TRADE NAME 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

Device Description

TRADE NAME Multipurpose Solution is a sterile, isotonic, buffered, aqueous solution containing sodium chloride, potassium chloride, phosphate buffer, edetate disodium, and Poloxamer 237 with polyhexamethylene biguanide 0.0001% as a preservative. As with COMPLETE® brand Multi-Purpose Solution, this product is a clear, coloriess solution, packaged in the same plastic bottles with controlled dropper tips.

AI/ML Overview

Acceptance Criteria and Study for Allergan TRADE NAME Multipurpose Solution

The provided document describes the acceptance criteria and supporting studies for Allergan's "TRADE NAME Multipurpose Solution," which is a soft (hydrophilic) contact lens care product. The submission is a 510(k) premarket notification, seeking substantial equivalence to predicate devices (COMPLETE® brand Multi-Purpose Solution, K003252 and K013479). The key change in the new product is the removal of the lubricant HPMC, leading to the deletion of the "conditioning" claim. Therefore, the studies primarily focus on demonstrating that removing HPMC does not negatively impact the remaining indicated uses and that the new formulation is comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a non-clinical device (not an AI/ML medical device as would typically have performance metrics like sensitivity/specificity), the "acceptance criteria" are based on demonstrating equivalence to the predicate device. The performance is assessed through various nonclinical studies.

Acceptance Criteria (Demonstrate Equivalence to Predicate)	Reported Device Performance (TRADE NAME Multipurpose Solution)
Solution Compatibility: Maintain lens diameter, power, basecurve, integrity, and visual appearance with Group I and IV soft contact lenses.	Results were comparable to or better than COMPLETE® brand Multi-Purpose Solution.
Cleaning Studies (Surface deposits & general cleanliness): Maintain clean Group I and IV lenses over a 30-day/30-cycle period including artificial tears soak.	Comparable to the predicate device/regimen and an effective cleaner for soft (hydrophilic) contact lenses.
Cleaning Studies (Passive protein removal): Remove lysozyme protein adsorbed to contact lens surfaces and within the lens matrix.	Comparable to the predicate device formulation and significantly (2 times) better than a competitive product.
Microbiological Studies (Antimicrobial efficacy): Meet predefined standards for antimicrobial efficacy.	All results were satisfactory, using methods from predicate 510(k)s (K003252 and K013479).
Toxicological Studies (In-vitro cytotoxicity): Not cytotoxic.	Not cytotoxic and comparable to COMPLETE® brand Multi-Purpose Solution.
Toxicological Studies (Ocular effects in vivo): No ocular toxicity or clinically significant regimen-related ocular toxicity findings in rabbit study.	No ocular toxicity observed and no clinically significant regimen-related ocular toxicity findings associated with the modified disinfecting solution.

2. Sample Size and Data Provenance

The document does not specify exact sample sizes for each study, but provides the following details:

Solution Compatibility: Used FDA Group I and IV soft contact lenses for 30 cycles.
Cleaning Studies: Used Group I and IV lenses over a 30-day/30-cycle period.
Toxicological Studies (In-vivo): A 21-day rabbit study was performed.
Data Provenance: The studies were conducted by Allergan, presumably in the USA. Given the submission date (2002), these are retrospective studies on the newly formulated product.

3. Number of Experts and Qualifications for Ground Truth

This type of product (contact lens solution) does not typically involve human expert adjudication for ground truth in the way a diagnostic AI/ML device would. The "ground truth" for the non-clinical studies is based on objective measurements and established laboratory protocols.

Solution Compatibility/Cleaning: Assessment of lens parameters (diameter, power, basecurve), integrity, visual appearance, and presence of deposits would be performed by lab technicians or scientists following standardized procedures.
Microbiological Studies: Efficacy against microorganisms assessed via standardized microbiological assays.
Toxicological Studies: In-vitro cytotoxicity assessed by laboratory techniques. In-vivo rabbit study would involve veterinarians or toxicologists assessing ocular effects, but the document doesn't specify a "number of experts" or their specific qualifications beyond what implied for such studies.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission concerns non-clinical performance of a contact lens solution, not an AI/ML diagnostic system requiring human adjudication of results. The results are based on objective laboratory measurements and observations.

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

Not applicable. This is not an AI/ML device, and no human reader performance is being evaluated or compared with or without AI assistance. The studies assess the intrinsic properties and performance of the contact lens solution itself.

6. Standalone (Algorithm Only) Performance

Not applicable. This is not an algorithm based device. The "device" is a chemical solution. The studies describe the standalone performance of the solution as a product.

7. Type of Ground Truth Used

The ground truth for these studies is based on:

Objective measurements: E.g., lens diameter, power, basecurve changes, protein removal percentages, cytotoxicity levels.
Standardized protocols and assays: E.g., for microbiological efficacy, cleaning effectiveness.
Veterinary/Toxicological observations: For the in-vivo rabbit study regarding ocular effects.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "formulation" is the "design" of the product, which is then tested.

