SOLO-CARE PLUS MULTIPURPOSE SOLUTION

K012731 · Ciba Vision Corporation · LPN · Dec 26, 2001 · Ophthalmic

Device Facts

• Record ID: K012731
• Device Name: SOLO-CARE PLUS MULTIPURPOSE SOLUTION
• Applicant: Ciba Vision Corporation
• Product Code: LPN · Ophthalmic
• Decision Date: Dec 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

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 Story

SOLO-Care Plus is a sterile aqueous multipurpose contact lens solution; contains sodium chloride, edetate disodium dihydrate (0.025%), and polyhexanide (0.0001%). Used by patients for daily care of soft and rigid gas permeable lenses; functions include cleaning, rinsing, chemical disinfection, protein removal, and storage. Applied via rub/rinse or no-rub/no-rinse regimens depending on user preference and practitioner recommendation. Solution acts as a chemical disinfectant; replaces mechanical heat disinfection. Benefits include maintenance of lens hygiene, comfort, and safety; prevents microbial contamination and protein buildup. Used in home settings by contact lens wearers.

Clinical Evidence

Three clinical studies conducted. Study 1 (n=15, 2-week) and Study 2 (n=95, 3-month) compared SOLO-Care Plus to SOLO-Care Multipurpose Solution; demonstrated safety, effectiveness, and substantial equivalence. Study 3 (n=73, 1-month) compared SOLO-Care Plus (no-rub/no-rinse) to Complete Comfortplus (pre/post-rinse); demonstrated non-inferiority. Endpoints included safety variables, comfort levels, and subjective complaints. All studies showed low adverse events and high comfort, supporting equivalence.

Technological Characteristics

Sterile aqueous solution; active ingredients: sodium chloride, edetate disodium dihydrate (0.025%), polyhexanide (0.0001%). Chemical disinfection principle (non-heat). Compatible with soft (hydrophilic) and rigid gas permeable (fluoro silicon acrylate and silicon acrylate) lenses.

Indications for Use

Indicated for cleaning, rinsing, chemical disinfecting, protein removal, and storage of soft (hydrophilic) and rigid gas permeable (fluoro silicon acrylate and silicon acrylate) contact lenses.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• SOLO-Care Multipurpose Solution
• COMPLETE ComfortPlus Multipurpose Solution

Submission Summary (Full Text)

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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:
- 3. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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

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