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

COMPLETE® brand MULTI-PURPOSE Solution is a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand MULTI-PURPOSE Solution contains no chlorhexidine or thimerosal.

The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

AI/ML Overview

The provided text is a 510(k) summary for COMPLETE® brand Multi-Purpose Solution (K030092). This document focuses on demonstrating substantial equivalence to a predicate device for a contact lens care solution, rather than providing detailed acceptance criteria and a study design for evaluating a novel medical device's performance against specific metrics. Therefore, many of the requested categories are not directly applicable or explicitly stated in the document.

However, based on the information provided, here's an attempt to address your request:

Acceptance Criteria and Device Performance for COMPLETE® brand Multi-Purpose Solution (K030092)

Note: The document describes in-vitro and clinical studies to support substantial equivalence for a contact lens solution, not a medical imaging or diagnostic device. As such, the typical metrics for device performance (e.g., sensitivity, specificity, accuracy) are not relevant here. Instead, the focus is on physical, chemical, and subjective user experience.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from Study Goals)	Reported Device Performance (COMPLETE® brand Multi-Purpose Solution)
In-Vitro - Physical Properties	Viscosity Equivalence: Viscosity of COMPLETE® Solution with HPMC should be comparable to original COMPLETE® without HPMC and other multipurpose solutions.	"In Vitro Studies were conducted to compare the physical and chemical properties of COMPLETE® Solution with other multi-purpose solutions in order to evaluate the effects of adding hydroxypropyl methylcellulose (HPMC)." (General statement; no specific numeric values are provided in this summary.)
In-Vitro - Lens Interaction	HPMC Uptake & Release: Demonstrate uptake of HPMC onto the lens surface during soak and subsequent release in saline over time.	"The studies show uptake of HPMC onto the lens surface during the soak period, and its subsequent release, over time, in saline. This layer of adsorbed HPMC appears to enhance the lens' ability to retain moisture and remain more wettable." (Positive finding, indicating the desired mechanism of action.)
In-Vitro - Surface Wetting	Surface Fluid Retention: Comparable effect on surface fluid retention compared to B&L's ReNu® MultiPlus® and Alcon's OPTI-FREE® Express.	"Compare the effect of three COMPLETE® Solution formulations to B&L's ReNu® MultiPlus® and Alcon's OPTI-FREE® Express on surface fluid retention." (Study was conducted, results are implied to be satisfactory for substantial equivalence, but specific comparative data is not provided.)
In-Vitro - Wetting Angle	Receding Contact Angle: Comparable effect on receding contact angle (as a measure of wetting) to various multipurpose solutions.	"Examine the effect of various multipurpose solutions on receding contact angle as a measure of wetting." (Study was conducted, results are implied to be satisfactory for substantial equivalence, but specific comparative data is not provided.)
Clinical - Subjective Comfort	Comfort & Acceptability Equivalence: Subjective comfort and acceptability of COMPLETE® with HPMC should be substantially equivalent to original COMPLETE® without HPMC and competitor regimens.	"This subjective data shows that COMPLETE® Solution, used with a rub regimen, has comfort substantially equivalent to other marketed contact lens care multipurpose solutions." (Positive finding, demonstrating equivalence in user experience.)
Clinical - Rub vs. No-Rub Efficacy	Functional Equivalence (Rub vs. No-Rub): COMPLETE® Solution used in a "no-rub" regimen should demonstrate substantial equivalence to its use in a "rub" regimen.	"Objective data from an additional clinical study demonstrate the substantial equivalence of COMPLETE® Solution used in a 'no-rub' regimen, with COMPLETE® Solution used in a 'rub' regimen." (Positive finding, supporting the flexibility of use with equivalent performance.)

2. Sample Size and Data Provenance for Test Set

Clinical Studies: "Study subjects in three clinical studies" were used for subjective comfort and acceptability. An "additional clinical study" provided objective data for rub vs. no-rub regimens.
- Sample Size: Not explicitly stated. The number of participants in each study is not provided.
- Data Provenance: Not explicitly stated. However, given the context of a US regulatory submission (510(k)), it is highly probable the data originated from studies conducted in the United States and were prospective in nature, as they were designed to evaluate the new formulation.

3. Number of Experts and Qualifications for Ground Truth

Not applicable directly. This is a contact lens solution, not an interpretive device. The "ground truth" for subjective comfort comes from the study subjects themselves via questionnaires. For objective data (rub vs. no-rub), unspecified "objective data" was collected, likely related to lens cleanliness or disinfection efficacy, which would be measured by laboratory techniques rather than expert consensus on interpretation.

4. Adjudication Method for Test Set

Not applicable. There is no "adjudication" in the sense of multiple experts independently reviewing and then resolving discrepancies for medical image interpretation. Clinical subjective data was gathered via questionnaires, and objective data via laboratory methods.

