SOLO-CARE PLUS Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat)disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

Device Description

SOLO-Care Plus Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, bis-tris propane, pluronic F127. cremephor and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the SOLO-Care Plus Multipurpose Solution, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study/Test Category	Acceptance Criteria	Reported Device Performance
Silicone Hydrogel Lens Compatibility	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 (specifically, no significant difference from saline control in optical and physical changes).	The study showed no significant difference between SOLO-Care™ Plus Multi-Purpose Solution and the saline control solution with respect to optical and physical changes in the measured properties of Lotrafilcon A (silicone hydrogel) lenses. The device meets the specified FDA guidelines.
In Vitro Cleaning Efficacy (Protein Removal)	Substantially equivalent to currently marketed SOLO-Care Multipurpose Solution.	SOLO-Care Plus was found to be substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal.
Cytotoxicity	Non-cytotoxic and non-irritant.	Testing demonstrated that SOLO-Care Multipurpose Solution (which SOLO-Care Plus is based on) is non-cytotoxic and a non-irritant.
Microbiological Efficacy (Disinfection)	Meets "stand-alone criteria with organic load for disinfection" for both rub/rinse and pre-rinse/no rub regimens. Regimen test criteria also met for both regimens.	Both the rub/rinse and pre-rinse/no rub regimens demonstrated that SOLO-Care Multipurpose Solution met the stand-alone criteria with organic load for disinfection. The regimen test criteria were also met for both regimens for SOLO-Care Plus.
Clinical Testing	To support substantial equivalency to a predicate device.	A series of clinical studies were conducted, submitted, and reviewed in the original 510(k) submission (K012731) to support the substantial equivalency of SOLO-Care Plus. The current submission concludes substantial equivalence based on this data.

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

The provided text does not explicitly state the sample sizes used for the test sets in the various studies (Silicone Hydrogel Lens Compatibility, In Vitro Cleaning Efficacy, Cytotoxicity, Microbiological, Clinical Testing).

The data provenance is retrospective for most tests. The document repeatedly states, "This data was previously submitted and reviewed in original 510(k) submission - K012731," indicating that the results from previous studies on the predicate device (SOLO-Care Multipurpose Solution) or an earlier version of SOLO-Care Plus were used to support the current submission. The Silicone Hydrogel Lens Compatibility study, however, appears to be a new study specific to the current submission ("A study was conducted to verify that Lotrafilcon A (silicone hydrogel) lenses are compatible with SOLO-Care Plus.").

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

This information is not provided in the document. For an in vitro device like a contact lens solution, "ground truth" often refers to objective laboratory measurements (e.g., optical properties, protein levels, CFU counts, cell viability) rather than subjective expert assessment. Clinical "ground truth" would likely involve patient outcomes or assessments by eye care practitioners, but the specific details (number of experts, qualifications) are not given for the clinical studies mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the document. As noted above, for laboratory-based tests, adjudication methods typical for image-based or diagnostic studies (like 2+1) are not usually applicable. For clinical studies, the document does not elaborate on how outcomes were assessed or discrepancies resolved.

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

No, an MRMC comparative effectiveness study is not mentioned or applicable in this context. The document pertains to a medical device (contact lens solution) and its performance through in vitro and clinical studies, not an AI diagnostic algorithm requiring human reader comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

No, a standalone algorithm study is not applicable here. This device is a chemical solution, not an algorithm. The performance described (compatibility, cleaning, cytotoxicity, disinfection) is the standalone performance of the solution itself.

