KARATS MULTIPURPOSE SOLUTION

K021635 · Ciba Vision Corporation · LPN · Oct 28, 2002 · Ophthalmic

Device Facts

• Record ID: K021635
• Device Name: KARATS MULTIPURPOSE SOLUTION
• Applicant: Ciba Vision Corporation
• Product Code: LPN · Ophthalmic
• Decision Date: Oct 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Device Story

Karats Multi-Purpose Solution is a sterile aqueous chemical solution for soft (hydrophilic) contact lens care. Ingredients include sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, edetate disodium dihydrate, and polyhexanide 0.0001% preservative. Used by patients at home for daily lens maintenance; replaces manual rubbing/rinsing regimens. Solution cleans, disinfects, removes proteins, and stores lenses. Benefits include improved lens comfort, reduced lens deposits, and extended comfortable wear time compared to standard solutions. Healthcare providers recommend the product for routine lens hygiene.

Clinical Evidence

One-month prospective, randomized, double-masked clinical trial (n=not specified) comparing Karats 257 to SOLOCare Plus. Primary endpoints: safety, efficacy, and patient preference. Results: Karats 257 showed statistically significant improvements in overall comfort and lens awareness, fewer lens deposits at 1 month, and a trend for less corneal staining. Visual acuity was similar between groups. Microbiological bench testing confirmed the solution meets stand-alone criteria for disinfection with organic load.

Technological Characteristics

Sterile aqueous solution. Ingredients: sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, edetate disodium dihydrate, polyhexanide 0.0001% (preservative). Chemical disinfection (non-heat).

Indications for Use

Indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storage of soft (hydrophilic) contact lenses for patients as recommended by an eye care practitioner.

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

• SOLOCare Plus Multipurpose Solution

Submission Summary (Full Text)

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K0216355
OCT 2 8 2002

# 510(k) SUMMARY KO LANK TASHIN KA KA KARA KA KA KA KA KA KA KA KA KA K

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 Karats Multipurpose Solution

### 1. Submitter Information

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

### 2. Device Name Classification Name: Proprietary Name:

Soft (hydrophilic) Contact Lens Solution Karats Multipurpose Solution

### Predicate Devices 3.

SOLOCare Plus Multipurpose Solution

#### 4. Description of the Devices

Karats Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, edetate disodium dihydrate and preserved with polyhexanide 0.0001%.

#### న్న Indications for Use

Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) 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 equivalence of Karats Multi-Purpose Solution to the predicate device(s). All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic 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 Karats Multi-Purpose Solution and the control solution, with respect to optical and physical changes in the measured properties of the lenses.

### Cytotoxicity

A series of cytotoxicity studies were conducted to demonstrate the safety of Karats Multi-Purpose Solution. Results of the testing demonstrated that Karats Multi-Purpose Solution is non-cytotoxic and is a non-irritant.

### Microbiological

Microbiological studies were conducted to demonstrate the microbial efficacy Karats Multi-Purpose Solution. The studies evaluated the performance of the product under a

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pre-rinse/ no rub regimen. The studies demonstrated that Karats Multi-Purpose Solution meets the stand-alone criteria with organic load for disinfection and meets the reqimen test criteria.

# Clinical Testing

A clinical study was conducted to support the substantial equivalency of Karats Multipurpose to currently marketed SOLO-Care Plus Multipurpose Solution.

# Karat 257 versus SOLOCare Plus

Karats 257 is a new multipurpose contact lens care solution designed to help increase contact lens comfort and provide a better lens wear experience. The primary objective was to evaluate safety, efficacy and preference between Karats Multipurpose Solution using a no rub/no rinse regimen compared to SOLO-care ® Plus multipurpose solution. The trial was planned as a one-month prospective, randomized, double masked trial consisting of baseline, two-week, and final one-month visits. Subjects compared the test and control products on a contra-lateral basis and were randomized into two treatment groups according to which eye is to use the test and which eye is to use the control solutions.

Contact lens visual acuity was approximately similar between the eves with 69% of the Karats 257 eyes and 75% of the SOLO-care ® Plus eyes having a final VA same or better than the baseline. Symptoms were equivalent and slit lamp findings were generally of a low grade (<2). There was a trend for less corneal staining with Karats 257.

Karats 257 had fewer lens deposits at 1-month, a slightly longer period of hours of comfortable wear and a trend for less corneal staining. Subjectively Karats was rated higher for overall comfort and preferred for lens awareness at the 1-month visit. There was no difference in image analysis. There were a few more reports of mild burning on insertion with Karats 257. Overall comfort was approximately 0.5 of a grade higher, and lens awareness was also more favorably scored with the Karats 257 treated lens and these were statistically significant. Approximately twice as many SOLO-care ® treated lenses were reported with slight, moderate, or severe deposits at the one-month visit as compared to Karats 257 treated lenses, although there was no difference at the two-week visit. Approximately an additional quarter hour of comfortable wear was reported for the Karats 257 eye at the one-month visit that was a statistically significant difference.

The results of the study showed that Karats Multipurpose Solution is substantial equivalence to SOLO-care ® Plus.

## 7. Substantial Equivalence

The date provided in this 510(k) submission concludes that Karats Multipurpose Solution is substantially equivalent to SOLO-Care Plus Multipurpose Solution for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses (replaced in 30 days or less) as recommended by your eye care practitioner.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract design of an eagle, with three stylized lines representing the bird's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 8 2002

CIBA Vision Corporation C/O Steven Dowdley. RAC 11460 Johns Creek Parkway Duluth, GA 30097

Re: K021635

> Trade/Device Name: Karats Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: August 9, 2002 Received: August 12, 2002

Dear Mr. Dowdlev:

Wc 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 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 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). Other general 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

510(k) Number: K021635

Device Name: Karats Multi-Purpose Solution

## Indications for Use:

Karats MPS is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses as recommended by your eye care practitioner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

or over-the-counter:

Karen Washington

(Division Sig Division of Ophthalmic Nose and Throat Dev

510(k) Number K021635