COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:

Chemically (NOT HEAT) Disinfect
Clean
Rinse
Store
Remove Protein
Condition

Device Description

There are no formulation or other changes in the device description.

AI/ML Overview

The provided document describes the 510(k) summary for Allergan's COMPLETE® brand Multi-Purpose Solution. It details a clinical study conducted to demonstrate the substantial equivalence of a modified cleaning regimen with the existing standard regimen.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device (COMPLETE® brand Multi-Purpose Solution with modified cleaning regimen) was evaluated for its non-inferiority compared to the standard regimen. The primary acceptability criterion was the mean change from baseline in lens comfort score.

Criteria Category	Acceptance Criteria (Clinical)	Reported Device Performance (Clinical Study)
Primary Acceptability Variable	Non-inferiority of Modified Regimen to Standard Regimen for mean change from baseline in lens comfort score (established by 95% Confidence Intervals).	The modified regimen group was demonstrated to be non-inferior to the standard regimen for mean changes from baseline in lens comfort at Day 90.
Secondary Acceptability Variables (No statistically significant difference between regimens)	Mean lens comfort score at baseline or at any follow-up visit.	No statistically significant difference.
	Symptoms of discomfort.	No statistically significant difference.
	Maximum severity grade of any symptom of discomfort.	No statistically significant difference.
	Number of subject visits with clinically significant symptoms of discomfort (all causes).	No statistically significant difference.
	Change from baseline for burning and stinging, blurry vision, unusual eye secretion, excessive tearing, itching, increased lens awareness, redness, or light sensitivity.	No statistically significant difference.
	Overall subjective vision quality.	No statistically significant difference.
	Mean lens wearing time.	No statistically significant difference.
	Average daily lens wearing time change from baseline.	No statistically significant difference.
	Number of Type II or Type IV lenses analyzed at the final study visit.	No statistically significant difference.
	Subject ratings of the contact lens solution used, comfort rating, and vision quality.	No statistically significant difference.
Safety Results (No statistically significant difference between regimens)	Worst severity of subject eyes at each visit for slit lamp examination findings (edema, corneal neovascularization, bulbar hyperemia, palpebral conjunctival observations, or other complications).	No statistically significant difference.
	Maximum severity grade of any slit lamp examination finding.	No statistically significant difference.
	Maximum Joseline and the worst change from baseline in any slit lamp parameter.	No statistically significant difference.
	Number of subjects with clinically significant slit lamp examination findings.	No statistically significant difference.
	Number of visits with clinically significant slit lamp examination findings.	No statistically significant difference.
	Change from baseline in study lens-corrected visual acuity.	No statistically significant difference.
	Number of eyes discontinued from the study, in the average wear time of lenses, or in the number of missed visits.	No statistically significant difference.
Safety Results (No events or specific changes)	Unanticipated adverse device effect.	No subject experienced an unanticipated adverse device effect.
	Sight-threatening event, iritis, infiltrate, ulcer, ocular infection, or two-grade change in neovascularization.	No subject experienced these events.
Cleaning Effectiveness (Laboratory)	Equivalent to the standard regimen and effective cleaner for soft (hydrophilic) contact lenses based on surface deposits and general condition.	COMPLETE® brand Multi-Purpose Solution used with the modified regimen is equivalent to the standard regimen and is an effective cleaner.
Microbiological Studies	Meets FDA requirements for disinfection of contact lenses.	Meets FDA requirements for disinfection.
	Meets USP Modified criteria for Preservative Effectiveness Testing.	Meets USP Modified criteria.
	Meets USP Sterility test requirements.	Meets USP Sterility test requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 157 subjects were enrolled. 151 subjects completed the study.
Data Provenance: The document does not explicitly state the country of origin. However, Allergan is based in Irvine, California, USA, and the submission is to the US FDA, which implies the study was likely conducted within the USA or aligned with US regulatory standards. The study was prospective, as it involved enrolling subjects and randomizing them to different regimens over a three-month period.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth within the clinical study. However, it mentions that nine investigators enrolled the subjects. It's implied that these investigators, likely eye care professionals, were responsible for evaluating lens comfort, symptoms of discomfort, and performing slit lamp examinations which contributed to the clinical ground truth. Their specific qualifications (e.g., ophthalmologist, optometrist, years of experience) are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1 for resolving discrepancies). The clinical data likely rely on the assessments made by the individual investigators at each study site, potentially with standardized protocols for evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described in the provided text. This study was a clinical trial comparing two active treatment regimens (standard vs. modified) of the same product, rather than comparing human readers' performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This study relates to a contact lens care solution, a physical product used by humans, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission. The effectiveness of the solution is inherently tied to human use. The microbiological and cleaning effectiveness studies could be considered "standalone" in that they evaluate the product's intrinsic properties without human physiological interaction, but this is distinct from AI/algorithm standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on a combination of:

