(125 days)
The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis. The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.
The provided text describes the acceptance criteria and a study for the MedDev Contour™ and ThinProfile™ Eyelid Weight Implants.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| MRI Safety Review | MR-Conditional for static magnetic fields of 3-Tesla or less. | Successfully demonstrated MR-Conditional claim. |
| MRI Related force (Torque) | Minimal to no deflection/torque in a 3-Tesla MRI. (Implied: Acceptable deflection for safety, which for this device was 2 degrees, and torque rating of 0 for both axis, indicating no movement after initial 2 degree deflection) | 2° deflection for both gold and platinum samples (2.8g), with a torque rating of 0 (no torque) in both long and short axis for 2.8g Gold and Platinum Contour™ Eyelid Weight Implants. |
| MRI Related Heating | Maximum temperature change (over 15 minutes in a 3T field) within safe limits. (Implied: Typically |
§ 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.