delivered fluids. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. The logo is encircled by text that reads 'Department of Health'. The text is arranged along the curve of the circle, with the bird figure positioned inside the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 1 2005 Moss Medical Products, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K051206 Trade/Device Name: Y2K2 Enteral In-Line Filter Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 76 KNT Dated: October 15, 2005 Received: October 17, 2005 Dear Mr. Job: 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 (Premarket Approval), it may be subject to such 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); 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. {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. hogdon. Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K051206 Device Name:_Y2K2 Enteral In-Line Filter Indications For Use: The Y2K2 Enteral In-Line Filter is intended for use to filter liquid feeding solutions prior to delivery into a patient's pre-inserted feeding tube, to minimize the risk of tube occusion by macro particulates. This will be applicable to any size or length pediatric or adult feeding tube (e.g., nasogastric, nasoduodenal, nasojejunal, gastrostomy, jejunostomy, transgastric duodenal, or transgastic jejunal). Prescription Use X (Part 21 CFR 801 Subpart D) ANDIOR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 5 (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _