PEREGRINE SHIELDED DIFFUSION PROBE

{0}------------------------------------------------ K980027 MAR 3 1 1998 March 23, 1998 ## Premarket Notification [510(k)] Summary Submitter: Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901 Phone: (215) 348-0456 Fax: (215) 348-5526 Official Correspondent: Amy Hessenthaler Trade Name: Peregrine Shielded Diffusion Probe Common Name: Fiber Optic Light Pipe with wide angle dispersion of illuminated field Registration Number: 2529392 Classification: Class II Class Name: Not Known Panel: Ophthalmic Product Code: MPA Device Description: The Peregrine Shielded Diffusion Probe is a single use light guide approximately 6' in length consisting of the following: A Universal Aluminum connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic fiber runs. A Delrin Handpiece with a 20 GA Stainless Steel Needle at the distal end. The acrylic fiber, which is polished and affixed at both ends, is tapered and extends past the tip to achieve the diffusion of light. The Stainless Steel Needle is ground at an angle so as to "shield" a portion of the exposed fiber in order to reduce light emitted in the surgeon's eyes. (glare) Statement of Indications for use. - For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery. {1}------------------------------------------------ ## Substantial Equivalence Comparison | Peregrine<br>Peregrine Shielded<br>Diffusion Probe | Peregrine<br>Peregrine Diffusion Light Pipe | Peregrine<br>Peregrine Wide Angle<br>Light Pipe | |----------------------------------------------------|---------------------------------------------|-------------------------------------------------| | Application for 510(K) | Manufactured for Grieshaber | Manufactured for Storz | | Wide Angle Light Diffusion | Wide Angle Light Diffusion | Wide Angle Light Diffusion | | Delrin Handpiece | Delrin Handpiece | Delrin Handpiece | | 20 GA Stainless Steel Needle | 20 GA Stainless Steel Needle | 20 GA Stainless Steel Needle | | Polyethylene Jacket | Polyethylene Jacket | Teflon Jacket | | Acrylic Fiber w/Tapered End | Acrylic Fiber w/ Prism Wafer | Acrylic Fiber w/ Sapphire Ball | | Aluminum Connector | Aluminum Connector | Acetal Connector | | Single Use | Single Use | Single Use | | | | | . ## Sterility The Device will be ETO Sterilized The method used to validate the sterilization cycle is AAMI Overkill Method {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 3 | 1998 Mr. Todd Richmond Peregrine Surgical Ltd. Contract Manufacturer 4050D Skyron Drive Doylestown, PA 18901 Re: K980027 Trade Name: Peregrine Shielded Diffusion Probe Regulatory Class: II Product Code: 86 MPA Dated: December 30, 1997 Received: January 5, 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- 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 marked 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 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. Roepi Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## STATEMENT OF INDICATIONS FOR USE 510K Number (if known): Device Name: Peregrine Shielded Diffusion Probe Indications for Use: For wide angle illumination of the posterior segment during ophthalmic surgery PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED: Concurrence of CDRH, Office of Device Evaluation (ODE) ============================================================================================================================================================================== Prescription Use *✓* xx*_* Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ www.uuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuu Marsha L. Burke hi Stokes OR Division Sign-Off) Division of Ophthalmic Devices (k) Number K980627