Use blink™ CL Lubricant Eye Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses; to help relieve dryness, irritation and discomfort that may be associated with lens wear; and to cushion lenses by placing a drop on the lens prior to application on the eye.

Device Description

blink™ CL Lubricant Eye Drops is a sterile, isotonic, buffered solution containing a lubricant, a preservative, buffers, tonicity agents, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Nonclinical Studies
Lens Compatibility	Compatible with both soft (hydrophilic) and RGP contact lenses to be considered substantially equivalent to the control.	The product is compatible with soft (hydrophilic) and RGP contact lenses and substantially equivalent to the control.
Solution Compatibility	Compatible with leading contact lens care products on the market.	The product is compatible with leading contact lens care products.
Preservative Uptake and Release	Very little, if any, uptake of the preservative into or onto soft or RGP lenses, with any absorbed amounts quickly released, indicating compatibility and acceptability for use.	There is very little, if any, uptake of the preservative in or onto soft or RGP lenses. Any amounts taken up are quickly released. The product is compatible and acceptable for use with soft (hydrophilic) and RGP contact lenses.
Contact Lens Wetting Angle	Substantially equivalent in wetting properties to predicate lubricating and rewetting products.	blink™ CL Lubricant Eye Drops is substantially equivalent in wetting properties to the predicate devices.
Microbiological Studies (Preservative Efficacy)	Meets acceptance criteria for Preservative Effectiveness Testing as outlined in ISO 14730:2000(E), "Ophthalmic optics – Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date."	The product meets the acceptance criteria for Preservative Effectiveness Testing as outlined in ISO 14730:2000(E).
Microbiological Studies (Sterility)	Meets USP Sterility test requirements.	The product meets USP Sterility test requirements.
Stability	Remains stable for the labeled shelf-life based on accelerated testing.	Accelerated testing predicts that the product will remain stable for the labeled shelf-life.
Toxicology	Non-cytotoxic, non-irritating, and well-tolerated.	blink™ CL Lubricant Eye Drops is non-cytotoxic, non-irritating and well-tolerated.
Clinical Studies
Safety and Acceptability	Safe, acceptable, and substantially equivalent to the control.	The investigational formulation is safe, acceptable, and substantially equivalent to the control.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated for each non-clinical test. The clinical study was a "multi-center" and "parallel-group" evaluation, but specific patient numbers are not provided.
Data Provenance: The document does not specify the country of origin for the data. The clinical study was conducted by AMO (Advanced Medical Optics). No information is provided on whether it was retrospective or prospective, though a "multi-center, double-masked, randomized, parallel-group, one-month evaluation" suggests a prospective design.

3. Number of Experts and Qualifications

No information provided regarding the number or qualifications of experts used to establish ground truth for the test set in either non-clinical or clinical studies. The clinical study was "double-masked," implying that both participants and evaluators were unaware of treatment assignments, but it does not specify who established the clinical endpoints or evaluated outcomes for ground truth.

4. Adjudication Method

No information provided on adjudication methods for establishing ground truth in either non-clinical or clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The studies described are primarily aimed at demonstrating the equivalence of the device to predicate devices, not at evaluating the improvement of human readers with or without AI assistance. The device is a lubricant eye drop, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a lubricant eye drop and does not involve an algorithm or AI component.

7. Type of Ground Truth Used

Nonclinical Studies: Ground truth was established through in-vitro laboratory testing and adherence to recognized standards (e.g., ISO 14730:2000(E) for preservative efficacy, USP Sterility test requirements). The comparison was often against "control" or "predicate" devices, meaning the performance of an established, similar product served as the reference.
Clinical Studies: Ground truth for safety and acceptability would have been based on clinical evaluations and observations, likely including patient reported outcomes and objective clinical assessments, compared against a "control" in a "double-masked" study.

8. Sample Size for the Training Set

Not applicable. This device is a pharmaceutical product (lubricant eye drops), not an AI/ML model that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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SEP 2 5 2003

(Biomatrix).

Image /page/0/Picture/1 description: The image shows the logo for Advanced Medical Optics (AMO). The logo features the letters "AMO" in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words "ADVANCED MEDICAL OPTICS" are written in a smaller, sans-serif font. The logo is simple and professional, and it conveys the company's focus on medical optics.

K032030

510(k) SUMMARY

blink™ CL Lubricant Eye Drops

This summary uses the format provided in 21 CFR 807.92:

(a)(1)	Submitter:	Paul J. NowackiManagerRegulatory AffairsAdvanced Medical Optics1700 E. St. Andrew PlaceSanta Ana, CA 92799-5162
		Phone: (714) 247-8601Fax: (714) 247-8677EMail: paul.nowacki@amo-inc.com
	Summary Prepared:	June 30, 2003
(a)(2)	Device Trade Name:	blink ™ CL Lubricant Eye Drops
	Device Common Name:	Soft (Hydrophilic) and Rigid Gas PermeableContact Lens Lubricating and RewettingSolution
	Device Classification/Panel:	Class II (Special Controls)/Ophthalmic Device
	Device Classification Names:	Accessories to Contact Lenses - Cleaning andWetting Agents
(a)(3)	Identification of Predicate Device:	blink ™ CL Lubricant Eye Drops issubstantially equivalent to other lubricating and rewetting solutions currentlymarketed or cleared for commercial distribution in the U.S. These includeREFRESH® CONTACTS™ Lubricating and Rewetting Drops (Allergan), AQuifyLens Comfort Drops (CIBA Vision) and Hylashield® CL Lubricating Eye Drop

