SOLO-Care™ Plus Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) contact lenses as recommended by your eye care practitioner.

Device Description

SOLO-Care Plus Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, SOLO-Gare Plus Mulli Purpood Solution and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of SOLO-Care Plus Multipurpose Solution, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define numerical "acceptance criteria" in the way one might see for diagnostic accuracy. Instead, the acceptance criteria are implicitly framed as "substantial equivalence" to predicate devices, meaning the new device performs at least as well or doesn't show significant negative differences across various safety and efficacy measures.

Category	Acceptance Criteria (Implicit)	Reported Device Performance
Lens Compatibility	No significant difference in physical/optical properties compared to predicate devices.	"No significant difference between SOLO-Care™ Plus Multi-Purpose Solution and the predicate device... no significant optical and physical changes in the measured properties of the lenses."
	Safe, biocompatible, and comparable to other marketed solutions.	"Results was conduction in accordance with and in conformance to applicable device regulations. Results demonstrated that SOLO-Care Plus is safe and biocompatible, and is comparable to other currently marketed soft contact lens solutions."
Cleaning Efficacy	Substantially equivalent protein cleaning efficacy to predicate device.	"SOLOCare Plus is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal."
Cytotoxicity	Non-cytotoxic and non-irritant.	"SOLO-Care Multipurpose Solution is non-cytotoxic and is a non-irritant."
Microbiological	Meet regiment test criteria for microbial efficacy under rub/rinse and pre-rinse regimens.	"Both regimen demonstrated that SOLO-Care Multipurpose [sic] no rub regimen. The no [sic] also disinfection. Additionally, the regiment test criteria was also meet for both regimen for SOLO-Care Plus." (Suggests criteria were met for both rub/rinse and pre-rinse protocols based on substantial equivalence.)
Clinical Safety/Comfort (Study #1)	Acceptable for proceeding to validation study; low safety variables; high comfort; low acceptable subjective complaints; substantially equivalent to predicate.	"SOLO-Care Plus was found to be an effective multipurpose solution... safety variables were low with little difference between the test solution and the control. Comfort levels were high at all times, and the subjective complaints were low in number and acceptable... substantially equivalent to SOLO-Care Multipurpose Solution."
Clinical Safety/Effectiveness (Study #2)	Safe and effective; substantially equivalent to predicate.	"SOLO-Care Plus was found safe and effective multipurpose solution for soft contact lenses and was found to be substantially equivalent to SOLOCare Multipurpose Solution."
Clinical Non-inferiority (Study #3)	Non-inferior to predicate using a no-rub regimen.	"The data in this clinical trial was consistent in showing substantial equivalence between SOLO-Care Plus without a rub and rinse versus Comfortplus Multipurpose Solution with a pre and post rinse with overnight soaking."

2. Sample Sizes and Data Provenance

In-Vitro/Preclinical Studies:

Lens Compatibility Data: Not specified.
In Vitro Cleaning Efficacy: Not specified.
Cytotoxicity: Not specified.
Microbiological Studies: Not specified.
Data Provenance: Implied to be from CIBA Vision Corporation's internal testing facilities (likely US-based) and conducted to applicable device regulations. Retrospective or prospective nature not explicitly stated, but typically these in-vitro tests are prospective.

Clinical Studies:

Study #1: 15 subjects. Prospective, randomized, investigator masked, contralateral study. Likely conducted in the US based on the submitting company's location and FDA submission.
Study #2: 95 subjects. Prospective, investigator masked, contralateral study. Likely conducted in the US.
Study #3: 73 subjects. Prospective, randomized, investigator masked, contralateral study. Conducted in the UK ("BTP Crème versus Complete U.K. Clinical Trial").

3. Number and Qualifications of Experts for Ground Truth

For preclinical (in-vitro) studies, the "ground truth" is typically established through laboratory methodologies and internal quality control, not external expert consensus as would be seen for imaging diagnostics. The report doesn't specify an "expert" panel for these.

For clinical studies, the "ground truth" is generally patient-reported outcomes (comfort, subjective complaints) and investigator-assessed safety variables (e.g., ocular health parameters).

Number of experts: Not explicitly stated as a separate ground-truth panel. However, the studies involved "investigators" who performed assessments.
Qualifications of experts: Not specified beyond being "investigator masked." Given the nature of contact lens studies, these would typically be ophthalmologists, optometrists, or trained clinical researchers. Study #2 mentions "five investigator," implying five clinical sites or primary investigators.

