(259 days)
Blink Gold Eyelid Weight Implants, surgically implanted in the upper eyelid, work by gravity to restore a functional blink mechanism in the patient with lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve.
Functional defects which may be corrected or avoided with the use of Blink Gold Eyelid Weight Implants include inadequate eyelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.
The patient with lagophthalmos is unable to close the eyelid completely because of partial or complete paralysis to the facial nerve. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. The condition of paralysis can be either permanent or transient.
The Blink Gold Eyelid Weight Implants are spherically radiused strips of pure gold, constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. All product specifications are identical to the predicate device, the Series 3000 Gold Eyelid Implant, produced by MedDev Corporation.
The Blink Gold Eyelid Weight Implant is implanted into the evelid following the surgical technique described in the product brochure. This technique is identical to the technique used to implant the predicate device, the Series 3000 Gold Eyelid Implant.
Blink Gold Eyelid Weight Implants are constructed of pure gold (99.99%). 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. Suture holes are placed in the implant to allow the surgeon to secure it to the tarsus or orbital septum.
In the engineering specifications, dimensions are stated in the plano view. In the product literature, dimensions are stated in the radiused view.
The provided document is a 510(k) Summary for the Blink Gold Eyelid Weight Implants. This summary focuses on demonstrating substantial equivalence to a predicate device, the Series 3000 Gold Eyelid Implants, rather than presenting a performance study against specific acceptance criteria.
Therefore, the document does not contain information on:
- Acceptance criteria: No specific performance metrics or thresholds are defined.
- Device performance: No quantitative results from a study are reported for the Blink Gold device.
- Sample size: No test set or training set sample sizes are mentioned.
- Data provenance: No information about country of origin or retrospective/prospective nature of data.
- Number and qualifications of experts: Not applicable as no ground truth establishment is described.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone algorithm performance: This device is a physical implant, not an algorithm.
- Type of ground truth: Not applicable.
- Training set size and ground truth establishment: Not applicable.
Instead, the document asserts that the Blink Gold Eyelid Weight Implants are "substantially equivalent" to the predicate device, the Series 3000 Gold Eyelid Implant, across various characteristics.
Here's a breakdown of the comparison presented, which serves as the "study" and "acceptance criteria" in the context of a 510(k) substantial equivalence submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" in this context are a demonstration of sameness or substantial equivalence across key attributes to a legally marketed predicate device. The reported "device performance" is the assertion of this sameness.
| Acceptance Criteria (Attribute for Substantial Equivalence) | Reported Device Performance (Blink Gold Eyelid Implant) | Rationale / "Proof" (Implicit) |
|---|---|---|
| Indications for Use | Same as predicate | Explicitly stated in table and text |
| Target Population | Same as predicate | Explicitly stated in table |
| Design | Same as predicate | Explicitly stated in table and text ("spherically radiused strips of pure gold," "identical to the predicate device") |
| Materials | Same as predicate (pure gold 99.99%) | Explicitly stated in table and text |
| Performance (functional) | Same as predicate (works by gravity to restore functional blink) | Implied by identical design, materials, and intended use. The physical mechanism is identical. |
| Sterility | Same as predicate | Explicitly stated in table |
| Biocompatibility | Same as predicate | Explicitly stated in table |
| Mechanical Safety | Same as predicate | Explicitly stated in table |
| Anatomical Site | Same as predicate | Explicitly stated in table |
| Human Factors | Same as predicate | Explicitly stated in table |
| Where Used | Same as predicate | Explicitly stated in table |
The Study that Proves the Device Meets Acceptance Criteria:
The "study" in this submission is a comparison to a predicate device (Series 3000 Gold Eyelid Implants, a preamendment device). The manufacturer, Ipax, Inc., asserts that their Blink Gold Eyelid Weight Implants are identical or substantially equivalent to the predicate device in all critical aspects.
The document explicitly states:
- "All product specifications are identical to the predicate device, the Series 3000 Gold Eyelid Implant, produced by MedDev Corporation."
- "The Blink Gold Eyelid Weight Implant is implanted into the evelid following the surgical technique described in the product brochure. This technique is identical to the technique used to implant the predicate device, the Series 3000 Gold Eyelid Implant."
- "The intended use of the Blink Gold Eyelid Weight Implant is identical to the intended use of the predicate device, the Series 3000 Gold Eyelid Implant."
- "All technological characteristics of the Blink Gold Eyelid Weight Implants are identical to the technological characteristics of the predicate device, the Series 3000 Gold Eyelid Implant."
The FDA's review letter (K971242) concludes: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This FDA determination confirms that the comparison presented by Ipax, Inc. was sufficient to establish substantial equivalence based on the provided information.
The remaining numbered points (2-9) are not applicable to this document as it describes a 510(k) submission based on substantial equivalence to a predicate device, not a performance study of a novel device or an AI algorithm.
§ 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.