(a)(4) Device Description: blink™ CL Lubricant Eye Drops is a sterile, isotonic, buffered solution containing a lubricant, a preservative, buffers, tonicity agents, and purified water.
The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

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Intended Use (Indications for Use): Use blink™ CL Lubricant Eye Drops to (a)(5) lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, irritation and discomfort that maybe associated with lens wear, and to cushion lenses by placing a drop on the lens prior to application on the eve. The intended use is comparable to that of the predicate devices.
Comparison of Technological Characteristics: blink™ CL Lubricant Eye (a)(6) Drops has the same intended use and the same technological characteristics as the predicate lubricants/rewetters. The lubricant and preservative are materials which are used in the predicate lubricants/rewetters but not in combination in any one product. The ophthalmic demulcent, while not listed in 21 CFR 349.12, is used in one of the three predicate lubricants/rewetters in which we are requesting a determination of substantial equivalence. Additionally, a chemically similar lubricant is used in another one of the predicate lubricants/rewetters. Both of these lubricants have been cleared for commercial distribution in the U.S. All excipients are commonly recognized and used in ophthalmic and contact lens care products, including the predicate lubricants/rewetters.

Description of Safety and Substantial Equivalence

Nonclinical and clinical studies were performed to demonstrate the substantial equivalence of blink™ CL Lubricant Eye Drops to the predicate device(s). Testing was conducted in accordance with and in conformance to applicable device requlations. The following is a discussion of the study results.

Discussion of Nonclinical: (b)(1)

Lens Compatibility: In vitro lens compatibility testing was conducted to establish product compatibility with both soft (hydrophilic) and RGP contact lenses. The results show that the product is compatible with soft (hydrophilic) and RGP contact lenses and substantially equivalent to the control.

Solution Compatibility: A study was conducted to evaluate the compatibility of blink™ CL Lubricant Eye Drops when used with leading contact lens care products on the market. The results indicate that the product is compatible with these leading contact lens care products.

Preservative Uptake and Release: A study was conducted with soft (hydrophilic) and RGP contact lenses to determine the uptake and release of the preservative in blink™ CL Lubricant Eye Drops. The results show that there is very little, if any, uptake of the preservative in or onto soft or RGP lenses. Any amounts taken up are quickly released. The results indicate that the product is compatible and acceptable for use with soft (hydrophilic) and RGP contact lenses.

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Discussion of Nonclinical (Continued): (b)(1)

Contact Lens Wetting Anqle: A wetting angle study was conducted to assess the effectiveness of blink™ CL Lubricant Eye Drops in enhancing the wettability of RGP lenses compared with predicate lubricating and rewetting products. The results indicate that blink™ CL Lubricant Eye Drops is substantially equivalent in wetting properties to the predicate devices.

Microbiological Studies: The product was evaluated for preservative efficacy and sterility:

The product meets the acceptance criteria for Preservative Effectiveness . Testing as outlined in ISO 14730:2000(E), "Ophthalmic optics – Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date."
. The product meets USP Sterility test requirements.

Stability: Accelerated testing predicts that the product will remain stable for the labeled shelf-life.

Toxicology: The safety of blink™ CL Lubricant Eye Drops was evaluated using cytotoxicity and acute ocular toxicity tests. The results of the testing demonstrate that blink™ CL Lubricant Eye Drops is non-cytotoxic, non-irritating and well-tolerated.

Discussion of Clinical Data: (b)(2)

AMO conducted a multi-center, double-masked, randomized, parallel-group, one-month evaluation to assess the safety and acceptability of blink™ CL Lubricant Eye Drops. The results of this study indicate that the investigational formulation is safe, acceptable, and substantially equivalent to the control.

(b)(3) Conclusions Drawn from Data Supporting Equivalence Determination: It is concluded that the safety, efficacy and performance of blink™ CL Lubricant Eye Drops is substantially equivalent to the predicate products currently on the market or cleared for commercial distribution in the U.S.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

SEP 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Medical Optics. Inc c/o Paul J. Nowacki 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92799

Re: K032030

Trade/Device Name: blink™ CL Lubricant Eye Drops Regulation Number: 21 CFR 886.5928; 21 CFR 886.5918 Regulation Name: Soft (hydrophilic) contact lens care products; Rigid gas permeable contact lens care products Regulatory Class: Class II Product Code: LPN; MRC Dated: June 30, 2003 Received: July 1, 2003

Dear Mr. Nowacki:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A kalgi forentthal

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

Enclosure

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K032030

510(k) NUMBER: (IF KNOWN):

DEVICE NAME:

blink™ CL Lubricant Eye Drops

INDICATIONS FOR USE:

Use blink™ CL Lubricant Eye Drops to lubricate and rewet soft and rigid gas permeable . (RGP) contact lenses; to help relieve dryness, irritation and discomfort that may be associated with lens wear; and to cushion lenses by placing a drop on the lens prior to application on the eye.
(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 __X
(Optional Format 1-2-96)

Daniel W. Brown

(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

K032030 510(k) Number _

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”