4. Adjudication Method for the Test Set

Preclinical (in-vitro) studies: Not applicable in the sense of expert adjudication. Results are based on direct measurement and established laboratory protocols.
Clinical studies: The studies were "investigator masked" and "contralateral," meaning subjects used both the test and control solutions, and the investigator was unaware which eye received which solution until unmasking. This design intrinsically reduces bias. There is no mention of an independent adjudication committee for clinical endpoints beyond the assessing investigators themselves.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where multiple readers interpret cases to assess accuracy in comparison to a gold standard. The device here is a contact lens solution, and the studies focused on safety, comfort, and efficacy (cleaning, disinfection) rather than diagnostic interpretation. Therefore, measurements like "effect size of how much human readers improve with AI vs without AI assistance" are not relevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a contact lens solution, not an AI algorithm. The performance of the solution is assessed directly, sometimes with human "in-the-loop" performance in terms of patient use and investigator assessment (clinical studies), but not in the context of an algorithm's standalone performance.

7. Type of Ground Truth Used

Preclinical (in-vitro) ground truth:
- Lens Compatibility: Laboratory measurements of physical and optical lens properties.
- In Vitro Cleaning Efficacy: Quantification of protein removal (laboratory assay).
- Cytotoxicity: Standardized cell culture assays for toxicity and irritation.
- Microbiological: Standardized microbiological challenge tests and culture methods to assess disinfection efficacy.
Clinical (in-vivo) ground truth:
- Patient-reported outcomes: Subjective complaints, comfort levels.
- Investigator assessments: Ocular safety variables, clinical observations related to eye health and contact lens wear.
- Comparison to predicate device: The ground truth for proving substantial equivalence often relies on demonstrating non-inferiority or similar performance to an already accepted predicate device.

8. Sample Size for the Training Set

Not applicable. This device is a chemical solution, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training set" is not relevant here.

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

Not applicable, as there is no training set for this type of medical device.

Summary

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DEC 2 6 2001

K012731

510(k) SUMMARY (1) 11) 11 17 17 17 17 17 17 17 17 17 17 17 17 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary in response to the requirements addressed by the Substantial equivalence determination is based.

SUMMARY OF SAFETY AND EFFECTIVENESS FOR SOLOCare Plus Multipurpose Solution

1. Submitter Information CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person:Steven Dowdley Telephone No. 678-415-3897
Device Name 2. Soft (hydrophilic) Contact Lens Solution Classification Name: SOLOCare Plus Multipurpose Solution Proprietary Name:
1. Predicate Devices SOLOCare Multipurpose Solution COMPLETE ComfortPlus Multipurpose Solution

4. Description of the Devices

Description of the Bernoss
SOLO-Care Plus Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, SOLO-Gare Plus Mulli Purpood Solution and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%.

Indications for Use 5.

Indications for So disinfecting, protein removal, and storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) contact lenses as recommended by your eye care practitioner.

Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical studies were completed to demonstrate the substantial A sence of prodifined and official enalti-Purpose Solution to the predicate device(s). All testing equivalence of OOLS Ouro - with and in conformance to applicable device regulations. Results was conduction in docoracine and biocompatible, and is comparable to other currently marketed soft contact lens solutions. Results from all tests demonstrate the substantial equivalence to previously FDA approved predicate device.

Lens Compatibility Data:

There was no significant difference between SOLO-Care™ Plus Multi-Purpose Solution and the r nere was no ogminount and physical and physical changes in the measured properties of the lenses.

In Vitro Cleaning Efficacy

in Vitto Cleaning Encacy
This study was conducted to compare the protein cleaning efficacy of SOLO-Care™ Plus Multi-This study was conduction to competed SOLO-Care Multipurpose Solution. Results of the study r anwed that SOLOCare Plus is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal.

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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.

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-rinsel regimen. In the studies, both regimen demonstrated that SOLO-Care Multipurpose no rab roginion. The no etaalson's risinfection. Additionally, the regiment test criteria was also meet for both regimen for SOLOCare Plus.

