(194 days)
No
The device description and intended use clearly describe a sterile adhesive surgical drape, with no mention of computational analysis, algorithms, or learning capabilities.
No
The device is described as a surgical barrier or drape used to maintain a sterile field and retract lashes during ophthalmic procedures, not to treat or cure a disease or condition.
No
The device, an eyelid drape, is used to provide a sterile surgical barrier and maintain a clean and dry sterile field during ophthalmic procedures. It does not perform any diagnostic function such as detecting, identifying, or monitoring medical conditions.
No
The device description clearly states it is made of physical materials (medical grade polyethylene tape and acrylate adhesive) and is a physical drape, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a sterile adhesive surgical barrier for ophthalmic procedures, specifically to drape the eye area and maintain a clean and dry sterile field. This is a physical barrier function during surgery.
- Device Description: The device is described as a medical grade polyethylene tape with adhesive. This is a physical material used for draping.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are used to test samples like blood, urine, tissue, etc.
The device's function is purely mechanical and protective during a surgical procedure, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
KKX
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye, eyelid, eyebrow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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
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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
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
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