(78 days)
Blink External Eyelid Weights, attached to the outer skin of the upper eyelid with an adhesive, work by gravity to restore a functional blink mechanism to the patient who suffers from 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 External Eyelid Weights include inadequate evelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.
The Blink External Evelid Weights are spherically radiused strips of pure tantalum, constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. The Blink External Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or with mastisol. Blink External Eyelid Weights are offered in four flesh tone colors: White. Tan. Medium Brown and Dark Brown Only the top surface of the weight is painted. The underneath surface is bare tantalum metal. The physical specifications and materials used in the construction of the Blink External Eyelid Weights are identical to the EyeClose External Eyelid Weights. Blink External Eyelid Weights are produced to the same specifications as the EyeClose External Weights. Blink External Eyelid Weights are constructed of pure tantalum. 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. The top surface is painted with a Polane 2.8 T Plus polyurethane enamel paint.
This document is a 510(k) summary for the Blink™ External Eyelid Weights, which was submitted to the FDA in 1997. It describes the device and its intended use, and claims substantial equivalence to a predicate device, the Series 1000 External Eyelid Weight (MedDev).
Based on the provided text, the device's acceptance criteria and the study that proves it meets those criteria are not explicitly defined as a traditional performance study with specific quantifiable acceptance criteria and results against them. Instead, the basis for approval is a claim of substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not available or not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Blink External Eyelid Weight (Ipax) should be substantially equivalent to the Series 1000 External Eyelid Weight (MedDev) across various characteristics. | The document asserts "Same" across all comparable characteristics listed below, thereby claiming substantial equivalence. |
| Indications for Use | Same |
| Target Population | Same |
| Design | Same |
| Materials | Same |
| Performance | Same |
| Sterility | Same |
| Biocompatibility | Same |
| Mechanical Safety | Same |
| Anatomical Site | Same |
| Human Factors | Same |
| Where Used | Same |
Explanation: The "acceptance criteria" here is implicitly that the Blink device must demonstrate that it is "the same" as the predicate device in all critical aspects. The "reported device performance" is the direct assertion from the manufacturer that it is the same.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: N/A (No separate "test set" or clinical trial data for the Blink device itself is presented in this 510(k) summary for performance evaluation against acceptance criteria. The claim is based on equivalence to the predicate.)
- Data Provenance: N/A (The submission relies on a comparison table asserting "sameness" with a predicate device, rather than new performance data from the Blink device itself.)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: N/A
- Qualifications of Experts: N/A
(This type of expert review to establish ground truth is typically associated with clinical studies involving human subject data or image analysis, which isn't described in this 510(k) summary.)
4. Adjudication Method for the Test Set
- Adjudication Method: N/A (No test set or adjudication process described.)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is more common for diagnostic devices where human reader performance is a key metric.
- Effect Size of AI assistance: N/A (Not relevant, as this is a physical medical device, not an AI software.)
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance: N/A (This is a physical medical device, not an algorithm. Standalone performance for an algorithm would not be applicable.)
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established performance and safety profile of the predicate device (Series 1000 External Eyelid Weight by MedDev). The submission effectively states that the Blink device's "sameness" to this predicate device constitutes its "truth" of fitness for market. No new, independent ground truth for the Blink device itself (e.g., from pathology or patient outcomes) is provided.
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A (No "training set" in the context of an algorithm or statistical model is applicable here. The device is a physical product based on an existing design.)
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: N/A (As there's no training set, this is not applicable.)
Summary of the 510(k) Submission Approach:
The K971245 submission for the Blink™ External Eyelid Weights is a classic example of a "substantial equivalence" pathway to FDA clearance. Instead of conducting new clinical trials or extensive performance studies, the manufacturer (Ipax, Inc.) asserted that its device is exactly the same as a predicate device (Series 1000 External Eyelid Weight by MedDev) across all critical characteristics, including indications for use, design, materials, and performance. The FDA's letter of clearance confirms that they accepted this claim of substantial equivalence. This means the acceptance criteria were met by demonstrating identical characteristics to a legally marketed device rather than proving performance against specific pre-defined metrics through new studies.
§ 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.