ENDOVIEW SPPHIRE LENS SET

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for American Medical Devices, Inc. The logo consists of the letters "A MDI" in a bold, sans-serif font. The "A" is in a white box, while the "MDI" is in a black box. To the right of the logo, the words "AMERICAN MEDICAL DEVICES, Inc." are stacked vertically. AUG - 6 1997 K971853 May 16, 1997 # Premarket Notification [510(k)] Summary Submitter: American Medical Devices, Inc 1100 Northside Drive Atlanta, GA 30318 Phone: (404) 815-5233 (404) 815-5235 Fax: Official Correspondent: Frank J. Tighe Trade Name: Endoview™ Sapphire Lens Set Common Name: Surgical Contact Lens Set Registration Number: We have registered but have not received our application back as of this date. Class: Class II Class Name: Unknown Panel: Ophthalmic Product Code: 86HDQ #### Device Description The Endoview™ Sapphire Contact Lens Set consists of one sterilization container, one lens ring (either infusion or non-infusion), and one each of the following lenses: Plano Concave, Symmetric Concave-Concave, Asymmetric Concave, Prism 15° - Concave, Prism 30° Concave, and a Prism Concave-Concave Lens. The lenses, rings and sterilization container may be sold separately or as a set. During vitreoretinal surgery, the surgeon requires the aid of a contact lens in order to visualize the posterior segment of the eye. First, the ring is sewn onto the sclera to hold the lens in place on the cornea. Page 1 Summary | Toll-Free | Direct | Facsimile | Internet | |--------------|--------------|--------------|-----------------------------------| | 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com | {1}------------------------------------------------ The customer has the option of choosing a ring with an infusion port, which eliminates the need for the surgeon to constantly place irrigant on the corneal. This type of ring device is currently available from Ocular Instruments (510(k) 902496. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the eye. The surgeon changes the lenses during the case depending on where visualization is required. Most lenses on the market have been manufactured from quartz and high refractive index plastic because of their low cost and good refractive properties. However, these materials can be easily scratched, chipped and damaged during normal cleaning, handling and sterilization. Single Crystal Sapphire, on the other hand, is an ideal material for ophthalmic surgery because of its wide transmission band, extreme hardness and excellent chemical resistance. | Substantial Equivalence Comparison | | | | | |------------------------------------------------------|------|------------|-----------------------|---| | American Medical<br>Devices, Inc. | DORC | Grieshaber | Ocular<br>Instruments | | | Flat Lens for<br>Central viewing | X | X | X | X | | 15 degree lens for mid-<br>Peripheral viewing | X | X | X | X | | 30 degree lens for wide<br>field viewing | X | X | X | X | | Bi-concave lens<br>For air filled phakik<br>Patients | X | X | X | X | | Shipped Non Sterile | X | X | X | X | | Sterilize with either ETO<br>Or steam | X | X | X | X | | Sterilization Container | X | X | X | X | | Infusion Lens Ring | X | X | X | X | | Lens Ring** | X | X | X | X | Statement of indications for use. For magnification during vitreoretinal surgery. ** All lens sets have lens rings. American Medical Devices, Inc and Ocular Instruments offer a lens ring with an infusion port. Page 2 Summary {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for American Medical Devices, Inc. The logo is divided into two sections. The left section has a white background with the letter "A" in black, and a black background with the letters "MDI" in white. The right section has the words "AMERICAN MEDICAL DEVICES, Inc." stacked on top of each other in black. #### Sterility The Device is shipped non-sterile to the user. The user may either ETO or steam sterilize the lenses according AAMI or USP Standards. ETO and Steam Sterilization of Sapphire in Ophthalmic Devices has been performed since the mid 1980's A user instruction sheet is included with each lens set (See Page 4 of this summary), which instructs the user to clean the lenses immediately after used with warm soapy water. In addition, the instructions clearly state to only sterilize thoroughly cleaned instruments and to Steam or ETO sterilize the lenses prior to use according to AAMI or USP standards. #### Packaging The device is shipped in a high temperature plastic sterilization container, which contains a custom-molded cavity to secure the lenses and ring during sterilization. #### Materials Used in Manufacture Lenses - The lenses are manufactured from sapphire. Sapphire has been approved for use in ophthalmic devices since the mid-1980s with product code 86HNN and with the following 510(k)s: K853129 Rudolph Beaver Inc. Beaver Multipurpose Sapphire Knife. K860852 Med-Tech Development Corp. Sapphire Blade Surgical Knife. K861744 Keeler Instruments. Inc., Sapphire Knife Blade. These lenses are non-invasive and only contact the cornea during the surgical procedure whereas the sapphire knives are invasive and are used to make an entry into the cornea and actually enter the anterior chamber of the eve. Sterilzation Container: Manufactured from high temperature plastic. The Ocular Instruments and DORC sterilization containers are also manufactured from high temperature plastic. Lens Ring: Aluminum. Ocular Instruments, Grieshaber, and DORC all use aluminum for their lens rings | | | | Page 3 Summary | |--------------|--------------|--------------|-----------------------------------| | Toll-Free | Direct | Facsimile | Internet | | 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for American Medical Devices, Inc. The logo consists of two parts: a square divided into two halves, with the left half being white and the right half being black, and the letters "AMDI" in bold black font on the square. To the right of the square is the text "AMERICAN MEDICAL DEVICES, Inc." in a bold, sans-serif font. ## ENDOVIEW™ SAPPHIRE CONTACT LENS SET # USER, CLEANING AND STERILIZATION INSTRUCTIONS ## THIS DEVICE IS NON STERILE #### Device Description The Endoview™ Sapphire Contact Lens Set consists of one sterilization container, one lens ring (either infusion or non-infusion), and one each of the following lenses: Plano Concave, Symmetric Concave-Concave, Asymmetric Concave-Concave, Prism 15° - Concave, Prism 30° Concave, and a Prism Concave-Concave Lens. The lenses, rings and sterilization container may be sold separately or as a set. During vitreoretinal surgery, the surgeon requires the aid of a contact lens in order to visualize the posterior segment of the eye. First, the ring is sewn onto the sclera to hold the lens in place on the cornea. The customer has the option of choosing a ring with an infusion port, which eliminates the need for the surgeon to constantly place irrigant on the corneal. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the eye. The surgeon changes the lenses during the case depending on where visualization is required. Most lenses on the market have been manufactured from quartz and high refractive index plastic because of their low cost and good refractive properties. However, these materials can be easily scratched, chipped and damaged during normal cleaning, handling and sterilization. Single Crystal Sapphire, on the other hand, is an ideal material for ophthalmic surgery because of its wide transmission band, extreme hardness and excellent chemical resistance. Statement of indications for use. For magnification during vitreoretinal surgery. #### CLEANING Clean the lenses immediately after use with warm soapy water. #### STERILIZATION THIS DEVICE IS NON STERILE. Only sterilize the product after it has been thoroughly cleaned. ETO or steam sterilize the product prior to use according AAMI or USP Standards. | | | Summary Page 4 | | |--------------|--------------|----------------|-----------------------------------| | Toll-Free | Direct | Facsimile | Internet | | 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for American Medical Devices, Inc. On the left side of the logo, the letter "A" is in white on a black square, and the letters "MDI" are in black on a white square. To the right of the square logo, the words "AMERICAN MEDICAL DEVICES, Inc." are stacked on top of each other. ### ENDOVIEW™ SAPPHIRE LENS SET CONTENTS #### Trade or proprietary or model name ﺴ #### Model Number | 1. | EndoviewTM Sapphire Lens Set (Consisting of 1 each of the following)** | 600.00 | |-----|------------------------------------------------------------------------|--------| | 2. | EndoviewTM Flat Sapphire Lens (Machemer) | 600.01 | | 3. | EndoviewTM 15° Prism Sapphire Lens (Tolentino) | 600.02 | | 4. | EndoviewTM 30° Prism Sapphire Lens (Tolentino) | 600.03 | | 5. | EndoviewTM Biconcave Sapphire Lens (Landers) | 600.04 | | 6. | EndoviewTM Asymmetric Biconcave Sapphire Lens (de Juan) | 600.05 | | 7. | EndoviewTM 30° Biconcave Sapphire Lens (Woldoff,Tano) | 600.06 | | 8. | EndoviewTM Sapphire Lens Set Sterilization Container | 600.07 | | 9. | EndoviewTM Infusion Lens Ring** | 600.08 | | 10. | EndoviewTM Lens Ring** | 600.09 | **The customer has the option of choosing the lens ring with or without infusion. | Summary Page 5 | | | | |----------------|--------------|--------------|-----------------------------------| | Toll-Free | Direct | Facsimile | Internet | | 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three flowing lines representing the body, head, and arm. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. The logo is rendered in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 6 1997 American Medical Devices, Inc. c/o Mr. Frank |. Tighe 1100 Northside Drive Atlanta, GA 30318 Re: K971853 Trade Name: Endoview™ Sapphire Lens Set Regulatory Class: II Product Code: 86 HJK Dated: May 16, 1997 Received: May 20, 1997 Dear Mr. Tighe: 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 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 Flectronic Product Radiation Control provisions, or other Federal laws or regulations. {6}------------------------------------------------ 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 Rosyl Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo for American Medical Devices, Inc. The logo is divided into three sections. The first section is a white square with a large black letter A. The second section is a black square with the letters MDI in white. The third section has the words AMERICAN MEDICAL DEVICES, Inc. in black. (510(k) Number (if known): Device Name: Endoview™ Sapphire Lens Set Indications for Use: For magnification during vitreoretinal surgery. ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel W. C. Brown, Ph.D. Prescription Use ズ (Per 21 CFR 801.109) (Division Sign-Off) Division Ophthalmic Devices 510(k) Number Over-The-Counter Use (Optional Format 1-2-96) | 1 011-1 rec<br>STATIS AND AND PERSONAL PROPERTY OF CHARACT PUBLICATION OF CHEARTH | | |-----------------------------------------------------------------------------------|--| | 800-793-1473 | | Direct 404-815-5233