Expert Clinical Assessment: Mean change from baseline in lens comfort score, symptoms of discomfort, slit lamp examination findings (e.g., edema, neovascularization, hyperemia), visual acuity, and other ocular parameters assessed by the investigators.
Subjective Patient Reporting: Subject ratings of comfort, vision quality, and self-reported symptoms.
Laboratory Analysis: For cleaning effectiveness (surface deposits and general condition of lenses returned to Allergan).
Standardized Microbiological and Toxicological Testing: As per FDA and USP guidelines.

8. The Sample Size for the Training Set

The document describes a single clinical study of 157 subjects (151 completed) that serves as the basis for the 510(k) submission. It does not mention a separate "training set" in the context of device development or machine learning. This study is the primary evidence for the modified regimen.

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

As no separate "training set" is described in the context of machine learning, this question is not applicable to the provided information. The ground truth for the clinical study was established as described in point 7.

Summary

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ALLERGAN

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2525 Dupont Drive, P.O. Box 19534, Irvine, Calífornia, USA 92623-9534 Telephone: (714) 246-4500 Website: www.allergan.com

510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution FEB 1 1 2002 K013479

This summary uses the format provided in 21 CFR 807.92:

Paul J. Nowacki Submitter: (a)(1) Manager Requlatory Affairs Allergan 2525 Dupont Drive Irvine CA 92612

Phone: (714) 246-6761 (714) 246-4272 Fax:

Summary Prepared:

October 2001

COMPLETE® brand Multi-Purpose Solution Device Trade Name: (a)(2)

Soft (Hydrophilic) Contact Lens Solution Device Common Name:

Device Classification Names: Accessories to Contact Lens Solution (86LPN)

Identification of Predicate Device: Whether used with frequent replacement (a)(3) or conventional lenses (those replaced at intervals of 90 days or longer), the or convontional tell brand Multi-Purpose Solution care regimen is substantially equivalent to the approved COMPLETE® brand Multi-Purpose Solution care regimen.
Device Description: There are no formulation or other changes in the device (a)(4) description.
Intended Use (Indications for Use): COMPLETE® brand Multi-Purpose (a)(5) Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:
- Chemically (NOT HEAT) Disinfect .
- Clean .
- Rinse .
- . Store
- Remove Protein .
- Condition .
Comparison of Technological Characteristics: There are modified cleaning (a)(6) instructions for all soft contact lenses but there are no changes to the product formulation or other technological characteristics.

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510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution October 16, 2000 Page 2 of 3

(b)(1) Discussion of Nonclinical:

Microbiological Studies: We evaluated disinfection efficacy using methods outlined in FDA's May 1, 1997, Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products. COMPLETE® brand Multi-Purpose Solution meets FDA requirements for disinfection of contact lenses when used with the modified cleaning regimen. The product also meets USP Modified criteria for Preservative Effectiveness Testing and USP Sterility test requirements as shown by previous testing.

Toxicological Studies: Toxicological studies were included in 510(k) K003252 for frequent replacement lenses, on October 16, 2000.

(b)(2) Discussion of Clinical Data:

Nine investigators enrolled 157 subjects who replace hydrogel contact lenses at intervals of three months or longer (conventional wear) in a three-month, parallel group study. Subjects received new lenses and were randomized to use COMPLETE® in either the standard (rub, rinse, soak, optional rinse) regimen or a modified (rinse, soak, mandatory rinse) regimen. One-hundred and fifty-one subjects completed the study with three subjects withdrawing from each regimen.

