30 ML OR 60 ML PEDI-SYRINGE FILTER

{0}------------------------------------------------ ## Blood Product Specialties LLC Image /page/0/Picture/1 description: The image shows the text "K050805" and "March 29, 2005". The text appears to be handwritten, with the "K" and the numbers being in a cursive style. The date is written in a more standard font. 510(k) Notification Pedi-Śyringe Filter™ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 114 JUN 2 0 2005 Page 4 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . ## 510(k) Summary | Applicant:<br>Address | Blood Product Specialties LLC<br>65 Commerce Way<br>Hackensack, NJ 07601 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Alan A. Waldman. Ph.D. | | Address | Waldman Biomedical Consultancy<br>P.O. Box 575<br>Oceanside, NY 11572 | | Telephone | (516) 763-1158 | | FAX<br>Email | (516) 536-7628<br>draaw@aol.com | | Submission Correspondent: | Jane Campbell | | Telephone | (845) 469-4289 | | FAX | (845) 469-4212 | | Email | jdca@optonline.net | | Device Information: | | | Trade Name: | These devices will be marketed under the trade name<br>Pedi-Syringe Filter™ in either 30 mL or 60 mL size | | Common/Usual Name: | Fluid reservoir and delivery system | | Classification Name: | The classification name which most closely describes<br>these devices is "Set. Blood Transfusion" | | Establishment | | | Registration Number: | 2248588 | | Class: | II | | Panel: | 80 | | Product code: | BRZ | | Predicate Device: | Charter Medical Neonatal Syringe Set (K000685) | | Device Description: | Tubing assembly with a 150 micron filter connected by<br>tubing to a spike at one end and connected by tubing to a piston<br>syringe at the other end. Between the filter and the spike there<br>is a clamp. | | Intended Use: | Intended to prepare and deliver small aliquots of filtered whole<br>blood, red blood cells, platelets plasma and cryoprecipitate for<br>pediatric and/or neonatal transfusion. | : {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Public Health Service 1 3: 2 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Blood Products Specialties LLC C/O Alan A. Waldman, Ph.D. Waldman Biomedical Consultancy, Incorporated 184 Seiffert Court Oceanside, New York 11572 Re: K050805 Trade/Device Name: Pedi-Syringe Filter™ Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: BRZ, FMF Dated: March 29, 2005 Received: March 30, 2005 Dear Dr. Waldman: 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 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. {2}------------------------------------------------ Page 2 - Dr. Waldman 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. 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 vour 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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, Chiu Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K050805 ## Indications For Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Pedi-Syringe Filter™ Device Name: Indications For Use: Blood Product Specialties Pedi-Syringe Filter™ is intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma and cryoprecipitate for pediatric and/or neonatal transfusion. AND/OR Over-The-Counter Use Prescription Use _ (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) Cuts Vm (Division Sign-Off) (Division Sign-On) Division of Anesthesiology, General Hospital, Offision Control, Dental Devices Number: KDS0895 Page 1 of ____________________________________________________________________________________________________________________________________________________________________