BLINK EXTERNAL EYELID WEIGHT

K971245 · Ipax, Inc. · MML · Jun 20, 1997 · Ophthalmic

Device Facts

• Record ID: K971245
• Device Name: BLINK EXTERNAL EYELID WEIGHT
• Applicant: Ipax, Inc.
• Product Code: MML · Ophthalmic
• Decision Date: Jun 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5700
• Device Class: Class 2
• Attributes: Therapeutic

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. Functional defects which may be corrected or avoided with the use of Blink External Eyelid Weights include inadequate eyelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.

Device Story

Blink External Eyelid Weights are passive, gravity-operated devices used to treat lagophthalmos. The device consists of a spherically radiused strip of pure tantalum, available in twelve weights (0.6g to 2.8g). The device is applied to the outer skin of the upper eyelid using double-coated adhesive tape or mastisol. By adding weight to the eyelid, the device utilizes gravity to assist in eyelid closure, preventing corneal exposure, irritation, and potential vision loss in patients with facial paralysis. The device is intended for prescription use; patients or caregivers typically apply and replace the adhesive daily. No electronic, mechanical, or algorithmic components are involved.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical design, materials, and performance specifications to legally marketed predicate devices.

Technological Characteristics

Constructed of pure tantalum; rectangular shape with 12.7 mm spherical radius of curvature; edges smoothly rounded. Top surface coated with Polane 2.8 T Plus polyurethane enamel. Available in 12 weights (0.6g–2.8g). Passive gravity-based operation. No energy source, connectivity, or software.

Indications for Use

Indicated for patients with lagophthalmos due to temporary or permanent facial nerve paralysis (e.g., Bell's palsy, surgical trauma) affecting the orbicularis oculi muscle, requiring restoration of blink mechanism to prevent corneal exposure and associated keratopathy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Gold Eyelid Implants
• EyeClose External Eyelid Weights

Reference Devices

• Series 1000 External Eyelid Weight (MedDev)

Submission Summary (Full Text)

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K971245

JUN 20 1997

CONFIDENTIAL DOCUMENT

## 8. 510(k) Summary of Safety and Effectiveness

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

1. Name: Ipax, Inc.
Address: 2109 West Amherst
Englewood, CO 80110
Telephone: [phone]
Fax: [phone]
Contact: Phillip Pennell
Date of Summary Preparation: March 30, 1997

2. Name of Device: Blink™ External Eyelid Weights
Common Name: External Eyelid Weights
Classification Name: None known

3. Predicate Device: Gold Eyelid Implants, EyeClose External Eyelid Weights, preamendment and equivalent devices, respectively.

4. Device Description:
The Blink External Eyelid 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.

5. 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.

Ipax, Inc.
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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 eyelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.

6. Technological Characteristics of the Device:
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 External Eyelid Weight (Ipax) | Series 1000 External Eyelid 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 |

Ipax, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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CONFIDENTIAL DOCUMENT

# 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.


Prescription Use Susan Gouge
(Per 21 CFR 801.109)

Ipax, Inc.
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