Use LENS PLUS® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.

Device Description

Lens Plus® Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution containing sodium chloride and boric acid. The product is packaged in a plastic sterile reclosable vial which allows remaining drops can be used throughout the day (12 hours).

AI/ML Overview

The provided text describes a 510(k) summary for "Lens Plus® Rewetting Drops" and its substantial equivalence to a predicate device. This document focuses on the safety and performance of a medical device (rewetting drops) and not on the performance of an AI/ML algorithm.

Therefore, the requested information categories concerning AI/ML algorithm performance (such as sample sizes for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable to this document. The study described is a non-clinical bacteriostasis study.

Here's the relevant information that can be extracted from the provided text, structured to address the spirit of your request:

Acceptance Criteria and Device Performance Study for Lens Plus® Rewetting Drops (K042562)

The primary "acceptance criterion" for this device, as detailed in the 510(k) summary, revolves around demonstrating the ability of bacteria to not significantly grow and survive in the reclosable vials containing the rewetting drops over a designed period, specifically to support a 12-hour discard statement.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
No significant growth and survival of specified bacteria over time	Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger showed no significant growth and survive over the designed period.
Support for 12-hour discard statement	"The data support the desired discard statement on label of up to 12 hours."

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not explicitly stated in terms of number of vials or bacterial cultures beyond the types of bacteria tested. The study mentions testing against five specific microorganisms.
Data Provenance: The study was conducted "in accordance with Micro Appendix C of the Premarket Notification (510(K)) Guidance Document for contact Lens Care Products." This is a non-clinical, controlled laboratory study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a laboratory study evaluating bacteriostasis, not requiring human expert interpretation in the way AI/ML ground truth is established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was a laboratory study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" here is the objective microbial growth/survival data obtained from the bacteriostasis study, evaluated against established microbiological standards for such products.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and no training set was used.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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JUL 2 9 2005

510(k) SUMMARY

Lens Plus® Rewetting Drops

This summary uses the format provided in 21 CFR 807.92:

(a)(1)	Submitter:	Peter XuRegulatory Affairs ProfessionalAdvanced Medical Optics1700 E. St. Andrew PlaceSanta Ana, CA 92799-5162
		Phone: (714) 247-8592Fax: (714) 247-8677EMail: peter.xu@amo-inc.com
(a)(2)	Summary Prepared:Device Trade Name:Device Common Name:Device Classification/Panel:Device Classification Names:	July 19, 2005Lens Plus® Rewetting DropsSoft (Hydrophilic) Contact Lens SolutionClass II (Special Controls)/Ophthalmic DeviceAccessories to Contact Lens Solution (86LPN)

Identification of Predicate Device: When used as directed, Lens Plus® (a)(3) Rewetting Drops with the sterile daily-use (12 hours) vial is substantially equivalent to the currently-marketed Lens Plus® Rewetting Drops with the single-use vial.
Device Description: Lens Plus® Rewetting Drops is a sterile, preservative (a)(4) free, buffered, isotonic, aqueous solution containing sodium chloride and boric acid. The product is packaged in a plastic sterile reclosable vial which allows remaining drops can be used throughout the day (12 hours).
Intended Use (Indications for Use): Use LENS PLUS® Rewetting Drops (a)(5) while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.
of Technological Characteristics: The technological Comparison (a)(6) characteristics of the product remain the same.

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Discussion of Nonclinical: (b)(1)

A bacteriostasis study was conducted in accordance with Micro Appendix C of the Premarket Notification (510(K)) Guidance Document for contact Lens Care Products. The purpose of the study is to evaluate the ability of bacteria to survive in the reclosable vials containing Lens Plus® Rewetting Drops (unpreserved borate buffered saline). A neutralizer efficacy test was also performed to determine the most effective neutralizer recovery medium for the bacteriostasis testing. The results show that Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger have no significant growth and survive over the designed period. The data support the desired discard statement on label of up to 12 hours.

Conclusions Drawn from Data Supporting Equivalence Determination: (b)(2)

The safety and performance of Lens Plus® Rewetting Drops packaged in a sterile daily-use (12 hours) vial is substantially equivalent to the Lens Plus® Rewetting Drops packaged in the single-use vial currently on the market.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2005

Advanced Medical Optics, Inc. c/o Mr. Peter Xu Regulatory Affairs Professional 1700 E. St. Andrew Place Santa Ana, CA 92799-5162

Re: K042562

Trade/Device Name: Lens Plus Rewetting Drops Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: June 9, 2005 Received: June 13, 2005

Dear Mr. Xu:

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) 827-8910. 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/industry/support/index.html.

Sincerely yours.

David M. Whipple

Acting 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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Indications for Use

510(k) Number (if known): K042562

LENS PLUS® Rewetting Drops Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

hymn Smith

Page 1 of

(Division Sigh-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

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.”