Clinical Testing

Olinical toosing and been conducted to support the substantial equivalency of SOLO-A conton circles caudes heles hele Multipurpose Solution. As previously discussed, the Oal C Has to barronly manitoted Ober Sets of instructions for use, therefore multiple clinical studies will be discussed in this section. Below are the clinical summaries of the relevant studies conducted using SOLO-Care Plus.

Study #1 "BTP-crème Internal Clinical Evaluation

The primary objective of this clinical study was to demonstrate that SOLO-Care plus would be acceptable to proceed to a validation clinical study. The study was a two-week, prospective, randomized, investigator masked, contralateral study. A total of fifteen subjects were enrolled in this study. The predicate or control device selected for this study was currently marketed SOLO-Care Multipurpose Solution. The regimen used for the test product was a rub/rinse cleaning step, followed by a minimum 5 minute soak in SOLO-Care Plus. The regimen used for the control product was a rub/rinse cleaning step, followed by a minimum 10 minute soak in SOLO-Care Multipurpose Solution.

In this study, SOLO-Care Plus was found to be an effective multipurpose solution for soft contact in the cludy of safety variables were low with little difference between the test solution and the control. Comfort levels were high at all times, and the subjective complaints were low in number and acceptable. Based on the data collected in this study SOLO-Care Plus is substantially equivalent to SOLO-Care Multipurpose Solution.

Study #2 "BTP-crème Internal Clinical Evaluation

The primary objective of this clinical study was to demonstrate that SOLO-Care Plus was substantially equivalent to SOLO-Care Multipurpose Solution. This study was a five investigator, three-month, prospective, investigator masked, contralateral study. A total of ninety-five subjects were enrolled in this study. The predicate or control device selected for this study was currently marketed SOLO-Care Multipurpose Solution. The regimen used for the test product was a rub/rinse cleaning step, followed by a minimum 5 minute soak in SOLO-Care Plus. The regimen used for the control product was a rub/rinse cleaning step, followed by a minimum 10 minute soak in SOLO-Care Multipurpose Solution.

In this study SOLO-Care Plus was found safe and effective multipurpose solution for soft contact lenses and was found to be substantially equivalent to SOLOCare Multipurpose Solution.

Study #3 "BTP Crème versus Complete U.K. Clinical Trial

The primary objective of this clinical study was to demonstrate non-inferiority between BTP Crème (SOLO-Care Plus) using a no rub regimen as compared Complete (no rub with a pre and post rinse) Multipurpose Solution. The study was a one-month prospective, randomized, investigator masked, contralateral study. The visit schedule consisted of an initial/ dispensing, a two-week

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follow-up, and a one-month final visit. A total of seventy-three subjects were enrolled in this study. The predicate or control device selected for this study was Allergan Complete Comfortplus Multipurpose Solution. The regimen used for the test product was a no rub and no rinse regimen followed by a 6-hour soak in SOLO-Care Plus 5-minute soak in SOLO-Care Plus. The regimen used for the control product was a pre-rinse, no rub, followed by a 6-hour soak and a post rinse in Complete Comfortplus Multipurpose Solution.

The data in this clinical trial was consistent in showing substantial equivalence between SOLOCare Plus without a rub and rinse versus Comfortplus Multipurpose Solution with a pre and post rinse with overnight soaking.

7. Substantial Equivalence

The date provided in this 510(k) submission concludes that SOLO-Care Plus Multipurpose Solution is substantially equivalent to SOLO-Care Multipurpose Solution and Complete Comfortplus Multipurpose Solution for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner. In addition, SOLO-Care Plus Multipurpose Solution was substantially equivalent to SOLO-Care Multipurpose Solution with an indication for use with rigid gas permeable (fluoro sillcon acrylate and silicon acrylate) lenses.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings.

Public Health Service

Food and Drug Administra 9200 Corporate Boulevaro Rockville MD 20850

DEC 2 6 2001

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

Re: K012731

Trade/Device Name: SOLO-Care Plus Multi-Purpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft Lens Products Regulatory Class: Class II Product Code: LPN Dated: August 13, 2001 Received: August 15, 2001

Dear Mr. Dowdley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 p arketed 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). Toganance 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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PART III. INDICATIONS FOR USE STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

This is a new 510 (k) Notification. (Number to be assigned) 510(k) Number: K012731

Device Name: SOLO-Care Plus Multipurpose Solution

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

over-the-counter: [ or

Daniel W. C. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_012731

ロ

Page 6 of 411

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.”