BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)

K971242 · Ipax, Inc. · MML · Dec 17, 1997 · Ophthalmic

Device Facts

• Record ID: K971242
• Device Name: BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
• Applicant: Ipax, Inc.
• Product Code: MML · Ophthalmic
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Blink Gold Eyelid Weight Implants are passive, gravity-operated ocular implants. Device consists of spherically radiused, pure gold strips (0.6g to 2.8g) implanted into the upper eyelid by a surgeon. Principle of operation relies on gravity to assist eyelid closure in patients with lagophthalmos. Device prevents corneal exposure, irritation, and associated vision loss. Used in clinical settings by surgeons; no electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design, materials, and performance characteristics to the predicate device.

Technological Characteristics

Constructed of 99.99% pure gold. Rectangular shape with 12.7 mm spherical radius of curvature. Includes suture holes for fixation to tarsus or orbital septum. Passive mechanical device; no energy source or software.

Indications for Use

Indicated for patients of any age with lagophthalmos due to temporary or permanent facial paralysis (e.g., Bell’s palsy, surgical trauma to the facial nerve) affecting the orbicularis oculi muscle, requiring restoration of blink mechanism.

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

• Series 3000 Gold Eyelid Implants (preamendment device)

Submission Summary (Full Text)

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11242

# 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 80150
DEC 17 1997
Telephone: [phone]
Fax: [phone]
Contact: Phillip Pennell
Date of Summary Preparation: February 28, 1997

2. Name of Device: Blink™ Gold Eyelid Weight Implants
Common Name: Gold Eyelid Weights
Classification Name: None known

3. Predicate Device: Series 3000 Gold Eyelid Implants, a preamendment device

4. Device Description:
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 eyelid 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.

5. Intended Use:
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.

Ipax, Inc.
Page 18

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# CONFIDENTIAL DOCUMENT

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.

6. Technological Characteristics of the Device:

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.

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.

## SUBSTANTIAL EQUIVALENCE COMPARISON

| | Blink Gold Eyelid Implant (Ipax) | Series 3000 Gold Eyelid Implant (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.
Page 19

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

DEC 17 1997

Mr. Phillip E. Pennell
President, CEO
IPAX, INC.
2109 W. Amherst
Englewood, CO 80110

Re: K971242
Trade Name: Blink Gold Eyelid Weight Implants
Regulatory Class: Pre-amendment unclassified
Product Code: 86 MML
Dated: November 25, 1997
Received: December 1, 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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. Phillip 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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Page ______ of ______

510(k) Number (if known): K971242

Device Name: BLINK GOLD EYELID WEIGHT IMPLANTS

Indications For Use:

## Statement of Indications for Use

Blink Gold Eyelid Weight Implants, surgical 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.

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)

Danna Voclines
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971242