LASIK EYE DRAPE

{0}------------------------------------------------ # MAY 1 0 2005 ### ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Submitted: October 20, 2004 By: Ivan N. Harlan Trade Name: LASIK Eyelid Drape Common Name: Drape. Surgical Classification Name: Drape, Surgical [per 21 CFR 878] #### Summary: This device, made of medical grade polyethylene tape and coated with a pressure sensitive acrylate adhesive, is designed to support LASIK surgery, as well as a variety of other ophthalmic procedures by promoting a clean and dry sterile field. The LASIK Evelid Drape is intended by design to drape the eyebrow, completely drape the eye or provide complete occlusion of the eyelid. In addition, it can be trimmed to aid in retracting lashes without obstructing the surgical site. By design, material and intended use, the LASIK Eyelid Drape is substantially equivalent to the BD Visiflex incise Drape (Becton, Dickinson, and Company). Equivalences and differences between the two devices may be described as follows: Both the BD Visiflex incise and Odyssey Lasik Eyelid Drapes are designed to promote a clean and dry sterile field and are secured directly to the skin via a pressure sensitive adhesive. Both drapes have peelable liner backings and are indicated for refractive and general ophthalmic office procedures. In addition, both drapes are universally designed for sctup on the left or right eye and are indicated for complete or partial coverage of the eye, as well as retraction of the eyelids to reduce the risk of infection. The material and performance characteristics of the BD Visiflex incise Drape is unknown at this time. however, the Odyssey Lasik Eyelid Drape material is reportedly easy to apply and conformable with good adhesion to skin. The Odyssey product has a pressure sensitive adhesive. Both the BD Visiflex incise and Odyssey Lasik Eyelid Drapes are supplied sterile, utilizing Gamma Irradiation. The Odyssey Lasik Eyelid Drape is single sterile barrier pouched. The sterile barrier of the BD Visifiex incise Drape is unknown at this time. KU42977 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '0', then '42977'. The characters are handwritten and appear to be part of a code or identifier. ## SECTION 6- DEVICE DESCRIPTION This drape device with a pressure sensitive adhesive is designed to promote a clean and dry sterile ficld. It has good adhesion to the skin - It is also comfortable, transparent and easy to apply. The device is designed to drape the eyebrow or completely drape the eye. In addition, it can be trimmed to drape and retract the cyclids from the surgical site | Design Specifications | Reference | |-----------------------|-----------| | Lasik Eylid Drape | 6-2 | Material Specifications Transparcnt Polycthylene Medical Tape 6-3 6-1 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol. MAY 1 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Ivan Harlan Director Regulatory Affairs/Quality Assurance Odyssey Medical, Incorporated 5828 Shelby Oaks Drive Memphis, Tennessee 38134 Re: K042977 Trade/Device Name: LASIK Eye Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: May 2, 2005 Received: May 2, 2005 Dear Mr. Harlan: We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your securers in ed 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 mensiale comments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to ac research Act (Act) that do not require approval of a premarket me i cuchar i vou, Drag, and Coou may, therefore, market the device, subject to the general approvin uppression (1) he Act. The general controls provisions of the Act include controls provisions of the sixtration, 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 If your device is classified (oos as additional controls. Existing major regulations affecting (PMA), it may of subject to sam adatif federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register {3}------------------------------------------------ Page 2 - Mr. Harlan Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rised that 122 a determination that your device complies with other requirements Incall that I DA mas made a aves and regulations administered by other Federal agencies. of the Act of all ] reachar the Act's requirements, including, but not limited to: registration 1 od inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF Furt 807), assility systems (QS) regulation (21 CFR Part 820); and if requirements as sectionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow Jourse of Substantial equivalence of your device to a premairer notification - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at roof Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Snugte H. Michael Davis. Chu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K042977 Device Name: LASIK Eye Drape Indications For Use: Odyssey's L.E.D. provides a sterile adhesive surgical barrier for a variety of ophthalmic procedures, including LASIK. Prepare and drape the patient in the normal ophthalmic fashion. Hold back the eyelashes from the visual field as required. Care should be taken when removing the drape from the adhesive backing not to tear or damage the device. Apply the L.E.D. in the required area to provide proper occlusion and maintain a clean and dry sterile field. The Lasik Eyelid Drape is designed to drape the eyebrow, completely drape the perimeter of the eye or provide complete occlusion of the eyelid. It can also be trimmed to aid in retracting lashes without obstructing the surgical site. While the adhesive holds the drape securely in place, removal is easy and painless for patients. A non-adhesive red tab is located on each side of the drape to aid in removal. Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shiela H. Mugeleki veron Sign-Off) / Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices K(K) Number: K042977 Page 1 of