THE FREMSTAD RING

{0}------------------------------------------------ 3/16/99 # K982599 # Premarket Notification [510(k)] Summary Submitter: Ophthalmic Solutions, LLC 2179 Northlake Parkway Building 5, Suite 115 Tucker, Georgia 30084 Telephone: (770) 939-9040 Fax: (770) 934-4084 ## Official Correspondent: Daria Ann Fremstad Trade Name: Ophthalmic Solutions, LLC, The Fremstad Ring™ Common Name: Sponge, Ophthalmic Registration Number: We have registered but have not received our application back as of this date. Class: Class II Class Name: 886.4790 Panel: Ophthalmic Product Code: HOZ {1}------------------------------------------------ Device Description: The Ophthalmic Solutions, LLC, The Fremstad Ring™ is used as a sponge. The device material consists of cellulosic and synthetic fibers. 14mm diameter, round, inner diameter 11mm, thickness 0.1 mm. Statement of indications for use. - For use as an ophthalmic sponge, used to absorb fluids from the surgical area during ophthalmic procedures, not intended to contact the cornea. | Substantial Equivalence Comparison | | | | |---------------------------------------------|------------------------------|-------------------------------------|-----------------------------------------------------| | | Ophthalmic<br>Solutions, LLC | Visi-Spear Eyc<br>Sponge by Visitec | Cellulose Surgical<br>Spear Distributed<br>by Akorn | | Sterile | X | X | X | | Material Cellulosic<br>and Synthetic Fibers | X | | | | Material Cellulose | | X | X | | Sterilization ETO | X | | | | Sponge | X | X | X | ## atial Paulvalènce Com # Sterility The Device will be ETO Sterilized. The method used to validate the sterilization cycle is ANSI/AAMI Overkill, ISO 11135-1994. Packaging material: Tyvek Pouch with a Polymylar Sheath. ## The SAL is 10 to the -6. {2}------------------------------------------------ ## Biocompatibility: Test Facility: North American Science Associates. Inc. 2261 Tracy Road Coad Commend College Northwood, OH 43619-1397 #### Study Title: 1. Cytotoxicity Study- Using The ISO Elution Method: Test Article: Fremstad Ring™ Identification No: Lot 1000 Conclusion: Under the conditions of this study, the MEM test extracts showed no evidence of causing cell lysis or toxicity. The MEM test extracts were not cytotoxic and met the requirements of the test. The negative controls, reagent controls, and the positive controls performed as anticipated. ### Study Title: 2. ISO Ocular Irritation Study In The Rabbit: (Single Exposure) Test Article: Fremstad RingTM Identification No: Lot 1000 Conclusion: Under the conditions of this study, the SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbit. ### Study Title: 3. ISO Sensitization Study in the Guinea Pig (Maximization Method) Test Article: Fremstad Ring TM Identification No: Lot 1000 Conclusion: Under the conditions of this study, the SC and CSO test article extracts showed no evidence of causing delayed dermal contact sensitization in Carlos and Children Children Children the guinea pig. In {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 6 1999 Ms. Daria Ann Fremstad Official Correspondent Ophthalmic Solutions, LLC 2179 Northlake Parkway Building 5, Suite 115 Tucker, GA 30084 Re: K982599 Trade Name: The Fremstad Ring™ Regulatory Class: II Product Code: HOZ Dated: January 27, 1999 Received: January 29, 1999 Dear Ms. Fremstad: 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 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). 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 OS 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. {4}------------------------------------------------ Page 2 - Ms. Daria Ann Fremstad 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 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. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page_ 1 of_1 510(k) Number (if known): K982599 Device Name: The Fremstad Ring™ Indications For Use: Ophthalmic sponge, used to absorb fluids from the surgical area during ophthalmic procedures, not intended to contact the cornea. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kavin F. Walbank (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K982599 \$\mathcal{JS}\$ Prescription Use_ X (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)