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

No. This type of study is relevant for diagnostic imaging systems where human readers interpret cases. The provided document concerns a contact lens solution.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a chemical solution, not an algorithm.

7. Type of Ground Truth Used

Clinical Studies:
- Subjective Data: User-reported comfort and acceptability via questionnaires.
- Objective Data: Unspecified objective measures related to contact lens care performance (e.g., disinfection, cleaning, protein removal efficacy) for the rub vs. no-rub regimen comparison. This would typically be laboratory-based measurements.
In Vitro Studies: Laboratory measurements of physical (viscosity, surface fluid retention, receding contact angle) and chemical (HPMC uptake/release) properties.

8. Sample Size for Training Set

Not applicable. This isn't a machine learning model, so there isn't a "training set" in that sense. The studies described are for validation of the product's performance and equivalence.

9. How Ground Truth for Training Set was Established

Not applicable. See point 8.

Summary

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K030092

Image /page/0/Picture/1 description: The image shows the logo for AMO, which stands for Advanced Medical Optics. The logo features a stylized letter "A" with a curved line above the letters "AMO". Below the letters is the text "ADVANCED MEDICAL OPTICS" in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand.

APR 0 4 2003

510(k) SUMMARY COMPLETE® brand Multi-Purpose Solution

This summary uses the format provided in 21 CFR 807.92:

Paul J. Nowacki Submitter: (a)(1) Manager Regulatory Affairs Advanced Medical Optics, Inc. 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92799-5162 Phone: (714) 247-8601 Fax: (714) 247-8677 Summary Prepared: December 16, 2002 (a)(2) Device Trade Name: COMPLETE® brand Multi-Purpose Solution
- Soft (Hydrophilic) Contact Lens Solution Device Common Name:

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

(a)(3) Identification of Predicate Device: COMPLETE® brand Multi-Purpose Solution is substantially equivalent to other contact lens care multi-purpose solutions.
(a)(4) Device Description: COMPLETE® brand MULTI-PURPOSE Solution is a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand MULTI-PURPOSE Solution contains no chlorhexidine or thimerosal.

The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

.. ..

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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: No changes have been (a)(6) made to the product formulation subject to this application.

Discussion of Nonclinical: (b)(1)

In Vitro Studies were conducted to compare the physical and chemical properties of COMPLETE® Solution with other multi-purpose solutions in order to evaluate the effects of adding hydroxypropyl methylcellulose (HPMC). They were as follows:

Compare viscosity of COMPLETE® Solution with HPMC to COMPLETE® . without HPMC, and to other multipurpose solutions.
Investigate the uptake of HPMC onto the lens surface during the soak . period, and its subsequent release, over time, in a saline solution.
. Compare the effect of three COMPLETE® Solution formulations to B&L's ReNu® MultiPlus® and Alcon's OPTI-FREE® Express on surface fluid retention.
Examine the effect of various multipurpose solutions on receding contact . angle as a measure of wetting.

The studies show uptake of HPMC onto the lens surface during the soak period, and its subsequent release, over time, in saline. This laver of adsorbed HPMC appears to enhance the lens' ability to retain moisture and remain more wettable.

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Discussion of Clinical Data: (b)(2)

Study subjects in three clinical studies received questionnaires asking them to rate the comfort and acceptability of two COMPLETE® formulations with hydroxypropyl methylcellulose (HPMC) demulcent/lubricant, vs. original COMPLETE® without HPMC and other Advanced Medical Optics and competitor regimens. This subjective data shows that COMPLETE® Solution, used with a rub regimen, has comfort substantially equivalent to other marketed contact lens care multipurpose solutions.

Objective data from an additional clinical study demonstrate the substantial equivalence of COMPLETE® Solution used in a "no-rub" regimen, with COMPLETE® Solution used in a "rub" regimen.

Conclusions Drawn from Data Supporting Equivalence Determination: (b)(3) In view of the in vitro and clinical studies supporting this application, we believe the safety, efficacy and comfort of COMPLETE® brand Multi-Purpose Solution is substantially equivalent to other marketed contact lens care multipurpose solutions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Medical Optics c/o Paul J. Nowacki Manager, Regulatory Affairs 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 97299-5162

Re: K030092 Trade/Device Name: COMPLETE® brand 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: January 10, 2003 Received: January 10, 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.

APR 0 4 2003

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 vours,

A. Palgi 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

Enclosure

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510(k) NUMBER: (IF KNOWN):

K030092

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 .

Mirafratt

on Sign-C lean of Ophthalmic Ear, ୍ୟ and Throat Devises

Number K030092

(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	X
(Optional Format 1-2-96)

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.”