The primary acceptability variable was mean change from baseline in lens comfort score. The modified regimen group was demonstrated to be noninferior to the standard regimen by constructing 95% confidence intervals around the mean changes from baseline in lens comfort at Day 90.

Acceptability Results: There was no statistically significant difference between the two regimens in:

Mean lens comfort score at baseline or at any follow-up visit .
Symptoms of discomfort .
. Maximum severity grade of any symptom of discomfort
. Number of subject visits with clinically significant symptoms of discomfort (all causes).
Change from baseline for burning and stinging, blurry vision, unusual eye . secretion, excessive tearing, itchinq, increased lens awareness, redness, or light sensitivity
Overall subjective vision quality .
. Mean lens wearing time
Average daily lens wearing time change from baseline .
Number of Type II or Type IV lenses analyzed at the final study visit .
Subject ratings of the contact lens solution used, comfort rating, and vision . quality.

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510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution October 16, 2000 Page 3 of 3

Discussion of Clinical Data (Continued): (b)(2)

Safety Results: No subject in either regimen experienced an unanticipated adverse device effect or a sight-threatening event, iritis, infiltrate, ulcer, ocular infection, or two-grade change in neovascularization.

There were no statistically significant differences between the two regimens in:

Worst severity of subject eyes at each visit for the slit lamp examination . findings of edema, corneal neovascularization, bulbar hyperemia, palpebral conjunctival observations, or other complications
Maximum severity grade of any slit lamp examination finding .
Maximum Joseline and the worst change from baseline in any slit lamp . parameter
Number of subjects with clinically significant slit lamp examination findings .
Number of visits with clinically significant slit lamp examination findings .
Change from baseline in study lens-corrected visual acuity .
Number of eyes discontinued from the study, in the average wear time of . lenses, or in the number of missed visits.

Cleaning Effectiveness: Lenses from the clinical study were returned to Allergan and examined in the laboratory for surface deposits and general Allergan and Results show that COMPLETE® brand Multi-Purpose Solution used with the modified regimen is equivalent to the standard regimen and is an effective cleaner for soft (hydrophilic) contact lenses.

Conclusion: COMPLETE® brand Multi-Purpose Solution used with a modified regimen has an acceptable safety profile and is as effective as COMPLETE® Multi-Purpose Solution used with a standard regimen among hydrogel contact lens wearers who replace their lenses on a conventional replacement schedule of three months or longer.

Conclusions Drawn from Data Supporting Equivalence Determination: (b)(3) We conclude that the safety, efficacy and acceptability of COMPLETE® brand Multi-Purpose Solution, when used with the modified regimen, is substantially equivalent to COMPLETE® brand Multi-Purpose Solution used with the standard regimen and other multipurpose solutions currently on the market.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Allergan, Inc. C/O Paul J. Nowacki Manager, Regulatory Affairs 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534

Re: K013479

Trade/Device Name: COMPLETE® brand Multi-Purpose Solution (Modified lens care directions) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: December 19, 2001 Received: December 20, 2001

Dear Mr. Nowacki:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection 910(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars and the Medical Device Americal portor commerce prior to May 26, 1776, the enaomatic with the provisions of the Federal Food, Drug, devices that have been recassince in accessfire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approva and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the devices, basjon to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Fict liefeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional bontroller "Little 21, Parts 800 to 898. In addition, FDA may be found in the Code of Foucture ing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuates of a other complies with other requirements of the Act
that FDA has made a determination that your device complies with other requiremen that I DA has made a determination administered by other Federal agencies. You must or any rederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 800), good was and 10 applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Paul Nowacki

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph Rosenthal

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

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Page 1 of _1

K013479

510(K) NUMBER: (IF KNOWN):

DEVICE NAME:

COMPLETE® brand Multi-Purpose Solution

INDICATIONS FOR USE:

COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:

Chemically (NOT HEAT) Disinfect ●
Clean .
Rinse .
Store .
Remove Protein ●
Condition .

(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_ V (Optional Format 1-2-96)

Kaiser Walbert

C Far

/ 1.71.76

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.”