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.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "LASIK Eyelid Drape" (or "LASIK Eye Drape"). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or safety through extensive clinical trials with acceptance criteria and statistical analysis as would be required for a PMA (Premarket Approval).

Therefore, the provided document does not contain the information requested regarding acceptance criteria studies, sample sizes, expert involvement, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

Here's why the requested information is not present and what the document does provide:

Acceptance Criteria and Reported Device Performance: This document states the device's design, material, and intended use, and claims it is substantially equivalent to a predicate device (BD Visiflex incise Drape). There are no specific performance metrics or acceptance criteria listed for the LASIK Eyelid Drape that are backed by a study in this document. The only "performance" characteristics mentioned for the Odyssey product are anecdotal: "reportedly easy to apply and conformable with good adhesion to skin."
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): None of these elements are present because a 510(k) submission primarily relies on demonstrating equivalence to an existing device, often through bench testing, material comparisons, and a comparison of intended use, rather than de novo clinical studies. There is no mention of a clinical study, test set, training set, or expert involvement for establishing ground truth.
Type of Ground Truth: Not applicable, as there's no clinical study described. The "ground truth" for a 510(k) is essentially the established safety and efficacy of the predicate device.
Training Set Sample Size and Ground Truth Establishment (for training set): Not applicable, as there's no machine learning algorithm or training set for performance evaluation described in this document.

Summary of relevant information from the document:

This document is a 510(k) premarket notification (K042977) for the LASIK Eyelid Drape. The core of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate. It does not typically involve extensive clinical trials with acceptance criteria like those requested.

The predicate device identified is the BD Visiflex incise Drape (Becton, Dickinson, and Company).

The equivalence is based on:

Intended Use: Both are designed to promote a clean and dry sterile field, secured by pressure-sensitive adhesive, indicated for refractive and general ophthalmic procedures, universal for left/right eye, and for complete/partial coverage and eyelid retraction.
Design: Both use pressure-sensitive adhesive.
Sterilization: Both are supplied sterile via Gamma Irradiation.
Materials: The LASIK Eyelid Drape uses "Transparent Polyethylene Medical Tape". The material of the predicate is "unknown at this time" to the submitter, but the functional equivalence is still claimed.

The FDA's letter (pages 2-3) confirms the "substantial equivalence" determination, allowing the device to be marketed. This determination is not an approval of efficacy or a finding that the device meets specific performance criteria established through controlled studies, but rather that it is comparable to an already legally marketed device.

Summary

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MAY 1 0 2005

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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:

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

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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

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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

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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

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Indications for Use

510(k) Number (if known): K042977

Device Name: LASIK Eye Drape

Indications For Use:

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

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.