V.F.I.-VISCOUS FLUID INFUSION TUBING SET

{0}------------------------------------------------ Peregrine Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901 May 28, 1998 AUG 4 1998 # Premarket Notification [510(k)] Summary Submitter: Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901 Phone: (215) 348-0456 (215) 348-5526 Fax: Official Correspondent: Amy Hessenthaler Trade Name: V.F.I. (Viscous Fluid Injection) Tubing Set Common Name: Viscoelastic Infusion Tubing Set Registration Number: 2529392 Classification: Class II Class Name: Not Known Panel: Ophthalmic Product Code: MRH Device Description: The Peregrine V.F.I. Tubing Set is 8' in length and designed to infuse silicone oil into the posterior segment of the eye. It consists of the following: A connector at the proximal end to fit into a pneumatic injection system, 8' PVC tubing running from the connector and attaching to a Delrin Syringe Head which incorporates a .2um filter, and a syringe assembly (Terumo) which is attaches to the syringe head. Statement of indications for use. - For pneumatic infusion of silcone oil into the posterior segment. Tel: 215-348-0456 Fax: 215-348-5526 {1}------------------------------------------------ Substantial Equivalence Comparison: | Peregrine V.F.I.<br>Tubing Set | Grieshaber & Co.<br>V.I.S. Pack Tubing Set | |-------------------------------------------|-----------------------------------------------------| | Application for 510(K)<br>Product# 300.01 | Manufactured by Grieshaber & Co.<br>Product# 629.30 | | Silicone Oil Infusion | Silicone Oil Infusion | | nylon connectors | nylon connectors | | PVC Tubing 8' | PVC Tubing 8' | | Delrin Syringe Head | Delrin Syringe Head | | Terumo Syringe 35cc | Terumo Syringe 35cc | | Gelman . 2um filter | Gelman .2um filter | | Single Use | Single Use | The Peregrine V.F.I. Tubing Set, product #PD300.01, is identical to the Grieshaber V.I.S. Pack with the exception of the labeling specifications. # Sterility The Device will be ETO Sterilized. The method used to validate the sterilization cycle is AAMI Overkil! Method {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 4 1998 Mr. Todd Richmond Director of Product Development Peregrine Surgical LTD. 4050 D Skyron Drive Doylestown, PA 18901 Re: K981907 > Trade Name: V.F.I.-Viscous Fluid Infusion Tubing Set Regulatory Class: II Product Code: 86 MRH Dated: May 28, 1998 Received: June 1, 1998 Dear Mr. Richmond: 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 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 regulations. {3}------------------------------------------------ ### Page 2 - Mr. Todd Richmond 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) 594-4613. 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 i 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, A Roerl forenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### 510K Number (if known): Device Name: V.F.I. (Viscous Fluid Injection) Tubing Set # Indications for Use: For pneumatic infusion of silicone oil into the posterior segment. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED: Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ liaska L. Duske kicholas Division of Ophthalmic Devices 510(k) Number Page 4