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.

Device Description

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.

AI/ML Overview

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.

Summary

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K971245

CONFIDENTIAL DOCUMENT JUN 2 0 1997

510(k) Summary of Safety and Effectiveness 8.

In accordance with CFR 807.92 (April 26, 1992), the following information is submitted:

lpax, Inc. Name: 2109 West Amherst Address: Englewood, CO 80110

303-781-2444 Telephone: 303-781-2505 Fax

Phillip Pennell Contact:

Date of Summary Preparation: March 30, 1997

Name of Device: Blink ™ External Eyelid Weights 2. Common Name: External Eyelid Weights Classification Name: None known
Predicate Device: Gold Evelid Implants, EyeClose External 3. Eyelid Weights, preamendment and equivalent devices, respectively.

4. Device Description:

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.

ട്. Intended Use:
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.

�

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K971245

CONFIDENTIAL DOCUMENT

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.

Technological Characteristics of the Device: 6. 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. The material safety data sheet is enclosed in appendix 4.

SUBSTANTIAL EQUIVALENCE COMPARISON

	Blink ExternalEyelid Weight(Ipax)	Series 1000 ExternalEyelid Weight(MedDev)
Indications for Use	Same	Same
Target Population	Same	Same
Design	Same	Same
Materials	Same	Same
Performance	Same	Same
Sterility	Same	Same
Biocompatibility	Same	Same
Mechanical Safety	Same	Same
Anatomical Site	Same	Same
Human Factors	Same	Same
Where Used	Same	Same

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 1997

Mr. Phil Pennell IPAX, Inc. 2109 West Amherst Ave. -------------------------------------------------------------------------------------------------------------------------------------------------------Englewood, CO 80110

Re: K971245

Trade Name: Blink™ External Eyelid Weight Regulatory Class: I Product Code: 86 MML Dated: March 30, 1997 Received: April 3, 1997

Dear Mr. Pennell:

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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Phil Pennell

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

Blink External Eyelid Weight are attached with an adhesive tape or gum to the outer surface of the upper eyelid. This weight acts by gravity to restore a functional blink mechanism to the patient who is afflicted with lagophthalmos. Usually the adhesive is changed daily after bathing.

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.

Susan Sougé KYA for DRL
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971245

Prescription Use Susan Sougé
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.