BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)

{0}------------------------------------------------ 510(k) Premarket Notification BOSTON EO Contact Lens Material Image /page/0/Picture/1 description: The image shows a sequence of numbers and a letter. The sequence starts with the letter K, followed by the numbers 980741. The numbers are written in a bold, handwritten style, and there is a line underneath the sequence. ### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS MAY | | 1998 FOR ### BOSTON EO #### SUBMITTER INFORMATION: 1. Polymer Technology, a division of Wilmington Partners, L.P. Global Vision Care 1400 N. Goodman Street Rochester, New York 14692-0450 ### CONTACT PERSON: 2. Manager, Regulatory Affairs 1400 North Goodman Street Address: Rochester, New York 14692 (716) 338-8638 Telephone No .: (716) 338-0702 Fax No .: dketchum@bausch.com E-mail Address: Debra Ketchum #### 3. DEVICE IDENTIFICATION: Classification Name: Rigid Gas Permeable (hydrophobic) Contact Lens Material BOSTON EO Proprietary Name: (enflufocon B) Contact Lens Material fluoro silicone acrylate rigid gas permeable contact lens Common Name: material #### 4. PREDICATE DEVICE: BOSTON ES (enflufocon A) has been selected as the predicate device for BOSTON EO (enflufocon B). #### ડ. DESCRIPTION OF THE DEVICE: The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49). The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN). {1}------------------------------------------------ #### INDICATIONS FOR USE: 6. The BOSTON EO is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and notaphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfection system only. #### DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE: 7. A series of preclinical testing were performed to demonstrate the safety and effectiveness of the BOSTON EO. The results of all testing demonstrated that the safety and effectiveness of the BOSTON EO is equivalent to the currently marketed BOSTON ES lens material. A summary of these results from the preclinical studies is presented below. ### Toxicology: ### In-Vitro Cytotoxicity: USP Agar Diffusion Cytotoxicity was completed in accordance with USP XXII. The test article meets the requirements of the Agar Diffusion Test. ### Acute Ocular Irritation: Acute Ocular Irritation test was performed and produced no ocular irritation. ### Systemic Injection The lens material meets the requirements of the Systemic Injection Test and is considered non-toxic. # Shelf Life: The BOSTON EO (enflufocon B) is a hydrophobic rigid gas permeable contact lens material with <1% water content. This material will be shipped dry. The data presented supports substantial equivalence of this BOSTON EO (enflufocon B) to the already marketed BOSTON ES (enflufocon A) lens material. Based on the Premarket Notification Guidance Document for Daily Wear contact Lenses, May 12, 1994, shelf-life studies are not required for clearance of this material. {2}------------------------------------------------ # Solution Compatibility: Studies were conducted on blue tinted lens material with the ultraviolet light absorber. Lenses were run through 30 cycles of cleaning and conditioning to establish the compatibility of the lens material with the recommended care regimen. The parameters of ultraviolet and visible light (UV/vis) spectra, base curve, lens diameter, power and surface quality were recorded prior to and upon completion of 30 cycles. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cycles. ## Clinical Testing Below is a summary of the clinical study carried out to evaluate the safety and efficacy of the BOSTON EO (enflufocon B) contact lens material when used as a daily wear contact lens for the correction of visual acuity. The study utilized a controlled, double masked design. The predicate device, BOSTON ES rigid gas permeable lens, was used as the control material. A total of 240 eyes (120 patients) were entered into the study by 8 Investigators. Prior to entry into this study, each patient was required to read and sign a Statement of Informed Consent. The primary endpoints for this study were: - Safety: A difference of 15% in the proportion of total Grade 2 or greater . slit lamp findings, between the Test and Control lenses, will be considered clinically significant. - . Efficacy: A difference of 15% in the proportion of lens visual acuities at the level of 20/40 or better, between the Test and Control lenses, will be considered clinically significant. Both the safety and efficacy endpoints, as defined in the study protocol, were achieved, and there were no significant differences seen between the Test and Control lens. The sponsor concludes that BOSTON EO (enflufocon B) contact lens material is equivalent in safety and efficacy to the predicate device, BOSTON ES. #### 8. SUBSTANTIAL EQUIVALENCE The BOSTON EO is substantially equivalent to the currently marketed BOSTON ES, which was cleared in 510(k) Premarket Notification No. K943177 on August 25, 1994. The difference between the two devices is a change in the component ratios. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a bird-like figure with three lines extending from its head. The image is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 1 1998 Ms. Debra L.B. Ketchum Manager, Regulatory Affairs 1400 N. Goodman Street Rochester, New York 14692 Re: K980741 Trade Name: BOSTON EO Rigid Gas Permeable Contact Lens Material Regulatory Class: II Product Code: 86 HQD Dated: February 25, 1998 Received: February 26, 1998 Dear Ms. Ketchum: 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 . {4}------------------------------------------------ Page 2 - Ms. Debra L.B. Ketchum 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.I Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ・・ Polymer Technology, a division of Wilmington Partners, L.P. 1400 North Goodman Street Rochester, NY 14692-0450 ### Indications for Use Statement K980741 510(k) Number (if known): Device Name: BOSTON EO Indications for Use: BOSTON EO (enflufocon B) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only. (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 Daniel W. Brown PHD. ivision Sign-Off) Division of Ophthalmic Devices K980741 510(k) Number_