(77 days)
Labtician Lid Load External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos.
Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added, the optimal weight for implantation is ususally that which holds lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.
The corresponding implantable gold eyelid weight is then prescribed for implantation.
Sizing weights are not designed to be implanted, and are provided nonsterile and are re-usable following cleaning with soap and water and/or alcohol and rinsing with tap water.
Labtician Lid Load External Eyelid Sizing Weights are spherically radiused strips of pure tantalum (99.5%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments.
A Labtician Lid Load External Eyelid Sizing Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or other suitable adhesive.
The physical specifications and materials used in the construction of Labtician Iid Load External Eyelid Sizing Weights are identical to the EyeClose External Eyelid Weights, with the exception that Labtician Lid Load External Eyelid Sizing Weights are unpainted.
Labtician Lid Load External Eyelid Sizing Weights are constructed of pure tantalum (99.5%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded.
This document is a 510(k) Summary for the Labtician Lid Load External Eyelid Sizing Weights. It describes the device, its intended use, and claims substantial equivalence to a predicate device, the EyeClose External Eyelid Weights (K940974).
No specific acceptance criteria or details of a study demonstrating the device meets such criteria are provided in the provided text. The submission focuses on establishing substantial equivalence based on similar design, materials, and intended use as the predicate device, rather than presenting a performance study with defined acceptance criteria.
The information requested in the prompt, such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, is not available in this 510(k) summary. This type of regulatory submission typically does not involve clinical performance studies with detailed statistical analysis as would be required for novel devices or those demonstrating significant technological differences. The claim of substantial equivalence implies that the device is as safe and effective as the predicate device, obviating the need for extensive new performance data.
§ 886.5700 Eyelid weight.
(a)
Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).(1) The external eyelid weight is adhered to the outer skin of the upper eyelid.
(2) The implantable eyelid weight is implanted into the upper eyelid.
(b)
Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:(i) Testing demonstrating the biocompatibility of the device; and
(ii) Labeling must include the following information:
(A) Specific instructions regarding the proper placement, sizing, and removal of the device; and
(B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment.
(2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device;
(ii) Testing demonstrating the sterility and shelf life of the device;
(iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment.
(iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.