7. The Type of Ground Truth Used

Based on the descriptions:

Silicone Hydrogel Lens Compatibility: Objective physical and optical measurements of the lenses (e.g., as compared to a saline control).
In Vitro Cleaning Efficacy: Measured protein removal levels.
Cytotoxicity: Laboratory assays (e.g., cell viability, irritation scores) to determine non-cytotoxicity and non-irritancy.
Microbiological Efficacy: Quantitative microbial counts (e.g., Colony Forming Units - CFU) to demonstrate disinfection efficacy against specific microorganisms, compared to established "stand-alone criteria."
Clinical Testing: Not explicitly detailed, but would likely involve clinical endpoints related to lens wear comfort, ocular health, and adverse events as assessed by eye care practitioners or reported by patients, used to establish substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable or provided. This device is a chemical solution, not an AI algorithm that requires a "training set." The studies described involve testing the solution's properties, not training a model.

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

This information is not applicable for the same reasons as #8.

Summary

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K03/522

510(k) SUMMARY PART IX.

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.

510(k) SUMMARY FOR SOLOCare Plus Multipurpose Solution

1. Submitter Information

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Steven Dowdley Contact Person: 678-415-3897 Telephone No.

2. Device Name

Classification Name: Proprietary Name:

Soft (hydrophilic) Contact Lens Solution SOLO-Care Plus Multipurpose Solution

3. Predicate Device(s)

SOLO-Care Plus Multipurpose Solution

Description of the Device 4.

ട. Indications for Use

6. Description of Safety and Substantial Equivalence

SOLO-Care Plus Multipurpose solution is substantially equivalent in terms of its actions and indications for use, to SOLO-Care Plus Multipurpose Solution, cleared for marketing under 510(k) K012731. SOLO-Care Plus 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.

Silicone Hydrogel Lens Compatibility Data:

A study was conducted to verify that Lotrafilcon A (silicone hydrogel) lenses are compatible with SOLO-Care Plus. The study showed there was no significant difference between SOLO-Care™ Plus Multi-Purpose Solution and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses. SOLO-Care Plus meets the guidelines set forth in FDA's May 1, 1997 Guidance for

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Industry, Premarket Notification 510(k) Guidance Document for Contact Lens Care products.

In Vitro Cleaning Efficacy

This study was conducted to compare the protein cleaning efficacy of SOLO-Care™ Plus Multi-Purpose Solution to currently marketed SOLO-Care Multipurpose Solution. Results of the study showed that SOLO-Care Plus is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal. This data was previously submitted and reviewed in original 510(k) submission - K012731.

Cytotoxicity

A series of cytotoxicity studies were conducted to demonstrate the safety of SOLO-Care Multipurpose Solution. Results of the testing demonstrated that SOLO-Care Multipurpose Solution is non-cytotoxic and is a non-irritant. This data was previously submitted and reviewed in original 510(k) submission - K012731.

Microbiological

A two series of microbiological studies were conducted to demonstrate the microbial efficacy SOLO-Care Multipurpose Solution. The first series evaluated the product under a rub/rinse regimen, while the second regimen evaluated the performance of the product under a pre-rinse/ no rub regimen. In the studies, both regimen demonstrated that SOLO-Care Multipurpose Solution met the stand-alone criteria with organic load for disinfection. Additionally, the regimen test criteria was also meet for both regimen for SOLO-Care Plus. This data was previously submitted and reviewed in original 510(k) submission - K012731.

Clinical Testing

A series of clinical studies have been conducted, submitted and reviewed in original 510(k) submission - K012731 to support the substantial equivalency of SOLO-Care Plus.

7. Substantial Equivalence

The data provided in this 510(k) submission concludes that SOLO-Care Plus Multipurpose Solution is substantially equivalent to SOLO-CARE PLUS Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat)disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

CIBA Vision Corporation c/o Steven Dowdley, RAC CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097

Re: K031522

Trade/Device Name: SOLO-Care Plus Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: May 12, 2003 Received: May 28, 2003

Dear Mr. Dowdley:

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. Iisting 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 acivised 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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Page 2 - Steven Dowdley, RAC

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. Keipi 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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PART III. INDICATIONS FOR USE STATEMENT

510(k) Number: (Number to be assigned)

SOLO-Care™ Plus Multi-Purpose Solution Device Name:

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

or over-the-counter:

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

510(k) Number. K031522

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.”