BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) by IPAX, INC.

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.

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 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.

AI/ML Overview

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.

Summary

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K 1 1 2 4 2

CONFIDENTIAL DOCUMENT

510(k) Summary of Safety and Effectiveness 8.

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

Name: lpax, Inc. 1.
DEC 17 1997 Address: 2109 West Amherst Englewood, CO 80150

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

Phillip Pennell Contact:

Date of Summary Preparation: February 28, 1997

Blink™ Gold Eyelid Weight Implants 2. Name of Device: Common Name: Gold Eyelid Weights Classification Name: None known
Series 3000 Gold Eyelid Implants, a ತೆ. Predicate Device: preamendment device
1. Device Description:

1. 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.

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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.

1. 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 EyelidImplant(Ipax)	Series 3000 GoldEyelid 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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

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 (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. forentthal

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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510(k) Number (if known): 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.

(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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Donna Lochner

(Division Sign-Off) (Division of Ophthalmic Devices 1971242 510(k) Number ـ

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.