9. How Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

Summary

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ALLERGAN

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

FEB 2 0 2002

K014202

510(k) SUMMARY TRADE NAME Multipurpose Solution

This summary uses the format provided in 21 CFR 807.92:

Submitter: (a)(1)

Paul J. Nowacki Manager Requlatory Affairs Allergan 2525 Dupont Drive Invine CA 92612

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

Summary Prepared:

February 7, 2002

TRADE NAME 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: TRADE NAME Multipurpose Solution is (a)(3) substantially equivalent, in terms of disinfecting, cleaning, rinsing, storing and removing protein, to COMPLETE® brand Multi-Purpose Solution cleared for marketing under 510(k) K003252 and 510(k) K013479.
TRADE NAME Multipurpose Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
Device Description: TRADE NAME Multipurpose Solution is a sterile, isotonic, (a)(4) buffered, aqueous solution containing sodium chloride, potassium chloride, phosphate buffer, edetate disodium, and Poloxamer 237 with polyhexamethylene biguanide 0.0001% as a preservative.
As with COMPLETE® brand Multi-Purpose Solution, this product is a clear, coloriess solution, packaged in the same plastic bottles with controlled dropper tips.

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510(k) SUMMARY TRADE NAME Multipurpose Solution February 7, 2002 Page 2 of 3

Intended Use (Indications for Use): TRADE NAME Multi-Purpose Solution is (a)(5) 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 ତା
- � Rinse
- Store �
- Remove Protein �

These Indications for Use are the same as for COMPLETE® brand Multi-Purpose Solution except for the conditioning claim, which was deleted due to the removal of Hydroxypropyl methylcellulose (HPMC) from the formulation.

Comparison of Technological Characteristics: The formulation of TRADE (a)(6) NAME Multipurpose Solution is identical to the formulation of COMPLETE® brand Multi-Purpose Solution except it does not contain the lubricant, HPMC. Without this lubricant, the product loses its conditioning qualities, therefore this indication has been removed from the product labeling. There are no other indication nature the technological characteristics of TRADE NAME Multipurpose Solution and the predicate device.

Nonclinical Data: (b)(1)

Solution Compatibility: We compared the compatibility of the alternate formulation with the predicate device, COMPLETE® brand Multi-Purpose Solution, using FDA Group I and IV soft contact lenses. Lens diameter, power and basecurve were measured before, during and after completion of 30 and basecares were mity and visual appearance were observed and evaluated. The results for TRADE NAME Multipurpose Solution were comparable to or The results for THOE NAPLETE® brand Multi-Purpose Solution. Therefore, TRADE NAME Multipurpose Solution is compatible with all soft (hydrophilic) contact lenses.

Cleaning Studies: We compared the ability of TRADE NAME Multipurpose Solution to maintain clean soft (hydrophilic) contact lenses with COMPLETE® brand Multi-Purpose Solution. Group I and IV lenses were examined for Surface deposits and general cleanliness over a 30-day/30-cycle period which included a soak in artificial tears. Results show that TRADE NAME included a soak in anilisan tours.
Multipurpose Solution is comparable to the predicate device/regimen and is an effective cleaner for soft (hydrophilic) contact lenses.

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510(k) SUMMARY TRADE NAME Multipurpose Solution February 7, 2002 Page 3 of 3

We also compared the ability of the proposed and predicate device formulations and one competitive product to passively remove lysozyme protein adsorbed to contact lens surfaces and within the lens matrix. The results of the study show that the proposed formulation was comparable to the predicate device formulation and has significantly (2 times) better passive protein cleaning ability than the competitive product.

Microbiological Studies: Antimicrobial efficacy studies using the same methods submitted under 510(k) K003252 and 510(k) K013479 were conducted for TRADE NAME Multipurpose Solution. All results were satisfactory.

Toxicological Studies: We performed an in-vitro cytotoxicity study. The results show that the alternate formulation is not cytotoxic and is comparable to COMPLETE® brand Multi-Purpose Solution.

Additionally, we performed a 21-day rabbit study in which the ocular effects of hydrophilic contact lenses treated with TRADE NAME Multipurpose Solution were evaluated in regimens with and without weekly enzymatic cleaning. The predicate device/regimen was used as the control. No ocular toxicity was observed and there were no clinically significant regimen-related ocular toxicity findings associated with the modified disinfecting solution.

Clinical Data: (b)(2)

Our interpretation of the testing matrices in FDA's May 1, 1997 Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products is that this minor change in formulation does not require clinical testing to show substantial equivalence.

All nonclinical data show that TRADE NAME Multipurpose Solution is comparable to COMPLETE® brand Multi-Purpose Solution for its indicated uses: disinfecting, cleaning, rinsing, storing and removing protein.

Conclusions Drawn from Data Supporting Equivalence Determination: (b)(3) We conclude that the safety, efficacy and acceptability of TRADE NAME Multi-Purpose Solution is substantially equivalent to COMPLETE® brand Multi-Purpose Solution for disinfecting, cleaning, rinsing, storing and removing protein from all soft (hydrophilic) contact lenses.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2002

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

Re: K014202

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

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 If your de 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 corply 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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Page 2 - Mr. Paul Nowacki

This letter will allow you to begin marketing your device as described in your Section 510(k) I his lotter will and by of substantial equivalence of your device of your device to a legally promation notification " 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). Toganaton entired, " 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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K014202

510(k) NUMBER: (IF KNOWN):

DEVICE NAME:

TRADE NAME Multi-Purpose Solution

INDICATIONS FOR USE:

TRADE NAME 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 .

(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)
Division of Ophthalmic Ear,Nose and Throat Devices
510(k) Number	K014202

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.”